Objective To study the prevalence of atrial fibrillation （AF） and the relation with its risk factors in China. Methods A total of 19 363 participants （8635 males and 10 728 females） aged 〉35 years in geographical...Objective To study the prevalence of atrial fibrillation （AF） and the relation with its risk factors in China. Methods A total of 19 363 participants （8635 males and 10 728 females） aged 〉35 years in geographically dispersed urban and rural regions of China were included in this cross-sectional survey. All participants received questionnaire, physical and blood examination. Echocardiography were performed for AF patients found in the survey. Results Of the 19 363 participants, 199 were diagnosed with AF. The estimated age-standardized prevalence of AF was 0.78% in men and 0.76% in women. The prevalence of AF in participants aged 〈60 years was 0.41% in men and 0.43% in women, and was 1.83% in both men and women aged 〉_60 years. About 19.0% of males and 30.9% of females with AF were diagnosed with valve disease. Age- and sex-adjusted multivariable logistic regression analysis revealed that myocardial infarction, left ventricular hypertrophy （LVH）, obesity, and alcohol consumption were associated with a increased risk of AF（P〈0.05）. Conclusion The age standardized prevalence of AF is 0.77% in the participants enrolled in the present study. The number of AF cases aged 〉35 years is 5.26 million according to 2010 Chinese Census. Most risk factors for AF, identified mainly in Western countries, are also detected in China.展开更多
Parkinson's disease(PD) can be classified into three motor-based subtypes: postural instability/gait difficulty(PIGD), tremor dominant(TD), and indeterminate.The neuropathophysiological mechanisms of the three mot...Parkinson's disease(PD) can be classified into three motor-based subtypes: postural instability/gait difficulty(PIGD), tremor dominant(TD), and indeterminate.The neuropathophysiological mechanisms of the three motor subtypes are different, which may lead to different responses to therapy.Sixty-nine patients with idiopathic Parkinson's disease(Hoehn–Yahr stage ≤ 3) were screened from 436 patients with Parkinsonism recruited through outpatient services and the internet.According to the Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS) TD/PIGD ratio, the patients were divided into PIGD(TD/PIGD ≤ 0.09;n = 36), TD(TD/PIGD ≥1.15;n = 19), and indeterminate(TD/PIGD = 0.90–1.15;n = 14) groups.All patients received 2 weeks of multidisciplinary intensive rehabilitation treatment(MIRT) during hospitalization, as well as a remote home rehabilitation health education class.Compared with the scores at admission, all patients showed significant improvements in their MDS-UPDRS III score, walking ability, balance, and posture control at discharge.Moreover, the MDS-UPDRS III score improvement was greater in the PIGD group than in the TD group.The follow-up data, collected for 3 months after discharge, showed that overall symptom improvement in each group was maintained for 1–3 months.Furthermore, there were no significant differences in the duration or grade effects of symptom improvement among the three groups.These findings suggest that 2 weeks of MIRT is effective for improving motor performance in all three motor subtypes.Patients in the PIGD group had a better response after hospitalization than those in the TD group.This study was approved by the Institutional Ethics Committee of Beijing Rehabilitation Hospital of Capital Medical University of China(approval No.2018 bkky022) on May 7, 2018 and registered with the Chinese Clinical Trial Registry(registration No.Chi CTR1900020771) on January 19, 2019.展开更多
Background Coronary atherosclerosis and cognitive impairment are both age-related diseases,with similar risk factors.Coronary artery calcium(CAC),a marker of coronary atherosclerosis,may play a role in early detection...Background Coronary atherosclerosis and cognitive impairment are both age-related diseases,with similar risk factors.Coronary artery calcium(CAC),a marker of coronary atherosclerosis,may play a role in early detection of individuals prone to cognitive decline.This study aimed to investigate the relationship between CAC and cognitive function,and the capability of CAC to identify participants with a high risk of dementia in a Chinese community-based population.Methods A total of 1332 participants,aged 40-80 years and free of dementia from a community located in Beijing were included.All participants completed neurocognitive questionnaires and noncontrast CT examinations.Cognitive performance tests(including verbal memory,semantic fluency,executive function,and global cognitive function tests),the Cardiovascular Risk Factors,Aging,and Incidence of Dementia(CIDE)risk score,and the CAC score(CACS)were evaluated by questionnaires and CT.A CAIDE score≥10 was considered to indicate a high risk of dementia in late-life.Participants were divided into three groups according to CACS(0,1-399,≥400).Results After adjusting for risk factors,CACS was significantly associated with verbal memory(r=-0.083,P=0.003)and global cognitive function(r=-0.070,P=0.012).The prevalence of a high risk of dementia in the subgroups of CACS=0,1-399,and≥400 was 4.67%,13.66%,and 24.79%,respectively(P<0.001).Individuals with CACS≥400 had a higher risk of CAIDE score≥10[OR=2.30(1.56,4.56),P=0.014]than those with CACS=0.The receiver-operating characteristic curves showed that the capability of CACS to identify participants with a high risk of dementia was moderate(AUC=0.70,95%CI:0.67-0.72,P<0.001).Conclusions CAC,a marker of subclinical atherosclerosis,was significantly associated with cognitive performance in verbal memory and global cognitive function.CAC had a moderate capability to identify participants with a high risk of dementia,independent of age,education,and other risk factors.展开更多
Objective This study examined vegetable and fruit （VF） consumption rate and its associated factors among Chinese adults. Methods Nationally representative data from the 2013 China Chronic Disease Surveillance survey...Objective This study examined vegetable and fruit （VF） consumption rate and its associated factors among Chinese adults. Methods Nationally representative data from the 2013 China Chronic Disease Surveillance survey were used. Dietary intake data, including VF consumption during the last 12 months, were collected. All analyses were weighted to obtain nationally representative estimates. Associations between VF consumption and other factors （e.g., meal frequency and physical activity） were examined through logistic regression analysis. Results The average fruit consumption was 102.3 g/day （95% CI： 97.0-107.6） and the average vegetable consumption was 350.6 g/day （95% CI： 339.3-361.8）. Over half （53.2%, 95% CI： 50.9-55.4） of Chinese adults met the VF consumption of 400 g/day recommended by the World Health Organization （WHO）. Rural residents had a higher prevalence of low VF consumption rate than urban residents [49.20% （95% CI： 46.2%-52.2%） vs. 44.0% （95% CI： 41.7%-46.3%） P 〈 0.01]. Old age （OR = 1.01, 95% CI： 1.00-1.01）, low educational level, low income, minority ethnicity （OR = 1.41, 95% CI： 1.15-1.74）, underweight （OR = 1.17, 95% CI： 1.03-1.33）, single marital status （OR = 1.20, 95% CI： 1.08-1.33）, low health literacy, irregular breakfast （OR = 1.20, 95% CI： 1.04-1.38） or lunch （OR = 1.58, 95% CI： 1.26-1.99） habits, and no leisure-time physical activity were associated with low VF consumption. Conclusion Only half of Chinese adults met the VF consumption recommended by the WHO. Low socio-economic status, irregular diet, and poor health literacy were likely associated with low VF consumption. National efforts and programs are needed to promote VF consumption.展开更多
Background The comorbidity of cardiovascular disease(CVD)and depression has been well established,as depression usually presents simultaneously with CVD risk factors.However,the potential association between cumulativ...Background The comorbidity of cardiovascular disease(CVD)and depression has been well established,as depression usually presents simultaneously with CVD risk factors.However,the potential association between cumulative exposure to CVD risk and depression remains unclear,so we conducted the current investigation.To our knowledge,this is the first study that employs the cumulative risk model to examine the effect of CVD risk factors on depression using nationally representative population and gender,age and CVD status-stratified subpopulations.Aims To systematically study the possible individual and cumulative effect of 18 CVD risk factors on depression.Methods A cross-sectional,secondary analysis investigated associations between 18 CVD risk factors and depression.The interaction effect between CVD risk factors and age,gender and CVD status was also examined.Enrolment included 20816 participants from the US National Health and Nutrition Examination Survey 2005–2016.Participants with Patient Health Questionnaire-9 scores over 15 or who were using an antidepressant were considered depressive;18 known cardiovascular risk factors were incorporated in the present study.Results At the individual risk factor level,smoking,drinking,living alone,sleep quality,body mass index,waist circumference and diabetes status had differential associations with depression risk according to the gender,age or CVD status of the participants.Most importantly,gender-stratified cumulative risk analysis indicated that similar depression risk was found in both genders with a small number of CVD risk factors(odds ratio(OR)adjusted=1.32;95%confidence interval(CI):0.87 to 1.99),but females had a significantly higher depression risk compared with males under high cumulative risk exposure(ORadjusted=2.86;95%CI:1.79 to 4.59).Conclusions Clarifying the association of numerous CVD risk factors with depression according to gender,age and overall CVD status may be beneficial for risk stratification and the prevention of depression in clinical practice.Moreover,the observed novel evidence of high cumulative risk exposure-mediated gender disparities in depression risk may shed light on the underlying mechanism of females’greater vulnerability to depression.展开更多
BACKGROUND Previous studies have shown that patients with diabetes mellitus(DM) respond poorly to clopidogrel treatment.AIM To systematically evaluate the efficacy of clopidogrel for the treatment of acute coronary sy...BACKGROUND Previous studies have shown that patients with diabetes mellitus(DM) respond poorly to clopidogrel treatment.AIM To systematically evaluate the efficacy of clopidogrel for the treatment of acute coronary syndromes or ischemic stroke in patients with or without DM.METHODS Pub Med,the Cochrane Central Register of Controlled Trials,and EMBASE were searched from 1980 on 27 June 2019 to identify relevant randomized controlled trials that compared the effect of a combination of clopidogrel and aspirin with aspirin alone.A random-effects meta-analysis was used to estimate the hazard ratio(HR) and its 95% confidence interval(CI).Sensitivity analysis was performed using a fixed-effect model.The I2 statistic was used to evaluate the heterogeneity of the study data.RESULTS Six randomized controlled trials,comprising 43352 participants(13491 with and 29861 without DM) who had received antiplatelet therapy for≥3 mo,were included in the meta-analysis.Compared with aspirin alone,a combination of clopidogrel and aspirin significantly reduced the risk of any cardiovascular event in patients without DM(HR=0.78,95%CI:0.71–0.86,P<0.001;I2=23%,P=0.26).Clopidogrel plus aspirin also significantly reduced cardiovascular risk in patients with DM,although the effect was smaller(HR=0.89,95%CI:0.81–0.99,P=0.030;I2=0%,P=0.74).Nevertheless,there was no significant difference in the efficacy of clopidogrel at reducing the risk of cardiovascular events in patients with DM vs those without(P for interaction=0.062).CONCLUSION Thus,the present study shows that the addition of clopidogrel to aspirin significantly lowers cardiovascular risk in patients with or without DM who have experienced ischemic cardiovascular disease.The beneficial effect of the addition of clopidogrel to aspirin for patients with DM was lower than that in patients without DM,although the modifying effect of DM did not reach significance.展开更多
Objective To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes.Methods The power functions of ...Objective To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes.Methods The power functions of the Fieller-type confidence interval and the asymptotic confidence interval in crossover designs with serial-sampling data are here derived.Simulation studies were conducted to evaluate the derived power functions.Results Simulation studies show that two power functions can provide precise power estimates when normality assumptions are satisfied and yield conservative estimates of power in cases when data are log-normally distributed.The intra-correlation showed a positive correlation with the power of the bioequivalence test.When the expected ratio of the AUCs was less than or equal to 1, the power of the Fieller-type confidence interval was larger than the asymptotic confidence interval.If the expected ratio of the AUCs was larger than 1, the asymptotic confidence interval had greater power.Sample size can be calculated through numerical iteration with the derived power functions.Conclusion The Fieller-type power function and the asymptotic power function can be used to determine sample sizes of crossover trials for bioequivalence assessment of topical ophthalmic drugs.展开更多
In the development of eye drop medications,difficulty in sampling is a major challenge[1].Drug concentrations in the aqueous humor(AH)can only be measured when the eye is undergoing surgery,such as cataract replacemen...In the development of eye drop medications,difficulty in sampling is a major challenge[1].Drug concentrations in the aqueous humor(AH)can only be measured when the eye is undergoing surgery,such as cataract replacement.Sampling from tears may significantly reduce the amount of medication remaining in the eye.Owing to limitations caused by sampling difficulty,the concentration–time profile for each subject is generally unattainable when estimating the pharmacokinetics parameters for topical ophthalmic drugs.Instead,each subject can be sampled at one of several prespecified sampling times.展开更多
Background:Treatment of coronary bifurcation lesions remains challenging;a simple strategy has been preferred as of late,but the disadvantage is ostium stenosis or even occlusion of the side branch(SB).Only a few sing...Background:Treatment of coronary bifurcation lesions remains challenging;a simple strategy has been preferred as of late,but the disadvantage is ostium stenosis or even occlusion of the side branch(SB).Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported.This prospective,multicenter,randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon(PEB)compared with regular balloon angioplasty(BA)in the treatment of non-left main coronary artery bifurcation lesions.Methods:Between December 2014 and November 2015,a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers.Patients were randomly allocated at a 1:1 ratio to a PEB group(n=113)and a BA group(n=109).The primary efficacy endpoint was angiographic target lesion stenosis at 9 months.Secondary efficacy and safety endpoints included target lesion revascularization,target vessel revascularization,target lesion failure,major adverse cardiac and cerebral events(MACCEs),all-cause death,cardiac death,non-fatal myocardial infarction,and thrombosis in target lesions.The main analyses performed in this clinical trial included case shedding analysis,base-value equilibrium analysis,effectiveness analysis,and safety analysis.SAS version 9.4 was used for the statistical analyses.Results:At the 9-month angiographic follow-up,the difference in the primary efficacy endpoint of target lesion stenosis between the PEB(28.7%±18.7%)and BA groups(40.0%±19.0%)was-11.3%(95%confidence interval:-16.3%to-6.3%,Psuperiority<0.0001)in the intention-to-treat analysis,and similar results were recorded in the per-protocol analysis,demonstrating the superiority of PEB to BA.Late lumen loss was significantly lower in the PEB group than in the BA group(-0.06±0.32 vs.0.18±0.34 mm,P<0.0001).For intention-to-treat,there were no significant differences between PEB and BA in the 9-month percentages of MACCEs(0.9%vs.3.7%,P=0.16)or non-fatal myocardial infarctions(0 vs.0.9%,P=0.49).There were no clinical events of target lesion revascularization,target vessel revascularization,target lesion failure,all-cause death,cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting,SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov,NCT02325817;https://clinicaltrials.gov.展开更多
Background： Chronic kidney disease （CKD） with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limit...Background： Chronic kidney disease （CKD） with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limited. This study aimed to assess the efficacy and safety of the traditional Chinese medicine, Niaoduqing particles, for delaying renal dysfunction in patients with stage 3b-4 CKD.Methods： The present study was a prospective, randomized, double-blind, placebo-controlled, naulticentcr clinical trial. Frorn May 2013 to December 2013,300 CKD patients with an estimated glomerular filtration rate （eGFR） between 20 and 45 ml ＂rain ~＂ 1.73 m 2, aged 18-70 years were recruited from 22 hospitals in 11 Chinese provinces. Patients were randomized in a 1：1 ratio to either a test group, which was administered Niaoduqing particles 5 g thrice daily and 10 g before bedtime for 24 weeks, or a control group, which was administered a placebo using the same methods. The primary endpoints were changes in baseline serum creatinine （Scr） and eGFR after completion of treatment. The primary endpoints were analyzed using Student＇s t-test or Wilcoxon＇s rank-sum test. The present study reported results based on an intention-to-treat （ITT） analysis. Results： A total of 292 participants underwent the ITT analysis. At 24 weeks, the median （interquartile range） change in Scr was 1.1 （-13.0-24.1） and 11.7 （-2.6-42.9） p, mol/L for the test and control groups, respectively （Z = 2.642, P = 0.008）, and the median change in eGFR was -0.2 （-4.3-2.7） and -2.2 （-5.7-0.8） ml.min-1·1.73 m-2, respectively （Z = -2.408, P = 0.016）. There were no significant differences in adverse events between the groups. Conclusions： Niaoduqing particles safely and effectively delayed CKD progression in patients with stage 3b-4 CKD. This traditional Chinese medicine may be a promising alternative medication for patients with moderate-to-severe renal dysfunction.展开更多
Medical device technology develops rapidly,and the life cycle of a medical device is much shorter than drugs.It is necessary to evaluate the safety and effectiveness ofamedical device in a timelymanner to keep upwith ...Medical device technology develops rapidly,and the life cycle of a medical device is much shorter than drugs.It is necessary to evaluate the safety and effectiveness ofamedical device in a timelymanner to keep upwith technology flux.Bayesian methods provides an efficient approach to addressing this challenge.In this article,we review the characteristics of the Bayesian approach and some Bayesian designs that were commonly used in medical device regulatory setting,including Bayesian adaptive design,Bayesian diagnostic design,Bayesian multiregional design,and Bayesian label expansion study.We illustrate these designs with medical devices approved by the US Food and Drug Administration(FDA).We also review several innovative Bayesian information borrowing methods,and briefly discuss the challenges and future directions of the Bayesian application in medical device trials.Our objective is to promote the use of the Bayesian approach to accelerate the development of innovative medical devices and their accessibility to patients for effective disease diagnoses and treatments.展开更多
This paper aims to present a Statistical Analysis Software(SAS)macro%BBlplus,offering estimation and visualisation methods for the Bang's Blinding Index(BBl)for randomised controlled trials(RCTs)with various desig...This paper aims to present a Statistical Analysis Software(SAS)macro%BBlplus,offering estimation and visualisation methods for the Bang's Blinding Index(BBl)for randomised controlled trials(RCTs)with various designs.We developed the SAS macro programme%BBlplus to facilitate the implementation of BBl.This userfriendly programme allows for easy and rapid estimation and visualisation of BBl across different scenarios,including pairwise comparison RCTs with two arms,double-dummy design RCTs with three arms and factorial design RCTs with four arms.The programme requires no pre-existing data set,and users only need to input the number of individuals of correct,uncertain or wrong guesses in each intervention or control group.We illustrate the functionality of%BBlplus using blinding assessment data from three previously published RCTs:BBR(adjunctive berberine reduces antipsychotic-associated weight gain and metabolic syndrome in patients with schizophrenia:a randomised controlled trial),SELECTTDcS(the sertraline versus electrical current therapy for treating depression clinical study:results from a factorial,randomised controlled trial)and ELECT-TDCS(trial of electrical direct-current therapy versus escitalopram for depression)studies.The programme estimates the BBI for each arm,providing point estimates,95%Cl and associated p values.Additionally,%BBlplus can visualise the estimations through forest plots and make the judgement for the success of blinding easily and rapidly.This tool caters to the needs of clinical trial investigators,offering a comprehensive solution for estimating and visualising the blinding index under various RCT designs.展开更多
Background:A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator(rhTNK-tPA)has previously shown its preliminary efficacy in ST elevation myocardial infarction(STEMI)patients.This study w...Background:A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator(rhTNK-tPA)has previously shown its preliminary efficacy in ST elevation myocardial infarction(STEMI)patients.This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase(rt-PA)in Chinese patients with STEMI.Methods:In this multicenter,randomized,open-label,non-inferiority trial,patients with acute STEMI were randomly assigned(1:1)to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min.The primary endpoint was recanalization defined by thrombolysis in myocardial infarction(TIMI)flow grade 2 or 3.The secondary endpoint was clinically justified recanalization.Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events(MACCEs)and safety endpoints.Results:From July 2016 to September 2019,767 eligible patients were randomly assigned to receive rhTNK-tPA(n=384)or rt-PA(n=383).Among them,369 patients had coronary angiography data on TIMI flow,and 711 patients had data on clinically justified recanalization.Both used a–15%difference as the non-inferiority efficacy margin.In comparison to rt-PA,both the proportion of patients with TIMI grade 2 or 3 flow(78.3%[148/189]vs.81.7%[147/180];differences:–3.4%;95%confidence interval[CI]:–11.5%,4.8%)and clinically justified recanalization(85.4%[305/357]vs.85.9%[304/354];difference:–0.5%;95%CI:–5.6%,4.7%)in the rhTNK-tPA group were non-inferior.The occurrence of 30-day MACCEs(10.2%[39/384]vs.11.0%[42/383];hazard ratio:0.96;95%CI:0.61,1.50)did not differ significantly between groups.No safety outcomes significantly differed between groups.Conclusion:rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery,a validated surrogate of clinical outcomes,among Chinese patients with acute STEMI.Trial registration:www.ClinicalTrials.gov(No.NCT02835534).展开更多
Prostate cancer detected by autopsy is named latent prostate cancer.As the repertoire of clinical prostate cancer,latent cancer may better reflect the disease burden.Unlike clinical prostate specimens,which are obtain...Prostate cancer detected by autopsy is named latent prostate cancer.As the repertoire of clinical prostate cancer,latent cancer may better reflect the disease burden.Unlike clinical prostate specimens,which are obtained exclusively from biopsy-positive cases,prostate specimens obtained through autopsy provide information on biopsy-negative cases,helping calculate the true sensitivity of prostate biopsy.From 2014 to 2021,we collected autopsy specimens of the prostate from body donors in China and performed transperineal and transrectal biopsies on specimens before step-sectioning and pathological measurements.We found that the crude prevalence of latent prostate cancer in middle-aged and elderly men was 35.1%(81/231),which was higher than previous estimates for Chinese populations.The overall per-patient sensitivities of transperineal and transrectal biopsies were not significantly different(33.3%vs.32.1%,p=0.82),but the two approaches differed in preferential sampling area along the proximal-distal axis of the prostate.Transperineal biopsy had a higher sensitivity for detecting clinically significant lesions in the distal third(34.7%vs.16.3%,p=0.02)and distal half(30.6%vs.18.1%,p=0.04),while transrectal biopsy had a higher sensitivity for lesions in the proximal half(25.0%vs.13.9%,p=0.046).Both transperineal and transrectal methods of biopsy missed most small lesions(<0.1 mL)and 35.3%(6/17)of large lesions(>0.5 mL).In conclusion,the prevalence of latent prostate cancer in China has increased over the past 2 decades.Systematic transperineal and transrectal methods of biopsy had comparable sensitivities but had different preferential sampling areas.Both approaches miss one-third of large lesions.展开更多
Systemic lupus erythematosus(SLE)is becoming a growing public health concern due to increasing disease and economic burdens.Epidemiological information about SLE,especially its incidence rate,is limited in developing ...Systemic lupus erythematosus(SLE)is becoming a growing public health concern due to increasing disease and economic burdens.Epidemiological information about SLE,especially its incidence rate,is limited in developing countries.In the current study,we sought to investigate the incidence,prevalence,and economic burdens of SLE in urban China.We conducted a nationwide population-based cohort study using databases from Urban Employee Basic Medical Insurance and Urban Resident Basic Medical Insurance between 2013 and 2017,covering approximately 300 million residents in 23 provincial regions in China.Incidence rate and prevalence were standardized by age and gender to China's 2010 national census data.Additionally,we calculated the average annual costs and hospital visit rates.A total of132,258 SLE patients were identified during the study period,with a mean age of 43.03 years(standard deviation:15.29 years).Of these patients,81.33%were women.In 2017,the standardized incidence rate of SLE in China was 14.09(95%confidence interval(CI),11.95–16.41)per 100,000 person-years,with a higher incidence in women than in men(26.41 vs.5.92 per 100,000 person-years).Standardized prevalence in 2017 was 47.61(41.77–53.83),94.16(80.67–108.69),and 17.86(13.84–22.38)per 100,000 people in the overall,female,and male populations,respectively.The average annual rates of increase in prevalence were 21.50%,19.72%,and 25.67%from 2013 to 2017 in the overall,female,and male populations,respectively.The age-specific incidence rates peaked at 30–49 years old in women and 40–59 years old in men.SLE incident and prevalent cases were most common in North-West China and less common in southern and eastern China.Distinct variations in incidence rates across different regions are also consistent with the varying levels of ultraviolet radiation exposure in China.Additionally,the average estimated annual per-capita cost was 1599.34 US dollars in SLE patients,with the highest costs observed in adolescent and young adult patients among different age groups.The SLE population in China is rapidly expanding,and younger at onset,especially in women,which has placed significant burdens on China's healthcare system.展开更多
Background： The primary cause of ischemic heart failure （HF） is myocardial infarction （MI） resulting in left ventricle （LV） wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomi...Background： The primary cause of ischemic heart failure （HF） is myocardial infarction （MI） resulting in left ventricle （LV） wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device （CardioKinetix, lnc., CA, USA） in ischemic HF patients as a result of LV remodeling after anterior wall M1. Methods： Thirty-one patients with New York Heart Association （NYHA） Class I1, I11 ischemic HF, ejection traction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin tbr at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index （LVESVI） against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-SD and visual analog scale （VAS）. For quantitative data comparison, paired t-test （normality data） and signed-rank test （abnormality data） were used： application of signed-rank test was tbr the ranked data comparison. Results： A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ~ 20.0 ml/m-＇ to 53,1 ~ 17.0 ml/m-＂ （P 〈 0.0001 ）, The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than halfa class at 3 months （P 〈 0.001 ）. Quality of life assessed by the VAS value increased 11.5 points （P 〈 0.01 ）, demonstrating improvement at 3 months.Conclusion： The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration： ClinicalTrials.gov, NCT02240940; https：// clinicaltrials.gov/ct2/show/NCT02240940.展开更多
Objective:To evaluate the efficacy of deep vein thrombosis(DVT)prevention among realworld surgical inpatients who received panax notoginseng saponins(PNS)combined with low-molecularweight heparin(LMWH).Methods:A prosp...Objective:To evaluate the efficacy of deep vein thrombosis(DVT)prevention among realworld surgical inpatients who received panax notoginseng saponins(PNS)combined with low-molecularweight heparin(LMWH).Methods:A prospective cohort study was conducted among surgical patients between January 2016 and November 2018 in Xuanwu Hospital,Capital Medical University,Beijing,China.Participants received LMWH alone or PNS combined with LMWH for preventing DVT.The primary outcome was incidence of lower extremity DVT,which was screened once a week.Participants in the LMWH group were given LMWH(enoxaparin)via hypodermic injection,4000-8000 AxalU once daily.Participants in the exposure group received PNS(Xuesaitong oral tablets,100 mg,3 times daily)combined with LMWH given the same as LMWH group.Results:Of the 325 patients screened for the study,281 participants were included in the final analysis.The cohort was divided into PNS+LMWH group and LMWH group with 134 and 147 participants,respectively.There was a significant difference of DVT incidence between two groups(P=0.01),with 21(15.7%)incident DVT in the PNS+LMWH group,and 41(27.9%)incident DVT in the LMWH group.Compared with participants without DVT,the participants diagnosed with DVT were older and had higher D-dimer level.The multivariate logistic regression moclel showed a significant lower risk of incident DVT among participants in the PNS+LMWH group compared with the LMWH group(odds ratio 0.46,95%confidence interval,0.25-0.86).There were no significant differences in thromboelaslography values(including R,K,Angle,and MA)and differences in severe bleeding between two groups.No symptomatic pulmonary embolism occurred during the study.Conclusion:Combined application of PNS and LMWH can effectively reduce the incidence of DVT among surgical inpatients compared with LMWH monotherapy,without increased risk of bleeding.展开更多
Background:After radical hysterectomy for cervical cancer,the most common complication is lower urinary tract symptoms.Post-operatively,bladder capacity can alter bladder function for a prolonged period.This study aim...Background:After radical hysterectomy for cervical cancer,the most common complication is lower urinary tract symptoms.Post-operatively,bladder capacity can alter bladder function for a prolonged period.This study aimed to identify factors affecting bladder storage function.Methods:A multicenter,retrospective cohort study was conducted.Information of patients with stages IA2 to IIB cervical cancer with urodynamic study results were retrospectively collected from nine hospitals between June 2013 and June 2018 according to the inclusion criteria.Demographic,surgical,and oncological data were collected.The univariate and multivariate logistic regression was used to identify clinical factors associated with bladder storage function.Results:Two hundred and three patients with cervical cancer had urodynamic testing post-operatively.Ninety-five(46.8%)patients were diagnosed with stress urinary incontinence(SUI).The incidence of low bladder compliance(LBC)was 23.2%.Twenty-seven(13.3%)patients showed detrusor overactivity(DO).Fifty-seven patients(28.1%)presented with a decreased maximum cystometric capacity(DMCC).The probability of composite bladder storage dysfunction was 68.0%.Multivariate analysis confirmed that laparoscopy represents a protective factor for SUI with an odds ratio of 0.498(P=0.034).Patients who underwent a nerve-sparing procedure were less odds to experience SUI(P=0.014).A significant positive correlation between LBC and DO was observed(P<0.001).A greater length of the resected vagina and chemoradiotherapy were common risk factors for LBC and DO,while radiotherapy exerted a stronger effect than chemotherapy.Additionally,patients who received chemoradiotherapy frequently developed a DMCC.The follow-up time was not correlated with bladder storage function.Conclusion:A nerve-sparing procedure without longer resected vagina is recommended for protecting the bladder storage function.展开更多
The relationship between low levels of serum low-density lipoprotein cholesterol(LDL-C)and subsequent cognitive decline remains unclear.The present study aimed to evaluate the longitudinal association between low LDL-...The relationship between low levels of serum low-density lipoprotein cholesterol(LDL-C)and subsequent cognitive decline remains unclear.The present study aimed to evaluate the longitudinal association between low LDL-C levels and cognition decline in the context of the current aggressive guideline-recommended targets(LDL-C levels less than 55 mg/dL for individuals at very high risk of cardiovascular events,and less than 70 mg/dL for high risk individuals).Data from wave 13(2016)to wave 14(2018)of the Health and Retirement Study(HRS)were utilized.LDL-C concentrations measured at wave 13 were categorized into 5 levels,reflecting currently recommended values for lipid lowering treatment.Of 7129 included participants(mean age:69.0±9.9 years,60.3%female),we found that compared to participants with LDL-C levels of 70.0-99.9 mg/dL,those with LDL-C levels of<55 mg/dL had significantly slower 2-year decline rates in global cognitive function(0.244 point/year;95%confidence interval(CI):0.065-0.422;P=0.008),working memory(0.068 point/year;95%CI:0.004-0.133;P=0.038),and borderline significantly in episodic memory(0.155 point/year;95%CI:-0.004-0.315;P=0.057).Similarly,significantly slower decline rates were observed in those with LDL-C levels of 55.0-69.9 mg/dL.The present study demonstrated that compared with LDL-C levels 70.0-99.9 mg/dL,low LDL-C levels(<70 mg/dL,especially<55 mg/dL)were associated with significantly slower cognitive decline in population-based setting.Future randomized controlled trials are warranted to ascertain the safety and benefit of current aggressive guideline-recommended targets on cognitive function.展开更多
基金supported by the 10th National Five-Year Plan Projects(2001BA703B14,and 2001BA703B01)of Ministry of Science and Technology and Ministry of Health
文摘Objective To study the prevalence of atrial fibrillation （AF） and the relation with its risk factors in China. Methods A total of 19 363 participants （8635 males and 10 728 females） aged 〉35 years in geographically dispersed urban and rural regions of China were included in this cross-sectional survey. All participants received questionnaire, physical and blood examination. Echocardiography were performed for AF patients found in the survey. Results Of the 19 363 participants, 199 were diagnosed with AF. The estimated age-standardized prevalence of AF was 0.78% in men and 0.76% in women. The prevalence of AF in participants aged 〈60 years was 0.41% in men and 0.43% in women, and was 1.83% in both men and women aged 〉_60 years. About 19.0% of males and 30.9% of females with AF were diagnosed with valve disease. Age- and sex-adjusted multivariable logistic regression analysis revealed that myocardial infarction, left ventricular hypertrophy （LVH）, obesity, and alcohol consumption were associated with a increased risk of AF（P〈0.05）. Conclusion The age standardized prevalence of AF is 0.77% in the participants enrolled in the present study. The number of AF cases aged 〉35 years is 5.26 million according to 2010 Chinese Census. Most risk factors for AF, identified mainly in Western countries, are also detected in China.
基金supported by the National Key Research and Development Program Sub-project, No.2018 YFC0115405(to BYF)the Start-up Fund for Scientific Research Talents of Beijing Rehabilitation Hospital, Capital Medical University of China, No.2019 R-006(to ZHJ)。
文摘Parkinson's disease(PD) can be classified into three motor-based subtypes: postural instability/gait difficulty(PIGD), tremor dominant(TD), and indeterminate.The neuropathophysiological mechanisms of the three motor subtypes are different, which may lead to different responses to therapy.Sixty-nine patients with idiopathic Parkinson's disease(Hoehn–Yahr stage ≤ 3) were screened from 436 patients with Parkinsonism recruited through outpatient services and the internet.According to the Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS) TD/PIGD ratio, the patients were divided into PIGD(TD/PIGD ≤ 0.09;n = 36), TD(TD/PIGD ≥1.15;n = 19), and indeterminate(TD/PIGD = 0.90–1.15;n = 14) groups.All patients received 2 weeks of multidisciplinary intensive rehabilitation treatment(MIRT) during hospitalization, as well as a remote home rehabilitation health education class.Compared with the scores at admission, all patients showed significant improvements in their MDS-UPDRS III score, walking ability, balance, and posture control at discharge.Moreover, the MDS-UPDRS III score improvement was greater in the PIGD group than in the TD group.The follow-up data, collected for 3 months after discharge, showed that overall symptom improvement in each group was maintained for 1–3 months.Furthermore, there were no significant differences in the duration or grade effects of symptom improvement among the three groups.These findings suggest that 2 weeks of MIRT is effective for improving motor performance in all three motor subtypes.Patients in the PIGD group had a better response after hospitalization than those in the TD group.This study was approved by the Institutional Ethics Committee of Beijing Rehabilitation Hospital of Capital Medical University of China(approval No.2018 bkky022) on May 7, 2018 and registered with the Chinese Clinical Trial Registry(registration No.Chi CTR1900020771) on January 19, 2019.
基金supported by the Ministry of Science and Technology of China(grant 2016YFC1300400)Chinese National Key Research and Development Project(grant 2016-I2M-1-011)。
文摘Background Coronary atherosclerosis and cognitive impairment are both age-related diseases,with similar risk factors.Coronary artery calcium(CAC),a marker of coronary atherosclerosis,may play a role in early detection of individuals prone to cognitive decline.This study aimed to investigate the relationship between CAC and cognitive function,and the capability of CAC to identify participants with a high risk of dementia in a Chinese community-based population.Methods A total of 1332 participants,aged 40-80 years and free of dementia from a community located in Beijing were included.All participants completed neurocognitive questionnaires and noncontrast CT examinations.Cognitive performance tests(including verbal memory,semantic fluency,executive function,and global cognitive function tests),the Cardiovascular Risk Factors,Aging,and Incidence of Dementia(CIDE)risk score,and the CAC score(CACS)were evaluated by questionnaires and CT.A CAIDE score≥10 was considered to indicate a high risk of dementia in late-life.Participants were divided into three groups according to CACS(0,1-399,≥400).Results After adjusting for risk factors,CACS was significantly associated with verbal memory(r=-0.083,P=0.003)and global cognitive function(r=-0.070,P=0.012).The prevalence of a high risk of dementia in the subgroups of CACS=0,1-399,and≥400 was 4.67%,13.66%,and 24.79%,respectively(P<0.001).Individuals with CACS≥400 had a higher risk of CAIDE score≥10[OR=2.30(1.56,4.56),P=0.014]than those with CACS=0.The receiver-operating characteristic curves showed that the capability of CACS to identify participants with a high risk of dementia was moderate(AUC=0.70,95%CI:0.67-0.72,P<0.001).Conclusions CAC,a marker of subclinical atherosclerosis,was significantly associated with cognitive performance in verbal memory and global cognitive function.CAC had a moderate capability to identify participants with a high risk of dementia,independent of age,education,and other risk factors.
基金founded by the Central Finance of the Chinese Government and the National Natural Science Foundation of China[grant number 81202287]
文摘Objective This study examined vegetable and fruit （VF） consumption rate and its associated factors among Chinese adults. Methods Nationally representative data from the 2013 China Chronic Disease Surveillance survey were used. Dietary intake data, including VF consumption during the last 12 months, were collected. All analyses were weighted to obtain nationally representative estimates. Associations between VF consumption and other factors （e.g., meal frequency and physical activity） were examined through logistic regression analysis. Results The average fruit consumption was 102.3 g/day （95% CI： 97.0-107.6） and the average vegetable consumption was 350.6 g/day （95% CI： 339.3-361.8）. Over half （53.2%, 95% CI： 50.9-55.4） of Chinese adults met the VF consumption of 400 g/day recommended by the World Health Organization （WHO）. Rural residents had a higher prevalence of low VF consumption rate than urban residents [49.20% （95% CI： 46.2%-52.2%） vs. 44.0% （95% CI： 41.7%-46.3%） P 〈 0.01]. Old age （OR = 1.01, 95% CI： 1.00-1.01）, low educational level, low income, minority ethnicity （OR = 1.41, 95% CI： 1.15-1.74）, underweight （OR = 1.17, 95% CI： 1.03-1.33）, single marital status （OR = 1.20, 95% CI： 1.08-1.33）, low health literacy, irregular breakfast （OR = 1.20, 95% CI： 1.04-1.38） or lunch （OR = 1.58, 95% CI： 1.26-1.99） habits, and no leisure-time physical activity were associated with low VF consumption. Conclusion Only half of Chinese adults met the VF consumption recommended by the WHO. Low socio-economic status, irregular diet, and poor health literacy were likely associated with low VF consumption. National efforts and programs are needed to promote VF consumption.
基金This study was supported by the National Natural Science Foundation of China(grant no.81973698 and 81703942)the Young Elite Scientists Sponsorship Program by CACM(grant no.2019-QNRC2-B08)+2 种基金the BUCM Precision Cultivation Program(grant no.JZPY-202205)the Science Fund for Distinguished Young Scholars in BUCM(grant no.BUCM-2019-JCRC004)the BUCM Research Development Fund(grant no.2021-ZXFZJJ-052).
文摘Background The comorbidity of cardiovascular disease(CVD)and depression has been well established,as depression usually presents simultaneously with CVD risk factors.However,the potential association between cumulative exposure to CVD risk and depression remains unclear,so we conducted the current investigation.To our knowledge,this is the first study that employs the cumulative risk model to examine the effect of CVD risk factors on depression using nationally representative population and gender,age and CVD status-stratified subpopulations.Aims To systematically study the possible individual and cumulative effect of 18 CVD risk factors on depression.Methods A cross-sectional,secondary analysis investigated associations between 18 CVD risk factors and depression.The interaction effect between CVD risk factors and age,gender and CVD status was also examined.Enrolment included 20816 participants from the US National Health and Nutrition Examination Survey 2005–2016.Participants with Patient Health Questionnaire-9 scores over 15 or who were using an antidepressant were considered depressive;18 known cardiovascular risk factors were incorporated in the present study.Results At the individual risk factor level,smoking,drinking,living alone,sleep quality,body mass index,waist circumference and diabetes status had differential associations with depression risk according to the gender,age or CVD status of the participants.Most importantly,gender-stratified cumulative risk analysis indicated that similar depression risk was found in both genders with a small number of CVD risk factors(odds ratio(OR)adjusted=1.32;95%confidence interval(CI):0.87 to 1.99),but females had a significantly higher depression risk compared with males under high cumulative risk exposure(ORadjusted=2.86;95%CI:1.79 to 4.59).Conclusions Clarifying the association of numerous CVD risk factors with depression according to gender,age and overall CVD status may be beneficial for risk stratification and the prevention of depression in clinical practice.Moreover,the observed novel evidence of high cumulative risk exposure-mediated gender disparities in depression risk may shed light on the underlying mechanism of females’greater vulnerability to depression.
基金Supported by the National Natural Science Foundation of China,No.81974490Fundamental Research Funds for the Central Universities of China,No.BMU2017YJ005。
文摘BACKGROUND Previous studies have shown that patients with diabetes mellitus(DM) respond poorly to clopidogrel treatment.AIM To systematically evaluate the efficacy of clopidogrel for the treatment of acute coronary syndromes or ischemic stroke in patients with or without DM.METHODS Pub Med,the Cochrane Central Register of Controlled Trials,and EMBASE were searched from 1980 on 27 June 2019 to identify relevant randomized controlled trials that compared the effect of a combination of clopidogrel and aspirin with aspirin alone.A random-effects meta-analysis was used to estimate the hazard ratio(HR) and its 95% confidence interval(CI).Sensitivity analysis was performed using a fixed-effect model.The I2 statistic was used to evaluate the heterogeneity of the study data.RESULTS Six randomized controlled trials,comprising 43352 participants(13491 with and 29861 without DM) who had received antiplatelet therapy for≥3 mo,were included in the meta-analysis.Compared with aspirin alone,a combination of clopidogrel and aspirin significantly reduced the risk of any cardiovascular event in patients without DM(HR=0.78,95%CI:0.71–0.86,P<0.001;I2=23%,P=0.26).Clopidogrel plus aspirin also significantly reduced cardiovascular risk in patients with DM,although the effect was smaller(HR=0.89,95%CI:0.81–0.99,P=0.030;I2=0%,P=0.74).Nevertheless,there was no significant difference in the efficacy of clopidogrel at reducing the risk of cardiovascular events in patients with DM vs those without(P for interaction=0.062).CONCLUSION Thus,the present study shows that the addition of clopidogrel to aspirin significantly lowers cardiovascular risk in patients with or without DM who have experienced ischemic cardiovascular disease.The beneficial effect of the addition of clopidogrel to aspirin for patients with DM was lower than that in patients without DM,although the modifying effect of DM did not reach significance.
基金supported by sub-project of National Major Scientific and Technological Special Project of China for ‘Significant New Drugs Development’[2015ZX09501008-004]
文摘Objective To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes.Methods The power functions of the Fieller-type confidence interval and the asymptotic confidence interval in crossover designs with serial-sampling data are here derived.Simulation studies were conducted to evaluate the derived power functions.Results Simulation studies show that two power functions can provide precise power estimates when normality assumptions are satisfied and yield conservative estimates of power in cases when data are log-normally distributed.The intra-correlation showed a positive correlation with the power of the bioequivalence test.When the expected ratio of the AUCs was less than or equal to 1, the power of the Fieller-type confidence interval was larger than the asymptotic confidence interval.If the expected ratio of the AUCs was larger than 1, the asymptotic confidence interval had greater power.Sample size can be calculated through numerical iteration with the derived power functions.Conclusion The Fieller-type power function and the asymptotic power function can be used to determine sample sizes of crossover trials for bioequivalence assessment of topical ophthalmic drugs.
基金supported by the subproject of National Major Scientific and Technological Special Project of China for‘Significant New Drugs Development’[2015ZX09501008-004]
文摘In the development of eye drop medications,difficulty in sampling is a major challenge[1].Drug concentrations in the aqueous humor(AH)can only be measured when the eye is undergoing surgery,such as cataract replacement.Sampling from tears may significantly reduce the amount of medication remaining in the eye.Owing to limitations caused by sampling difficulty,the concentration–time profile for each subject is generally unattainable when estimating the pharmacokinetics parameters for topical ophthalmic drugs.Instead,each subject can be sampled at one of several prespecified sampling times.
文摘Background:Treatment of coronary bifurcation lesions remains challenging;a simple strategy has been preferred as of late,but the disadvantage is ostium stenosis or even occlusion of the side branch(SB).Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported.This prospective,multicenter,randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon(PEB)compared with regular balloon angioplasty(BA)in the treatment of non-left main coronary artery bifurcation lesions.Methods:Between December 2014 and November 2015,a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers.Patients were randomly allocated at a 1:1 ratio to a PEB group(n=113)and a BA group(n=109).The primary efficacy endpoint was angiographic target lesion stenosis at 9 months.Secondary efficacy and safety endpoints included target lesion revascularization,target vessel revascularization,target lesion failure,major adverse cardiac and cerebral events(MACCEs),all-cause death,cardiac death,non-fatal myocardial infarction,and thrombosis in target lesions.The main analyses performed in this clinical trial included case shedding analysis,base-value equilibrium analysis,effectiveness analysis,and safety analysis.SAS version 9.4 was used for the statistical analyses.Results:At the 9-month angiographic follow-up,the difference in the primary efficacy endpoint of target lesion stenosis between the PEB(28.7%±18.7%)and BA groups(40.0%±19.0%)was-11.3%(95%confidence interval:-16.3%to-6.3%,Psuperiority<0.0001)in the intention-to-treat analysis,and similar results were recorded in the per-protocol analysis,demonstrating the superiority of PEB to BA.Late lumen loss was significantly lower in the PEB group than in the BA group(-0.06±0.32 vs.0.18±0.34 mm,P<0.0001).For intention-to-treat,there were no significant differences between PEB and BA in the 9-month percentages of MACCEs(0.9%vs.3.7%,P=0.16)or non-fatal myocardial infarctions(0 vs.0.9%,P=0.49).There were no clinical events of target lesion revascularization,target vessel revascularization,target lesion failure,all-cause death,cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting,SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov,NCT02325817;https://clinicaltrials.gov.
基金This study was supported by grants from the National Key Technology R＆D Program （Nos. 2013BAI09B05 and 2015BAI12B06）, Key Program of the National Natural Science Foundation of China （No. 81330019）, General Program of the National Natural Science Foundation of China （No. 81270794）, and the Beijing Science and Technology Project （No. D 131100004713003 and No. D171100002817002）.
文摘Background： Chronic kidney disease （CKD） with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limited. This study aimed to assess the efficacy and safety of the traditional Chinese medicine, Niaoduqing particles, for delaying renal dysfunction in patients with stage 3b-4 CKD.Methods： The present study was a prospective, randomized, double-blind, placebo-controlled, naulticentcr clinical trial. Frorn May 2013 to December 2013,300 CKD patients with an estimated glomerular filtration rate （eGFR） between 20 and 45 ml ＂rain ~＂ 1.73 m 2, aged 18-70 years were recruited from 22 hospitals in 11 Chinese provinces. Patients were randomized in a 1：1 ratio to either a test group, which was administered Niaoduqing particles 5 g thrice daily and 10 g before bedtime for 24 weeks, or a control group, which was administered a placebo using the same methods. The primary endpoints were changes in baseline serum creatinine （Scr） and eGFR after completion of treatment. The primary endpoints were analyzed using Student＇s t-test or Wilcoxon＇s rank-sum test. The present study reported results based on an intention-to-treat （ITT） analysis. Results： A total of 292 participants underwent the ITT analysis. At 24 weeks, the median （interquartile range） change in Scr was 1.1 （-13.0-24.1） and 11.7 （-2.6-42.9） p, mol/L for the test and control groups, respectively （Z = 2.642, P = 0.008）, and the median change in eGFR was -0.2 （-4.3-2.7） and -2.2 （-5.7-0.8） ml.min-1·1.73 m-2, respectively （Z = -2.408, P = 0.016）. There were no significant differences in adverse events between the groups. Conclusions： Niaoduqing particles safely and effectively delayed CKD progression in patients with stage 3b-4 CKD. This traditional Chinese medicine may be a promising alternative medication for patients with moderate-to-severe renal dysfunction.
文摘Medical device technology develops rapidly,and the life cycle of a medical device is much shorter than drugs.It is necessary to evaluate the safety and effectiveness ofamedical device in a timelymanner to keep upwith technology flux.Bayesian methods provides an efficient approach to addressing this challenge.In this article,we review the characteristics of the Bayesian approach and some Bayesian designs that were commonly used in medical device regulatory setting,including Bayesian adaptive design,Bayesian diagnostic design,Bayesian multiregional design,and Bayesian label expansion study.We illustrate these designs with medical devices approved by the US Food and Drug Administration(FDA).We also review several innovative Bayesian information borrowing methods,and briefly discuss the challenges and future directions of the Bayesian application in medical device trials.Our objective is to promote the use of the Bayesian approach to accelerate the development of innovative medical devices and their accessibility to patients for effective disease diagnoses and treatments.
基金funded by International Postdoctoral Exchange Fellowship Program(YJ20220238)China Postdoctoral Science Foundation(2023TQ0018)。
文摘This paper aims to present a Statistical Analysis Software(SAS)macro%BBlplus,offering estimation and visualisation methods for the Bang's Blinding Index(BBl)for randomised controlled trials(RCTs)with various designs.We developed the SAS macro programme%BBlplus to facilitate the implementation of BBl.This userfriendly programme allows for easy and rapid estimation and visualisation of BBl across different scenarios,including pairwise comparison RCTs with two arms,double-dummy design RCTs with three arms and factorial design RCTs with four arms.The programme requires no pre-existing data set,and users only need to input the number of individuals of correct,uncertain or wrong guesses in each intervention or control group.We illustrate the functionality of%BBlplus using blinding assessment data from three previously published RCTs:BBR(adjunctive berberine reduces antipsychotic-associated weight gain and metabolic syndrome in patients with schizophrenia:a randomised controlled trial),SELECTTDcS(the sertraline versus electrical current therapy for treating depression clinical study:results from a factorial,randomised controlled trial)and ELECT-TDCS(trial of electrical direct-current therapy versus escitalopram for depression)studies.The programme estimates the BBI for each arm,providing point estimates,95%Cl and associated p values.Additionally,%BBlplus can visualise the estimations through forest plots and make the judgement for the success of blinding easily and rapidly.This tool caters to the needs of clinical trial investigators,offering a comprehensive solution for estimating and visualising the blinding index under various RCT designs.
基金supported by the Guangzhou Recomgen Biotech Co.,Ltd.The funder had no role in the design and conduct of the studycollection,management,analysis,and interpretation of the data
文摘Background:A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator(rhTNK-tPA)has previously shown its preliminary efficacy in ST elevation myocardial infarction(STEMI)patients.This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase(rt-PA)in Chinese patients with STEMI.Methods:In this multicenter,randomized,open-label,non-inferiority trial,patients with acute STEMI were randomly assigned(1:1)to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min.The primary endpoint was recanalization defined by thrombolysis in myocardial infarction(TIMI)flow grade 2 or 3.The secondary endpoint was clinically justified recanalization.Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events(MACCEs)and safety endpoints.Results:From July 2016 to September 2019,767 eligible patients were randomly assigned to receive rhTNK-tPA(n=384)or rt-PA(n=383).Among them,369 patients had coronary angiography data on TIMI flow,and 711 patients had data on clinically justified recanalization.Both used a–15%difference as the non-inferiority efficacy margin.In comparison to rt-PA,both the proportion of patients with TIMI grade 2 or 3 flow(78.3%[148/189]vs.81.7%[147/180];differences:–3.4%;95%confidence interval[CI]:–11.5%,4.8%)and clinically justified recanalization(85.4%[305/357]vs.85.9%[304/354];difference:–0.5%;95%CI:–5.6%,4.7%)in the rhTNK-tPA group were non-inferior.The occurrence of 30-day MACCEs(10.2%[39/384]vs.11.0%[42/383];hazard ratio:0.96;95%CI:0.61,1.50)did not differ significantly between groups.No safety outcomes significantly differed between groups.Conclusion:rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery,a validated surrogate of clinical outcomes,among Chinese patients with acute STEMI.Trial registration:www.ClinicalTrials.gov(No.NCT02835534).
基金This work was supported by National High Level Hospital Clinical Research Funding[2022-PUMCH-B-009][2022-PUMCH-A-063].We thank EditSprings(https://www.editsprings.cn)for the expert linguistic services provided.We thank Professor Chao Ma of the Department of Human Anatomy,Histology and Embryology,Institute of Basic Medical Sciences,Chinese Academy of Medical Sciences for his contribution during the construction of Human Tissue and Organ Bank and the collection of autopsy prostate specimens.We would also like to thank every post-mortem donor who makes this study possible.
文摘Prostate cancer detected by autopsy is named latent prostate cancer.As the repertoire of clinical prostate cancer,latent cancer may better reflect the disease burden.Unlike clinical prostate specimens,which are obtained exclusively from biopsy-positive cases,prostate specimens obtained through autopsy provide information on biopsy-negative cases,helping calculate the true sensitivity of prostate biopsy.From 2014 to 2021,we collected autopsy specimens of the prostate from body donors in China and performed transperineal and transrectal biopsies on specimens before step-sectioning and pathological measurements.We found that the crude prevalence of latent prostate cancer in middle-aged and elderly men was 35.1%(81/231),which was higher than previous estimates for Chinese populations.The overall per-patient sensitivities of transperineal and transrectal biopsies were not significantly different(33.3%vs.32.1%,p=0.82),but the two approaches differed in preferential sampling area along the proximal-distal axis of the prostate.Transperineal biopsy had a higher sensitivity for detecting clinically significant lesions in the distal third(34.7%vs.16.3%,p=0.02)and distal half(30.6%vs.18.1%,p=0.04),while transrectal biopsy had a higher sensitivity for lesions in the proximal half(25.0%vs.13.9%,p=0.046).Both transperineal and transrectal methods of biopsy missed most small lesions(<0.1 mL)and 35.3%(6/17)of large lesions(>0.5 mL).In conclusion,the prevalence of latent prostate cancer in China has increased over the past 2 decades.Systematic transperineal and transrectal methods of biopsy had comparable sensitivities but had different preferential sampling areas.Both approaches miss one-third of large lesions.
基金supported by the Chinese National Key Technology R&D Program,Ministry of Science&Technology(2021YFC2501300 and 2020YFC2003503)the Beijing Municipal Science&Technology Commission(Z201100005520022,23,25–27)+1 种基金the CAMS Innovation Fund for Medical Sciences(CIFMS)(2021-I2M-1-005)the National High Level Hospital Clinical Research Funding(2022-PUMCH-B-013,C-002,D-009)。
文摘Systemic lupus erythematosus(SLE)is becoming a growing public health concern due to increasing disease and economic burdens.Epidemiological information about SLE,especially its incidence rate,is limited in developing countries.In the current study,we sought to investigate the incidence,prevalence,and economic burdens of SLE in urban China.We conducted a nationwide population-based cohort study using databases from Urban Employee Basic Medical Insurance and Urban Resident Basic Medical Insurance between 2013 and 2017,covering approximately 300 million residents in 23 provincial regions in China.Incidence rate and prevalence were standardized by age and gender to China's 2010 national census data.Additionally,we calculated the average annual costs and hospital visit rates.A total of132,258 SLE patients were identified during the study period,with a mean age of 43.03 years(standard deviation:15.29 years).Of these patients,81.33%were women.In 2017,the standardized incidence rate of SLE in China was 14.09(95%confidence interval(CI),11.95–16.41)per 100,000 person-years,with a higher incidence in women than in men(26.41 vs.5.92 per 100,000 person-years).Standardized prevalence in 2017 was 47.61(41.77–53.83),94.16(80.67–108.69),and 17.86(13.84–22.38)per 100,000 people in the overall,female,and male populations,respectively.The average annual rates of increase in prevalence were 21.50%,19.72%,and 25.67%from 2013 to 2017 in the overall,female,and male populations,respectively.The age-specific incidence rates peaked at 30–49 years old in women and 40–59 years old in men.SLE incident and prevalent cases were most common in North-West China and less common in southern and eastern China.Distinct variations in incidence rates across different regions are also consistent with the varying levels of ultraviolet radiation exposure in China.Additionally,the average estimated annual per-capita cost was 1599.34 US dollars in SLE patients,with the highest costs observed in adolescent and young adult patients among different age groups.The SLE population in China is rapidly expanding,and younger at onset,especially in women,which has placed significant burdens on China's healthcare system.
文摘Background： The primary cause of ischemic heart failure （HF） is myocardial infarction （MI） resulting in left ventricle （LV） wall motion abnormality secondary to ventricular remodeling. A prospective, nonrandomized study conducted in China was designed to assess safety and efficacy of the percutaneous ventricular restoration therapy using Parachute device （CardioKinetix, lnc., CA, USA） in ischemic HF patients as a result of LV remodeling after anterior wall M1. Methods： Thirty-one patients with New York Heart Association （NYHA） Class I1, I11 ischemic HF, ejection traction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled from seven sites in China from October to December 2014. The Parachute device was implanted through femoral artery. All patients received low-dose aspirin and anticoagulation with warfarin tbr at least 12 months postdevice implantation. The primary end-point was the assessment of efficacy as measured by the reduction in LV end-systolic volume index （LVESVI） against baseline LVESVI at 3 months postdevice implantation, determined by the echocardiography and measured by echocardiography core laboratory. Quality of life was assessed using EQ-SD and visual analog scale （VAS）. For quantitative data comparison, paired t-test （normality data） and signed-rank test （abnormality data） were used： application of signed-rank test was tbr the ranked data comparison. Results： A change in LVESVI as measured by echocardiography from the preimplant baseline to 3-month postdevice implantation revealed a statistically significant reduction from 77.5 ~ 20.0 ml/m-＇ to 53,1 ~ 17.0 ml/m-＂ （P 〈 0.0001 ）, The trial met its primary end-point. Of the 31 patients, the procedural success was 96.8%. Overall, NYHA HF class assessment results showed an improvement of more than halfa class at 3 months （P 〈 0.001 ）. Quality of life assessed by the VAS value increased 11.5 points （P 〈 0.01 ）, demonstrating improvement at 3 months.Conclusion： The favorable outcomes observed in the high-risk patients provide reassuring safety and efficacy data to support adoption of this technology as a therapeutic option for ischemic HF patients. Trial Registration： ClinicalTrials.gov, NCT02240940; https：// clinicaltrials.gov/ct2/show/NCT02240940.
基金Supported by Beijing Traditional Chinese Medicine Technology Development Fund Project(No.JJ2015-09)Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support(No.ZYLX201706)。
文摘Objective:To evaluate the efficacy of deep vein thrombosis(DVT)prevention among realworld surgical inpatients who received panax notoginseng saponins(PNS)combined with low-molecularweight heparin(LMWH).Methods:A prospective cohort study was conducted among surgical patients between January 2016 and November 2018 in Xuanwu Hospital,Capital Medical University,Beijing,China.Participants received LMWH alone or PNS combined with LMWH for preventing DVT.The primary outcome was incidence of lower extremity DVT,which was screened once a week.Participants in the LMWH group were given LMWH(enoxaparin)via hypodermic injection,4000-8000 AxalU once daily.Participants in the exposure group received PNS(Xuesaitong oral tablets,100 mg,3 times daily)combined with LMWH given the same as LMWH group.Results:Of the 325 patients screened for the study,281 participants were included in the final analysis.The cohort was divided into PNS+LMWH group and LMWH group with 134 and 147 participants,respectively.There was a significant difference of DVT incidence between two groups(P=0.01),with 21(15.7%)incident DVT in the PNS+LMWH group,and 41(27.9%)incident DVT in the LMWH group.Compared with participants without DVT,the participants diagnosed with DVT were older and had higher D-dimer level.The multivariate logistic regression moclel showed a significant lower risk of incident DVT among participants in the PNS+LMWH group compared with the LMWH group(odds ratio 0.46,95%confidence interval,0.25-0.86).There were no significant differences in thromboelaslography values(including R,K,Angle,and MA)and differences in severe bleeding between two groups.No symptomatic pulmonary embolism occurred during the study.Conclusion:Combined application of PNS and LMWH can effectively reduce the incidence of DVT among surgical inpatients compared with LMWH monotherapy,without increased risk of bleeding.
基金the National Key R&D Program of China(2018YFC2002200 and 2018YFC2002204)the Beijing Municipal Science&Technology Commission(No.D151100001915003).
文摘Background:After radical hysterectomy for cervical cancer,the most common complication is lower urinary tract symptoms.Post-operatively,bladder capacity can alter bladder function for a prolonged period.This study aimed to identify factors affecting bladder storage function.Methods:A multicenter,retrospective cohort study was conducted.Information of patients with stages IA2 to IIB cervical cancer with urodynamic study results were retrospectively collected from nine hospitals between June 2013 and June 2018 according to the inclusion criteria.Demographic,surgical,and oncological data were collected.The univariate and multivariate logistic regression was used to identify clinical factors associated with bladder storage function.Results:Two hundred and three patients with cervical cancer had urodynamic testing post-operatively.Ninety-five(46.8%)patients were diagnosed with stress urinary incontinence(SUI).The incidence of low bladder compliance(LBC)was 23.2%.Twenty-seven(13.3%)patients showed detrusor overactivity(DO).Fifty-seven patients(28.1%)presented with a decreased maximum cystometric capacity(DMCC).The probability of composite bladder storage dysfunction was 68.0%.Multivariate analysis confirmed that laparoscopy represents a protective factor for SUI with an odds ratio of 0.498(P=0.034).Patients who underwent a nerve-sparing procedure were less odds to experience SUI(P=0.014).A significant positive correlation between LBC and DO was observed(P<0.001).A greater length of the resected vagina and chemoradiotherapy were common risk factors for LBC and DO,while radiotherapy exerted a stronger effect than chemotherapy.Additionally,patients who received chemoradiotherapy frequently developed a DMCC.The follow-up time was not correlated with bladder storage function.Conclusion:A nerve-sparing procedure without longer resected vagina is recommended for protecting the bladder storage function.
基金supported by the National Natural Science Foundation of China (81974490)the 2019 Irma and Paul MilsteinProgram for Senior Health Research Project Award。
文摘The relationship between low levels of serum low-density lipoprotein cholesterol(LDL-C)and subsequent cognitive decline remains unclear.The present study aimed to evaluate the longitudinal association between low LDL-C levels and cognition decline in the context of the current aggressive guideline-recommended targets(LDL-C levels less than 55 mg/dL for individuals at very high risk of cardiovascular events,and less than 70 mg/dL for high risk individuals).Data from wave 13(2016)to wave 14(2018)of the Health and Retirement Study(HRS)were utilized.LDL-C concentrations measured at wave 13 were categorized into 5 levels,reflecting currently recommended values for lipid lowering treatment.Of 7129 included participants(mean age:69.0±9.9 years,60.3%female),we found that compared to participants with LDL-C levels of 70.0-99.9 mg/dL,those with LDL-C levels of<55 mg/dL had significantly slower 2-year decline rates in global cognitive function(0.244 point/year;95%confidence interval(CI):0.065-0.422;P=0.008),working memory(0.068 point/year;95%CI:0.004-0.133;P=0.038),and borderline significantly in episodic memory(0.155 point/year;95%CI:-0.004-0.315;P=0.057).Similarly,significantly slower decline rates were observed in those with LDL-C levels of 55.0-69.9 mg/dL.The present study demonstrated that compared with LDL-C levels 70.0-99.9 mg/dL,low LDL-C levels(<70 mg/dL,especially<55 mg/dL)were associated with significantly slower cognitive decline in population-based setting.Future randomized controlled trials are warranted to ascertain the safety and benefit of current aggressive guideline-recommended targets on cognitive function.
