摘要
目的:客观评价糖肾宁颗粒治疗糖尿病肾病(DKD)临床疗效,并对其作用机制进行初步探讨。方法:采用多中心、随机、双盲、阳性药物平衡对照的试验设计方法,将符合诊断标准的早期DKD患者250例,随机分为治疗组和对照组,对照组在饮食控制、控制血糖基础上,口服氯沙坦,1片/d;治疗组在此基础上予口服糖肾宁颗粒8g,2次/d,疗程为12周。重点观察两组患者的中医临床症状、24h白蛋白排泄率(24h UAER)、估算肾小球滤过率(e GFR)、超氧化物歧化酶(SOD)、超敏C反应蛋白(hs-CRP)等指标治疗前后变化。结果:治疗组总有效率为86.0%,对照组总有效率为58.8%,治疗组的疗效明显优于对照组(P<0.05);治疗组在降低患者的24h UAER和改善中医临床症状方面明显优于对照组(P<0.01)。治疗组患者血清SOD水平明显高于对照组(P<0.05),血清MDA、hs-CRP水平明显低于对照组(P<0.05);试验过程中未出现任何不良反应。结论:糖肾宁颗粒是治疗早期DKD安全有效的药物,其作用机制可能与改善机体微炎性反应状态及氧化应激状态有关。
Objective: To observe the clinical therapeutic effect and illuminate the mechanism of Tang Shen Ning Granules(TSN) on diabetic kidney disease(DKD). Methods: A multicenter, randomized double-blind and positive drug controlled clinical trial was performed in our study. A total of 250 patients, who had been diagnosed with early stage of DKD, were randomly divided into 2 groups: the normal control group(NC group) and the treatment group(TSN group). Both 2 groups were treated with dietary control and hyperglycemia control. Moreover, the patients of NC group were treated with Losartan(50 mg, qd), the patients of TSN group were treated with TSN(8 g, bid). The treatment was lasted for 12 weeks. The clinical symptom, UAER, e GFR, SOD and hs-CRP were observed in 2 groups. Results: The total effective rate of TSN group was 86.0%, and the NC group was 58.8%(P<0.05). Compared with the NC group, TSN effectively decreased the UAE and relieved the clinical signs of DKD patients(P<0.01). Compared with the NC group, the level of serum SOD was significantly increased and the level of MDA, hsCRP was significantly decreased in the TSN group(P<0.05). No adverse reactions and side effects were observed during the trail. Conclusion: TSN is a safe and effective drug for the treatment of early diabetic nephropathy, and its mechanism might be related to the improvement of micro inflammatory state and oxidative stress.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2017年第11期5212-5215,共4页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家重点基础研究发展计划(973计划)项目(No.2012CB518602)~~
关键词
糖肾宁颗粒
临床研究
糖尿病肾病
多中心随机双盲对照试验
微炎性反正状态
氧化应激状态
Tang Shen Ning Granules
Clinical research
Diabetic kidney disease
Multicenter
randomized doubleblind controlled trial
Micro inflammatory state
Oxidative stress
