摘要
目的分析注射用重组人尿激酶原（rh Pro-UK）治疗急性ST段抬高型心肌梗死（STEMI）的疗效、安全性及出血的影响因素。方法选取2013年5月—2015年3月天津市人民医院心脏重症监护室（CCU）病房收治的经rh Pro-UK静脉溶栓治疗且符合纳入与排除标准的STEMI患者87例为研究对象。根据全球急性冠脉综合征（ACS）注册研究（GRACE）评分,将患者分为低危组（GRACE评分〈109分,45例）、中危组（GRACE评分109~140分,29例）、高危组（GRACE评分〉140分,13例）;根据心肌梗死溶栓试验（TIMI）危险评分,将患者分为低危组（TIMI危险评分0~3分,49例）、中危组（TIMI危险评分4~6分,24例）和高危组（TIMI危险评分≥7分,14例）。观察并比较不同发病至静脉溶栓治疗时间患者静脉溶栓治疗后30、60、90、120 min的冠状动脉再通率,比较各组出血发生率及主要不良心血管事件（MACE）发生率。出血的影响因素采用多因素Logistic回归分析。绘制GRACE评分、TIMI危险评分预测出血及MACE的受试者工作特征曲线（ROC曲线）,计算ROC曲线下面积（AUC）。GRACE评分、TIMI危险评分预测出血及MACE的拟合优度比较采用H-L检验。结果静脉溶栓治疗后30、60、90、120 min总冠状动脉再通率分别为21.8%（19/87）、51.7%（45/87）、65.5%（57/87）、77.0%（67/87）。随着发病至静脉溶栓治疗时间的延长,静脉溶栓治疗后不同时间冠状动脉再通率比较,差异均无统计学意义（P〉0.05）。轻度出血10例（11.5%）;MACE发生情况：梗死后心绞痛12例（13.8%）、心律失常8例（9.2%）、再发心肌梗死7例（8.0%）、心力衰竭5例（5.7%）、死亡3例（3.4%）。GRACE评分中危组、高危组出血、MACE发生率均高于GRACE评分低危组,GRACE评分高危组出血、MACE发生率均高于GRACE评分中危组（P〈0.05）。TIMI危险评分中危组、高危组出血、MACE发生率均高于TIMI危险评分低危组,TIMI危险评分高危组出血、MACE发生率均高于TIMI危险评分中危组（P〈0.05）。多因素Logistic回归分析结果显示,女性、高龄（≥70岁）、白细胞计数（WBC）≥4×109/L、血红蛋白（Hb）〈110 g/L、血肌酐（Scr）≥133μmol/L、使用低分子肝素（UFH）＋血小板膜糖蛋白Ⅱb/Ⅲa受体拮抗剂（GPI）是出血的影响因素（P〈0.05）。GRACE评分、TIMI危险评分预测出血及MACE的AUC分别为0.875〔95%CI（0.776,0.974）〕、0.867〔95%CI（0.684,0.934）〕,其对出血及MACE均有预测价值（其与AUC=0.5相比的P值分别为0.030、〈0.001）。TIMI危险评分预测出血及MACE的拟合优度（R2=0.775）与GRACE评分预测出血及MACE的拟合优度（R2=0.698）比较,差异无统计学意义（P〉0.05）。结论对于不能及时施行经皮冠状动脉介入治疗（PCI）的STEMI患者,可考虑优先应用rh Pro-UK进行静脉溶栓治疗,其冠状动脉再通率高,安全性好,不增加出血及MACE发生风险,值得临床进一步推广应用。高龄女性患者,尤其合并WBC升高、贫血、肾功能不全及联合使用UFH、GPI时,其出血及MACE发生风险增大。
Objective To observe the clinical efficacy and safety of rh Pro-UK in the treatment of ST- segment elevation myocardial infarction（ STEMI） and analyze the risk factors for in- hospital bleeding. Methods A total of 87 patients with STEMI after thrombolytic therapy with rh Pro-UK in CCU of Tianjin People＇ s Hospital from May 2013 to March 2015 who accorded with the inclusion and exclusion criteria were enrolled. According to the score of the Global Registry of Acute Coronary Events（ GRACE）,we divided the patients into GRACE low- risk group（ GRACE 〉109,45 cases）,GRACE mid- risk group（ GRACE 109 ~ 140,29 cases） and GRACE high- risk group（ GRACE 〉140,13 cases）. According to Thrombolysis in Myocardial Infarction（ TIMI） risk score,we divided the patients into TIMI low- risk group（ TIMI 0 ~ 3,49 cases）,TIMI mid- risk group（ TIMI 4 ~ 6,24 cases） and TIMI high- risk group（ TIMI ≥ 7,14 cases）. 30,60,90,120 min after thrombolytic therapy,the coronary recanalization rates were observed and compared among patients with different time from onset to thrombolytic therapy. The incidence of bleeding and major adverse cardiac events（ MACE） were compared among each group.Influencing factors for bleeding were investigated by multivariate Logistic regression analysis. ROC curves of GRACE score and TIMI risk score predicting bleeding and MACE was made,and AUC values were calculated. H- L test was conducted to compare the goodness of fit between GRACE score and TIMI risk score in the prediction of bleeding and MACE. Results The total coronary recanalization rates were 21. 8%（ 19 /87）,51. 7%（ 45 /87）,65. 5%（ 57 /87） and 77. 0%（ 67 /87） 30 min,60 min,90 min and 120 min after thrombolytic therapy. With the time extending from onset to thrombolytic therapy,there were no significant differences among the coronary recanalization rates of different time after thrombolytic therapy（ P〈0. 05）. The incidence of minor bleeding was 11. 5%（ 10 cases）. There were 12 cases of post- infarction angina（ 13. 8%）,8 cases of arrhythmia（ 9. 2%）,7 cases of recurrent myocardial infarction（ 8. 0%）,5 cases of heart failure（ 5. 7%） and 3 cases of death（ 3. 4%）. The incidence rates of bleeding and MACE of mid- risk groups and high- risk groups of GRACE score and TIMI risk score were higher than those of low- risk groups of GRACE score and TIMI risk score respectively, the incidence rates of bleeding and MACE of high- risk groups of GRACE score and TIMI risk score were higher than those of the mid- risk groups of GRACE score and TIMI risk score respectively（ P〈0. 05）. Multivariate Logistic regression analysis showed that female,age（ ≥70 years old）,WBC≥4 × 109/ L,Hb 110 g / L,Scr≥133 μmol / L and use of UFH ＋ GPI were independent risk factors for in- hospital bleeding（ P〈0. 05）. The AUC of predicting bleeding and MACE was 0. 875 〔95% CI（ 0. 776,0. 974） 〕for GRACE score and 0. 867 〔95% CI（ 0. 684,0. 934） 〕for TIMI risk score,which showed the two indicators both had predictive value for bleeding and MACE（ the P values were 0. 030 and 0. 001 compared with AUC = 0. 5）. H- L test results showed that the goodness of fit of TIMI risk score（ R2= 0. 775） was not significantly different from that of GRACE score（ R2= 0. 698）（ P〉0. 05）. Conclusion For STEMI patients who cannot take percutaneous coronary intervention（ PCI） timely, thrombolytic therapy rh Pro-UK can be applied for it brings high coronary recanalization rate and better safety and causes no increase in the incidence of bleeding and MACE, so thrombolytic therapy rh Pro-UK is worth further application in clinical practice. Female STEMI patients with higher age have greater risk of bleeding and MACE,especially for patients complicated with increased WBC,anemia,renal insufficiency and using both UFH and GPI.
出处
《中国全科医学》
CAS
CSCD
北大核心
2016年第9期1061-1066,共6页
Chinese General Practice
