通心络胶囊治疗冠心病随机对照试验的系统评价  

Systematic Review on Randomized Controlled Trials for Treatment of Coronary Heart Disease by Tongxinluo Capsule

作　　者：何穗智[1] 吴伟康[2] 邓卓燊[1] 欧顺云[1] 刘素芳[1] 曾百乐[1] 

机构地区：[1]中山大学公共卫生学院//预防医学研究所医学统计与流行病学系,广东广州510080 [2]中山大学中西医结合研究所,广东广州510080

出　　处：《中山大学学报（医学科学版）》2007年第5期573-577,共5页Journal of Sun Yat-Sen University:Medical Sciences

基　　金：国家重点基础研究发展计划项目(973项目;2005CB523305)

摘　　要：【目的】评价通心络胶囊与消心痛等西药治疗冠心病的疗效差异及安全性。【方法】两名作者独立收集资料和评价纳入文献质量,运用meta分析对资料进行定量综合,评价不良反应。【结果】(1)对17项研究的临床疗效有效率合并效应量的检验:OR合并=2.38,其95%CI为[1.83,3.09](P<0.01);(2)对12项研究的心电图疗效有效率合并效应量的检验:OR合并=2.08,95%CI为[1.54,2.82](P<0.01);(3)有4篇论文报道未发现通心络明显毒副作用,11篇报道胃肠不适、头痛等不良反应例数:通心络组17例,发生率为2.64%;对照组63例,发生率为10.92%;(4)在治疗前后对通心络组患者血、尿、粪常规、肝肾功能、心肌酶和电解质的检验,均未发现异常变化。【结论】现有证据提示通心络胶囊临床疗效和心电图疗效优于消心痛,且不良反应少。受纳入文献的质量限制,其疗效有待高质量的随机对照试验来评价。[Objective] To evaluate the differences in curative effect on coronary heart disease between Tongxinluo capsule and western medicine like Isosorbide Dinitrate, and their safety. [Methods ] Two authors collected data and evaluated the quality of the included studies independently. The data were quantified by meta- analysis to review the adverse drug reactions. [Results] （1）Test of the combined curative effect of 17 studies showed an OR affiliate of 2.38, 95%, and the confidence interval of OR was [1.83, 3.09] , P〈 0.01. The result of meta-analysis was statistically significant; （2）Test of the combined curative effect based on the cardiograms in 12 articles showed an OR affiliate of 2.08, 95%, and the confidence interval of OR was [1.54, 2.82] , P〈0.01; （3）Four studies reported that obvious side effects were not detected in patients taking Tongxinluo capsule. Some patients were reported to have adverse reactions such as gastrointestinal tract disorder and headache in 11 articles, in which 17 patients were included in the Tongxinluo capsule group （2.64%）, while 63 patients were included in the control group （10.92%）; （4）By examining the results of blood, urine, and excrement tests, liver and renal functions, cardiac creatase, and electrolytes before and after the trial, we did not find any significant changes. [Conclusion] Now we have evidence to indicate that the Tongxinluo capsule can improve curative effect better than Isosorbide Dinitrate. Due to the limited quality of the included studies, the curative effect will be evaluated by high quality RCT.

关 键 词：通心络胶囊 冠心病 心绞痛 META分析 随机对照试验 系统评价 

分 类 号：R54[医药卫生—心血管疾病]