通心络胶囊治疗冠心病疗效及安全性的系统评价  

Tongxinluo Capsule for Coronary Heart Disease:A Systematic Review

作　　者：周忠冉[1] 唐海沁[1] 李结华[1] 杨琳琳[1] 胡昊[1] 

机构地区：[1]安徽医科大学第一附属医院老年心血管科,合肥230022

出　　处：《中国循证医学杂志》2011年第9期1078-1083,共6页Chinese Journal of Evidence-based Medicine

基　　金：安徽省科研计划项目(编号:10021303007);安徽省高校省级科研项目(编号:KJ2010A199)

摘　　要：目的系统评价通心络胶囊治疗冠心病心绞痛的有效性及安全性。方法计算机检索Cochrane图书馆临床对照试验资料库(2010年第4期)、PubMed(2000～2010.4)、万方数据库(1996～2010.4)、CNKI(1994～2010.4)、VIP(1989～2010.4),收集通心络胶囊治疗冠心病心绞痛的随机和半随机对照试验,按纳入和排除标准由2名评价者独立选择试验、提取资料,交叉核对并进行方法学质量评估后,使用RevMan 5.0软件进行Meta分析。结果共纳入13个研究,共计1 496例患者。Meta分析结果显示:与硝酸酯类药物相比,在治疗冠心病有效性方面,通心络胶囊疗效优于消心痛[RR=0.50,95%CI(0.36,0.70)]、硝酸异山梨酯[RR=0.19,95%CI(0.12,0.30)],两组总体临床疗效有效性差异有统计学意义[RR=0.34,95%C(I0.26,0.44),P<0.000 01];在心电图改善方面,通心络胶囊疗效优于消心痛[RR=0.55,95%CI(0.46,0.66)]、硝酸异山梨酯[RR=0.58,95%CI(0.48,0.70)],两组总体心电图改善差异有统计学意义[RR=0.56,95%CI(0.49,0.64),P<0.000 01)];在胃肠道不适、头痛等不良反应发生率方面,通心络组低于硝酸酯组,其差异有统计学意义[RR=0.33,95%CI为(0.20,0.53),P<0.000 01]。结论现有证据显示,通心络胶囊治疗冠心病的临床疗效及心电图改善优于单用西药消心痛或硝酸异山梨酯,且不良反应少。鉴于本系统评价纳入研究的证据质量较低且样本量有限,尚需开展更多设计合理、执行严格的多中心大样本且随访时间足够长的随机对照试验来验证其疗效及安全性。Objective To assess the effectiveness and safety of tongxinluo capsule for coronary heart disease.Methods Both the randomized controlled trials（RCTs） and quasi-RCTs of tongxinluo capsule for coronary heart disease were collected through searching on computer from the following databases,The Cochrane Library（Issue 4,2010）,Pub-Med（2000 to April 2010）,WanFang Data（1996 to April 2010）,CNKI（1994 to April 2010） and VIP（1989 to April 2010）.The trials selection based on inclusion and exclusion criteria,data extraction,cross check and quality assessment were conducted by two reviewers independently,and meta-analysis was performed with RevMan 5.0 so ware.Results A total of 13 studies involving 1 496 participants were included.The results of meta-analyses showed that： compared with the ni-trate esters group,the tongxinluo capsule group had a better curative e ect on the coronary heart disease than isosorbide dinitrate（RR=0.50,95%CI 0.36 to 0.70） and isosorbide mononitrate（RR=0.19,95%CI 0.12 to 0.30）;there was signi cant difference in the total curative e ect between the two groups（RR=0.34,95%CI 0.26 to 0.44,P0.000 01）;the tongxinluo capsule was also better in improving the ECG than isosorbide dinitrate（RR=0.55,95%CI 0.46 to 0.66） and isosorbide mononitrate（RR=0.58,95%CI 0.48 to 0.70）;there was signi cant difference in the total ECG improvement between the two groups（RR=0.56,95%CI 0.49 to 0.64,P0.000 01）;the tongxinluo capsule group had a lower incidence rate of adverse reaction than the nitrate esters group with a significant difference（RR=0.33,95%CI 0.20 to 0.53,P0.000 01）.Conclu-sion e present evidence indicates that tongxinluo capsule is not inferior to isosorbide dinitrate or isosorbide mon-onitrate in improving the curative e ect and ECG,and it has fewer adverse reactions.More well-designed and large scale multi-centered RCTs are required with longer follow-up time to con rm this conclusion.

关 键 词：通心络胶囊 消心痛 硝酸异山梨酯 冠心病 心绞痛 随机对照试验 Meta分析 系统评价 

分 类 号：R259[医药卫生—中西医结合]