曲美他嗪治疗稳定型心绞痛疗效与安全性的系统评价

目的系统评价曲美他嗪(Trimetazidine,TMZ)治疗稳定型心绞痛(stable angina pectoris,SAP)的临床疗效和安全性。方法计算机检索CBM(1989～2011.6)、CNKI(1997～2011.6)、WanFang Data(1989～2011.6)、MEDLINE(1966～2011.6)、EMbase(1974～2011.6)和Cochrane对照试验资料库(1989～2011.6)中有关曲美他嗪治疗稳定型心绞痛的随机对照试验(RCT),按纳入与排除标准选择文献并进行资料提取和质量评价后,采用RevMan 5.0软件进行Meta分析。结果共纳入15个RCT,1 500例患者。Meta分析结果显示:在平板/踏车试验ST段压低1 mm阈值[WMD=0.84,95%(0.74,0.93),P<0.000 01]、运动持续时间[WMD=0.82,95%(0.73,0.91),P<0.000 01]、心绞痛发作阈值[WMD=1.18,95%(0.87,1.50),P<0.000 01]、每周心绞痛发作次数[WMD=–1.79,95%(–1.93,–1.66),P<0.000 01]和每周硝酸甘油消耗量[WMD=–0.60,95%(–0.74,–0.46),P<0.000 01]五个方面,曲美他嗪组均明显优于对照组;而在副反应方面,曲美他嗪组与对照组的差异无统计学意义[RR=0.83,95%CI(0.52,1.32),P=0.42]。结论曲美他嗪治疗稳定型心绞痛疗效优于对照药物,而副反应与对照药物无明显差别,疗效确切,安全性较好。受纳入文献的质量限制及可能存在的发表偏倚影响,本Meta分析结论尚需开展更多高质量、大样本、多中心、随机双盲对照试验加以证实。

Efficacy and Safety of Trimetazidine for Stable Angina Pectoris:A Systematic Review

Objective To evaluate the efficacy and safety of trimetazidine(TMZ) in the treatment of Stable Angina Pectoris(SAP).Methods Randomized controlled trials(RCTs) on the efficacy and safety of Trimetazidine in treating patients with SAP were retrieved in the following databases as CNKI(1997 to June 2011),WanFang Data(1989 to June 2011),MEDLINE(1966 to June 2011),EMbase(1974 to June 2011),CBM(1989 to June 2011) and Cochrane Central Database(1989 to June 2011).The literature which met the inclusion and exclusion criteria were selected,data were extracted,the quality was evaluated,and meta-analysis was performed by using RevMan 5.0 software.Results A total of 15 RCTs involving 1 500 patients were included.The meta-analysis showed that,compared with the control group,TMZ was significantly superior in the following 5 aspects: the time to 1 mm drop of ST segment(WMD=0.84,95%CI 0.74 to 0.93,P=0.000 01),duration of doing exercise(WMD=0.82,95%CI 0.73 to 0.91,P=0.000 01),and time to onset of angina(WMD=1.18,95%CI 0.87 to 1.50,P<0.000 01) in the treadmill test,weekly mean number of angina attacks(WMD= –1.79,95%CI –1.93 to –1.66,P<0.000 01),and weekly side effects between TMZ and the control group(RR=0.83,95%CI 0.52 to 1.32,P=0.42).Conclusion Based on current studies,TMZ is superior to other medicines in the control group for SAP at present,and it has no significant difference in side effects compared with the control group,so it is regarded as an effective and safe drug.For the quality restrictions and possible publication bias of the included studies,this conclusion needs to be confirmed by more high quality,large sample,multi-center,double blind RCTs.