中国人群使用曲美他嗪治疗稳定型心绞痛疗效评价

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (12): 723-729.

中国人群使用曲美他嗪治疗稳定型心绞痛疗效评价

章锦丽¹,杨雪²,张惠霞²,卢洁³,王丽²,程刚^4*

1.河南省食品药品监督管理局,河南郑州 450000；
2.河南省食品药品评价中心,河南郑州 450004；
3.郑州大学公共卫生学院,河南郑州 450001；
4.国家食品药品监督管理局药品评价中心,北京100045

收稿日期:2013-05-16 修回日期:2016-03-09 出版日期:2013-12-08 发布日期:2016-03-09
通讯作者: 程刚,男,硕士,药事管理,药物警戒与上市后再评价。 E-mail:chenggang@cdr.gov.cn
作者简介:章锦丽,女,硕士,药品管理,药品安全监测。

A Systematic Review of Efficacy of Trimetazidine for Stable Angina Pectoris in Chinese People

ZHANG Jin -li¹ ,YANG Xue² ,ZHANG Hui -xia², LU Jie³, WANG Li² ,CHENG Gang^4*

1.Henan Food and Drug Administration, Henan Zhengzhou 450000, China;
2.Food and Drug Reevaluation Center of Henan Province, Henan Zhengzhou 450004, China;
3.College of Public Health, Zhengzhou University, Henan Zhengzhou 450001, China;
4.Center for Drug Reevaluation, SFDA, Beijing 100045, China

Received:2013-05-16 Revised:2016-03-09 Online:2013-12-08 Published:2016-03-09

摘要/Abstract

摘要： 目的系统评价曲美他嗪治疗稳定型心绞痛（stable angina pectoris,SAP）的临床疗效。方法 2012年10月以曲美他嗪相关药品名称、口服制剂等做检索词,检索PubMed、Embase、Cochrane、中国生物医学文献数据库（CBM）、中国期刊全文专题数据库（CNKI）、中国科技期刊数据库（VIP）及万方数据库等,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Meta分析等统计学方法对曲美他嗪治疗稳定型心绞痛的疗效作系统评价。结果共纳入13个RCT,869例患者。Meta分析结果显示：在总有效率、每周心绞痛发作次数、每周硝酸甘油消耗量、ST段压低1mm阈值、心绞痛发作阈值5个方面,治疗组均明显优于对照组；而在运动持续时间方面,不支持曲美他嗪有增加患者运动持续时间的作用。结论曲美他嗪治疗稳定性心绞痛的疗效优于常规对照组,但因纳入的研究存在一定的方法学缺陷,本研究结论尚需进一步开展严格设计的大样本、多中心、随机双盲对照试验来证实。

关键词: 中国人群, 曲美他嗪, 稳定型心绞痛, 疗效, Meta分析

Abstract: Objective To evaluate the efficacy of trimetazidine(TMZ) in the treatment of stable angina pectoris(SAP). Methods All literatures related to trimetazidine were retrieved in the following databases as PubMed, EMbase, Cochrane Central Database, CBM, CNKI, VIP and WanFang Data. The literatures which met the inclusion and exclusion criteria were selected, data were extracted, the quality was evaluated, and then statistical Methods such as Meta-analysis were performed. Results A total of 13 RCTs involving 869 patients were included. The Meta -analysis showed that, compared with the control group, TMZ was significantly superior in the following5 aspects: total efficiency, weekly mean number of angina attacks, weekly nitroglycerin consumption, the time to 1 mm drop of ST segment and angina pectoris threshold. But TMZ has no significant difference in duration of doing exercise compared with the control group. Conclusion Based on current studies, TMZ is superior to other medicines in the control group for SAP at present. However, due to defect of the data analysis method, this Conclusion needs to be confirmed by more high quality, large sample, multi-center, double blind RCTs.

Key words: Chinese people, trimetazidine, stable angina pectoris, efficacy, Meta-analysis

中图分类号:

R453

章锦丽,杨雪,张惠霞,卢洁,王丽,程刚 . 中国人群使用曲美他嗪治疗稳定型心绞痛疗效评价[J]. 中国药物警戒, 2013, 10(12): 723-729.

ZHANG Jin -li ,YANG Xue ,ZHANG Hui -xia, LU Jie, WANG Li ,CHENG Gang . A Systematic Review of Efficacy of Trimetazidine for Stable Angina Pectoris in Chinese People [J]. Chinese Journal of Pharmacovigilance, 2013, 10(12): 723-729.

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