注射用红花黄色素治疗稳定型劳累性心绞痛疗效的系统评价

中国临床药理学与治疗学 ›› 2008, Vol. 13 ›› Issue (9): 1029-1036.

注射用红花黄色素治疗稳定型劳累性心绞痛疗效的系统评价

杨娟, 何迎春, 许羚, 吕映华, 陈君超, 郑青山

上海中医药大学药物临床研究中心, 上海市高校E 研究院, 上海201203

收稿日期:2008-05-28 修回日期:2008-09-11 出版日期:2008-09-26 发布日期:2020-10-13
通讯作者: 郑青山, 男, 教授, 博士生导师, 主要从事临床药理学和生物统计学研究。Tel:021-51323006 E-mail:zhengqs11@21cn.com
作者简介:杨娟, 女, 硕士, 研究方向:临床药理学和生物统计学。Tel:021-51322420 E-mail:janeyang5006@163.com
基金资助:
上海市教委重点学科建设项目(J50303);上海市高校E 研究院项目(E0308);上海高校选拔培养优秀青年教师科研专项基金资助

Effectiveness of safflor yellow injection in the treatment for stable angina pectoris:a systematic review

YANG Juan, HE Ying-chun, XU Lin, LV Ying-hua, CHEN Jun-chao, ZHENG Qing-shan

Center for Drug Clincal Reserch, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

Received:2008-05-28 Revised:2008-09-11 Online:2008-09-26 Published:2020-10-13

摘要/Abstract

摘要： 目的:系统评价注射用红花黄色素(saffloryellow injection, SYI) 在大样本、扣除多中心疗效变异时, 治疗稳定型劳累性心绞痛不同症状的有效性。方法:收集4 个多中心临床试验资料, 试验由26 个分中心完成, 结果不完全一致, 将每个分中心试验作为一个独立研究, 根据筛选标准, 选择合适的25 个分中心资料(总病例数1242 例, 试验组787 例, 对照组455 例) 作为Meta 分析的合并对象, 并对纳入研究的质量进行评价。计数资料采用相对危险度(RR)、计量资料采用加权均数差值(WMD) 进行合并分析。发表偏倚以失效安全数(N_fs) 进行分析。结果:SYI 治疗稳定型劳累性心绞痛的疗效均优于对照组, 包括胸痛疗效(RR_合并=1.25, 95% CI 1.12～1.39), 胸闷疗效(RR_合并=1.14, 95% CI 1.06～1.22), 心悸疗效(RR_合并=1.13, 95% CI 1.04～1.22), 症状综合疗效(RR_合并=1.21, 95% CI 1.13～1.31), 症状总积分下降值[WMD_合并=0.83, 95% CI 为(0.55, 1.12)] 。单项症状胸痛、胸闷、心悸改善的有效率分别为60% 、77.7% 、73.0%, 症状综合疗效有效率为81.7% 。失效安全数分析显示结果可靠。结论:扣除中心间变异的大样本分析提示, SYI 治疗稳定型劳累性心绞痛疗效确切;在多中心试验中, 如果各分中心试验结果差异较大或彼此相反, Meta 分析对试验的最终结论具有决定意义。

关键词: 注射用红花黄色素, 稳定型劳累性心绞痛, Meta分析, 多中心临床试验

Abstract: AIM: To review the effectiveness of the safflor yellow injection (SYI) in the treatment for stable angina pectoris under the condition of large sample and deduction of multicentre effectiveness variation.METHODS: Four multicenter clinical trials (completed by 34 sub-centers with different efficacy) were collected.Each sub-center clinical trial was regarded as an independent study.According to our criteria, 25 suitable sub-centers were identified.A total of 1242 participants (787 participants in treatment group and 455 subjects in control group) were analyzed by Meta-analysis.Quality of included trials was assessed.Relative risk (RR) was used for the analysis of dichotomous outcomes, and the weighted mean difference (WMD) for continuous outcomes.Analysis of publication bias was shown with Fail-Safe number (N_fs).RESULTS: The effectiveness of SYI in treating stable angina pectoris were superior to control group, such as the efficacy of chest pain with pooled RR 1.25 and 95% CI 1.12 to 1.39, the chest distress with pooled RR 1.14 and 95% CI 1.06 to 1.22, the cardiopalmus with pooled RR 1.13, 95% CI 1.04 to 1.22, the effective rate of total scores of symptoms with pooled RR 1.21, and 95% CI 1.13 to 1.31, and the decrease of total scores of symptoms with pooled WMD 0.83 and 95% CI 0.55 to 1.12.The effective rates of chest pain, chest distress and cardiopalmus are 60%, 77.7% and 73.0%, respectively.It was 81.7% in total scores of symptoms.Fail-Safe number showed that the publication bias was not significant and the results were reliable.CONCLUSION: SYI is an effective agent for stable angina pectoris.This study also shows that if the result from each sub-center clinical trial is quite different or opposite, Meta-analysis can make decision about efficacy in multicentre clinical trial.

Key words: saffloryellowinjection(SYI), stableanginapectoris, Meta-analysis, multicentreclinicaltrial

中图分类号:

R969.1

杨娟, 何迎春, 许羚, 吕映华, 陈君超, 郑青山. 注射用红花黄色素治疗稳定型劳累性心绞痛疗效的系统评价[J]. 中国临床药理学与治疗学, 2008, 13(9): 1029-1036.

YANG Juan, HE Ying-chun, XU Lin, LV Ying-hua, CHEN Jun-chao, ZHENG Qing-shan. Effectiveness of safflor yellow injection in the treatment for stable angina pectoris:a systematic review[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(9): 1029-1036.

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