中药治疗动脉硬化性闭塞症疗效及安全性的系统评价

Effects and Safety of Traditional Chinese Medicine in Treating Arteriosclerosis Obliterans:A Systematic Review

目的系统评价中药治疗动脉硬化性闭塞症疗效及可能的不良反应。方法电子检索EMbase(1978～2009.10)、OVID-MEDLIND(1950～2009.10)、Cochrane图书馆临床试验资料库(2009年第3期)、Current Controlled Trials、The National Research Register、中国生物医学文献数据库(1983～2009.9)、中国期刊全文数据库(1995～2009.9)、万方(1994～2009)、维普(1989～2009),并手工检索相关领域杂志。检索时间截至2009年10月,所有检索均不受语种限制。评价纳入研究的质量,并用RevMan5.0.2软件进行统计学分析。结果共纳入10个随机对照试验,包括837例患者,各研究样本量36～260例。因各研究采用不同的中药或对照,故仅能进行单个描述和重新计算各研究的疗效效应量。多数研究显示,中药对治愈率、总有效率、降低血清总胆固醇、血清甘油三酯的疗效与阿司匹林、阿昔莫司、前列腺素E1等西药相当;个别研究显示中药优于西药;1篇研究报道了对副作用的观察,中药的副作用少于西药。结论中药治疗动脉硬化性闭塞症的疗效证据仍十分有限,尚需高质量的研究以增加证据强度。

Objective To assess the effects and possible adverse reactions of traditional Chinese medicine （TCM） in treating arteriosclerosis obliterans.Methods Materials were collected with both electronic retrieval including EMbase （1978 to October 2009）,OVID-MEDLINE （1950 to October 2009）,Cochrane Controlled Trials Register （Issue 3,2009）,Current Controlled Trials,The National Research Register,CBM （1983 to September 2009）,CNKI （1995 to September 2009）,Wanfang Data （1994 to 2009）,and VIP Data （1989 to 2009）,and manual retrieval of related journals.All the retrievals were published before November 10,2009 without limitation of languages.The quality of included studies was evaluated,and meta-analysis was conducted with RevMan 5.0.2 software.Results A total of 10 included studies were all randomized controlled trials,including 837 patients,and the sample size of each study was from 36 to 260 cases.Because both Chinese medicines and control drugs used in studies were different from each other,the effect size of each study can only be singley described and newly calculated.Most included studies showed that,the effects of TCM on cure rate,total effective rate and decrease of TC and TG were similar to that of aspirin,acipimox,prostaglandin E1;a few studies showed the effect of TCM was much better;one study on side effect showed that,TCM was less than western medicine.Conclusion The evidences of TCM effects in treating arteriosclerosis obliterans is quite limited,which has to be strengthened by more studies of high quality.