比较复方丹参滴丸与地奥心血康胶囊治疗心绞痛随机对照临床试验的系统评价和meta分析

背景：复方丹参滴丸与地奥心血康胶囊是治疗冠心病心绞痛的常用中成药,已有临床试验比较它们的疗效,但尚未发现比较两者治疗心绞痛疗效的系统评价报告。目的：基于复方丹参滴丸和地奥心血康胶囊治疗心绞痛的临床随机对照试验（radominzed controlled trial,RCT）,通过meta分析系统评价两者治疗心绞痛的疗效。检索策略：检索发表于1994年至2011年的复方丹参滴丸和地奥心血康胶囊治疗心绞痛的RCT报告。检索的中文数据库包括中国博士学位论文全文数据库、中国期刊全文数据库、中国优秀硕士学位论文全文数据库和万方数据库;检索的外文数据库为Cochrane图书馆、荷兰医学文摘、ScienceDirect、MEDLINE（EBSCOhost）和PubMed。最后检索日期为2011年4月7日。纳入标准：报告描述为RCT,不限定发表语言;干预措施为使用药物治疗心绞痛;治疗组和对照组分别采用复方丹参滴丸和地奥心血康胶囊;治疗结局指标包括总体疗效和心电图改善;试验参与者需为冠心病心绞痛患者;疗程至少为28d。资料提取与分析：提取的数据项如下：发表年份;作者姓名;试验日期;试验组与对照组参与者的基线可比性;总样本量;疗效指标,包括总体疗效和心电图改善;疗程;每天给药剂量;复方丹参滴丸和地奥心血康胶囊的不良反应;总体疗效和心电图改善的有关数据。通过纳入和排除标准筛选检索到的RCT,利用Jadad评分量表和Cochrane偏倚风险评估量表进行质量评分。采用优势比（odds ratio,OR）和95%可信区间（confidence interval,CI）衡量总体疗效和心电图改善的效应值。根据纳入RCT的基本特征,进行亚组分析和敏感性分析。结果：最终纳入9篇RCT报告,包括926名试验参与者。9篇RCT中8篇的Jadad得分为2,另外1篇得分为4。复方丹参滴丸对地奥心血康胶囊的总体疗效的优势比为2.06（95%CI：1.03～4.12;P总效应=0.04）。6篇报告心电图疗效的RCT中复方丹参滴丸对地奥心血康胶囊的优势比为1.92（95%CI：1.23～3.00;P心电图疗效=0.004）。亚组分析及敏感性分析未发现可以显著影响结果稳定性的因素。结论：研究结果表明复方丹参滴丸治疗冠心病心绞痛的疗效优于地奥心血康,但尚需要更多高质量的RCT以确定疗效的差异程度。

Systematic review and meta-analysis of randomized controlled trials comparing Chinese patent medicines Compound Danshen Dripping Pills and Di'ao Xinxuekang in treating angina pectoris

BACKGROUND： Chinese patent medicines Compound Danshen Dripping Pills （DSP） and Di’ao Xinxuekang （DXK） capsules were both found effective in treating angina pectoris. However, there is no systematic review comparing their efficacy. OBJECTIVE： This systematic review aims to compare the efficacy of DSP and DXK in treating angina pectoris based on randomized controlled trials （RCTs） comparing their efficacy. SEARCH STRATEGY： RCT reports published between 1994 and 2011 were retrieved from databases including China Doctoral Dissertations Full-text Database, Chinese Journal Full-text Database, China Master’s Theses Full-text Database, Wanfang Data, Cochrane Library, Excerpta Medica Database, ScienceDirect, MEDLINE （EBSCOhost） and PubMed. The last retrieval was performed on April 7, 2011. INCLUSION CRITERIA： RCT reports comparing the effects of DSP and DXK were included, regardless publishing language. DATA EXTRACTION AND ANALYSIS： Included RCT reports were assessed for their study quality by using the Jadad scale and the Cochrane risk of bias tool. Data including overall effect and electrocardiography （ECG） improvements were extracted from the included RCTs for meta-analysis. The effect sizes based on overall and ECG diagnosis were measured by odds ratio （OR） and 95% confidence interval （CI）. Subgroup analysis and sensitivity analysis were also performed. RESULTS： Nine RCT reports with 926 participants were included. Eight were scored 2 and the other one was scored 4 by using the Jadad scale. The OR between DSP and DXK based on overall diagnosis was 2.06 （95% CI： 1.03-4.12; Poverall=0.04）. Six out of the nine included RCTs reported ECG data. The OR between DSP and DXK based on the ECG diagnosis was 1.92 （95% CI： 1.23-3.00; PECG =0.004）. The OR results were stable under subgroup analysis and sensitivity analysis. CONCLUSION： DSP was consistently more effective than DXK according to meta-analysis, which was verified by subgroup analysis and sensitivity analysis. However, more RCTs of higher quality are needed for further confirmation.