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[比较中成药复方丹参滴丸与地奥心血康治疗心绞痛的随机对照试验的系统评价与荟萃分析]

[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].

作者信息

Ng Cui-shan, Wang Shan-ping, Cheong Jun-long, Wu Yu-dan, Jia Yong-liang, Leung Siu-wai

机构信息

University of Macau, Macao, China.

出版信息

Zhong Xi Yi Jie He Xue Bao. 2012 Jan;10(1):25-34. doi: 10.3736/jcim20120105.

Abstract

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, Excerpts 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; P(overall)=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; P(ECG)=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.

摘要

背景

中成药复方丹参滴丸(DSP)和地奥心血康(DXK)胶囊在治疗心绞痛方面均被证实有效。然而,尚无比较二者疗效的系统评价。

目的

本系统评价旨在基于比较DSP和DXK疗效的随机对照试验(RCT),比较二者治疗心绞痛的疗效。

检索策略

从中国博士学位论文全文数据库、中国期刊全文数据库、中国硕士学位论文全文数据库、万方数据、考克兰图书馆、医学文摘数据库、ScienceDirect、MEDLINE(EBSCOhost)和PubMed等数据库中检索1994年至2011年发表的RCT报告。末次检索时间为2011年4月7日。

纳入标准

纳入比较DSP和DXK疗效的RCT报告,不限发表语言。

数据提取与分析

采用Jadad量表和考克兰偏倚风险工具对纳入的RCT报告进行研究质量评估。从纳入的RCT中提取包括总体疗效和心电图(ECG)改善情况的数据进行荟萃分析。基于总体诊断和ECG诊断的效应量采用比值比(OR)和95%置信区间(CI)进行测量。同时进行亚组分析和敏感性分析。

结果

纳入9篇RCT报告,共926例参与者。采用Jadad量表评分,8篇得2分,1篇得4分。基于总体诊断,DSP和DXK之间的OR为2.06(95%CI:1.03 - 4.12;P(总体)=0.04)。9篇纳入的RCT中有6篇报告了ECG数据。基于ECG诊断,DSP和DXK之间的OR为1.92(95%CI:1.23 - 3.00;P(ECG)=0.004)。在亚组分析和敏感性分析中,OR结果稳定。

结论

荟萃分析表明,DSP疗效始终优于DXK,亚组分析和敏感性分析也证实了这一点。然而,需要更多高质量的RCT进行进一步验证。

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