复方丹参滴丸治疗稳定型心绞痛随机对照试验的系统评价

作者	单位
王蕾	四川大学华西医院中西医结合科成都610041
熊泽宇	四川大学华西医院中西医结合科成都610041
王刚	四川大学华西医院中西医结合科成都610041
李廷谦	四川大学华西医院中西医结合科成都610041

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中文摘要:

目的评价复方丹参滴丸与硝酸酯制剂对照治疗稳定型心绞痛的疗效和安全性。方法搜集使用复方丹参滴丸与硝酸酯制剂作对照治疗稳定型心绞痛的随机对照试验的文献 ,无语种限制。纳入试验的质量用Jadad计分表评价。对纳入的试验作Cochrane系统评价。结果符合纳入标准的论文共有 17篇 ,均为中文发表。两组心绞痛症状疗效和心电图疗效的合并效应量RR(相对危险度 )和 95 %的可信区间 (CI值 )分别为 1 12〔1 0 6 ,1 19〕和 1 4 2〔1 2 0 ,1 5 7〕。结论根据Cochrane系统评价 ,复方丹参滴丸治疗稳定型心绞痛 ,其心绞痛症状疗效和心电图改善优于硝酸酯制剂 ,且不良反应少 ,耐受性好。由于试验的方法学质量普遍较低 ,且缺乏一些重要的终点指标和与生活质量相关的指标 ,目前尚不能就此得出结论 ,需要设计更加合理、严格执行的大样本随机试验。

英文摘要:

ObjectiveTo assess the therapeutic effect and safety of compound salvia pellet (CSP) in treating stable angina pectoris (SAP).Methods Literatures regarding randomized clinical trials of CSP versus nitrate ester preparation in treating SAP, without any language limitation, were reviewed. Jadad scale was used to assess the methodological quality of the inclusive trials, and Cochrane systematic evaluation was applied for it. Results Seventeen randomized trials conformed to the inclusion criteria were reviewed, all in Chinese language. The combined results of the two comparing groups on therapeutic effect in symptom of angina and electrocardiogram (ECG) showed that the relative risk (RR) was 1 12 (1 06, 1 19) and the 95% credibility interval (CI) was 1 42 (1 20, 1 57). ConclusionBased on the Cochrane systematic review, CSP showed the therapeutic effect in treating SAP on relieving angina and improving ECG better than that of nitrate ester preparation, and with less adverse reaction and good tolerance. However the conclusion cannot be reached yet due to the low methodological quality of the trials collecting and lacking in some important final markers and relevant criteria for quality of life, more rationally designed and strictly executed randomized trials with large samples are necessary.

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