复方丹参方制剂治疗稳定型心绞痛随机对照试验的系统评价

Systemic evaluation of Compound Preparation of Salvia Miltiorrhiza in treating stable angina in a randomized controlled trial

关键词:  复方丹参方  心绞痛  系统评价  荟萃分析

Key words:  Compound Preparation of Salvia Miltiorrhiza  angina  systematic evaluation

摘要:

[目的]评价复方丹参方制剂(与硝酸酯类作对照)治疗稳定型心绞痛的疗效和安全性。[方法]通过检索Cochrane Centre,MEDLINE,EMBASE,中国生物医学文献数据库(CBM),中文全文期刊数据库(CNKI)和维普中文期刊数据库(VIP)等数据库(截至2007年1月),全面搜集有关复方丹参方制剂(丹参、三七、冰片组成)治疗稳定型心绞痛的随机对照试验。质量评价参照Cochrane handbook4.26提供的标准。[结果]有33篇文献纳入评价。32个研究采用心绞痛症状改善为指标,合并效应量RR(random)及95%可信区间(CI)为1.16(1.10,1.23)。30个研究采用心电图改善为指标,合并效应量RR(random)及95%可信区间为1.38(1.25,1.51)。复方丹参方制剂的不良反应主要表现为轻度的胃部不适,发生率为3.4%,95%CI(2.5%,4.2%)。[结论]根据系统评价结果,提示复方丹参方治疗冠心病心绞痛与硝酸酯类相比,在改善心绞痛症状、改善心肌缺血状态等方面显示出一定的优势,且不良反应少。但由于原始研究质量较低,影响了结论的可靠性,有待高质量研究提供更有力的证据。

Abstract:

[Objective] To evaluate the curative effect and safety of Compound Preparation of Salvia Miltiorrhiza in treating stable angina in a randomized controlled trial. [Methods] From Cochrane Centre, MEDLINE, EMBASE, CBM, CNKI and VIP database the corresponding materials of Compound Preparation of Salvia Miltiorrhiza in treating stable angina in a randomized controlled trial were collected. Quality evaluation was done referring to the standard of Cochrane handbook 4.26. [Results] Thirty-three literatures were selected altogether. The symptomatic improvement of angia was adopted as the evaluation index in thirty-two researches and its RR(random) value and 95% CI were 1.16(1.10, 1.23). The improvement in ECG was adopted as evaluation index in thirty researches and its RR(random) value and 95% CI were 1.38(1.25, 1.51). The adverse reaction induced by Compound Salvia Miltiorrhiza Preparation was light stomach discomfort. Its incidence rate was 3.4% and 95% CI 2.5%, 4.5%. [Conclusions] According to the systematic evaluation result and comparing to nitrate medicine, it is considered that the Compound Preparation of Salvia Miltiorrhiza has some superiority in improving angina symptoms and myocardial ischemia.