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葛根素注射液治疗不稳定型心绞痛

Puerarin injection for unstable angina pectoris.

作者信息

Wang Q, Wu T, Chen X, Ni J, Duan X, Zheng J, Qiao J, Zhou L, Wei J

出版信息

Cochrane Database Syst Rev. 2006 Jul 19(3):CD004196. doi: 10.1002/14651858.CD004196.pub2.

Abstract

BACKGROUND

Puerarin is extracted from the Chinese herb puerariae lobata. Many users of Chinese herbal medicine believe that puerarin has positive effects in the treatment of coronary heart disease (CHD). In recent years puerarin injection has been widely used to treat CHD and angina pectoris.

OBJECTIVES

To assess the benefits and harms of puerarin injection for unstable angina.

SEARCH STRATEGY

The following electronic databases were searched: The Cochrane Controlled Trials Register on The Cochrane Library (Issue 3, 2004), MEDLINE (1995 to 2004), EMBASE (1995 to 2004), CBM (1995 to 2004), Chinese Cochrane Centre Controlled Trials Register (to 2004), Current Controlled Trials (www.controlled-trials.com) and The National Research Register. We also hand searched 60 Chinese traditional medicine journals.

SELECTION CRITERIA

Randomised controlled trials undertaken on adults with unstable angina evaluating the following types of interventions: Puerarin injection compared to western drugs or placebo, or puerarin injection used with western drugs compared to western drugs alone.

DATA COLLECTION AND ANALYSIS

Data were extracted and analysed independently by two reviewers. Differences in data extraction and analysis were resolved by consensus, referring back to the original article. Study authors were contacted for additional information. Adverse effects information was collected from the trials.

MAIN RESULTS

20 trials involving 1240 people were included. All trials identified were classified as having a high risk of bias because of poor reported methodology. The duration of treatment was 7-20 days and no information supplied suggested longer follow-ups were conducted for any trials. This limited the observation to participants who were not undertaking normal activities of daily living. The primary outcome (death) was not report in any trial. For all the secondary outcome measures, frequency of acute angina attacks, improvements in ECG, doses and incidence of nitroglycerine needed and levels of plasma endothelin, there was no evidence that puerarin had better or worse effects to other conventional treatments. There was strong evidence to suggest that puerarin injection plus western drugs was a better treatment option than western drugs alone.

AUTHORS' CONCLUSIONS: Puerarin injection may be effective in unstable angina when used in addition to conventional treatments. However, these finding should be interpreted with care because of the very low methodological quality of studies and potential publication bias. In the light of the findings, a more rigorously designed, randomised double-blind placebo-controlled trial is needed.

摘要

背景

葛根素是从中药野葛中提取的。许多中药使用者认为葛根素在治疗冠心病(CHD)方面有积极作用。近年来,葛根素注射液已被广泛用于治疗冠心病和心绞痛。

目的

评估葛根素注射液治疗不稳定型心绞痛的利弊。

检索策略

检索了以下电子数据库:考克兰图书馆的考克兰对照试验注册库(2004年第3期)、MEDLINE(1995年至2004年)、EMBASE(1995年至2004年)、中国生物医学文献数据库(1995年至2004年)、中国考克兰中心对照试验注册库(截至2004年)、当前对照试验(www.controlled-trials.com)和国家研究注册库。我们还手工检索了60种中医期刊。

选择标准

对成年不稳定型心绞痛患者进行的随机对照试验,评估以下类型的干预措施:葛根素注射液与西药或安慰剂相比,或葛根素注射液与西药联合使用与单纯西药相比。

数据收集与分析

由两名评价员独立提取和分析数据。数据提取和分析中的差异通过协商一致解决,如有必要会参考原文。与研究作者联系以获取更多信息。从试验中收集不良反应信息。

主要结果

纳入了20项试验,涉及1240人。由于报告的方法学较差,所有纳入的试验均被归类为存在高偏倚风险。治疗持续时间为7至20天,没有提供信息表明有任何试验进行了更长时间的随访。这限制了对未进行正常日常生活活动的参与者的观察。任何试验均未报告主要结局(死亡)。对于所有次要结局指标,急性心绞痛发作频率、心电图改善情况、所需硝酸甘油剂量和发生率以及血浆内皮素水平,没有证据表明葛根素与其他传统治疗相比有更好或更差的效果。有强有力的证据表明,葛根素注射液联合西药比单纯西药是更好的治疗选择。

作者结论

葛根素注射液在联合传统治疗时可能对不稳定型心绞痛有效。然而,由于研究的方法学质量非常低以及潜在的发表偏倚,这些发现应谨慎解读。鉴于这些发现,需要进行一项设计更严谨的随机双盲安慰剂对照试验。

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