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[参附注射液治疗心绞痛疗效的Meta分析]

[Meta-analysis on effect of Shenfu injection in treating angina pectoris].

作者信息

Zhou Xin-Bin, Miao Jing, Zhuang Qin, Xu Xiao-Ming, Mao Wei

机构信息

Department of Cardiology, First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou 310006, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2016 Feb;41(3):536-540. doi: 10.4268/cjcmm20160330.

Abstract

To systematically evaluate the efficiency and safety of Shenfu injection in treating patients with angina pectoris. Retrievals were made in Embase, Pubmed, Cochrane Library, Clinical Trials.gov, CNKI, CBM, VIP and Wanfang (before September 2015) for randomized or semi-randomized controlled trials reporting data of Shenfu injection in the adjuvant treatment of angina pectoris. The quality of included trials was evaluated according to tool evaluation at cochrane.org. STATA version 12.0 was applied for Meta analysis after quality assessment of included studies. Finally, a total of 17 studies, including 16 randomized controlled trials (RCTs) and 1 controlled clinical trial (CCT) involving 1 309 patients, met the inclusion criteria, of which 659 patients received Shenfu injection treatment. Meta-analysis results showed that Shenfu injection treatment group significantly improved angina pectoris symptoms (OR=3.38, 95%CI: 2.47-4.64, P=0.000) and ischemic ST-T changes in electrocardiogram (OR=3.30, 95%CI: 2.22-4.90, P=0.000), compared with control group. In the Meta-regression analysis, the average age of patients was positively correlated with the improved clinical (β=0.17) and electrocardiogram (β=1.15) efficacies. Major complication rate of Shenfu injection was 3.4%, and no serious adverse events were reported. Current clinical evidence in this study proved that Shenfu injection could significantly improve clinical symptoms and ECG ischemic changes for angina pectoris patients, with a good safety.

摘要

为系统评价参附注射液治疗心绞痛患者的有效性和安全性。检索了Embase、Pubmed、Cochrane图书馆、ClinicalTrials.gov、中国知网、中国生物医学文献数据库、维普资讯和万方数据库(截至2015年9月),查找报告参附注射液辅助治疗心绞痛数据的随机或半随机对照试验。根据cochrane.org上的工具评估对纳入试验的质量进行评价。对纳入研究进行质量评估后,应用STATA 12.0版进行Meta分析。最终,共有17项研究符合纳入标准,其中包括16项随机对照试验(RCT)和1项对照临床试验(CCT),涉及1309例患者,其中659例患者接受参附注射液治疗。Meta分析结果显示,与对照组相比,参附注射液治疗组显著改善了心绞痛症状(OR=3.38,95%CI:2.47-4.64,P=0.000)和心电图缺血性ST-T改变(OR=3.30,95%CI:2.22-4.90,P=0.000)。在Meta回归分析中,患者的平均年龄与临床疗效(β=0.17)和心电图疗效(β=1.15)的改善呈正相关。参附注射液的主要并发症发生率为3.4%,未报告严重不良事件。本研究的当前临床证据证明,参附注射液可显著改善心绞痛患者的临床症状和心电图缺血性改变,安全性良好。

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