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振源胶囊联合西药治疗心力衰竭疗效及安全性的Meta分析

ISSN号：1674-070X
期刊名称：《湖南中医药大学学报》
时间：0
分类：R256.2[医药卫生—中医内科学;医药卫生—中医学] R541.6[医药卫生—心血管疾病;医药卫生—临床医学;医药卫生—内科学]
作者机构：湖南中医药大学,湖南长沙410208
相关基金：国家自然科学基金资助项目（81373576,81503536）;湖南省教育厅项目（148136,14C0872）;湖南省中医药管理局重点课题（201304）;湖南省科技厅一般项目（2014SK3034）;中西医结合防治心脑疾病的相关基础研究湖南省高校科技创新团队科研项目.

关键词：心力衰竭, 振源胶囊, 疗效及安全性, META分析, heart failure, Zhenyuan capsule, safety, Meta-analysis

中文摘要：

目的以Meta分析的方法对振源胶囊联合西药常规治疗心力衰竭的临床疗效与安全性进行系统评价.方法通过中国期刊全文数据库、中国生物医学文献数据库、万方数据库、维普数据库,检索振源胶囊治疗心力衰竭的随机对照临床试验文献.分别采用Review Manager 5.2软件、stata14软件、GRADEprofiler 3.6.1软件对数据进行偏倚风险评估、Meta分析,以及质量整体评价.结果符合纳入标准文献有13篇,共纳入1051例患者,文献整体质量偏低,Meta分析结果显示：在左室射血分数（LVEF）指标中,由于存在异质故将纳入研究按疗程分为两组,疗程大于6周组[SMD=0.85,95%CI（0.66,1.04）,Z=8.75,P〈0.0001]与疗程小于6周组中治疗组均优于对照组;在心功能改善的总有效率[OR=3.71,95%CI（2.53,5.45）,Z=6.71,P〈0.0001]和不良反应发生率[RR=0.35,95%CI（0.18,0.67）,Z=3.27,P=0.001]两指标中治疗组均优于对照组;以上结果均有统计学意义.结论对于心力衰竭的治疗,西药治疗基础上加用振源胶囊疗效更好,而且药物的安全性较好.受纳入研究质量所限,上述结论可能存在偏倚,需开展更多高质量研究予以验证.

英文摘要：

Objective To evaluate the clinical efficacy and safety of Zhenyuan capsule combined with Western medicine in the treatment of heart failure by Meta analysis. Methods The randomized controlled trials papers on heart failure with Zhenyuan capsule were searched from CNKI, Wanfang Data, Weipu Data, CBM Data. Review 5.2 Manager software, stata14 software, GRADEprofiler 3.6.1 software were used to bias risk assessment, Meta analysis, and quality evaluation of the studies. Results The 13 papers including 1051 patients were included into the review. The overall quality of studies is low. The Meta analysis results showed that in the left ventricular ejection fraction （LVEF） index, due to the presence of heterogeneity, the studies were was divided into two groups according to the course of treatment. The group with more than 6 weeks course treatment [SMD=0.85,95% CI （0.66, 1.04）,Z=8.75, P〈0.0001] and the group with less than 6 weeks course treatment were su-perior to the control group. The total efficiency of improving heart function [OR=3.71,95% CI （2.53,5.45）,Z=6.71,P〈0.0001] and the adverse reaction rate [RR= 0.35, 95% CI （0.18,0.67）,Z=3.27,P=0.001] in the treatment group were better than the control group. The above results were statistically significant. Conclusion The Western medicine plus Zhenyuan capsule show better curative effect and good safety on heart failure.Because of the quality of included RCTs in this study is poor, the con-clusions above may exist bias, more RCTs with high quality are needed for confirming this tendency.