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用于心力衰竭的中药注射剂:系统评价与网状Meta分析方案

Chinese herbal injections for heart failure: A protocol for systematic review and network meta-analyses.

作者信息

Yang Fengwen, Zou Jiahan, Ge Long, Tian Jinhui, Lee Myeong Soo, Jun Ji Hee, Zhang Junhua

机构信息

Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin Evidence-Based Medicine Center, Lanzhou University, Lanzhou, China Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

出版信息

Medicine (Baltimore). 2018 Feb;97(8):e9973. doi: 10.1097/MD.0000000000009973.

DOI:10.1097/MD.0000000000009973
PMID:29465597
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5842018/
Abstract

BACKGROUND

Chinese herbal injections (CHIs) are commonly used for the treatment of heart failure in China. Due to the variety of CHIs used in clinic, selecting a suitable CHI for patients with heart failure is vital. This study aims to assess and compare the effect of different CHIs for heart failure using network meta-analysis (NMA).

METHODS

Six electronic databases, including PubMed, the Cochrane Central Register of Controlled Trials, Embase, China National Knowledge Infrastructure, Wanfang, and Chinese Biomedical Literature Database will be search from inception to January 2018. Randomized controlled trial (RCT) comparing CHI with another CHI will be included. The primary outcome will be changes in heart function classification and left ventricular ejection fraction. Risk of bias assessment of the included RCTs will be conducted according to the Cochrane Handbook 5.1.0. A Bayesian NMA will be performed using WinBUGS 14 software and the result figures will be generated using Stata 13 software. GRADE will be used to explore the quality of evidence.

RESULTS

The results of this NMA will be published in a peer-reviewed journal.

CONCLUSION

Our study will generate evidence of CHIs for patients with heart failure and provide suggestions for Chinese medicine clinical practice or guideline.

ETHICS AND DISSEMINATION

Ethics approval and patient consent are not required because this study is an NMA based solely on the published literature. The results of this NMA will be submitted to a peer-reviewed journal.

PROTOCOL REGISTRATION NUMBER

PROSPERO CRD 42018086740.

摘要

背景

在中国,中药注射剂常用于治疗心力衰竭。由于临床使用的中药注射剂种类繁多,为心力衰竭患者选择合适的中药注射剂至关重要。本研究旨在采用网状Meta分析(NMA)评估和比较不同中药注射剂治疗心力衰竭的效果。

方法

检索包括PubMed、Cochrane对照试验中心注册库、Embase、中国知网、万方和中国生物医学文献数据库在内的6个电子数据库,检索时间从建库至2018年1月。纳入比较一种中药注射剂与另一种中药注射剂的随机对照试验(RCT)。主要结局将是心功能分级和左心室射血分数的变化。将根据Cochrane手册5.1.0对纳入的RCT进行偏倚风险评估。将使用WinBUGS 14软件进行贝叶斯NMA,并使用Stata 13软件生成结果图。将使用GRADE来探讨证据质量。

结果

本NMA的结果将发表在同行评审期刊上。

结论

我们的研究将为心力衰竭患者生成中药注射剂的证据,并为中医临床实践或指南提供建议。

伦理与传播

由于本研究是一项仅基于已发表文献的NMA,因此无需伦理批准和患者同意。本NMA的结果将提交给同行评审期刊。

方案注册号

PROSPERO CRD 42018086740。

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A randomized, double-blind, multicenter, placebo-controlled clinical study on the efficacy and safety of Shenmai injection in patients with chronic heart failure.一项关于参麦注射液治疗慢性心力衰竭患者有效性和安全性的随机、双盲、多中心、安慰剂对照临床研究。
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Shenmai injection as an adjuvant treatment for chronic cor pulmonale heart failure: a systematic review and meta-analysis of randomized controlled trials.参麦注射液辅助治疗慢性肺源性心脏病心力衰竭:一项随机对照试验的系统评价与Meta分析
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BMJ. 2015 Jan 2;350:g7647. doi: 10.1136/bmj.g7647.
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