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用于慢性心力衰竭的中药制剂:系统评价和荟萃分析的伞状评价研究方案

Chinese herbal preparations for chronic heart failure: Study protocol for an umbrella review of systematic reviews and meta-analyses.

作者信息

Li Yong, Zhang Xiaohua, Chen Xiaoxiao, Chen Dezhu, Yu Qian, Yang Shenglan, Lang Mingjian

机构信息

Department of Cardiology, The Fifth People's Hospital affiliated to Chengdu University of Traditional Chinese Medicine.

Jane Lab, Big Data Research Center, University of Electronic Science and Technology of China, Chengdu, China.

出版信息

Medicine (Baltimore). 2020 Feb;99(7):e18966. doi: 10.1097/MD.0000000000018966.

Abstract

BACKGROUND

Chinese herbal preparations (CHPs) have been reported to be effective in the management of chronic heart failure (CHF); they are beneficial in improving cardiac function, reducing hospital stays and readmission. However, the credibility of their effectiveness evidence has not been evaluated. We aim to summarize and evaluate current effectiveness evidence of traditional Chinese medicine in the management of CHF.

METHODS

We will search PubMed, Embase, the Cochrane Database of Systemic Review (CDSR), and Web of Science from inception to December 2019 for systematic reviews that assessing the effectiveness of CHPs for CHF. The search will be performed without language restriction. Experimental interventions will include any type of CHPs, and control interventions will include placebo, sham interventions, usual care, or no controls. The primary outcome will be the changes in heart function classification defined by the New York Heart Association. Secondary outcomes include left ventricular ejection fraction, Six Minute Walk Test, other efficacy outcomes, and adverse events. We will use I statistics to assess the between-study heterogeneity in each meta-analysis, Eager test to detect publication bias, and the ratio of observed versus expected number of trials with positive findings. We will summarize the evidence and classify them into convincing, highly suggestive, suggestive, or weak.

RESULTS

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

ETHICS AND DISSEMINATION

No ethical approval and patient consent are required since this study data is based on published literature. The results of the study will be submitted to a peer-reviewed journal.

PROTOCOL REGISTRATION NUMBER

PROSPERO CRD 42019139649 (https://www.crd.york.ac.uk/PROSPERO/#joinuppage).

摘要

背景

据报道,中药制剂(CHPs)在慢性心力衰竭(CHF)的管理中有效;它们有助于改善心脏功能、减少住院时间和再入院率。然而,其有效性证据的可信度尚未得到评估。我们旨在总结和评估中医在CHF管理中的当前有效性证据。

方法

我们将检索PubMed、Embase、Cochrane系统评价数据库(CDSR)和Web of Science,检索时间从建库至2019年12月,以查找评估CHPs治疗CHF有效性的系统评价。检索将不受语言限制。实验性干预措施将包括任何类型的CHPs,对照性干预措施将包括安慰剂、假干预、常规护理或无对照。主要结局将是纽约心脏协会定义的心脏功能分级的变化。次要结局包括左心室射血分数、六分钟步行试验、其他疗效结局和不良事件。我们将使用I统计量评估每项荟萃分析中的研究间异质性,使用Egger检验检测发表偏倚,以及有阳性结果的观察性试验与预期试验数量之比。我们将总结证据并将其分为令人信服、高度提示、提示或薄弱。

结果

本研究结果将发表在同行评审期刊上。

伦理与传播

由于本研究数据基于已发表文献,因此无需伦理批准和患者同意。研究结果将提交给同行评审期刊。

方案注册号

PROSPERO CRD 42019139649(https://www.crd.york.ac.uk/PROSPERO/#joinuppage)。

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Intern Emerg Med. 2020 Jan;15(1):49-58. doi: 10.1007/s11739-019-02024-4. Epub 2019 Jan 18.
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Korean Guidelines for Diagnosis and Management of Chronic Heart Failure.《韩国慢性心力衰竭诊断与管理指南》
Korean Circ J. 2017 Sep;47(5):555-643. doi: 10.4070/kcj.2017.0009. Epub 2017 Sep 18.

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