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中药注射液治疗心力衰竭的系统评价和网状 Meta 分析研究方案

Traditional Chinese medicine injections for heart failure: a protocol for systematic review and network meta-analysis of randomised controlled trials.

机构信息

Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.

Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

出版信息

BMJ Open. 2020 Sep 28;10(9):e037331. doi: 10.1136/bmjopen-2020-037331.

Abstract

INTRODUCTION

Heart failure (HF) has always been an important issue in global public health. The research and development of traditional Chinese medicine (TCM) provide more possibilities for improving the prognosis of HF patients. Because multiple TCM injections (TCMIs) are being widely applied in clinical work, it is important to choose the right TCMIs for HF patients. The purpose of this study is to assess and compare the effect of different TCMIs for HF using network meta-analysis (NMA) and further provide references for clinical decision-making.

METHODS AND ANALYSIS

The clinical randomised controlled trials (RCTs) and meta-analyses of TCMIs for treating HF will be searched in the relevant database, including PubMed, EMBASE, Cochrane Library (No. 2 of 2020), Chinese BioMedical Literature Database, China National Knowledge Infrastructure, Wan Fang Database and Chinese Scientific Journal Database from inception to 29 February 2020. The outcomes of interest include all-cause mortality, rehospitalisation rate, left ventricular ejection fraction, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, brain natriuretic peptide (BNP), N-terminal pro-BNP, cardiac output, stroke volume, 6 min walking distance and adverse events. The risk of bias assessment of the included RCTs will be conducted according to the Cochrane Collaboration's tool for assessing the risk of bias. NMA will be performed in a Bayesian hierarchical framework using R V.3.6.1 with the gemtc package. Finally, we will rank the efficacy of these treatment programmes according to the surface under the cumulative ranking curve, and perform quality assessment and recommendation grading of the evidence according to the Grading of Recommendations Assessment, Development and Evaluation system.

ETHICS AND DISSEMINATION

This study will extract data from the published literature and will not involve private information from individuals or compromise their rights. Therefore, the study does not require ethical approval. The results will eventually be published in a peer-reviewed journal and disseminated at relevant conferences.

PROSPERO REGISTRATION NUMBER

CRD42020166900.

摘要

简介

心力衰竭(HF)一直是全球公共卫生的重要问题。传统中药(TCM)的研究和开发为改善 HF 患者的预后提供了更多的可能性。由于多种中药注射剂(TCMIs)在临床工作中得到广泛应用,因此为 HF 患者选择合适的 TCMIs 非常重要。本研究旨在通过网络荟萃分析(NMA)评估和比较不同 TCMIs 治疗 HF 的效果,并为临床决策提供参考。

方法与分析

将在相关数据库中检索 TCMIs 治疗 HF 的临床随机对照试验(RCTs)和荟萃分析,包括 PubMed、EMBASE、Cochrane 图书馆(第 2 期,2020 年)、中国生物医学文献数据库、中国国家知识基础设施、万方数据库和中国科学期刊数据库,检索时间截至 2020 年 2 月 29 日。感兴趣的结局包括全因死亡率、再住院率、左心室射血分数、左心室舒张末期直径、左心室收缩末期直径、脑钠肽(BNP)、N 末端 pro-BNP、心输出量、每搏输出量、6 分钟步行距离和不良事件。根据 Cochrane 协作组评估偏倚风险的工具对纳入的 RCTs 进行风险偏倚评估。NMA 将在 R V.3.6.1 贝叶斯层次框架中使用 gemtc 包进行。最后,我们将根据累积排序曲线下的面积对这些治疗方案的疗效进行排名,并根据推荐评估、制定和评价系统(Grading of Recommendations Assessment, Development and Evaluation system)对证据进行质量评估和推荐分级。

伦理与传播

本研究将从已发表的文献中提取数据,不会涉及个人的私人信息或损害他们的权利。因此,该研究不需要伦理批准。研究结果最终将发表在同行评议的期刊上,并在相关会议上传播。

PROSPERO 注册号:CRD42020166900。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dae6/7523221/5fa8b47b69de/bmjopen-2020-037331f01.jpg

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