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口服中成药治疗心力衰竭的疗效与安全性:一项系统评价与网状Meta分析方案

Effect and safety of oral Chinese patent medicine for heart failure: A protocol for systematic review and network meta-analysis.

作者信息

Guan Hui, Dai Guohua, Wang Ning, Gao Wulin, Ren Lili, Cai Zhenhao

机构信息

First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine.

Department of Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China.

出版信息

Medicine (Baltimore). 2020 Oct 16;99(42):e22754. doi: 10.1097/MD.0000000000022754.

DOI:10.1097/MD.0000000000022754
PMID:33080741
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7571918/
Abstract

BACKGROUND

Heart failure (HF) is the terminal stage of various common cardiovascular diseases with quite a frequent readmission and a high mortality rate, and brings heavy financial burdens to families and society. Oral Chinese patent medicine (CPM) has been widely applied in the treatment of HF in China because of its simplicity, cheapness, convenience, and high efficiency. However, due to the large number and broad clinical selectivity of oral CPMs, there is a lack of uniformity and clinical application standardization. To choose more effective and safe medicine among so many oral CPMs is particularly essential for further improving the therapeutic effect. In this study, the efficacy and safety of different oral CPMs will be compared by a network meta-analysis (NMA), and the best CPM will be selected for the treatment of HF.

METHODS

According to the search strategy, 4 English and 4 Chinese databases will be searched from the construction of the library to July 31, 2020. The NMA will include clinical randomized controlled trials (RCTs) of different oral CPMs in HF treatment. The methodological quality is assessed according to the bias risk assessment tool of Cochrane. The Bayesian NMA is performed by Aggregate Data Drug Information System (ADDIS), and the results are visualized using Stata 15.0 software. The GRADE approach is used to assess the quality of evidence and recommendation intensity.

RESULTS

The NMA will identify the best oral CPM in the complementary treatment of HF. A peer-reviewed journal will publish the results of the study.

CONCLUSION

This study can provide reliable evidence for the efficacy and safety of oral CPMs in the treatment of HF, and help decision-makers and patients to select more effective and safer oral CPM.

PROTOCOL REGISTRATION NUMBER

INPLASY202090053.

摘要

背景

心力衰竭(HF)是各种常见心血管疾病的终末期,再入院率相当高,死亡率也很高,给家庭和社会带来沉重的经济负担。口服中成药(CPM)因其简便、价廉、方便且高效,在中国已广泛应用于HF的治疗。然而,由于口服CPM种类繁多且临床选择性广泛,缺乏一致性和临床应用标准化。在众多口服CPM中选择更有效、更安全的药物对于进一步提高治疗效果尤为重要。在本研究中,将通过网状Meta分析(NMA)比较不同口服CPM的疗效和安全性,并选择最佳的CPM用于HF的治疗。

方法

根据检索策略,将检索4个英文数据库和4个中文数据库,检索时间从建库至2020年7月31日。NMA将纳入不同口服CPM治疗HF的临床随机对照试验(RCT)。根据Cochrane偏倚风险评估工具评估方法学质量。采用汇总数据药物信息系统(ADDIS)进行贝叶斯NMA,并使用Stata 15.0软件对结果进行可视化。采用GRADE方法评估证据质量和推荐强度。

结果

NMA将确定HF辅助治疗中最佳的口服CPM。该研究结果将发表在同行评审期刊上。

结论

本研究可为口服CPM治疗HF的疗效和安全性提供可靠证据,有助于决策者和患者选择更有效、更安全的口服CPM。

方案注册号

INPLASY202090053。

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