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芪参益气滴丸治疗慢性心力衰竭的作用:系统评价与Meta分析概述

The role of Qishen Yiqi dripping pills in treating chronic heart failure: An overview of systematic reviews and meta-analyses.

作者信息

Chen Wensheng, Chen Jiezhen, Wang Yuanping, Yan Jiaqi, Yan Xia, Wang Dawei, Liu Yuntao

机构信息

Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.

Shunde Hospital of Guangzhou University of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.

出版信息

Front Cardiovasc Med. 2022 Oct 24;9:1001072. doi: 10.3389/fcvm.2022.1001072. eCollection 2022.

Abstract

OBJECTIVES

Evidence from systematic reviews/meta-analyses about the efficacy and safety of Qishen Yiqi (QSYQ) dripping pills in chronic heart failure (CHF) remains unclear. This study comprehensively reviewed available systematic reviews on latest evidence to provide reliable information for the clinical use of QSYQ in CHF.

METHODS

The systematic review was performed on studies retrieved from six major medical databases. Eligible studies were evaluated in terms of methodological quality and quality of evidence using the Assessment of Multiple Systematic review 2 (AMSTAR-2) tool, the Risk of Bias in Systematic Reviews (ROBIS) was used to assess the risk of bias, and the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) 2020 was utilized for assessing reporting quality. In addition, the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was used to determine primary outcome indicators' evidence quality.

RESULTS

A total of 14 systematic reviews were included in this study, based on which it could be concluded that QSYQ combined with conventional medicine (CM) treatment tended to be superior to CM treatment alone in terms of improving cardiac function-related indices (e.g., increasing the left ventricular ejection fraction [LVEF] and reducing the left ventricular end-diastolic dimension [LVEDD] and left ventricular end-systolic internal diameter [LVESD]), improving the total effective rate and 6-min walking distance (6MWD), and reducing N-terminal pro-brain natriuretic peptide (NT-proBNP). Overall, no serious QSYQ-related adverse events were observed. However, the GRADE results showed "very low" to "moderate" evidence for these outcomes, with no high-quality evidence supporting them. Unsatisfactory results were obtained in terms of methodological quality, risk of bias and reporting quality after assessment using the AMSTAR-2, ROBIS, and PRISMA 2020, limited mainly by deficiencies in the following areas: registration of study protocols, explanation of the inclusion of randomized controlled trials (RCTs), complete and detailed search strategy, list of excluded literature, description of funding sources for inclusion in RCTs, investigation of the impact of risk of bias on the results of meta-analysis, and reporting of potential conflicts of interest.

CONCLUSION

The efficacy and safety of QSYQ adjuvant therapy in CHF remain to be further clarified due to the lack of high-quality evidence provided by current systematic reviews.

摘要

目的

关于芪参益气滴丸(QSYQ)治疗慢性心力衰竭(CHF)疗效及安全性的系统评价/荟萃分析证据尚不明确。本研究全面回顾现有系统评价的最新证据,为QSYQ在CHF临床应用提供可靠信息。

方法

对从六个主要医学数据库检索到的研究进行系统评价。使用多重系统评价评估2(AMSTAR - 2)工具,从方法学质量和证据质量方面对符合条件的研究进行评估,采用系统评价中的偏倚风险(ROBIS)评估偏倚风险,并利用系统评价和荟萃分析的首选报告项目(PRISMA)2020评估报告质量。此外,使用推荐分级评估、制定和评价(GRADE)来确定主要结局指标的证据质量。

结果

本研究共纳入14项系统评价,据此可得出结论:QSYQ联合常规药物(CM)治疗在改善心功能相关指标(如增加左心室射血分数[LVEF]、减小左心室舒张末期内径[LVEDD]和左心室收缩末期内径[LVESD])、提高总有效率和6分钟步行距离(6MWD)以及降低N末端脑钠肽前体(NT - proBNP)方面,往往优于单纯CM治疗。总体而言,未观察到严重的与QSYQ相关的不良事件。然而,GRADE结果显示这些结局的证据质量为“极低”至“中等”,没有高质量证据支持。使用AMSTAR - 2、ROBIS和PRISMA 2020评估后,在方法学质量、偏倚风险和报告质量方面得到的结果不尽人意,主要受以下方面不足的限制:研究方案的注册、随机对照试验(RCT)纳入标准的解释、完整详细的检索策略、排除文献清单、RCT纳入研究的资金来源描述、偏倚风险对荟萃分析结果影响的调查以及潜在利益冲突的报告。

结论

由于当前系统评价缺乏高质量证据,QSYQ辅助治疗CHF的疗效和安全性仍有待进一步阐明。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b2d6/9637556/868b3f31ed5f/fcvm-09-1001072-g001.jpg

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