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芪苈强心胶囊联合沙库巴曲缬沙坦治疗慢性心力衰竭的疗效与安全性:一项系统评价和Meta分析

The Efficacy and Safety of a Qiliqiangxin Capsule Combined with Sacubitril/Valsartan in the Treatment of Chronic Heart Failure: A Systematic Review and Meta-Analysis.

作者信息

Chen Wensheng, Chang Huihua, Wang Xiaoqi, Wang Yuanping, Liu Yuntao, Wang Dawei

机构信息

Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China.

Shunde Hospital of Guangzhou University of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou 528333, Guangdong, China.

出版信息

Evid Based Complement Alternat Med. 2023 Feb 3;2023:2701314. doi: 10.1155/2023/2701314. eCollection 2023.

Abstract

BACKGROUND

Qiliqiangxin (QLQX) capsules are a commonly used proprietary Chinese medicine for the adjuvant treatment of chronic heart failure (CHF) in China. In recent years, several randomized controlled trials (RCTs) have reported on the efficacy and safety of QLQX combined with sacubitril/valsartan for CHF.

OBJECTIVE

The purpose of this study was to systematically analyze the clinical efficacy and safety of QLQX combined with sacubitril/valsartan in the management of CHF and to provide clinicians as well as scientists with optimal evidence-based medical evidence.

METHODS

We searched RCTs to evaluate the efficacy and safety of QLQX combined with sacubitril/valsartan in the treatment of CHF in the Wanfang Database, China National Knowledge Infrastructure, China Science and Technology Journal Database, PubMed, Embase, and Cochrane Library databases from their inception until January 8, 2022. RCTs on QLQX in combination with sacubitril/valsartan for CHF were included. The outcome measures considered were total effective rate, left ventricular ejection fraction (LVEF), left ventricular end-diastolic dimension (LVEDD), 6-minute walking distance (6-MWD), and adverse events. The quality of the included RCTs was assessed thereafter using the Cochrane risk of bias tool. RevMan 5.3 software was used to conduct the meta-analysis.

RESULTS

The meta-analysis included 17 trials involving 1427 CHF patients. The results indicated that with sacubitril/valsartan administration combined with QLQX treatment, the total effective rate (relative risk (RR) = 1.24; 95% confidence interval (CI) (1.17, 1.31); < 0.01), LVEF (mean difference (MD) = 6.20; 95% CI (5.36, 7.05; < 0.01)), and 6-MWD (MD = 55.87; 95% CI (40.66, 71.09); < 0.01) of CHF patients were significantly increased, and the LVEDD value of CHF patients was noted to be significantly reduced (MD = -3.98; 95% CI (-4.47, -3.48); < 0.01). Moreover, there was no increase in the number of adverse events during treatment (RR = 0.67; 95% CI (0.33, 1.34); < 0.01).

CONCLUSIONS

This study indicated that in CHF patients, on the basis of sacubitril/valsartan treatment, combination with QLQX can potentially enhance the total effective rate, improve LVEF and 6-MWD, and reduce LVEDD values, with good safety. However, considering the poor quality of the included studies, a multicenter, randomized, double-blind controlled study is needed for further confirmation.

摘要

背景

芪苈强心胶囊是中国常用于辅助治疗慢性心力衰竭(CHF)的一种中成药。近年来,多项随机对照试验(RCT)报道了芪苈强心联合沙库巴曲缬沙坦治疗CHF的疗效和安全性。

目的

本研究旨在系统分析芪苈强心联合沙库巴曲缬沙坦治疗CHF的临床疗效和安全性,为临床医生和科研人员提供最佳的循证医学证据。

方法

我们检索了万方数据库、中国知网、维普数据库、PubMed、Embase和Cochrane图书馆数据库中从建库至2022年1月8日期间评估芪苈强心联合沙库巴曲缬沙坦治疗CHF疗效和安全性的RCT。纳入芪苈强心联合沙库巴曲缬沙坦治疗CHF的RCT。所考虑的结局指标包括总有效率、左心室射血分数(LVEF)、左心室舒张末期内径(LVEDD)、6分钟步行距离(6-MWD)和不良事件。此后使用Cochrane偏倚风险工具评估纳入RCT的质量。使用RevMan 5.3软件进行荟萃分析。

结果

荟萃分析纳入了17项试验,涉及1427例CHF患者。结果表明,在给予沙库巴曲缬沙坦联合芪苈强心治疗后,CHF患者的总有效率(相对危险度(RR)=1.24;95%置信区间(CI)(1.17,1.31);P<0.01)、LVEF(平均差值(MD)=6.20;95%CI(5,36,7.05);P<0.01)和6-MWD(MD=55.87;95%CI(40.66,71.09);P<0.01)显著提高,CHF患者的LVEDD值显著降低(MD=-3.98;95%CI(-4.47,-3.48);P<0.01)。此外,治疗期间不良事件数量没有增加(RR=0.67;95%CI(0.33,1.34);P<0.01)。

结论

本研究表明,在CHF患者中,在沙库巴曲缬沙坦治疗的基础上联合芪苈强心可能会提高总有效率,改善LVEF和6-MWD,并降低LVEDD值,安全性良好。然而,考虑到纳入研究的质量较差,需要进行多中心、随机、双盲对照研究进行进一步证实。

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