[关键词]
[摘要]
目的 运用网状Meta分析方法,对不同中成药联合指南导向药物(guideline-directed medicine,GDM)治疗慢性心力衰竭患者的有效性和安全性进行评估。方法 检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Embase、Cochrane Library、Web of Science数据库,检索时限设定为各数据库建立至2025年7月,尽可能全面收集有关中成药联合GDM治疗慢性心力衰竭的随机对照试验(randomized controlled trials,RCTs),采用RevMan 5.4、Stata16软件进行质量评价及网状Meta分析。结果 最终纳入128项RCTs,总样本量15 913例,其中试验组8 003例,对照组7 910例,涉及7种中成药。网状Meta分析结果显示中成药联合GDM治疗慢性心力衰竭的疗效优于单纯GDM治疗,且未见严重不良反应。(1)临床总有效率累积概率排名前3位的中成药为芪苈强心胶囊、麝香通心滴丸、芪参益气滴丸;(2)在改善左心室射血分数(left ventricular ejection fraction,LVEF)方面,排名前3位的中成药为参松养心胶囊、芪苈强心胶囊、通心络胶囊;(3)在改善6 min步行试验(6-minute walk test,6MWT)方面,排名前3位的中成药为芪参益气滴丸、麝香通心滴丸、稳心颗粒;(4)在降低左心室舒张末期内径(left ventricular end-diastolic dimension,LVEDD)方面,排名前3位的中成药为麝香通心滴丸、稳心颗粒、芪参益气滴丸;(5)在降低左心室收缩末期内径(left ventricular end-systolic diameter,LVESD)方面,排名前3位的中成药为参松养心胶囊、通心络胶囊、芪苈强心胶囊;(6)在降低N末端脑钠肽前体(N-terminal pro-brain natriuretic peptide,NT-proBNP)方面,排名前3位的中成药为芪参益气滴丸、麝香通心滴丸、芪苈强心胶囊。结论 中成药联合GDM较单用GDM可显著提高临床有效率,改善心功能和运动耐力,延缓心室重构,降低心衰血清标志物水平。由于研究结果受限于文献的质量及研究数量,以上结论需更多高质量RCTs进一步验证。
[Key word]
[Abstract]
Objective To assess the efficacy and safety of various Chinese patent medicines (CPMs) combined with guideline-directed medicine (GDM) for chronic heart failure (CHF) using network meta-analysis. Methods The randomized controlled trials (RCTs) regarding CPMs for CHF were searched in CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, Cochrane Library, and Web of Science from inception to July 2025. RevMan 5.4 and Stata16 software were used for quality assessment and network meta-analysis. Results A total of 128 RCTs involving, 15 913cases and seven types of CPMs, with 8 003 cases in the experimental group and 7 910 cases in the control group. Network meta-analysis indicated that CPMs combined with GDM outperformed GDM alone in efficacy without serious adverse reactions. (1) The top CPMs in terms of clinical efficacy were Qili Qiangxin Capsule (芪苈强心胶囊), Shexiang Tongxin Dripping Pill (麝香通心滴丸), and Qishen Yiqi Dripping Pill (芪参益气滴丸). (2) For improving left ventricular ejection fraction (LVEF), the top three were Shensong Yangxin Capsule (参松养心胶囊), Qili Qiangxin Capsule, and Tongxinluo Capsule (通心络胶囊). (3) In the 6-minute walk test (6MWT), the top three were Qishen Yiqi Dripping Pill, Shexiang Tongxin Dripping Pill, and Wenxin Granule (稳心颗粒). (4) For reducing left ventricular end-diastolic dimension (LVEDD), the top three were Shexiang Tongxin Dripping Pill, Wenxin Granule, and Qishen Yiqi Dripping Pill. (5) For reduction in left ventricular end-systolic diameter (LVESD), the top three were Shensong Yangxin Capsule, Tongxinluo Capsule, and Qili Qiangxin Capsule. (6) In terms of improvement in N-terminal pro-brain natriuretic peptide (NT-proBNP), the top three were Qishen Yiqi Dripping Pill, Shexiang Tongxin Dripping Pill, and Qili Qiangxin Capsule. Conclusion The results indicated that the combination of Chinese patent medicines with GDM for heart failure could effectively improve clinical efficacy, enhance cardiac function and exercise tolerance, delay ventricular remodeling, reduce serum markers of heart failure compared to the GDM alone. However, due to limitations in the quality and number of included studies, the above conclusions need further verification through more high-quality RCTs.
[中图分类号]
R285.64
[基金项目]
国家自然科学基金重点项目(82030120);国家科技重大专项(2024ZD0522000);河南省科技攻关项目(252102311270)