芪参益气滴丸治疗慢性心力衰竭(气虚血瘀证)的Meta分析

目的:评价芪参益气滴丸治疗慢性心力衰竭的有效性及安全性。方法:计算机检索国内外8个数据库,筛选芪参益气滴丸治疗慢性心力衰竭的随机对照试验;运用Cochrane协作网偏倚风险评价工具对纳入研究进行文献质量评价,利用Rev Man 5. 3软件进行Meta分析。结果:检索相关文献606篇,最终纳入11项研究,涉及931例患者,纳入文献质量普遍偏低。Meta分析结果显示,芪参益气滴丸联合常规西药在改善B型利钠肽[加权均数差(WMD)=-29. 47,95%置信区间(CI)(-37. 29,-21. 64),P 0. 000 01],左心室射血分数[WMD=4. 64,95%CI(3. 82,5. 47),P 0. 000 01],心功能分级疗效[相对危险度(RR)=1. 25,95%CI(1. 16,1. 35),P 0. 000 01],中医证候疗效[RR=1. 23,95%CI(1. 07,1. 43),P=0. 005],6分钟步行试验[WMD=50. 13,95%CI(22. 32,77. 93),P=0. 000 4]指标方面,疗效均优于单用常规西药。安全性指标方面,1篇研究拟观察安全性指标,但实际文献中并未报告,其余研究均未发现芪参益气滴丸联合常规西药治疗的不良反应。结论:该研究结果支持临床使用芪参益气滴丸联合常规西药治疗慢性心力衰竭,但鉴于纳入临床研究在数量及质量上存在一定局限性,得出的阳性结果仅作为临床诊疗的提示与参考,还需更多高质量的研究进一步证实其疗效。

Meta-analysis for Qishen Yiqi Dropping Pills in Treatment of Chronic Heart Failure with Syndrome of Qi Deficiency and Blood Stasis

Objective: To evaluate the efficacy and safety of Qishen Yiqi dropping pills in the treatment of chronic heart failure. Method: Eight databases were searched at home and abroad, and the randomized controlled trials of Qishen Yiqi dropping pills in the treatment of chronic heart failure were screened. Literature quality of the included studies was evaluated by the bias risk assessment tool of Cochrane collaboration network, and the Meta-analysis was performed by RevMan 5.3 software. Result: A total of 606 related literature were retrieved, and 11 studies were eventually included, involving 931 patients. The quality of the included literature was generally low. Meta-analysis results showed that efficacy of Qishen Yiqi dropping pills combined with conventional western medicine was better than conventional western medicine alone in improving B-type natriuretic peptide[weighted mean difference (WMD)=-29.47, 95% confidence interval (CI) (-37.29,-21.64), P<0.000 01], left ventricular ejection fraction[WMD=4.64, 95%CI (3.82, 5.47), P<0.000 01], cardiac function classification efficacy[relative risk (RR)=1.25, 95%CI (1.16, 1.35), P<0.000 01], therapeutic effect of traditional Chinese medicine syndrome[RR=1.23, 95%CI (1.07, 1.43), P=0.005], 6-minute walk test[WMD=50.13, 95%CI (22.32, 77.93), P=0.000 4]. In terms of safety indicators, one study intended to observe safety indicators, but it was not reported in the actual literature, and the remaining studies did not find adverse reactions of Qishen Yiqi dropping pills combined with conventional western medicine. Conclusion: The results of this study support the clinical use of Qishen Yiqi dropping pills combined with conventional western medicine in the treatment of chronic heart failure, but in view of the limitations in the quantity and quality of clinical studies, the positive results are only used as a reminder and reference for clinical diagnosis and treatment. In the future, more high-quality researches are needed to further confirm its efficacy.