真武汤合血府逐瘀汤加减治疗慢性心力衰竭的Meta分析及试验序贯分析

Meta-analysis and Trial Sequential Analysis of Modified Zhenwu Decoction Combined with Xuefu Zhuyu Decoction in the Treatment of Chronic Heart Failure

目的 系统评价真武汤合血府逐瘀汤加减治疗慢性心力衰竭(CHF)的临床疗效。方法 计算机检索从建库至2022年3月1日万方数据库(Wanfang)、维普数据库(VIP)、中国知网(CNKI)、Cochrane Library、Web of Science、PubMed等数据库发表的所有关于真武汤合血府逐瘀汤加减治疗CHF的文献。纳入文献质量参照Cochrane评估标准评价,使用RevMan 5.4及TSA 0.9.5.10 Beta软件分别对数据进行Meta分析和试验序贯分析(TSA)。结果 纳入20项真武汤合血府逐瘀汤加减治疗CHF的随机对照研究,共计1 619例患者。与对照组比较,试验组(真武汤合血府逐瘀汤加减结合西医常规治疗)的临床疗效[RR=1.23,95%CI=(1.18,1.29),P<0.000 01]、左室射血分数[WMD=7.59,95%CI=(5.53,9.64),P<0.000 01]、心脏指数[WMD=0.32,95%CI=(0.25,0.39),P<0.000 01]显著提高,左室舒张末期内径缩小[WMD=-2.30,95%CI=(-2.41,-2.18),P<0.000 01],B型利钠肽[WMD=-25.47,95%CI=(-26.93,-24.02),P<0.000 01]及氨基末端脑钠肽前体[WMD=-281.44,95%CI=(-406.06,-156.83),P<0.000 01]降低,6 min步行距离明显增加[WMD=69.40,95%CI=(59.93,78.86),P<0.000 01],药物不良反应明显减少[RR=0.29,95%CI=(0.15,0.56),P=0.000 2]。试验序贯分析进一步证实了其临床疗效,排除了假阳性。结论 真武汤合血府逐瘀汤结合西医常规治疗CHF的临床疗效优于单纯西医常规治疗,且临床不良反应少。鉴于纳入文献的质量一般,上述结果尚需更多高质量、大样本的临床随机对照试予以证实。

Objective To systematically evaluate the therapeutic effects of modified Zhenwu Decoction combined with Xuefu Zhuyu Decoction on chronic heart failure(CHF). Methods Computer retrieval databases, including Wanfang,VIP,CNKI,Cochrane Library,Web of Science,PubMed were selected in the study. All the studies of modified Zhenwu Decoction combined with Xuefu Zhuyu Decoction in the treatment of CHF published from the establishment of the database to March 1,2022 were searched. The quality of the included literature was evaluated according to the Cochrane bias risk assessment method. Meta-analysis and trial sequentrial analysis(TSA) were performed using RevMan 5.4 and TSA 0.9.5.10 Beta software,respectively. Results A total of 1619 patients were included in 20 randomized controlled trials(RCTs). The results showed that the clinical efficacy [RR=1.23,95%CI=(1.18,1.29),P<0.000 01],left ventricular ejection fraction [WMD=7.59,95%CI=(5.53,9.64),P<0.000 01]and cardiac index [WMD=0.32,95%CI=(0.25,0.39),P<0.000 01] in trial group(modified Zhenwu Decoction combined with Xuefu Zhuyu Decoction + conventional treatment of western medicine),compared to those in control group,were significantly improved. The left ventricular end-diastolic diameter [WMD=-2.30, 95%CI=(-2.41,-2.18),P<0.000 01] decreased,B-type natriuretic peptide [WMD=-25.47,95%CI=(-26.93,-24.02),P<0.000 01] and amino-terminal pro-brain natriuretic peptide [WMD=-281.44,95%CI=(-406.06,-156.83),P<0.000 01] simultaneously decreased,6-minutes walking distance was significantly increased [WMD=69.40,95%CI=(59.93, 78.86), P<0.000 01], adverse drug reactions were significantly reduced [RR=0.29, 95% CI=(0.15,0.56),P=0.000 2]. The clinical efficacy was further confirmed by TSA,which excluded false positive. Conclusion The clinical efficacy of modified decoction of Zhenwu and Xuefu Zhuyu combined with conventional treatment of western medicine in the treatment of CHF is better than that of western medicine alone,and the clinical adverse reactions are mild. In view of the general quality of the included literature and the limited results,high-quality and large-sample RCTs are needed to further explore.