芪参益气滴丸治疗慢性心力衰竭的Meta分析

Meta-analysis of Qishenyiqi drop pills treatment for chronic heart failure

目的系统评价芪参益气滴丸治疗慢性心力衰竭(CHF)的临床疗效和安全性。方法检索Cochrane图书馆、Pubmed、PMC、Medline、Embase、CNKI、CBM、VIP和万方数据资源系统等,全面收集芪参益气滴丸治疗CHF的临床研究。参照Cochrane系统评价手册5.1.0版评价文献质量,采用RevMan5.2.3软件对芪参益气滴丸治疗CHF的研究进行Meta分析。选取心功能、心脏彩超、脑钠肽、6 min步行试验、再次住院率、死亡率和不良反应作为观察指标,得出心功能(NYHA分级)、每分钟心排出量、左室舒张末期内径、左室收缩末期内径和再次住院率进行定量综合评估。结果共纳入18个临床研究,包括2 244例患者。Meta分析结果显示在常规抗心衰治疗基础上加芪参益气滴丸在改善患者心功能(RD=0.14,95%CI:0.1 1~0.17,P<0.000 01)、增加每分钟心排出量(CO)(SMD=1.43,95%CI:1.22~1.64,P<0.000 01)、缩小左室舒张末期内径(LVEDD)(SMD=-0.54,95%C1:-0.76^-0.31,P<0.000 01)和收缩末期内径(LVESD)(SMD=-0.53,95%CI:-0.72^-0.34,P<0.000 01)及降低再次住院率(0R=0.41,95%CI:0.23~0.72,p=0.002)方面均优于常规组。结论在常规抗心衰治疗基础上加芪参益气滴丸可改善患者心功能,增加C0、缩小LVEDD和LVESD、减少再次住院率。但由于本系统评价纳入的研究质量欠佳、存在发表性偏倚且涉及部分结局指标的样本量小,需要更大样本量的随机双盲平行对照研究证实。

AIM To assess the efficacy and safety of Qishenyiqi drop pills for chronic heart failure （CHF） treatment. METHODS All clinical studies of Qishenyiqi drop pills for CHF were searched from Cochrane Library, Pubmed, PMC, Medline, Embase, CNKI, CBM, VIP, and WANFANG DATA. The quality of the included studies was evaluated referring to the Cochrane Reviewer＇ s Handbook 5.1.0. Meta- analysis of Qishenyiqi drop pills for CHF was performed using RevMan 5.2.3 software. Observation index including cardiac function and heart color Doppler ultrasound and brain natriuretic peptide （BNP） and 6 min walk test and rehospitalization rate and mortality and adverse reaction was analyzed. The cardiac function （NYHA grade） and cardiac minute output （CO） and left ventricular end diastolic diameter （LVEDD） and left ventricular end systolic diameter （LVESD） and rehospitalization rates were used for quantification. RESULTS Eighteen studies including 2 244 CHF patients were included. The results of meta-analyses showed that Qishenyiqi drop pills combined with conventional anti- CHF treatment significantly improved cardiac function （NYHA grade） （RD = 0.14, 95%CI： 0.11 - 0.17, P 〈 0.000 01）, increased CO （SMD = 1.43, 95%CI： 1.22 - 1.64, P 〈 0.000 01）, and decreased LVEDD and LVESD （（SMD = -0.54, 95%CI： -0.76 - -0.31, P 〈 0.000 01） ＆ （SMD = -0.53, 95%CI： -0.72 - -0.34, P 〈 0.000 01）） and rehospitalization rate （OR = 0.41, 95%CI： 0.23 - 0.72, P = 0.002） compared with conventional anti-CHF treatment alone. CONCLUSION Qishenyiqi drop pills combined with conventional anti- CHF treatment improve cardiac function, increase CO and decrease LVEDD and LVESD and rehospitalization rate. However, there are several limitations in this study, such as the poor quality of the included studies, the existence of publication bias and small sample size, therefore it is necessary to do the randomized double-blind controlled study with large sample size.