芪参益气滴丸治疗慢性心力衰竭的循证药物经济学评价

Evidence-Based Pharmacoeconomic Evaluation of Qishen Yiqi Dripping Pills in the Treatment of Chronic Heart Failure

目的:基于循证证据,综合评价芪参益气滴丸治疗慢性心力衰竭的安全性、有效性和经济性,为临床治疗提供循证药物经济学依据。方法:计算机检索PubMed数据库、EMBase数据库、Cochrane图书馆、Clinical trials.gov、中国期刊全文数据库、维普中文科技期刊全文数据库和万方医学数据库,收集芪参益气滴丸(研究组,在常规抗心力衰竭治疗方案基础上联合应用芪参益气滴丸)对比常规抗心力衰竭药(对照组,常规抗心力衰竭治疗)治疗慢性心力衰竭的随机对照试验,筛选文献、提取资料后,采用Review Manager 5.3软件进行荟萃分析(Meta分析),最后结合有效性、安全性和经济性进行药物经济学评价。结果:纳入27篇文献,合计3893例患者。Meta分析结果显示,研究组患者心功能改善总有效率显著高于对照组,差异有统计学意义(RR=1.20,95%CI=1.16~1.23,P<0.00001);与对照组相比,研究组治疗方案可显著改善患者的左心室射血分数(MD=6.79,95%CI=6.50~7.07,P<0.00001)、6 min步行距离(MD=45.08,95%CI=43.09~47.08,P<0.00001)和血脑钠肽含量(MD=-108.51,95%CI=-112.54^-104.49,P<0.00001),差异均有统计学意义;两组患者不良反应(肝肾功能异常、恶心及干咳)发生率的差异均无统计学意义(P>0.05)。成本-效果分析显示,增量成本-效果比为2503.03。结论:与常规抗心力衰竭药比较,芪参益气滴丸可显著提高慢性心力衰竭患者的有效率、左心室射血分数、6 min步行距离和血脑钠肽含量,每增加1个效果需要多花费2503.03元,在临床治疗中可根据患者自身支付意愿选择治疗方案。

OBJECTIVE:To comprehensively evaluate the safety,efficacy and economy of Qishen Yiqi dropping pills in the treatment of chronic heart failure based on evidence-based evidence,so as to provide evidence-based pharmacoeconomics basis for clinical treatment.METHODS:PubMed,EMBase,the Cochrane library,Clinical trials.gov,CNKI,VIP database and Wanfang database were retrieved to collect randomized controlled trials(RCT)of Qishen Yiqi dropping pills(the research group was given Qishen Yiqi dropping pills on the basis of routine anti-heart failure treatment)and conventional anti-heart failure drugs(the control group received conventional anti-heart failure therapy)in the treatment of chronic heart failure.After literature screening and data extraction,Review Manager 5.3 software was used for Meta-analysis.Pharmacoeconomic evaluation was performed with efficacy,safety and economy.RESULTS:Totally 27 literature was collected,including 3893 patients.Meta-analysis results showed that the total effective rate of improvement of cardiac function in the research group was significantly higher than that in the control group,and the difference was statistically significant(RR=1.20,95%CI=1.16-1.23,P<0.00001).Compared with the control group,the treatment regimen of the research group can significantly improve patients’left ventricular ejection fraction(MD=6.79,95%CI=6.50-7.07,P<0.00001),6 min walking distance(MD=45.08,95%CI=43.09-47.08,P<0.00001)and brain natriuretic peptide content(MD=-108.51,95%CI=-112.54--104.49,P<0.00001),the difference was statistically significant.The incidence of adverse drug reactions(abnormal liver and kidney function,nausea and cough)was not significantly different between two groups(P>0.05).Cost-effectiveness analysis showed that the incremental cost-effectiveness ratio was 2503.03.CONCLUSIONS:Compared with conventional anti-heart failure drugs,Qishen Yiqi dropping pills can significantly improve the effective rate,left ventricular ebitus fraction,6min walking distance and the content of blood brain natriuretic peptide in patients with chronic heart failure.Each additional effect will cost more 2503.03 yuan,the treatment regimen can be selected according to patients’own willingness to pay in clinical treatment.