芪苈强心胶囊治疗慢性射血分数减少心衰的成本-效果分析

Cost-effectiveness analysis of Qili Qiangxin capsule in treating chronic heart failure and reduced ejection fraction

目的评价芪苈强心胶囊联合常规方案治疗慢性射血分数减少心衰(HFrEF)病人的有效性和经济性。方法基于中国一项多中心、随机、安慰剂的研究数据,随访12周时间,研究对象为中国23个临床研究中心的512例心功能为Ⅱ~Ⅳ级的病人,随机按照1∶1的比例分为实验组和对照组,对照组使用常规治疗,实验组在常规治疗的基础上服用芪苈强心胶囊12周。以N末端B型利钠肽原(NT-proBNP)中位数减少率、复合事件(composite cardiac events,CCEs)发生率、心功能分级的总有效率、心脏左室射血分数(LVEF值)的变化、明尼苏达心衰生活质量量表(MLHFQ)总分改善值、6 min步行距离(6 minute walk distance,6MWD)等效果指标进行成本-效果分析。结果实验组和对照组的NT-proBNP中位数减少率分别为24.7%、0%;CCEs的发生率分别为4.5%、10.9%;心功能分级的总有效率为32.3%、19.6%;LVEF值变化率为6.5%、4.4%;MLHFQ改善的变化率33.0%、5.0%;6MWD增加40.0 m、17.2 m,两组比较均差异有统计学意义(P<0.05),实验组疗效优于对照组。药物经济学结果表明,NT-proBNP减少的百分比,心功能分级的总有效率、LVEF值变化率、MLHFQ改善的变化、6MWD等正向指标的成本-效果比均高于对照组,CCEs的发生率反向指标低于对照组。结论芪苈强心胶囊联合常规方案治疗慢性心力衰竭疗效优于常规治疗方案,成本-效果分析表明联合用药更具有经济性。

Objective To evaluate the effectiveness and pharmacoeconomics of Qili Qiangxin capsule combined with conventional therapy in patients with heart failure and reduced ejection fraction(HFrEF).Methods Based on the data of a multi-center,randomized,placebo study in China,512 patients with cardiac function gradeⅡ~Ⅳfrom 23 clinical research centers in China were selected as the subjects of the study and followed up for 12 weeks,and they were randomly assigned into experimental groups and the control group at a ratio of 1∶1.The control group received conventional treatment,while the experimental group took Qili Qiangxin capsule on the basis of conventional treatment for 12 weeks.The median reduction rate of N-terminal pro-B-type natriuretic peptide(NT-proBNP),the incidence of composite cardiac events(CCEs),the total effective rate of cardiac function classification,and the change of left ventricular ejection fraction(LVEF)of the heart,the total score improvement value of the Minnesota Heart Failure Quality of Life Scale(MLHFQ),6 minute walk distance(6MWD)and other efficacy indicators were analyzed by cost-effectiveness analysis.Results The median reduction rates of NT-proBNP in the experimental group and the control group were 24.7%and 0%,respectively;the incidence of CCEs was 4.5%and 10.9%,respectively;the total effective rate of cardiac function classification was 32.3%and 19.6%,respectively;LVEF value change rate was 6.5%and 4.4%,respectively;MLHFQ improved change rate was 33.0%and 5.0%,respectively;6MWD increased by 40.0m and 17.2m,respectively,and the differences between the two groups were statistically significant(P<0.05),the effect of the experimental group was better that of the control group.Pharmacoeconomics results showed that the cost-effectiveness ratio of positive indicators such as the percentage reduction of NT-proBNP,the total effective rate of cardiac function classification,the change rate of LVEF value,the change of MLHFQ improvement,and 6MWD were all higher than those of the control group,and the re‐verse index of the incidence of CCEs was lower than the control group.Conclusion Qili Qiangxin capsule combined with conventional regimen is more effective than conventional treatment regimen in the treatment of chronic heart failure.Cost-effectiveness analysisshows that combined medication is more economical.