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芪苈强心胶囊治疗慢性心力衰竭的药物经济学评价


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        官海静 ,赵志刚(首都医科大学附属北京天坛医院药学部,北京 100070)
        中图分类号 R956          文献标志码 A          文章编号 1001-0408(2022)02-0209-08
        DOI  10.6039/j.issn.1001-0408.2022.02.14

        摘  要   目的 评估芪苈强心胶囊治疗慢性心力衰竭的疗效、安全性及经济性,为相关机构开展药品遴选与评价提供参考。方法
        通过Meta分析,探讨芪苈强心胶囊联合常规治疗(联合治疗组)相比常规治疗(常规治疗组)用于慢性心力衰竭的临床疗效与安全
        性。从中国卫生体系角度出发,构建决策树模型,模型研究时限为1年,以Meta分析得到的治疗有效率为效果指标,以药品成本和
        住院成本计算总成本,评价联合治疗相比常规治疗在慢性心力衰竭患者中的经济性;按疗程及文献质量进行亚组分析,并采用单
        因素敏感性分析和概率敏感性分析探讨基础分析结果的稳健性。结果 Meta分析共纳入72篇文献,涉及患者9 575例。Meta分析
        结果显示,联合治疗组患者的有效率、左室射血分数、血浆N末端B型利钠肽原、6 min步行距离均显著优于常规治疗组,且安全性
        与常规治疗组相当。成本-效果分析结果显示,联合治疗方案成本比常规治疗方案高 1 867 元,但患者可多获得 0.016 QALYs,增
        量成本-效果比(ICER)为 117 861元/QALY。若仅纳入高质量文献开展Meta分析并据此计算有效性参数,则联合治疗方案相对
        常规治疗方案的ICER分别为102 162元/QALY(基于所有高质量文献)、72 354 元/QALY(基于疗程为24周的高质量文献)。概率
        敏感性分析结果显示,以2020年我国2倍人均国内生产总值为意愿支付阈值,芪苈强心胶囊联合常规治疗具有经济性的概率为
        67.1%。结论 相比常规治疗,芪苈强心胶囊联合常规治疗的临床疗效更优,安全性相当,同时也更具有经济性。
        关键词 芪苈强心胶囊;慢性心力衰竭;疗效;安全性;Meta分析;药物经济学评价;决策树模型

        Pharmacoeconomic evaluation of Qili qiangxin capsule in the treatment of chronic heart failure
        GUAN Haijing,ZHAO Zhigang(Dept. of Pharmacy,Beijing Tiantan Hospital,Capital Medical University,
        Beijing 100070,China)

        ABSTRACT    OBJECTIVE To evaluate the efficacy,safety and cost-effectiveness of Qili qiangxin capsule in the treatment of
        chronic heart failure,and provide reference for drug selection and evaluation in relevant institutions. METHODS Meta-analysis was
        performed to investigate clinical efficacy and safety of Qili qiangxin capsule combined with routine treatment(combined treatment
        group)versus routine treatment(routine treatment group)in the treatment of chronic heart failure. From the perspective of Chinese
        health care system,a decision tree model was constructed. The time horizon of the model was 1 year. The effective rate obtained by
        meta-analysis was taken as the effect parameter,and the total cost was calculated by drug cost and hospitalization cost,to evaluate
        the cost-effectiveness of combined treatment versus routine treatment in the treatment of chronic heart failure. Subgroup analysis
        was carried out according to the course of treatment and literature quality,and one-way sensitivity analysis and probability
        sensitivity analysis were adopted to check the robustness of basic analysis results. RESULTS Total of 72 literatures involving 9 575
        patients were included in meta-analysis. Results of meta-analysis showed that effective rate,left ventricular ejection fraction,
        N-terminal fragment of the prohomone brain-type natriuretic peptide and 6 minute walking distance in combined treatment group
        were all better than those of routine treatment group, while its safety was similar to routine therapy. The results of
        cost-effectiveness analysis showed that the cost of combined therapy was 1 867 yuan higher than that of routine therapy,patients
        could get 0.016 QALYs more,and the incremental cost-effectiveness ratio(ICER)was 117 861 yuan/QALY. If only high-quality
        literature were included for meta-analysis and the effectiveness parameters were obtained,the ICERs of the combined therapy versus
        routine therapy were 102 162 yuan/QALY(based on all high-quality literature) and 72 354 yuan/QALY(based on high-quality
        literature with treatment course of 24 weeks). The results of the probability sensitivity analysis showed that taking twice China’s
        per capita gross domestic product in 2020 as the willingness to pay threshold,the probability of cost-effectiveness for Qili qiangxin
        capsule combined with routine therapy was 67.1% . CONCLUSIONS Compared with routine therapy,Qili qiangxin capsule
        combined with routine therapy has better clinical efficacy,equivalent safety and cost-effective.
        KEYWORDS     Qili qiangxin capsule; chronic heart failure; clinical efficacy; safety; meta-analysis; pharmacoeconomic
        evaluation;decision tree model

                                                               心力衰竭是由于心脏结构或功能异常导致心室充
           *药师,博士。研究方向:药物经济学。E-mail:guanhaijing_1@
                                                           盈或射血能力受损所致的复杂临床综合征,是各种心脏
        163.com
                                                                              [1]
           # 通信作者:主任药师,教授。研究方向:临床药学。E-mail:                病的严重和终末阶段 。高血压、冠心病、心房颤动是心
        1022zzg@sina.com                                   力衰竭最常见的合并症。研究显示,在我国35岁以上人


        中国药房    2022年第33卷第2期                                               China Pharmacy 2022 Vol. 33 No. 2  ·209 ·
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