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金叶败毒颗粒上市后药物经济学评价

[Post-marketing pharmaco-economics evaluation of Jinye Baidu Granules].

作者信息

Liu Huan, Han Sheng, Xie Yan-Ming, Yu Yan-Shun, Jiang Jun-Jie

机构信息

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.

School of Pharmacy, Peking University Beijing 100191, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2020 Aug;45(15):3497-3504. doi: 10.19540/j.cnki.cjcmm.20200517.501.

Abstract

To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.

摘要

为评价金叶败毒颗粒治疗急性上呼吸道感染的经济性和适用性,本研究进行了一项随机、双盲、阳性药物平行对照临床试验。采用分层区组随机、双盲双模拟试验。试验组服用金叶败毒颗粒,每次10 g,每日3次,同时服用复方双花颗粒安慰剂,每次6 g,每日4次。对照组服用复方双花颗粒,每次6 g,每日4次,同时服用金叶败毒颗粒安慰剂,每次10 g,每日3次。疗程为5天。本研究的总成本包括直接医疗成本和间接医疗成本。采用增量成本-效果分析方法进行评价。使用Treeage Pro软件构建药物经济学模型并进行统计分析。来自10家医院的患者分为试验组(304例)和对照组(302例)。比较两组患者的年龄、性别比、临床症状和体征评分以及重要体格检查指标的基线值。治疗5天后,试验组人均成本为(388.06±94.17)元,对照组人均成本为(378.47±95.46)元。试验组人均直接医疗费用为(271.24±54.11)元,对照组人均直接医疗费用为(264.88±112.71)元。试验组间接医疗平均费用为(116.82±82.75)元,对照组间接医疗平均费用为(113.59±87.77)元,两组人均医疗费用、人均直接医疗费用和人均间接医疗费用差异均无统计学意义。基于治疗5天后症状和体征总分差值的增量成本-效果分析结果显示,ICER=23.39元/分,低于通过专家访谈确定的支付意愿100元/分。试验组相对于对照组具有经济优势,经济概率为53%。敏感性分析支持结果的稳健性。基于症状和体征总治愈率的增量成本-效果分析结果显示,与试验组相比,对照组成本更低、效果更好且具有绝对经济优势,相应概率为55%。基于以上结果,得出结论:金叶败毒颗粒与复方双花颗粒治疗急性上呼吸道感染的经济结果无显著差异。

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