丁苯酞联合再灌注方案治疗缺血性卒中的成本效果分析：基于BASTⅢ期试验

摘要/Abstract

摘要： 目的：基于中国卫生服务体系角度评价丁苯酞对比安慰剂治疗缺血性卒中患者的经济性。方法：基于丁苯酞的Ⅲ期对照试验和已发表的文献数据构建Markov模型，模拟患者终身的质量调整生命年（quality-adjusted life year，QALY）和增量成本效果比（Incremental cost-effectiveness ratio ICER），并进行单因素敏感性分析、亚组分析和概率敏感性分析检验模型的不确定性。结果：研究结果显示，丁苯酞组患者比安慰剂组患者在多获得0.28个QALYs的同时成本增加了2 750.66元，ICER值为9 700.31元/QALY，小于0.5倍人均GDP，丁苯酞组患者比安慰剂组治疗缺血性卒中更具有经济性。单因素敏感性分析结果显示，对模型结果影响程度最大的4个因素分别是mRS3-5状态的首次住院成本、mRS0-2状态的首次住院成本、贴现率和mRS0-2状态的效用值。亚组分析结果显示，丁苯酞组患者比安慰剂组患者在NIHSS评分4~7、8~14和15~25 3个亚组中的ICER值分别为16 430.66、3 146.91和9 745.38元/QALY，均小于0.5倍人均GDP。概率敏感性分析结果显示，丁苯酞相较于安慰剂方案在0.5倍人均GDP的阈值下具有经济性的概率为98%。丁苯酞在NIHSS评分4~7、8~14和15~25 3个亚组中具有经济性的概率分别为84%、97%和87%。结论：在我国0.5倍人均GDP的意愿支付值之下，丁苯酞在接受静脉溶栓和/或血管内再灌注治疗缺血性卒中患者具有经济性。

关键词: font-size:medium, ">丁苯酞；缺血性卒中；Markov模型；成本效果分析

Abstract: Objective： To evaluate the economics of Butylphthalide versus placebo for the treatment of ischaemic stroke patients based on the perspective of the Chinese health service system. Methods： A markov model was constructed based on the phase Ⅲ controlled trial of Butylphthalide and published literature data to simulate the quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER) of patients over their lifetime， and One-way sensitivity analyses， subgroup analyses and probabilistic sensitivity analyses were performed to test model uncertainty. Results： The results of the study showed that patients in the Butylphthalide group had an incremental cost of ￥2，750.66 while gaining 0.28 more QALYs than patients in the placebo group， with an ICER value of ￥9，700.31/QALY， which is less than 0.5 times the per capita GDP， and that patients in the Butylphthalide group were more economically viable for the treatment of ischemic stroke than those in the placebo group. The results of one-way sensitivity analysis showed the most influential model results The four factors with the most influential model results were the cost of the first hospitalisation for the mRS3-5 status， the cost of the first hospitalisation for the mRS0-2 status， the discount rate， and the utility value for the mRS0-2 status. The results of subgroup analyses showed that patients in the Butylphthalide group had ICER values of ￥16，430.66，￥3，146.91， and ￥9，745.38/QALY compared to patients in the placebo group in the three subgroups of NIHSS scores of 4-7， 8-14， and 15-25， which were less than 0.5 times GDP per capita.The results of probabilistic sensitivity analyses showed that the Butylphthalide compared to placebo regimen had an ICER value of 0.5 times GDP per capita under the 0.5 times GDP threshold with a 98% probability of being economical. The probability that Butylphthalide would be economical in the subgroups with NIHSS scores of 4-7， 8-14， and 15-25 was 84%， 97%， and 87%， respectively. Conclusion： Under our willingness-to-pay value of 0.5 times per capita GDP， Butylphthalide is economical in the treatment of patients undergoing intravenous thrombolysis and/or endovascular reperfusion for ischaemic stroke.

Key words: font-size:medium, ">Butylphthalide； Cost effectiveness analysis； Stroke

中图分类号:

黄月凤1, 陈烽1, 魏晓霞2, 吴文华2, 林慧婷2. 丁苯酞联合再灌注方案治疗缺血性卒中的成本效果分析：基于BASTⅢ期试验[J]. 中国药物评价, 2024, 41(4): 321-326.

HUANG Yue-feng1, CHEN Feng1, WEI Xiao-xia2, WU Wen-hua2, LIN Hui-ting2. Cost-effectiveness Analysis of Butylphthalide Combined with Reperfusion Therapy in the Treatment of Ischemic Stroke： Based on BAST Phase Ⅲ Trial[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2024, 41(4): 321-326.

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