摘要
目的从全社会角度出发,通过成本-效果/成本-效用分析评价润燥止痒胶囊与尿素乳膏治疗慢性湿疹的经济性。方法本研究基于一项随机、双盲、安慰剂平行对照、多中心临床研究中收集慢性湿疹患者的临床数据。其中,尿素乳膏组和润燥胶囊组在全分析集(Full analysis set, FAS)纳入62例和64例患者,在符合方案集(Per-protocol set, PPS)纳入58例和62例患者,生命质量数据通过欧洲五维健康量表(EQ-5D-3L)收集,成本数据通过成本问卷收集,疗效数据通过疗效评估量表获取。成本-效果分析的时间跨度为4周,成本-效用分析的时间跨度为1年,对润燥止痒胶囊与尿素乳膏治疗慢性湿疹进行成本-效果/成本-效用分析,并对关键参数进行敏感性分析。结果成本-效果分析表明,对于FAS,以治疗后痊愈率、成功率分别为效果指标时,润燥止痒胶囊组相比于尿素乳膏组的增量成本效果比分别为1965和460;对于PPS,以治疗后痊愈率、成功率分别为效果指标时,润燥止痒胶囊组相比于尿素乳膏组的增量成本效果比分别为1645和445。成本-效用分析表明,对于FAS,润燥止痒胶囊组相比于尿素乳膏组的增量成本效用比为85 939元/QALY;对于PPS,润燥止痒胶囊组相比于尿素乳膏组的增量成本效用比为109 945元/QALY。结论成本-效果分析表明,润燥止痒胶囊组相比于尿素乳膏组的增量成本效果比在445～1965之间;成本-效用分析表明,在中国当前经济水平条件下(2017年3倍人均GDP为178 980元)润燥止痒胶囊相比于尿素乳膏具有成本-效果。
Objective To conduct cost-effectiveness/cost-utility analysis of Runzao Zhiyang capsules vs. Urea cream in the treatment of chronic eczema from social perspective. Methods This evaluation was conducted based on the data collected from a randomized, double-blind, placebo controlled, multi-center clinical study. For full analysis set （FAS）, 62 in the urea cream arm and 64 patients in the Runzao Zhiyang capsule arm. For per-protocol set （PPS）, 58 in the urea cream arm and 62 patients in the Runzao Zhiyang capsule arm. The quality of life data was exacted from EQ-5D-3L questionnaire. The cost data was collected by a cost questionnaire. And efficacy data was evaluated by the efficacy assessment scale. The cost-effectiveness analysis （CEA） was conducted with a time horizon of 4 weeks and the cost-utility analysis （CUA） was conducted with a time horizon of 1 year.CENCUA of Runzao Zhiyang capsule vs. Urea cream was conducted in the treatment of chronic eczema,and Sensitivity analyses were completed to examine the robustness of the base-case findings. Results For the FAS, when the cure rate and success rate were the effect indicators, the CEA showed that the incremental cost-effectiveness ratio of the Runzao Zhiyang capsule arm compared with the urea cream arm was 1,965 and 460, respectively. For the PPS, the incremental cost-effectiveness ratio of the Runzao Zhiyang capsule arm compared with the urea cream arm was 1,645 and 445, respectively. The CUA showed that for the FAS, the incremental cost-utility ratio of the Runzao Zhiyang capsule arm was 85,939 RMB per QALY compared with the urea cream arm. For the PPS, the incremental cost-utility ratio of the Runzao Zhiyang capsule arm was 109,945 RMB per QALY compared with the urea cream arm. Conclusion The CEAdemonstrated that the incremental cost-effectiveness ratio of Runzao Zhiyang Capsule group was between 445 and 1,965 compared with that of urea cream group. The CUA demonstrated that Runzao Zhiyang capsule arm was cost-effective when compared with the ur
作者
朱水清
肖敦明
宣建伟
ZHU Shui-qing;XIAO Dun-ming;XUAN Jian-wei
出处
《中国药物经济学》
2018年第9期17-23,共7页
China Journal of Pharmaceutical Economics
