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两种甲癣新疗法的成本效益:两项对比临床试验分析

Cost-effectiveness of two new treatments for onychomycosis: an analysis of two comparative clinical trials.

作者信息

Bootman J L

机构信息

College of Pharmacy, University of Arizona, Tucson, USA.

出版信息

J Am Acad Dermatol. 1998 May;38(5 Pt 3):S69-72. doi: 10.1016/s0190-9622(98)70488-8.

Abstract

BACKGROUND

Pharmacoeconomic analyses are becoming an increasingly integral component of the overall profile of new drugs. This is particularly true for terbinafine and itraconazole, because both agents have been shown to be clinically effective and relatively safe.

OBJECTIVE

This study examined the cost-effectiveness of terbinafine and itraconazole in two recent comparative clinical trials of these new agents for onychomycosis of the toenails.

METHODS

Data as reported in the two clinical trials were used as the basis for an analytic decision-tree model that included cost of drug, medical management of the disease and any adverse reactions, and clinical efficacy data into calculations that estimated the relative cost effectiveness ratio for each drug on the basis of cost per disease-free day.

RESULTS

The total cost of terbinafine therapy ranged from $697.55 to $699.11, and the total cost of itraconazole therapy ranged from $1216.40 to $1218.80. The expected cost per disease-free day of itraconazole was $2.05 and $2.37, in the Bräutigam and De Backer trials, respectively; similar costs for terbinafine were $1.27 and $1.50. Relative to terbinafine, which was assigned a value of 1.0, the cost-effectiveness ratio of itraconazole was 1.62 and 1.58 in each trial, indicating a lower cost-effectiveness than terbinafine.

CONCLUSION

Terbinafine is more cost-effective than itraconazole in the treatment of toenail onychomycosis.

摘要

背景

药物经济学分析正日益成为新药整体评估中不可或缺的组成部分。特比萘芬和伊曲康唑尤其如此,因为这两种药物均已证明具有临床疗效且相对安全。

目的

本研究在两项近期针对这些新药治疗趾甲甲真菌病的比较临床试验中,考察了特比萘芬和伊曲康唑的成本效益。

方法

两项临床试验报告的数据被用作分析决策树模型的基础,该模型将药物成本、疾病的医疗管理及任何不良反应和临床疗效数据纳入计算,以基于无病日成本估算每种药物的相对成本效益比。

结果

特比萘芬治疗的总成本在697.55美元至699.11美元之间,伊曲康唑治疗的总成本在1216.40美元至1218.80美元之间。在布罗伊蒂根试验和德贝克尔试验中,伊曲康唑每无病日的预期成本分别为2.05美元和2.37美元;特比萘芬的类似成本为1.27美元和1.50美元。相对于被赋值为1.0的特比萘芬,伊曲康唑在每项试验中的成本效益比分别为1.62和1.58,表明其成本效益低于特比萘芬。

结论

在治疗趾甲甲真菌病方面,特比萘芬比伊曲康唑更具成本效益。

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