连续使用特比萘芬与间歇使用伊曲康唑治疗皮肤癣菌性 toenail 甲真菌病的成本效益：基于 L.I.ON. 研究结果的分析。兰美抒与伊曲康唑治疗甲真菌病的对比。（注：“toenail”结合语境推测可能是“趾甲”，但原词表述不太准确规范）

Cost effectiveness of continuous terbinafine compared with intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis: an analysis of based on results from the L.I.ON. study. Lamisil versus Itraconazole in Onychomycosis.

作者信息

Jansen R, Redekop W K, Rutten F F

机构信息

Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands.

出版信息

Pharmacoeconomics. 2001;19(4):401-10. doi: 10.2165/00019053-200119040-00007.

DOI:10.2165/00019053-200119040-00007

PMID:11383756

Abstract

OBJECTIVE

To compare the costs and effectiveness of 2 oral antifungal treatment regimens in patients with dermatophyte toenail onychomycosis.

DESIGN AND METHODS

A cost-effectiveness analysis using a model based on data from the Lamisil versus Itraconazole in Onychomycosis (L.I.ON.) study, a randomised controlled trial comparing continuous terbinafine with intermittent itraconazole. The trial included 4 treatment arms: terbinafine 250 mg/day for 12 or 16 weeks (T12, T16) and itraconazole 400 mg/day for 1 week in every 4 weeks for 12 or 16 weeks (I3, I4). Cost calculations for 6 countries (Finland, Germany, Iceland, Italy, The Netherlands, UK) included costs for medication, physician visits, laboratory tests, management of adverse events and management of relapse. Effectiveness was based on complete cure rates (mycological cure plus 100% toenail clearing). Costs per complete cure were determined and both average and incremental cost-effectiveness ratios were calculated.

PERSPECTIVE

Healthcare system.

MAIN OUTCOME MEASURES AND RESULTS

In the L.I.ON. study, terbinafine was seen to be more effective than itraconazole (cure rates, 45.8 vs 23.4%). In most comparisons (5 of the 6 countries), the costs of T12 were statistically significantly lower than those of I3 [range: -37 to -173 euros (EUR); 1998 values; 1.172 US dollars = EUR1], indicating that T12 was the dominant strategy (i.e. less expensive and more effective). One exception (Finland) showed an incremental cost-effectiveness ratio of EUR524 per additional cure. In the other 5 countries, T16 and 14 were essentially equal in cost, but the greater effectiveness of T16 (cure rates, 55.1 vs 25.9%) resulted in a situation of extended dominance.

CONCLUSION

From a healthcare system perspective, continuous terbinafine is less costly and more effective than intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis.

摘要

目的

比较两种口服抗真菌治疗方案治疗皮肤癣菌性 toenail 甲真菌病的成本和效果。

设计与方法

采用基于甲真菌病中特比萘芬与伊曲康唑对比研究（L.I.ON.）数据的模型进行成本效益分析，该研究为一项随机对照试验，比较连续服用特比萘芬与间歇服用伊曲康唑的效果。该试验包括4个治疗组：特比萘芬250mg/天，服用12周或16周（T12、T16）；伊曲康唑400mg/天，每4周服用1周，共服用12周或16周（I3、I4）。对6个国家（芬兰、德国、冰岛、意大利、荷兰、英国）的成本计算包括药物成本、医生诊疗费用、实验室检查费用、不良事件管理费用和复发管理费用。效果基于完全治愈率（真菌学治愈加趾甲100%清除）。确定每例完全治愈的成本，并计算平均成本效益比和增量成本效益比。

视角

医疗保健系统。

主要结局指标与结果

在L.I.ON.研究中，特比萘芬比伊曲康唑更有效（治愈率分别为45.8%和23.4%）。在大多数比较中（6个国家中的5个），T12的成本在统计学上显著低于I3[范围：-37至-173欧元（EUR）；1998年数值；1.172美元=1欧元]，表明T12是主导策略（即成本更低且更有效）。一个例外（芬兰）显示每增加一例治愈的增量成本效益比为524欧元。在其他5个国家，T16和I4的成本基本相等，但T16更高的有效性（治愈率分别为55.1%和25.9%）导致了一种扩展优势的情况。