Volmer T, Kielhorn A, Weber H H, Wiessmann K J
GlaxoWellcome GmbH, Hamburg, Germany.
Pharmacoeconomics. 1999 Nov;16(5 Pt 2):525-31. doi: 10.2165/00019053-199916050-00008.
The aim of this study was to determine the cost effectiveness of 2 inhaled corticosteroids, fluticasone propionate and flunisolide, in the management of asthma from a third-party payer perspective in Germany (German Sickness Fund).
Direct treatment costs were retrospectively applied to 2 prospective randomised parallel group clinical trials conducted in Germany comparing fluticasone propionate and flunisolide: one 6-week open-label study (n = 332) and one 8-week double-blind study (n = 308) in corticosteroid-naive patients with asthma of moderate severity aged between 18 and 70 years. All costs were adjusted to 1997 Deutschmarks. Efficacy parameters included changes in morning and evening peak expiratory flow rate (PEFR) measurements, the number of successfully treated patients (defined as those with a PEFR improvement of > or = 10%) and proportion of symptom-free days.
The fluticasone propionate groups had higher respective proportions of successfully treated patients and symptom-free days than the flunisolide groups in both the open-label (56.8 vs 39.6% and 36.4 vs 28.5%) and double-blind (55.3 vs 44.5% and 35.1 vs 31.1%) studies. Improvements in both morning and evening PEFR measurements were also significantly (p < 0.01) greater with fluticasone propionate than with flunisolide. Although average daily treatment costs were slightly higher in the fluticasone propionate groups than in the flunisolide groups, all cost-effectiveness ratios (daily cost per successfully treated patient and daily cost per symptom-free day) favoured fluticasone propionate. Sensitivity analysis showed that these results were robust over a wide range of assumptions.
In these patients, management with fluticasone propionate was more cost effective than with flunisolide in the German healthcare setting.
本研究旨在从德国第三方支付方（德国疾病基金）的角度，确定两种吸入性糖皮质激素丙酸氟替卡松和曲安奈德在哮喘治疗中的成本效益。
将直接治疗成本追溯应用于在德国进行的两项前瞻性随机平行组临床试验，比较丙酸氟替卡松和曲安奈德：一项为期6周的开放标签研究（n = 332）和一项为期8周的双盲研究（n = 308），研究对象为年龄在18至70岁之间、中度哮喘且未使用过糖皮质激素的患者。所有成本均按1997年德国马克进行调整。疗效参数包括早晚呼气峰值流速（PEFR）测量值的变化、成功治疗的患者数量（定义为PEFR改善≥10%的患者）和无症状天数的比例。
在开放标签研究（56.8%对39.6%以及36.4%对28.5%）和双盲研究（55.3%对44.5%以及35.1%对31.1%）中，丙酸氟替卡松组成功治疗的患者比例和无症状天数的比例均高于曲安奈德组。丙酸氟替卡松早晚PEFR测量值的改善也显著（p < 0.01）大于曲安奈德。尽管丙酸氟替卡松组的平均每日治疗成本略高于曲安奈德组，但所有成本效益比（每位成功治疗患者的每日成本和每个无症状天数的每日成本）均有利于丙酸氟替卡松。敏感性分析表明，在广泛的假设范围内，这些结果是稳健的。
在德国医疗环境中，对于这些患者，使用丙酸氟替卡松治疗比使用曲安奈德更具成本效益。
