Boyer P, Danion J M, Bisserbe J C, Hotton J M, Troy S
URA 1957 CNRS Hôpital La Salpetriere, Paris, France.
Pharmacoeconomics. 1998 Jan;13(1 Pt 2):157-69. doi: 10.2165/00019053-199813010-00015.
In a double-blind study in a primary-care setting in France, outpatients fulfilling DSM IV criteria for a major depressive episode were randomised to receive sertraline (50 to 150 mg/day; n = 122) or fluoxetine (20 to 60 mg/day; n = 120). Assessments, including clinical evaluation [Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impressions (CGI)] and quality of life [Functional Status Questionnaire (FSQ)], were made at study entry and after 4 and 6 months of treatment. Use of medical services, absences from work and productivity losses were recorded for calculation of direct and indirect costs from both the overall societal perspective and in terms of sickness insurance. In total, 231 patients (116 receiving sertraline, 115 receiving fluoxetine) were included in an intention-to-treat analysis assessed up to the last visit. Statistically significant clinical and quality-of-life improvements from baseline were observed in both treatment groups, with no between-group differences. Utilisation of medical resources was higher in fluoxetine-treated patients, with significantly more consultations with specialists. The 2 treatment groups were similar in terms of number of hospitalisations and duration of stay, whether related to depression or not. There were no significant differences between groups for work or productivity losses. Cost comparisons favoured sertraline treatment from both the societal (FF7780 vs FF8706) and sickness insurance (FF2936 vs FF3224) viewpoints, with cost differentials of FF926 and FF288, respectively. From the societal perspective, the total cost per patient over the 6-month course of the trial, irrespective of the study treatment given, was FF8241, and the corresponding sickness insurance cost was FF3079. At the time of the study, FF1 = $US0.1993.
在法国一家初级保健机构进行的一项双盲研究中,符合《精神疾病诊断与统计手册》第四版(DSM IV)重度抑郁发作标准的门诊患者被随机分为两组,分别接受舍曲林(50至150毫克/天;n = 122)或氟西汀(20至60毫克/天;n = 120)治疗。在研究开始时以及治疗4个月和6个月后进行评估,评估内容包括临床评估[蒙哥马利-阿斯伯格抑郁评定量表(MADRS)、临床总体印象(CGI)]和生活质量[功能状态问卷(FSQ)]。记录医疗服务的使用情况、缺勤情况和生产力损失情况,以便从整个社会角度以及医疗保险角度计算直接和间接成本。共有231名患者(116名接受舍曲林治疗,115名接受氟西汀治疗)纳入意向性分析,直至最后一次随访进行评估。两个治疗组均观察到从基线水平起临床和生活质量有统计学意义的改善,且组间无差异。氟西汀治疗组的医疗资源利用率较高,与专科医生的会诊显著更多。两个治疗组在住院次数和住院时间方面相似,无论是否与抑郁症相关。两组在工作或生产力损失方面无显著差异。从社会(7780法郎对8706法郎)和医疗保险(2936法郎对3224法郎)角度来看,成本比较都有利于舍曲林治疗,成本差异分别为926法郎和288法郎。从社会角度来看, 无论给予何种研究治疗,试验6个月期间每位患者的总成本为8241法郎,相应的医疗保险成本为3079法郎。在研究进行时,1法郎 = 0.1993美元。