Tome M B, Isaac M T
United Medical School, University of London.
Int J Psychiatry Med. 1997;27(4):377-90. doi: 10.2190/6T1E-A6E1-V2J6-JL99.
This article describes a method for evaluating the value of the increased cost of pharmacologic augmentation of an antidepressant.
Data to illustrate the method and interpretation of results were derived from a randomized, placebo controlled double blind trial. Eighty outpatients meeting ICD-10 criteria for depressive disorder and scoring > 18 on the Montgomery Asberg Depression Rating Scale (MADRS) were recruited from a primary care population. All patients received SSRI antidepressant and either "augmenting agent" or placebo. The trial period was six weeks, during which the patients were monitored for changes in depressive symptoms using the MADRS. The economic analysis is based only on direct costs of treatment. The analytic approach includes decision analysis, cost-effectiveness and cost-benefit techniques, and a sensitivity analysis.
The economic analysis was performed on both the intention-to-treat and per-protocol population. Intention-to-treat and per-protocol results show that the direct cost of six weeks' treatment with the combination of "augmenting agent" and SSRI antidepressant, if the acceleration effect is taken into account, was more cost effective than the SSRI antidepressant and placebo.
The direct costs of treatment are higher than those of previous pharmaco-economic studies, but the rate of onset of antidepressant action must be taken into account. The application of the evaluative model appears valid and useful. The model is pragmatic and should be expanded for generalizability.
本文描述了一种评估抗抑郁药增效治疗成本增加的价值的方法。
用于说明该方法及结果解读的数据来自一项随机、安慰剂对照双盲试验。从初级保健人群中招募了80名符合ICD-10抑郁症标准且蒙哥马利-阿斯伯格抑郁评定量表(MADRS)得分>18的门诊患者。所有患者均接受选择性5-羟色胺再摄取抑制剂(SSRI)抗抑郁药治疗,并分别接受“增效剂”或安慰剂治疗。试验期为6周,在此期间使用MADRS监测患者抑郁症状的变化。经济分析仅基于治疗的直接成本。分析方法包括决策分析、成本效益分析和成本效益分析技术以及敏感性分析。
对意向性分析人群和符合方案人群均进行了经济分析。意向性分析和符合方案分析结果表明,如果考虑加速效应,“增效剂”与SSRI抗抑郁药联合使用6周治疗的直接成本比SSRI抗抑郁药和安慰剂更具成本效益。
治疗的直接成本高于以往药物经济学研究,但必须考虑抗抑郁作用的起效速度。评估模型的应用似乎有效且有用。该模型实用,应加以扩展以提高通用性。