Glazer W M, Johnstone B M
Harvard Medical School, USA.
J Clin Psychiatry. 1997;58 Suppl 10:50-4.
Medications comprise a minor portion of the costs of schizophrenia, but may have a major impact on the likelihood of successful outcome of care. Novel antipsychotic medications which demonstrate superior symptom control, an improved safety profile, and benefits to quality-of-life may also reduce patients' need for medical services and the associated costs of these treatments. This report first considers key experimental design elements involved in integrating pharmacoeconomic and clinical objectives in studies of new drug therapies for schizophrenia. We briefly discuss the choice of therapies for comparison, randomization and blinding, sample size and composition, data collection, selection of the time frame for economic evaluation, and the importance of an intent-to-treat perspective. Second, as an example we present the design and selected results from a new economic clinical trial of the novel antipsychotic olanzapine. This trial utilized a randomized, double-blind design to compare the use of medical services and the cost of treatment for 817 schizophrenic patients from the United States treated with olanzapine or haloperidol. In comprehensive health care cost comparisons that incorporated the expenditures for study medications, the total cost of health care for olanzapine-treated patients was reduced by an average of $431 per month in comparison with haloperidol-treated patients during the initial 6 weeks of treatment. Among treatment responders receiving double-blind therapy for a maximum of 1 year, the total cost of care among olanzapine responders was reduced by an average of $345 per month in comparison with haloperidol responders. The results of this economic evaluation suggest that olanzapine's superior treatment profile may lead to reductions in the overall costs of medical care for patients with schizophrenia.
药物治疗在精神分裂症的费用中占比不大,但可能对治疗成功的可能性产生重大影响。新型抗精神病药物具有更好的症状控制效果、更优的安全性以及对生活质量有益,这也可能减少患者对医疗服务的需求以及这些治疗的相关费用。本报告首先考虑在精神分裂症新药治疗研究中整合药物经济学和临床目标所涉及的关键实验设计要素。我们简要讨论比较疗法的选择、随机化和盲法、样本量和构成、数据收集、经济评估时间框架的选择以及意向性治疗观点的重要性。其次,作为一个例子,我们展示新型抗精神病药物奥氮平一项新的经济临床试验的设计和选定结果。该试验采用随机双盲设计,比较了美国817名接受奥氮平或氟哌啶醇治疗的精神分裂症患者的医疗服务使用情况和治疗费用。在纳入研究药物支出的综合医疗保健成本比较中,与氟哌啶醇治疗的患者相比,奥氮平治疗的患者在治疗的最初6周内每月医疗保健总成本平均降低了431美元。在接受双盲治疗最长1年的治疗反应者中,与氟哌啶醇反应者相比,奥氮平反应者的护理总成本平均每月降低了345美元。这项经济评估的结果表明,奥氮平优越的治疗效果可能会降低精神分裂症患者的总体医疗费用。