美国Ｒｏｓｅｎｈｅｃｋ等的一项随机、双盲、为期１年的多中心对照临床研究显示，奥氮平治疗精神分裂症的疗效并不比氟哌啶醇优越，而治疗费用却高得多. 奥氮平是最常用于治疗精神分裂症的非典型抗精神病药物，也是非典型抗精神病药物中最昂贵的一种。虽然既往研究得出“奥氮平可以在降低总医疗费用的同时，更有效改善患者症状，提高生活质量”的结论，但近期有文献综述指出，奥氮平的长期疗效不佳，对上述结论提出了质疑。因此，Ｒｏｓｅｎｈｅｃｋ等开展了这项大规模、随机的长期研究，旨在证明“在精神分裂症治疗的三个主要终点（患者症状、生活质量和费用）中，奥氮平优于传统抗精神病药物氟哌啶醇”，但最终却得出了相反的结论。 该研究纳入了１７家医院的３０９例精神分裂症患者，随机分成２组，一组（１５０例）每天接受氟哌啶醇５～２０ ｍｇ和预防性苯扎托品１～４ ｍｇ治疗１２个月，另一组接受奥氮平５～２０ ｍｇ和苯扎托品安慰剂治疗１２个月。研究结果显示，２组患者的依从性相似；２组患者的精神分裂症阳性症状、阴性症状及总症状评分无差异；虽然奥氮平组静坐不能（ａｋａｔｈｅｓｉａ）的改善情况显著优于氟哌啶醇组，但２组患者的生活质量和其他锥体外系症状都没有差异；奥氮平组的体重增加显著高于氟哌啶醇组，且医疗费用比氟哌啶醇组高４～５倍（３０００～９０００美元）。
Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial.
Rosenheck R, Perlick D, Bingham S, et al.
JAMA. 2003 Nov 26;290(20):2693-702.
CONTEXT: Although olanzapine has been widely adopted as a treatment of choice for schizophrenia, its long-term effectiveness and costs have not been evaluated in a controlled trial in comparison with a standard antipsychotic drug. OBJECTIVE: To evaluate the effectiveness and cost impact of olanzapine compared with haloperidol in the treatment of schizophrenia. DESIGN AND SETTING: Double-blind, randomized controlled trial with randomization conducted between June 1998 and June 2000 at 17 US Department of Veterans Affairs medical centers. PARTICIPANTS: Three hundred nine patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of schizophrenia or schizoaffective disorder, serious symptoms, and serious dysfunction for the previous 2 years. Fifty-nine percent fully completed and 36% partially completed follow-up assessments. INTERVENTIONS: Patients were randomly assigned to receive flexibly dosed olanzapine, 5 to 20 mg/d, with prophylactic benztropine, 1 to 4 mg/d (n = 159); or haloperidol, 5 to 20 mg/d (n = 150), for 12 months. MAIN OUTCOME MEASURES: Standardized measures of symptoms, quality of life, neurocognitive status, and adverse effects of medication. Veterans Affairs administrative data and interviews concerning non-VA service use were used to estimate costs from the perspective of the VA health care system and society as a whole (ie, consumption of all resources on behalf of these patients). RESULTS: There were no significant differences between groups in study retention; positive, negative, or total symptoms of schizophrenia; quality of life; or extrapyramidal symptoms. Olanzapine was associated with reduced akathisia in the intention-to-treat analysis (P<.001) and with lower symptoms of tardive dyskinesia in a secondary analysis including only observations during blinded treatment with study drug. Small but significant advantages were also observed on measures of memory and motor function. Olanzapine was also associated with more frequent reports of weight gain and significantly greater VA costs, ranging from 3000 dollars to 9000 dollars annually. Differences in societal costs were somewhat smaller and were not significant. CONCLUSION: Olanzapine does not demonstrate advantages compared with haloperidol (in combination with prophylactic benztropine) in compliance, symptoms, extrapyramidal symptoms, or overall quality of life, and its benefits in reducing akathisia and improving cognition must be balanced with the problems of weight gain and higher cost.
转自 shmu
