Dossenbach Martin, Pecenak Jan, Szulc Agata, Irimia Victoria, Anders Martin, Logozar-Perkovic Dusanka, Peciukaitiene Dalia, Kotler Moshe, Smulevich Anatoly B, West Teena M, Lowry Amanda J, Treuer Tamas
Eli Lilly and Co., GmbH, Vienna, Austria.
J Clin Psychiatry. 2008 Dec;69(12):1901-15. Epub 2008 Sep 9.
Noninterventional, naturalistic studies facilitate examination of current clinical practices and provide an understanding of the impact of the biopsychosocial aspects of schizophrenia. This article describes disease burden and patient outcomes, with an emphasis on the comparative effectiveness and tolerability of antipsychotic monotherapy.
Outpatients initiating or changing antipsychotic therapy for DSM-IV- or ICD-10-defined schizophrenia (N = 7658) were allocated to olanzapine or nonolanzapine cohorts (November 2000 to December 2001). Treatment was at the psychiatrist's discretion, including flexible dosing and use of concomitant therapies and medications, with assessments at 0, 3, 6, 12, 18, 24, 30, and 36 months. Longitudinal clinical, pharmacologic, functional, and social data were collected over 36 months across 27 countries.
At entry, 76% of patients were initiated/switched to antipsychotic monotherapy, most commonly with olanzapine (N = 3222), risperidone (N = 1117), quetiapine (N = 189), or haloperidol (N = 257). Patients prescribed olanzapine were more likely to maintain their baseline monotherapy (p < .001) and did so for a longer period (p < .001) compared with other antipsychotics. Median time to discontinuation (in months) was as follows: olanzapine 30.0, risperidone 23.1, quetiapine 13.9, haloperidol 12.5. Olanzapine-treated patients were also more likely to respond, and did so more rapidly than patients on other monotherapies (p < .001). Response data were also favorable for risperidone; median time to response (in months) was as follows: olanzapine 5.2, risperidone 6.3, quetiapine 11.3, haloperidol 11.7. Treatment-emergent adverse events varied: olanzapine patients had less favorable odds for significant weight gain (p < .001); haloperidol patients, for motor dysfunction (p < or = .002).
These naturalistic data from less-studied outpatient communities highlight the variability in clinical and functional outcomes associated with long-term antipsychotic treatment.
非干预性、自然主义研究有助于审视当前的临床实践,并增进对精神分裂症生物心理社会层面影响的理解。本文描述了疾病负担和患者预后,重点关注抗精神病药物单一疗法的相对疗效和耐受性。
将开始或改变抗精神病药物治疗的门诊患者(根据《精神疾病诊断与统计手册》第四版或《国际疾病分类》第十版定义为精神分裂症,N = 7658)分配到奥氮平组或非奥氮平组(2000年11月至2001年12月)。治疗由精神科医生自行决定,包括灵活给药以及使用辅助疗法和药物,并在0、3、6、12、18、24、30和36个月时进行评估。在27个国家收集了36个月的纵向临床、药理学、功能和社会数据。
入组时,76%的患者开始/换用抗精神病药物单一疗法,最常用的是奥氮平(N = 3222)、利培酮(N = 1117)、喹硫平(N = 189)或氟哌啶醇(N = 257)。与其他抗精神病药物相比,使用奥氮平的患者更有可能维持其基线单一疗法(p < .001),且维持时间更长(p < .001)。停药的中位时间(以月为单位)如下:奥氮平30.0、利培酮23.1、喹硫平13.9、氟哌啶醇12.5。接受奥氮平治疗的患者也更有可能产生反应,且比接受其他单一疗法的患者反应更快(p < .001)。利培酮的反应数据也较好;反应的中位时间(以月为单位)如下:奥氮平5.2、利培酮6.3、喹硫平11.3、氟哌啶醇11.7。治疗中出现的不良事件各不相同:奥氮平组患者体重显著增加的几率较低(p < .001);氟哌啶醇组患者出现运动功能障碍的几率较低(p ≤ .002)。
这些来自研究较少的门诊患者群体的自然主义数据突出了长期抗精神病药物治疗相关的临床和功能结果的变异性。