Silva de Lima Maurício, de Jesus Mari Jair, Breier Alan, Maria Costa Anna, Pondé de Sena Eduardo, Hotopf Matthew
Eli Lilly Brazil, São Paulo, Brazil.
J Clin Psychiatry. 2005 Jul;66(7):831-8.
To assess the effectiveness of olanzapine for treating schizophrenia and to assess if olanzapine promotes a better quality of life than first-generation antipsychotics (FGAs).
Multicenter, naturalistic, randomized controlled study, comparing olanzapine with FGAs, at hospitalization and during a 9-month follow-up. Outcome assessors were blind to the allocated drug. The dose of antipsychotic was determined by doctors according to their clinical practice routines. Data collection was performed from April 1999 to August 2001.
197 patients with DSM-IV-diagnosed schizophrenia were allocated to olanzapine (N = 104) and FGA (N = 93). Patients taking olanzapine showed greater improvements in Positive and Negative Syndrome Scale (PANSS) negative symptoms (mean difference = 2.3, 95% CI = 0.6 to 4.1) and general psychopathology (mean difference = 4.0, 95% CI = 0.8 to 7.2) sub-scales and fewer incidences of tardive dyskinesia (RR = 2.4, 95% CI = 1.4 to 4.2, p < .0001). Olanzapine was also associated with greater improvement in a number of health-related quality-of-life outcomes on the Medical Outcomes Study 36-item Short-Form Health Survey, including physical functioning (mean difference = 6.6, 95% CI = 1.2 to 11.9), physical role limitations (mean difference = 13.7, 95% CI = 3.0 to 24.3), and emotional role limitations (mean difference = 12.1, 95% CI = 0.7 to 23.5). Patients taking olanzapine gained significantly more weight during the trial than patients taking FGAs, with a correspondent endpoint increase in the body mass index (BMI) of 28.7 versus 25.3 (p < .001).
Compared with FGAs, olanzapine has advantages in terms of improvements of negative symptoms and quality of life. It is also associated with fewer incidences of tardive dyskinesia and greater increases in weight and BMI. These findings are highlighted by the naturalistic approach adopted in this trial.
评估奥氮平治疗精神分裂症的有效性,并评估奥氮平是否比第一代抗精神病药物(FGA)能带来更好的生活质量。
多中心、自然主义、随机对照研究,在住院期间及9个月的随访期内,将奥氮平与FGA进行比较。结果评估者对分配的药物不知情。抗精神病药物的剂量由医生根据其临床常规确定。数据收集于1999年4月至2001年8月进行。
197例经DSM-IV诊断为精神分裂症的患者被分配至奥氮平组(N = 104)和FGA组(N = 93)。服用奥氮平的患者在阳性和阴性症状量表(PANSS)阴性症状(平均差异 = 2.3,95%CI = 0.6至4.1)和一般精神病理学(平均差异 = 4.0,95%CI = 0.8至7.2)子量表上有更大改善,迟发性运动障碍的发生率更低(RR = 2.4,95%CI = 1.4至4.2,p <.0001)。在医学结果研究36项简短健康调查中,奥氮平还与许多与健康相关的生活质量结果的更大改善相关,包括身体功能(平均差异 = 6.6,95%CI = 1.2至11.9)、身体角色限制(平均差异 = 13.7,95%CI = 3.0至24.3)和情感角色限制(平均差异 = 12.1,95%CI = 0.7至23.5)。在试验期间,服用奥氮平的患者比服用FGA的患者体重增加明显更多,相应的终点体重指数(BMI)增加分别为28.7和25.3(p <.001)。
与FGA相比,奥氮平在改善阴性症状和生活质量方面具有优势。它还与更少的迟发性运动障碍发生率以及更大的体重和BMI增加相关。本试验采用的自然主义方法突出了这些发现。