Randomized, double-blind trial of olanzapine versus placebo in patients prodromally symptomatic for psychosis
Randomized, double-blind trial of olanzapine versus placebo in patients prodromally symptomatic for psychosis
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DOI：
10.1176/appi.ajp.163.5.790
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发表时间：
2006-05-01
影响因子：
17.7
通讯作者：
Breier, A
中科院分区：
文献类型：
--
作者：
McGlashan, TH;Zipursky, RB;Breier, A
目的：本研究评估了奥氮平在延迟或预防精神分裂症前驱症状患者转化为精神病以及减轻症状方面的疗效。
方法：这项随机试验在“通过风险识别、管理和教育进行预防”项目的北美四家诊所进行。门诊患者在为期1年的双盲治疗期接受奥氮平（5 - 15毫克/天，n = 31）或安慰剂（n = 29）治疗，并在为期1年的随访期不接受治疗。疗效衡量指标包括转化为精神病的比率以及前驱症状量表评分。
结果：在治疗年期间，16.1%的奥氮平治疗患者和37.9%的安慰剂治疗患者经历了向精神病的转化，差异接近显著。安慰剂治疗患者的转化风险约为奥氮平治疗患者的2.5倍，这也接近显著水平。在随访年期间，两组之间的转化率没有显著差异。在治疗期间，奥氮平组前驱阳性症状的平均评分比安慰剂组改善更多，并且混合模型重复测量最小二乘平均评分显示在第8周和第28周之间奥氮平治疗有更显著的改善。奥氮平治疗患者体重增加明显更多（平均值 = 8.79千克，标准差 = 9.05，而安慰剂组平均值 = 0.30千克，标准差 = 4.24）。
结论：在转化为精神病的比率方面未显示出显著的治疗差异。然而，这些结果可能受到检验效能低的影响。接近显著的差异表明奥氮平可能降低转化率并延迟精神病的发作。奥氮平对前驱阳性症状有效，但会导致体重增加。在这种疾病阶段有必要进行进一步的治疗研究。
Objective: This study assessed the efficacy of olanzapine in delaying or preventing conversion to psychosis and reducing symptoms in people with prodromal symptoms of schizophrenia.Method: This randomized trial occurred at four North American clinics in the Prevention Through Risk Identification, Management, and Education project. Outpatients received olanzapine (5 - 15 mg/day, N = 31) or placebo (N = 29) during a 1-year double-blind treatment period and no treatment during a 1-year follow-up period. Efficacy measures included the conversion-to- psychosis rate and Scale of Prodromal Symptoms scores.Results: During the treatment year, 16.1% of olanzapine patients and 37.9% of placebo patients experienced a conversion to psychosis, a nearly significant difference. The hazard of conversion among placebo patients was about 2.5 times that among olanzapine-treated patients, which also approached significance. In the follow-up year, the conversion rate did not differ significantly between groups. During treatment, the mean score for prodromal positive symptoms improved more in the olanzapine group than in the placebo group, and the mixed-model repeated-measures least-squares mean score showed significantly greater improvement between weeks 8 and 28 with olanzapine. The olanzapine patients gained significantly more weight (mean = 8.79 kg, SD = 9.05, versus mean = 0.30 kg, SD = 4.24).Conclusions: A significant treatment difference in the conversion-to-psychosis rate was not demonstrated. However, these results may be influenced by low power. The nearly significant differences suggest that olanzapine might reduce the conversion rate and delay onset of psychosis. Olanzapine was efficacious for positive prodromal symptoms but induced weight gain. Further treatment research in this phase of illness is warranted.