Woods Scott W, Breier Alan, Zipursky Robert B, Perkins Diana O, Addington Jean, Miller Tandy J, Hawkins Keith A, Marquez Eva, Lindborg Stacy R, Tohen Mauricio, McGlashan Thomas H
Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut 06519, USA.
Biol Psychiatry. 2003 Aug 15;54(4):453-64. doi: 10.1016/s0006-3223(03)00321-4.
The prodromal phase of schizophrenic disorders has been described prospectively. The present study aimed to determine the short-term efficacy and safety of olanzapine treatment of prodromal symptoms compared with placebo.
This was a double-blind, randomized, parallel-groups, placebo-controlled trial with fixed-flexible dosing conducted at four sites. Sixty patients met prodromal diagnostic criteria, including attenuated psychotic symptoms, as determined by structured interviews. Olanzapine 5-15 mg daily or placebo was prescribed for 8 weeks.
In the mixed-effects, repeated-measures analysis, the treatment x time interaction for the change from baseline on the Scale of Prodromal Symptoms total score was statistically significant, and post hoc analyses revealed that the olanzapine-placebo difference reached p<.10 by week 6 and p<.05 at week 8. Ratings of extrapyramidal symptoms remained low in each group and were not significantly different. Olanzapine patients gained 9.9 lb versus.7 lb for placebo patients (p<.001).
This short-term analysis suggests olanzapine is associated with significantly greater symptomatic improvement but significantly greater weight gain than is placebo in prodromal patients. Extrapyramidal symptoms with olanzapine were minimal and similar to those with placebo. Future research over the longer term with more patients will be needed before recommendations can be made regarding routine treatment.
精神分裂症谱系障碍的前驱期已被前瞻性地描述。本研究旨在确定与安慰剂相比，奥氮平治疗前驱症状的短期疗效和安全性。
这是一项在四个地点进行的双盲、随机、平行组、安慰剂对照试验，采用固定-灵活给药方案。60名患者符合前驱期诊断标准，包括通过结构化访谈确定的精神病性症状衰减。每天服用5-15毫克奥氮平或安慰剂，持续8周。
在混合效应重复测量分析中，前驱症状量表总分自基线变化的治疗×时间交互作用具有统计学意义，事后分析显示，奥氮平与安慰剂的差异在第6周时p<0.10，在第8周时p<0.05。每组锥体外系症状评分均较低，且无显著差异。奥氮平组患者体重增加9.9磅，而安慰剂组患者体重增加0.7磅（p<0.001）。
这项短期分析表明，在前驱期患者中，奥氮平与症状改善显著更大相关，但体重增加也显著大于安慰剂。奥氮平引起的锥体外系症状极少，与安慰剂相似。在就常规治疗提出建议之前，需要对更多患者进行更长时间的未来研究。
