Department of Psychiatry, Zucker Hillside Hospital, North Shore-Long Island Jewish Health System, Albert Einstein College of Medicine, 75-59 263rd St., Glen Oaks, NY 11004, USA.
Am J Psychiatry. 2010 Feb;167(2):181-9. doi: 10.1176/appi.ajp.2009.07081221. Epub 2009 Dec 15.
The purpose of the present study was to evaluate the efficacy and tolerability of olanzapine long-acting injection for maintenance treatment of schizophrenia.
Outpatients with schizophrenia who had maintained stability on an oral regimen of olanzapine (10, 15, or 20 mg/day) for 4 to 8 weeks were randomly assigned to 24 weeks of double-blind treatment with "low" (150 mg every 2 weeks; N=140), "medium" (405 mg every 4 weeks; N=318), or "high" (300 mg every 2 weeks; N=141) doses of olanzapine long-acting injection; a very low reference dose of olanzapine long-acting injection (45 mg every 4 weeks; N=144); or their stabilized dose of oral olanzapine (N=322). Rates of and time to psychotic exacerbation were estimated using Kaplan-Meier methodology.
At 24 weeks, the majority of oral olanzapine-treated patients (93%), as well as most olanzapine long-acting injection-treated patients receiving high (95%), medium (90%), low (84%), and very low doses (69%), remained exacerbation free, with the therapeutic 4-week regimen (medium dose) and pooled 2-week regimen (low and high doses) demonstrating efficacy similar to that of oral olanzapine as well as to each other. The three standard long-acting doses were superior to the very low reference dose based on time to exacerbation. Incidence of weight gain > or = 7% of baseline was 21% for oral olanza-pine compared with 21%, 15%, 16%, and 8% for the high, medium, low, and very low olanzapine long-acting treatment groups, respectively. No clinically significant differences were observed between the long-acting injection and oral olanzapine groups in general safety parameters. Few injection-site reactions occurred (3%). Two patients experienced sedation and delirium consistent with olanzapine overdose following possible accidental intravascular injection.
Olanzapine long-acting injection was efficacious in maintenance treatment of schizophrenia for up to 24 weeks, with a safety profile similar to oral olanzapine except for injection-related adverse events.
本研究旨在评估奥氮平长效注射剂用于精神分裂症维持治疗的疗效和耐受性。
接受奥氮平（10、15 或 20 mg/天）口服治疗 4 至 8 周后病情稳定的精神分裂症门诊患者，被随机分配接受 24 周的双盲治疗，分别接受低剂量（150mg，每 2 周 1 次；N=140）、中剂量（405mg，每 4 周 1 次；N=318）或高剂量（300mg，每 2 周 1 次；N=141）奥氮平长效注射剂；极低剂量（45mg，每 4 周 1 次；N=144）奥氮平长效注射剂；或其稳定剂量的奥氮平口服（N=322）。采用 Kaplan-Meier 方法估计精神病恶化的发生率和时间。
24 周时，大多数口服奥氮平治疗的患者（93%），以及大多数接受高（95%）、中（90%）、低（84%）和极低剂量（69%）奥氮平长效注射剂治疗的患者，均未恶化，其中 4 周治疗方案（中剂量）和合并的 2 周治疗方案（低剂量和高剂量）与口服奥氮平以及彼此之间的疗效相似。基于恶化时间，三种标准长效剂量均优于极低参考剂量。与口服奥氮平相比，体重增加≥7%的发生率分别为 21%、21%、15%、16%和 8%，而奥氮平长效注射治疗组高、中、低和极低剂量分别为 21%、15%、16%和 8%。长效注射剂和口服奥氮平组在一般安全性参数方面无显著差异。少数患者出现注射部位反应（3%）。2 例患者发生镇静和意识障碍，可能与奥氮平过量有关，疑似发生意外血管内注射。
奥氮平长效注射剂用于精神分裂症维持治疗长达 24 周，疗效与奥氮平口服制剂相似，安全性也相似，除了与注射相关的不良反应。
