Hamilton S H, Revicki D A, Genduso L A, Beasley C M
Lilly Research Laboratories, Indianapolis, Indiana 46285, USA.
Neuropsychopharmacology. 1998 Jan;18(1):41-9. doi: 10.1016/S0893-133X(97)00111-5.
This double-blind study evaluated the impact of treatment with olanzapine compared with haloperidol, and placebo on improvements in symptomatology and quality of life in patients with a DSM-III-R diagnosis of schizophrenia. A total of 335 patients was randomized to five treatment groups; olanzapine 5 +/- 2.5 mg/day, olanzapine 10 +/- 2.5 mg/day, olanzapine 15 +/- 2.5 mg/day, haloperidol 15 +/- 5 mg/day, and placebo. Patients responding to treatment during the 6-week acute phase were eligible to enter a 46-week extension. Efficacy measures included the brief psychiatric rating scale total, scale for assessment of negative symptoms summary, and clinical global impressions severity scores. Quality of life was evaluated using the quality of life scale. Data analyzed after 24 weeks of therapy showed that olanzapine was significantly superior to placebo in reducing clinical severity and significantly superior to haloperidol in reducing negative symptoms in patients responding to acute treatment. Furthermore, improvement in quality of life was observed in olanzapine-treated responders.
这项双盲研究评估了奥氮平与氟哌啶醇及安慰剂治疗对诊断为DSM-III-R精神分裂症患者症状改善及生活质量的影响。总共335例患者被随机分为五个治疗组；奥氮平5±2.5毫克/天、奥氮平10±2.5毫克/天、奥氮平15±2.5毫克/天、氟哌啶醇15±5毫克/天以及安慰剂组。在6周急性期对治疗有反应的患者有资格进入46周的延长期。疗效指标包括简明精神病评定量表总分、阴性症状评定量表总分以及临床总体印象严重程度评分。使用生活质量量表评估生活质量。治疗24周后分析的数据表明，在急性治疗有反应的患者中，奥氮平在降低临床严重程度方面显著优于安慰剂，在减轻阴性症状方面显著优于氟哌啶醇。此外，在接受奥氮平治疗且有反应的患者中观察到生活质量有所改善。
