Revicki D A, Genduso L A, Hamilton S H, Ganoczy D, Beasley C M
Center for Health Outcomes Research, MEDTAP International, Bethesda, MD, USA.
Qual Life Res. 1999 Aug;8(5):417-26. doi: 10.1023/a:1008958925848.
Little information is available on the impact of the atypical antipsychotic olanzapine on quality of life (QOL). A 6-week, double-blind randomized multicenter trial, with a long-term extension, was conducted to evaluate the clinical efficacy and QOL of olanzapine and haloperidol in treating schizophrenia and other psychotic disorders.
A total of 828 outpatients provided QOL data. Study patients were aged greater than 18 years with a DSM-III-R diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and baseline BPRS (items scored on 0-6 scale) total scores, > or = 18 were randomized to 6 weeks of treatment with olanzapine 5 to 20 mg/day or haloperidol 5 to 20 mg/day. Patients entered a 46-week double-blind extension if they demonstrated minimal clinical response and were tolerant to study medication. The Quality of Life Scale (QLS) and SF-36 Health Survey were used to evaluate QOL.
During the 6-week acute phase, olanzapine treatment significantly improved BPRS total (p = 0.004), PANSS total scores (p = 0.043), QLS total (p = 0.005), intrapsychic foundations (p < 0.001) and interpersonal relations scores (p = 0.036), and SF-36 mental component summary scores (p < 0.001) compared with haloperidol. During the extension phase, olanzapine treatment significantly improved PANSS negative scores (p = 0.035) and improved QLS total (p = 0.001), intrapsychic foundations (p < 0.001), and instrumental role category scores (p = 0.015) versus haloperidol treatment. Significantly more haloperidol patients discontinued treatment due to adverse events during the acute and extension phases (p = 0.041 and p = 0.014, respectively). Changes in QLS total and MCS scores were associated with changes in clinical symptoms, depression scores and extrapyramidal symptoms.
Olanzapine was more effective than haloperidol in reducing severity of psychopathology and in improving QOL in patients with schizophrenia and other psychotic disorders. The QOL benefits of olanzapine, although modest, may be important for long-term treatment.
关于非典型抗精神病药物奥氮平对生活质量（QOL）影响的信息较少。开展了一项为期6周的双盲随机多中心试验，并进行长期延长期试验，以评估奥氮平和氟哌啶醇治疗精神分裂症及其他精神障碍的临床疗效和生活质量。
共有828名门诊患者提供了生活质量数据。研究患者年龄大于18岁，符合DSM-III-R诊断标准的精神分裂症、精神分裂症样障碍或分裂情感性障碍，且基线简明精神病评定量表（BPRS，评分范围为0 - 6分）总分≥18分，被随机分为接受为期6周的奥氮平5至20毫克/天或氟哌啶醇5至20毫克/天治疗。若患者显示出最小临床反应且对研究药物耐受，则进入为期46周的双盲延长期试验。使用生活质量量表（QLS）和SF-36健康调查评估生活质量。
在6周急性期，与氟哌啶醇相比，奥氮平治疗显著改善了BPRS总分（p = 0.004）、阳性和阴性症状量表（PANSS）总分（p = 0.043）、QLS总分（p = 0.005）、心理内在基础得分（p < 0.001）和人际关系得分（p = 0.036）以及SF-36精神健康综合得分（p < 0.001）。在延长期，与氟哌啶醇治疗相比，奥氮平治疗显著改善了PANSS阴性得分（p = 0.035），并改善了QLS总分（p = 0.001）、心理内在基础得分（p < 0.001）和工具性角色类别得分（p = 0.015）。在急性期和延长期，因不良事件而停药的氟哌啶醇患者显著更多（分别为p = 0.041和p = 0.014）。QLS总分和MCS得分的变化与临床症状、抑郁得分和锥体外系症状的变化相关。
在降低精神病理学严重程度及改善精神分裂症和其他精神障碍患者的生活质量方面，奥氮平比氟哌啶醇更有效。奥氮平对生活质量的益处虽不显著，但对长期治疗可能很重要。
