Lambert Martin, Holzbach Rüdiger, Moritz Steffen, Postel Nils, Krausz Michael, Naber Dieter
Department for Psychiatry and Psychotherapy, University of Hamburg, Martinistrasse 52, 20246 Hamburg, Germany.
Int Clin Psychopharmacol. 2003 Sep;18(5):251-60. doi: 10.1097/00004850-200309000-00001.
The aim of the present study was to evaluate the objective and subjective efficacy as well as tolerability of olanzapine in acute treatment of schizophrenia spectrum disorders under naturalistic non-selective conditions. Inpatients with schizophrenia spectrum disorders, consecutively admitted over an 18-month period, treated with olanzapine, were included. Diagnoses were made according to ICD-10 criteria based on repeated clinical assessments. Efficacy and tolerability of olanzapine were assessed at baseline and at the end of inpatient acute treatment including Positive and Negative Symptom Scale (PANSS), Clinical Global Impression, subjective assessments, UKU and biological investigations. One hundred and twenty non-selected patients who met ICD-10 criteria for schizophrenia (73%), schizophreniform disorder (14%) or schizoaffective disorder (13%) were treated with olanzapine 15.3+/-5.2 mg/day. Baseline severity (PANSS total mean score 102.2) was higher compared to various admittance studies (PANSS total mean score 86-90). In 32% of patients (n=38), olanzapine treatment was discontinued, mainly because of inefficacy for positive (89%, n=34) and/or negative (95%, n=36) symptoms and/or because of adverse events (37%, n=14). Response rates as improvement in PANSS total score (after > or =3 weeks of treatment) of > or =20%, 30% or 40% were 68%, 55% and 35%, respectively. Response rates in post-hoc defined treatment resistant patients were not significantly different from non-refractory patients. Sedation (26%) was the most common side-effect, followed by weight gain (22%). With regards to subjective efficacy, 30% of the patients were not satisfied with the efficacy of olanzapine, while only 6% of the patients reported a not satisfying subjective tolerability. According to duration of olanzapine treatment, the results for patients, who remained in hospital, revealed a faster increase of weight compared to admittance studies (7 kg in 14 weeks versus 7 kg in 38 weeks). Olanzapine has been found to be effective and tolerable, also under naturalistic acute treatment conditions. Compared to previous double-blind admittance studies, patients had a higher severity of illness at entry and a lower > or =40% PANSS total score response rate. By contrast to previous results, mean dose of olanzapine was similar for multiple- and first-episode patients, and weight gain was more severe. The results underline the need of Phase IV studies for the assessment of clinical antipsychotic efficacy and tolerability.
本研究的目的是评估在自然主义非选择性条件下奥氮平治疗精神分裂症谱系障碍急性期的客观和主观疗效以及耐受性。纳入在18个月期间连续入院并接受奥氮平治疗的精神分裂症谱系障碍住院患者。根据ICD - 10标准，基于重复的临床评估进行诊断。在基线和住院急性治疗结束时评估奥氮平的疗效和耐受性，包括阳性和阴性症状量表（PANSS）、临床总体印象、主观评估、UKU量表和生物学检查。120例符合ICD - 10精神分裂症标准（73%）、精神分裂症样障碍标准（14%）或分裂情感性障碍标准（13%）的未选择患者接受15.3±5.2mg/天的奥氮平治疗。与各种入院研究相比，基线严重程度（PANSS总分平均102.2）更高（PANSS总分平均86 - 90）。32%的患者（n = 38）停止奥氮平治疗，主要原因是对阳性症状（89%，n = 34）和/或阴性症状（95%，n = 36）无效和/或不良事件（37%，n = 14）。治疗≥3周后PANSS总分改善≥20%、30%或40%的缓解率分别为68%、55%和35%。事后定义的难治性患者的缓解率与非难治性患者无显著差异。镇静（26%）是最常见的副作用，其次是体重增加（22%）。关于主观疗效，30%的患者对奥氮平疗效不满意，而只有6%的患者报告主观耐受性不满意。根据奥氮平治疗持续时间，住院患者的结果显示体重增加速度比入院研究更快（14周增加7kg，而入院研究38周增加7kg）。已发现奥氮平在自然主义急性治疗条件下也是有效且耐受性良好的。与先前的双盲入院研究相比，患者入院时病情更严重，PANSS总分缓解率≥40%更低。与先前结果相反，多发作患者和首发患者的奥氮平平均剂量相似，且体重增加更严重。结果强调了进行IV期研究以评估临床抗精神病药物疗效和耐受性的必要性。
