Takahashi Hitoshi, Kamata Mitsuhiro, Yoshida Keizo, Ishigooka Jun, Higuchi Hisashi
Yuri Kumiai General Hospital, Honjoh, Akita, Japan.
J Clin Psychiatry. 2006 Oct;67(10):1577-82. doi: 10.4088/jcp.v67n1013.
The efficacy and safety of switching to olanzapine were investigated in patients with first-episode schizophrenia who failed to attain an adequate clinical response to an initial therapeutic trial of risperidone (2-6 mg/day for 12 weeks).
A total of 58 first-episode patients with DSM-IV schizophrenia who had residual symptoms following treatment with risperidone were enrolled in an open-label, 12-week study of olanzapine. Dosing was determined by clinical judgment. The main efficacy measure was the Brief Psychiatric Rating Scale (BPRS). Patients with a 20% or greater decrease in BPRS total score plus a final Clinical Global Impressions-Severity of Illness scale score of <or= 3 (mildly ill) were considered responders. The study was conducted from April 2001 to March 2005.
Fifty-one patients completed the study, and 7 discontinued due to side effects and medication noncompliance. The mean dosage of olanzapine was 15.3 (SD 4.2) mg/day at study endpoint. Total BPRS scores significantly decreased (12.3%) during olanzapine treatment (p < .001). In addition, BPRS subscales of anxiety/depression and excitement significantly decreased (19.1% and 29.5%, respectively; p < .001). The responder rate was 29.3% (17/58). BPRS positive symptom subscale score at baseline was significantly higher in nonresponders compared to responders (p < .001). Comparison of percentage change in BPRS total scores between responders and nonresponders revealed a significant difference at week 4 that continued until study endpoint (p < .001). Of 58 patients, 27 (46.6%) showed clinically significant weight gain (>or= 7%) from baseline.
Although we cannot draw any conclusion from a study without a control group, favorable outcomes and good tolerance were observed after switching to olanzapine from risperidone in our population. In addition, factors that predicted a good overall response included a relative absence of positive symptoms at baseline and the percentage reduction in total BPRS score at 4 weeks of treatment. Double-blind, crossover trials are needed to confirm these observations.
在对利培酮(2 - 6毫克/天,治疗12周)初始治疗试验未获得充分临床反应的首发精神分裂症患者中,研究了换用奥氮平的疗效和安全性。
共有58例经利培酮治疗后仍有残留症状的DSM - IV首发精神分裂症患者,纳入一项为期12周的奥氮平开放标签研究。给药剂量由临床判断确定。主要疗效指标为简明精神病评定量表(BPRS)。BPRS总分下降20%或更多,且最终临床总体印象 - 疾病严重程度量表评分≤3(轻度疾病)的患者被视为有反应者。该研究于2001年4月至2005年3月进行。
51例患者完成研究,7例因副作用和药物不依从性而停药。研究终点时奥氮平的平均剂量为15.3(标准差4.2)毫克/天。在奥氮平治疗期间,BPRS总分显著下降(12.3%)(p <.001)。此外,焦虑/抑郁和兴奋的BPRS分量表显著下降(分别为19.1%和29.5%;p <.001)。有反应者比例为29.3%(17/58)。无反应者的基线BPRS阳性症状分量表评分显著高于有反应者(p <.001)。有反应者与无反应者之间BPRS总分变化百分比的比较显示,在第4周存在显著差异,且持续至研究终点(p <.001)。58例患者中,27例(46.6%)自基线起出现临床上显著的体重增加(≥7%)。
尽管在无对照组的研究中我们无法得出任何结论,但在我们的研究人群中,从利培酮换用奥氮平后观察到了良好的结果和耐受性。此外,预测总体反应良好的因素包括基线时相对缺乏阳性症状以及治疗4周时BPRS总分的降低百分比。需要进行双盲交叉试验来证实这些观察结果。