Schering-Plough (formerly NV Organon), now Merck Sharp & Dohme, Oss, The Netherlands.
Pharmacopsychiatry. 2010 Jun;43(4):138-46. doi: 10.1055/s-0030-1248313. Epub 2010 Mar 4.
We conducted a double-blind 1-year trial of asenapine in patients with schizophrenia or schizoaffective disorder.
Patients were randomized to asenapine (5 or 10 mg BID; n=913) or olanzapine (10-20 mg QD; n=312), and monitored regularly.
Trial completion rates were 38% with asenapine, 57% with olanzapine; main reasons for discontinuation were withdrawal of consent (22%, 16%) and insufficient response (25%, 14%); fewer discontinuations were due to adverse events (6%, 7%). Mean weight gain was 0.9 kg with asenapine, 4.2 kg with olanzapine. Extrapyramidal symptoms reported as adverse events were more common with asenapine. Mean reductions in PANSS total score with asenapine and olanzapine were -21.0 and -27.5 ( P<0.0001); the exclusion of patients who had previous poor experience with olanzapine may have biased the results in favor of olanzapine. Scores on the subjective well-being on neuroleptics scale and functionality measures were similar between groups.
Asenapine was well tolerated over 1 year of treatment, causing less weight gain than olanzapine but more frequent extrapyramidal symptoms. PANSS total score improved with both agents; the improvement was greater with olanzapine than with asenapine using last observations carried forward but not in an observed-case analysis.
我们进行了一项为期 1 年的阿塞那平双盲试验，该试验针对的是精神分裂症或分裂情感性障碍患者。
患者随机分为阿塞那平（5 或 10mg，bid；n=913）或奥氮平（10-20mg，qd；n=312）组，并定期监测。
阿塞那平组的试验完成率为 38%，奥氮平组为 57%；主要停药原因为失访（22%，16%）和疗效不佳（25%，14%）；因不良事件停药的比例较低（6%，7%）。阿塞那平组平均体重增加 0.9kg，奥氮平组增加 4.2kg。报告为不良事件的锥体外系症状在阿塞那平组更常见。阿塞那平和奥氮平治疗后 PANSS 总分分别平均降低 21.0 和 27.5（P<0.0001）；排除对奥氮平既往疗效不佳的患者可能使奥氮平的结果更偏向于有利。两组的神经阻滞剂主观幸福感量表评分和功能测量评分相似。
阿塞那平在 1 年的治疗期间耐受性良好，体重增加少于奥氮平，但锥体外系症状更频繁。两种药物均可改善 PANSS 总分；采用末次观察结转（LOCF）的方法分析，奥氮平的改善优于阿塞那平，但在观察病例分析中并非如此。
