帕利哌酮缓释片与奥氮平治疗精神分裂症患者的对照研究

A controlled comparison study on paliperidone extended-release tablets and olanzapine in the treatment of schizophrenia

目的:比较帕利哌酮缓释片与奥氮平治疗精神分裂症患者的疗效和安全性。方法:对156例精神分裂症患者随机分成帕利哌酮缓释片组和奥氮平组。采用简明精神病评定量表(BPRS)和不良反应症状量表(TESS),于治疗前、治疗1周、2周、4周和8周分别评定疗效和不良反应。结果:帕利哌酮缓释片组和奥氮平组的有效率分别为68.75%和65.78%,无显著差异。帕利哌酮缓释片组起效快,治疗1周后BPRS评分即显著下降,与奥氮平组有显著性差异(P<0.05),治疗8周后BPRS评分差异也有统计学意义(P<0.05)。帕利哌酮缓释片组不良反应轻微且低于奥氮平组。帕利哌酮组常见不良反应(发生率≥5%)为泌乳、闭经和便秘;奥氮平组(发生率≥5%)常见不良反应主要为镇静嗜睡、体重增加、血糖异常、头昏、便秘和转氨酶升高。结论:帕利哌酮缓释片与奥氮平对改善精神分裂症患者的有效率相当,但帕利哌酮缓释片起效迅速,不良反应少且轻微。

Objective： To evaluate the efficacy and safety of paliperidone extended-release （ER） tablets compared with olanzapine in the treatment of patients with schizophrenia. Methods： A randomized, controlled clinical trial was conducted. All 156 hospitalized patients with schizophrenia were treated with paliperdone ER or olanzapine for 8 weeks. The efficacy was evaluated by the total score changes in the brief psychiatric rating scale （BPRS） and the treatment emergent symptoms scale （TESS）. All patients were assessed at the baseline, and the 1st, 2nd, 4th and 8th week. Results： The effective rate of treatment was 68.75% in paliperdone ER group and 65.78% in olanzapine group, with no statistically significant difference between the two groups. However, paliperidone ER had faster onset than olanzapine, with a significantly reduction in BPRS in the 1st and 8th weeks （P 〈 0.05）. The adverse effects of paliperidone were lower and milder than those of olanzapine. The common adverse reactions of paliperdione group（occurance rate ≥5% ） were lactation or amenorrhoea, and constipation; the common adverse reactions of olanzapine group （occurance rate≥5% ） were sedation or somnolence, weight gain, glucose abnormalities, dizziness constipation and transaminase elevation. Conclusion ： Paliperidone ER has similar effective rate with olanzapine. However, paliperidone ER has faster onset, lower and milder adverse effects than olanzapine.