阿立哌唑与奥氮平治疗精神分裂症的疗效及安全性临床比较研究

Comparison of efficacy and safety of Aripiprazole and Olanzapine in the treatment of schizophrenia

目的:以奥氮平为对照,探讨阿立哌唑治疗精神分裂症的疗效和安全性。方法:将200例符合CCMD-3诊断标准的精神分裂症患者随机分为阿立哌唑组和奥氮平组各100例,分别给予阿立哌唑和奥氮平治疗观察时间为6周。于治疗前、治疗第1、2、4、6周末采用阳性症状和阴性症状量表(PANSS)评定临床疗效,采用治疗中需处理的不良反应量表(TESS)评定副反应,采用血生化指标和心电图的改变评价治疗的安全性。最终进入分析共197例(阿立哌唑组98例,奥氮平组99例)。结果:阿立哌唑组于治疗第1周末(除阴性症状分外)、奥氮平组自治疗第4周末,PANSS阳性、阴性症状分、精神病理症状分和总分均明显下降(P<0.05或P<0.01)。治疗第6周末,阿立哌唑组PANSS阳性症状分、阴性症状分、精神病理症状分,总分(54.7±21.3)分,与治疗前评分的差异均有统计学意义(P均<0.01),且疗效优于奥氮平组(P<0.01)。治疗第6周后,阿立哌唑组治愈率35例(36%),显著好转31例(32%),好转14例(14%),症状无效及恶化共18例(18%);治愈率为36%,显效率为67%;有效率为82%,高于奥氮平组(74%)。6周的观察中,未发现阿立哌唑导致的体重明显增加及心电图明显改变。结论:阿立哌唑和奥氮平对精神分裂症有良好的疗效,且起效较迅速,安全性较好。

Objective：To investigate the clinical efficacy and satety of Aripiprazole in the treatment of schizophrenia. Methods：200 patients with schizophrenia by CCMD - 3 were randomly allocated to two groups treated with Aripiprazole or Risperidone for 6 weeks. The positive and negative syndrome scale （PANSS） and treatment emergent symptoms scale （TESS） were used to evaluate efficacy and adverse effects respectively before and at the ends of 1,2,4,6 weeks of treatment. Results：The therapeutic efficacy in Aripiprazole group was similar to that in Olanzapine group（ P 〉 0.05 ） ; There was no signigieant difference between the two groups （ P 〉 0.05 ）. Incidence of adverse effects in the Aripiprazole group was lower than that in the Olanzapine group, but the difference was lower than that in the Olanzapine group, but the difference was not significant （ P 〉 0.05 ）. The rates of extra - pyramindal symptoms and endocrine changes were significantly higher in the Olanzapine group than those in the Aripiprazole group. Conclusion：Aripiprazole and Olanzapine has good curative effect of Schizophrenia, and more quickly works, safety better.