阿立哌唑与利培酮治疗首发精神分裂症对照研究

A control study of aripiprazole vs risperidone in the treatment of first-episode schizophrenia

目的 探讨阿立哌唑与利培酮治疗首发精神分裂症的临床疗效及安全性.方法 将90例首发精神分裂症患者随机分为两组,每组45例,研究组口服阿立哌唑治疗,对照组口服利培酮治疗.观察8周.于治疗前及治疗1周、2周、4周、8周末采用阳性与阴性症状量表、副反应量表评定临床疗效和不良反应.结果 治疗后两组阳性与阴性症状量表总分及各因子分均较治疗前有显著下降（P＜0.01）,同期两组评分差异均无显著性（P＞0.05）;治疗8周末,研究组显效率73.3%、有效率84.4%,对照组分别为71.1%和86.7%,两组差异无显著性（χ^2=0.06、0.11,P＞0.05）.两组不良反应均轻微,研究组主要表现为失眠、头痛、焦虑;对照组主要表现为体质量增加、月经紊乱或泌乳、静坐不能、震颤;研究组体质量增加、月经紊乱或泌乳以及锥体外系反应发生率均显著低于对照组（P＜0.05或0.01）.结论 阿立哌唑治疗精神分裂症疗效显著且与利培酮相当,但阿立哌唑对内分泌和代谢影响较小,几乎不引起体质量增加及月经紊乱或泌乳,锥体外系反应发生率低,安全性更高,依从性更好.

Objective To explore the efficacy and safety of aripiprazole and risperidone in the treatment of first-episode schizophrenia. Methods Ninety first episode schizophrenics were randomly assigned to groups of 45 patients each, research group took orally aripiprazole and control group did risperidone for 8 weeks. Efficacies were assessed with the Positive and Negative Syndrome Scale （PANSS） and adverse reactions with the Treatment Emergent Symptom Scale （TESS） before treatment and at the end of the 1^st, 2^nd , 4^th and 8^th week. Results The total and each factor scores of the PANSS in both group lowered more significantly after treatment compared with pretreatment （P〈0.01）, there were no notable differences in contemporaneous group comparisons （P〉0.05） ; at the end of the 8^th week, obvious effective and effective rates were 73.3% and 84.4% in research group and 71.1% and 86.7% in control group, which showed no significant differences （χ^2=0. 06,0.11; P〈0.05）. Adverse reactions of both groups were mild, mainly in somnia, headache and anxiety in research group and weight gain, menstrual disorder or lactation, akathisia and tremor; the incidences of weight gain, menstrual disorder or lactation and extrapyramidal symptoms were significantly lower in research than in control group （P〈0.05 or 0.01）. Conclusion Aripiprazole has an evident effect equivalent to risperidone in the treatment of schizophrenis, but the former has less effect on endocrine and metabolism, scarcely causes weight gain, menstrual disorder or lactation, has low incidences of extrapyramidal symptoms, higher safety and better compliance.