阿立哌唑与利培酮治疗精神分裂症对照研究

A controlled study of aripiprazole vs. risperidone in the treatment of schizophrenia

目的探讨阿立哌唑与利培酮治疗精神分裂症的临床疗效和安全性。方法将86例精神分裂症患者随机分为两组，每组43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2周、4周、8周末采用阳性与阴性症状量表及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〈0.05或0．01），同期两组间评分比较差异均无显著性（P〉0．05）；治疗8周末，研究组总有效率为86．0％，对照组为83．7％，两组比较差异无显著性（χ^2=0．09，P〉0．05）。研究组不良反应发生率为48．8％，对照组为55．8％，两组总体不良反应发生率比较差异无显著性（χ^2=0．42，P〉0.05），但研究组兴奋／激越、恶心呕吐发生率显著高于对照组（P〈0.05），肌强直、震颤、静坐不能、体质量增加、月经改变和泌乳发生率显著低于对照组（P〈0.05或0．01）。结论阿立哌唑与利培酮治疗精神分裂症疗效显著且相当，但阿立哌唑对女性患者的月经影响较小，安全性更高，依从性更好。

Objective To explore the efficacy and safety of aripiprazole vs. risperidone in the treatment of schizophrenia. Methods Eighty-six schizophrenia patients were randomly divided into two groups of 43 ones each, research group took orally aripiprazole and control 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） at baseline and at the end of the 2^nd , 4^th and 8^th week. Results After treatment the total and each factor scores of both groups lowered more significantly compared with pretreatment （P〈0.05 or 0.01）, there were no significant group differences （P〈0. 05）; total effective rate was respectively 86.0% in research and 83.7% in control group, which showed no significant differences at the end of the 8th week （χ^2=0. 09,P〉0. 05）. The incidence of adverse reactions was respectively 48. 8%in research and 55.8% in control group, there was no significant group difference in total incidence （χ^2 =0. 42,P〉0.05）, but the incidences of excitation/agitation, nausea and vomiting were significantly higher （P〈0.05） and those of myotonia, tremor, akathisia, increased body weight, menstruation changes and lactation lower （P〈0.05 or 0.01）in research than in control group. Conclusion Aripiprazole equivalent to risperidone has an evident effect in the treatment of schizophrenia, but the former has little influence on menstruation of female patients, higher safety and better compliance.