利培酮与氯氮平治疗精神分裂症对照研究

A clinical control study of risperidone vs. clozapine in schizophrenia

目的 探讨利培酮与氯氮平治疗精神分裂症的临床疗效及安全性.方法 将84例精神分裂症患者随机分为利培酮组和氯氮平组,每组42例,分别口服利培酮与氯氮平治疗.观察8周.于治疗前及治疗1周、2周、4周、6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1周末,利培酮组阳性与阴性症状量表总分、阳性症状及精神病理因子分均较治疗前有显著下降（P〈0.05或0.01）;氯氮平组阳性与阴性症状量表总分、阳性症状因子分较治疗前有显著下降（P〈0.05或0.01）.治疗2周末起,两组阳性与阴性症状量表总分及各因子分较治疗前下降更显著（P〈0.01）.同期两组间比较差异均无显著性（P〉0.05）.利培酮组不良发生率显著低于氯氮平组（χ2=3.95,P〈0.05）. 结论 利培酮与氯氮平治疗精神分裂症疗效相当,但利培酮口服剂量小,不良反应发生率低、安全性更高、依从性更好.

Objective To explore the clinical efficacy and safety of risperidone and clozapine in schizophre- nia. Methods Eighty-four schizophrenics were randomized to risperidone and clozapine group （each n= 42） for 8 weeks. Clinical 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 1st, 2nd, 4th, 6th and 8th week. Results At the end of the 1st week, total, positive symptoms and general psychopathology scores of the PANSS lowered more significantly compared with pre-treatment in the risperidone group （P〈0.05 or 0. 01）, so did the total and positive symptoms scores in the clozapine group （P〈0.05 or 0.01）. Since the end of the 2nd week, the total and each factor scores of both groups lowered more significantly compared with pre-treatment （P〈0.01）. There were no significant differences in contemporary group comparisons （P〈0.05）. Incidences of adverse reactions were significantly lower in the risperidone than in the clozapine group （χ2= 3.95, P〈0.05）. Conclusion Risperidone has an efficacy equivalent to clozapine, but the former has smaller oral dosage, fewer adverse reactions and better compliance.