利培酮口服液治疗儿童孤独症32例的疗效及安全性

Efficacy and safety of risperidone oral solution in the treatment of thirty-two adolescent patients with autism

目的:探讨利培酮口服液治疗儿童孤独症的临床疗效及安全性。方法:对32儿童孤独症患者使用利培酮口服液治疗,观察12周。采用临床疗效总评量表(CGI)和孤独症治疗评估量表(ATEC)评定临床疗效,使用不良反应量表(TESS)及实验室监测评估安全性。结果:CGI中严重程度评分(SI)于治疗4周起与治疗前有所下降(P<0.05),于治疗12周下降更显著(P<0.01);疗效总评(GI)在治疗2周与治疗12周比较有显著性差异(P<0.01)。ATEC总分在治疗4周与治疗前比较有下降(P<0.05),于治疗12周下降更显著(P<0.01)。ATEC各项目分中,除社交项评分在治疗前后均无明显下降外(P>0.05),其他项目评分在治疗12周后均有明显下降(P<0.01),特别是行为项评分在治疗2周后与治疗前比较有显著性差异(P<0.05)。不良反应轻微,多自行缓解,17例(48.57%)患者有体质量增加。结论:利培酮口服液治疗儿童孤独症患者疗效确切,不良反应少,安全性高。

Objective ： To evaluate the efficacy and safety of risperidone oral solution in the treatment of ad- olescent patients with autism. Methods： All patients （n = 32） were treated with risperidone oral solution for 12 weeks. The Clinical Global Impression （CGI） and the Autism Treatment Evaluation Checklist （ATEC） were used to evaluate the clinical efficacy, and the Treatment Emergent Symptom Scale （TESS） and laboratory monitoring were used to evaluate the clinical safety. Results： Severity score in CGI decreased from the 4th week of treatment （P 〈 0.05） , and was significantly reduced at the end of the 12 weeks （P 〈 0.01 ）. GI had statistical difference between 2nd week and 12th week of treatment （P 〈 0.01）. Total ATEC scores decreased from the 4th week of treatment （P 〈0.05）, and was significantly reduced at the end of the 12 weeks （P 〈 0.01）. The social inter- course ability was not significantly declined in the ATEC, but scores of other items were significantly reduced after 12-week treatment （P 〈 0.01 ） , especially behavior scores significantly reduced at the end of 2 weeks （P 〈 0.05 ）. The adverse events were mild and most of them were alleviated without any special intervention. Body mass in- creased in 17 patients （48.57%）. Conclusion： Risperidone oral solution is effective in the treatment of autism. Ithas a favorable safety and its side effects are mild.