帕利哌酮缓释片治疗孤独症的开放性研究  

An open-label study of paliperidone extended release tablet in the treatment of autism

作　　者：孙凌[1,2] 周天红[1,2] 张嫦[2] 毛富强[1] 

机构地区：[1]天津医科大学精神医学教研室,天津300070 [2]天津市安定医院,天津300222

出　　处：《中国新药杂志》2013年第9期1060-1063,共4页Chinese Journal of New Drugs

摘　　要：目的:探讨帕利哌酮缓释片治疗孤独症的疗效及安全性。方法:用帕利哌酮缓释片治疗33例孤独症患者,观察8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;通过治疗满意度调查问卷(MSQ)调查治疗满意度;采用副反应量表(TESS)评定不良反应,并进行实验室检查和心电图监测。结果:CGI中SI评分、ATEC总分及ATEC行为项评分于治疗1周末即较治疗前有所减低(P<0.05);治疗2周末、4周末及8周末均明显低于治疗前(P<0.01)。ATEC评分中,除了社交项评分在治疗前后无明显改变之外,言语、感知和行为评分均有不同程度的改善。常见不良反应为锥体外系不良反应(12.1%),合用苯海索片可缓解。少数患者出现轻微嗜睡、口干、疲乏等,未予特殊处理,均自行缓解。实验室检查和心电图检测均未见明显异常。观察结束时,治疗满意度为90.9%。结论:帕利哌酮缓释片可有效控制孤独症易怒症状,继而提高康复训练的依从性,改善患儿的语言和感知症状,起效快,不良反应轻微,安全性高,依从性好。Objective： To evaluate the efficacy and safety of paliperidone extended release （ER） tablet in the treatment of autism. Methods： Totally 33 autism patients were treated with paliperidone ER and observed for 8 weeks. Clinical Global Impression Scale （CGI） and autism treatment Assessment Scale （ATEC） were adopted to assess clinical efficacy. Treatment satisfaction was evaluated by Medication Satisfaction Questionnaire （MSQ）. Ad- verse reactions were evaluated with Treatment Emergent Symptom Scale （TESS） and laboratory tests. Results： In CGI scale, SI score, ATEC total score and behavior items score of ATEC were reduced compared with those of 1st week-end or before treatment （P 〈 0.05 ）. At the end of 2nd, 4th and 8th weeks the scores were significantly lower than those of before treatment （P 〈 0.01 ）. In addition, no significant score change before and after treatment was found in social items in ATEC scale, but speech perception and behavior scores were improved by various degrees. Adverse reactions such as extracortieospinal reactions were mild, and most of them were relieved spontaneously. The treatment satisfaction was 90.9%. Conclusion： Paliperidone ER can effectively control the irritability symptoms of autism, and improve the rehabilitation of compliance, patient children＇s language and perceptual symptoms. It has advantages of rapid onset, mild adverse reactions, high safety and good compliance.

关 键 词：帕利哌酮缓释片 孤独症 儿童 疗效 安全性 依从性 

分 类 号：R971.4[医药卫生—药品]