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阿立哌唑与利培酮治疗自闭症谱系障碍与注意缺陷多动障碍共病患儿的疗效与安全性评价
引用本文:贾小红,张倩,朱凤莲,王勇,王蕾.阿立哌唑与利培酮治疗自闭症谱系障碍与注意缺陷多动障碍共病患儿的疗效与安全性评价[J].中国医院药学杂志,2018,38(17):1816-1822.
作者姓名:贾小红  张倩  朱凤莲  王勇  王蕾
作者单位:开封市儿童医院儿科, 河南 开封 475000
基金项目:河南省卫生厅医学科技攻关资助项目(编号:2015T03025)
摘    要:目的:评价阿立哌唑与利培酮治疗自闭症谱系障碍(ASD)与注意缺陷多动障碍(ADHD)共病患儿的疗效与安全性。方法:选取在某院精神科治疗的ASD和ADHD共病患儿68例,根据随机数字表法将患儿分为阿立哌唑组(n=34)和利培酮组(n=34)。阿立哌唑组患儿接受起始剂量为5 mg·d-1的阿立哌唑片口服治疗,最终剂量增加至15 mg·d-1。利培酮组患儿接受起始剂量为1 mg·d-1的利培酮片口服治疗,最终剂量增加至2 mg·d-1;2组患儿均治疗12周。在基线(T0)、治疗6周(T1)与12周(T2)时,采用注意缺陷/多动评定量表(ADHD-RS)评价患儿总体ADHD症状变化情况;采用康纳斯行为评定量表(CRSR)教师用量表多动因子(CRSR-I)评价患儿多动症的改善情况;采用CRSR不注意缺陷-冲动因子(CRSR-H)评价患儿注意力缺陷的改善情况;采用临床整体印象-严重程度量表(CGI-S)及儿童总体评估量表(C-GAS)评分评价患儿整体功能。对患儿的相关临床指标进行常规监测,比较2组患儿药物不良事件与安全性。结果:与T0时比较,阿立哌唑组患儿T1与T2时,ADHD-RS、CRSR-I、CRSR-H与CGI-S评分均显著降低(均P<0.05),C-GAS评分显著提高(P<0.05)。利培酮组患儿T2时,ADHD-RS、CRSR-I、CRSR-H与CGI-S评分均显著降低(均P<0.05),C-GAS评分显著提高(P<0.05)。2组患儿的ADHD症状显著改善,多动症状与不注意缺陷-冲动症状显著改善,患儿的整体功能也显著改善。2组患儿主要的不良事件是食欲增加、体质量增加与嗜睡,但均没有发生严重的不良事件。T2时,利培酮组患儿催乳素水平显著提高(t=9.619,P<0.001),其他临床指标没有显著性差异(均P>0.05)。结论:阿立哌唑和利培酮能够通过减少ASD和ADHD共病患儿的注意力涣散和多动症症状来改善患儿整体功能,具有较高的疗效、安全性,值得临床推广应用。

关 键 词:自闭症谱系障碍  注意缺陷多动障碍  阿立哌唑  利培酮  疗效  
收稿时间:2018-03-02

Efficacy and safety of aripiprazole and risperidone in the treatment of comorbidity of ASD and ADHD
JIA Xiao-hong,ZHANG Qian,ZHU Feng-lian,WANG Yong,WANG Lei.Efficacy and safety of aripiprazole and risperidone in the treatment of comorbidity of ASD and ADHD[J].Chinese Journal of Hospital Pharmacy,2018,38(17):1816-1822.
Authors:JIA Xiao-hong  ZHANG Qian  ZHU Feng-lian  WANG Yong  WANG Lei
Affiliation:The Department of Pediatrics, Kaifeng Children's Hospital, Henan Kaifeng 475000, China
Abstract:OBJECTIVE To evaluate the efficacy and safety of aripiprazole and risperidone in the treatment of comorbidity of autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD).METHODS Sixty eight children with ASD and ADHD comorbidities treated in our hospital were selected. According to the random number table, the children were divided into aripiprazole group (n=34) and risperidone group (n=34). The children in the aripiprazole group received oral aripiprazole at an initial dose of 5 mg·d-1 and the final dose was increased to 15 mg·d-1. Children in the risperidone group received oral treatment with risperidone at an initial dose of 1 mg·d-1 and the final dose was increased to 2 mg·d-1. Two groups of children were treated for 3 months. At baseline (T0), 6 weeks (T1), and 12 weeks (T2), attention-deficit/hyperactivity disorder rating scale (ADHD-RS) was used to assess overall ADHD symptoms in the children. The conners rating scales-revised (CRSR) teacher-scale multi-activity factor (CRSR-I) was used to evaluate children with ADHD improvement. CRSR carelessness-impulsivity factor (CRSR-H) was used to evaluate the improvement of attention deficit in children. The overall function of children was assessed using the clinical global improvement-severity scale (CGI-S) and children's global assessment scale (C-GAS). The children's clinical indicators were routinely monitored. The incidence of adverse events and the tolerance of children in both groups were compared.RESULTS Compared with T0, the scores of ADHD-RS, CRSR-I, CRSR-H and CGI-S in the aripiprazole group were significantly decreased at T1 and T2 (all P<0.05). C-GAS score was significantly increased (P<0.05). The scores of ADHD-RS, CRSR-I, CRSR-H and CGI-S in risperidone group were significantly decreased at T2 (all P<0.05). C-GAS score was significantly increased (P<0.05). The ADHD symptoms were significantly improved in both groups. The hyperactivity symptoms and attention deficits-impulsive symptoms significantly improved. The overall function of children was also significantly improved. The two major adverse events in children with increased appetite were weight gain and drowsiness. No serious adverse events occurred. At T2, the level of prolactin in risperidone group was significantly higher (t=9.619, P<0.001). There was no significant difference in other clinical indexes (all P>0.05).CONCLUSION Aripiprazole and risperidone improve their overall function by reducing attention deficit disorder and symptoms of ADHD in children with ASD and ADHD, and has high efficacy and safety. It is worth clinical application.
Keywords:autism spectrum disorder  attention-deficit hyperactivity disorder  aripiprazole  risperidone  efficacy  tolerance  
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