摘要
目的探讨阿立哌唑治疗Tourette综合征患儿的疗效和安全性。方法采用前瞻性多中心病例对照研究方法，最终纳入研究的195例5—17岁Tourette综合征患儿分为阿立哌唑组98例，剂量5～25mg／d；硫必利组97例，剂量100～500mg／d；疗程12周。于基线（0周）及治疗第2、4、8、12周末，采用耶鲁综合抽动严重程度量表（YGTSS）评定临床疗效，采用不良反应症状量表、血生化指标和心电图检查评定药物不良反应。结果从治疗第2周末开始阿立哌唑组和硫必利组YGTSS运动抽动分、发声抽动分、功能损害分和总分与治疗前比较均有明显下降（P〈0．0001），且治疗第2周末时阿立哌唑组的功能损害分显著低于硫必利组（P〈0．05）。治疗第12周末阿立哌唑组YGTSS总分从基线的（53．74±15．71）分降至（24．36±16．38）分，平均减分29．38分；硫必利组YGTSS总分从基线的（51．66±13．63）分降至（23．26±15．31）分，平均减分28．40分；两组平均减分差值的差异无统计学意义（P〉0．05）。第12周末时阿立哌唑组和硫必利组的有效率分别为60．21％和63．92％，差异无统计学意义（P〉0．05）。阿立哌唑组和硫必利组均无严重不良反应，不良反应的发生率分别为29．6％和27．8％，差异无统计学意义（P〉0．05）。结论阿立哌唑治疗Tourette综合征患儿的疗效与硫必利相当，不良反应较少，其为临床治疗儿童抽动障碍提供了一种新的药物选择。
Objective To evaluate the efficacy and safety of aripiprazole in the treatment of children with Tourette syndrome. Method A prospective, multi-center, controlled clinical trial was conducted in 195 children aged 5-17 years with Tourette syndrome. The patients were assigned to two groups： aripiprazole group （ n =98 ） and tiapride group （ n = 97 ）, with the treatment dosage of 5-25 mg/d and 100-500 mg/d, respectively. After 12 weeks treatment, the clinical efficacy was assessed by the Yale Global Tic Severity Scale （YGTSS） score, and adverse reactions were observed by side effects symptoms scale, blood biochemical indexes, and electrocardiography. Result Significant pre- and post-treatment differences were ascertained for motor tie, phonic tic, function damage and total scores of YGTSS in the both groups from the second week of treatment （P 〈 0. 0001 ）. Compared with the tiapride group, the aripiprazole group showed a more significantly decreased function damage score of YGTSS by the second week of treatment （ P 〈 0. 05 ）. After 12 weeks treatment, total scores of YGTSS in the aripiprazole group decreased from 53.74 ± 15.71 at baseline to 24. 36 ±16. 38, while in the tiapride group from 51.66 ±13.63 to 23.26 ±15.31. The mean reduction scores of YGTSS were 29. 38 in the aripiprazole group and 28.40 in the tiapride group at the end of treatment, and the clinical response rates were 60. 21% and 63.92%, respectively. There were no significant differences between the 2 groups （P 〉 0. 05）. The incidence of adverse reactions was similar in the aripiprazole and tiapride groups, with 29.6% and 27.8% respectively. There were no significant differences in the incidence of adverse reactions between aripiprazole and tiapride groups and no severe adverse events were found in either group. Conclusion The results showed that aripiprazole showed similartherapeutic effect to tiapride in treatment of children with Tourette syndrome. Aripiprazole was safe and well tolerated in Chinese population, an
出处
《中华儿科杂志》
CAS
CSCD
北大核心
2011年第8期572-576,共5页
Chinese Journal of Pediatrics
基金
志谢 感谢北京大学第一医院小儿神经科秦炯教授、林庆教授对本课题的关怀和指导,感谢武汉市妇幼保健院彭安娜医生对本课题统计工作给予的帮助
