摘要
目的观察和评估小儿智力糖浆治疗儿童注意缺陷多动障碍（ADHD）的临床疗效和安全性。方法本研究采用自身前后对照的多中心临床观察方法，2013年6月至2015年12月纳入18个临床中心，共1833例ADHD患儿进行6个月的小儿智力糖浆药物治疗效果和安全性的临床评价，使用中文版ADHD评定量表父母版（ADHDRS—Ⅳ—P）、临床疗效总评定量表（CGI）进行治疗效果评价，使用不良反应登记表和药物安全等级量表进行安全性评估。结果小儿智力糖浆治疗后，ADHD总人群组、男性ADHD组、女性ADHD组、轻度ADHD组、中度ADHD组和重度ADHD组的ADHDRS—Ⅳ—P量表总分、注意缺陷量表分和多动-冲动量表分的得分均降低，差异均有统计学意义（均P〈0．01）。不同性别在治疗前后的量表总分、注意缺陷量表分和多动．冲动量表分改变量和有效率差异均无统计学意义（均P〉0．05）。CGI—I结果显示，在总人群组、男性组和女性组中，“改善较明显”及以上的比例分别为1379例（80．98％）、1089例（79．95％）和290例（85．05％）。在药物不良反应中，共有6例男童报告药物不良反应。在安全评价分析中，未发现患儿服药后出现安全性问题。结论小儿智力糖浆药物治疗ADHD基本有效，未发现明显安全性问题。
Objective To observe and evaluate the clinical efficacy and safety of Xiaoerzhili syrup in attention defieit/hyperaetivity disorder（ADHD） in children. Methods This study was performed by a multicenter self - con- trolled clinical observation trial. A total of 1 833 children with ADHD selected from 18 elinical centers from June 2013 to December 2015 were treated by Xiaoerzhili syrup for 6 months, and the clinical efficacy and safety were evaluated. Chinese Version of ADHD Rating Scale - 1g - Parent（ ADHDRS - IV - P） and Clinical Global Impression （CGI） were used to evaluate the clinical efficacy, and the registration form of side reaction and the questionnaire of drug safety grade were used to assess the safety. Results Compared with the scores before treatment, the total scores of ADHDRS - Ⅳ - P, attention deficit subseale scores and hyperactivity impulsivity subscale scores decreased with statistically significant differences after treatment with Xiaoerzhili syrup in the total ADHD group,male ADHD group,female ADHD group,mild ADHD group,moderate ADHD group and severe ADHD group（ all P 〈 0.01 ）. The statistically significant differences in the total scores of ADHDRS - Ⅳ - P, attention deficit subscale score and hyperactivity impulsivity subseale scores were not found in different gender before and after treatment（ all P 〉 0.05 ）. According to the results of CGI - I, the proportion of ＂improved obviously＂ and above were 80.98% （1 379 cases） ,79.95% （1 089 cases） and 85.05% （290 cases） ,in the total population group, male group and female group, respectively. The side effects of drugs were found in six male eases. After treatment,safety problems were not found in the analysis of the safety evaluation. Conclusion Xiaoerzhili syrup treatment is effective in children with ADHD treatment, and security problems are not found.
出处
《中华实用儿科临床杂志》
CSCD
北大核心
2017年第17期1331-1334,共4页
Chinese Journal of Applied Clinical Pediatrics
基金
湖南省自然科学基金（12JJ5066）
关键词
注意缺陷多动障碍
小儿智力糖浆
疗效
安全性
儿童
Attention deficit/hyperactivity disorder： Xiaoerzhili syrup
Efficacy
Safety
Child
