ISSN 1674-3865  CN 21-1569/R
主管：国家卫生健康委员会
主办：中国医师协会
　　　辽宁省基础医学研究所
　　　辽宁中医药大学附属医院
中国中西医结合儿科学

中国中西医结合儿科学 ›› 2023, Vol. 15 ›› Issue (6): 479-485.

• 儿童抽动障碍康复专栏 • 上一篇    下一篇

中成药治疗儿童抽动障碍有效性和安全性的Meta分析

  

  • 出版日期:2023-12-25 上线日期:2024-03-06

Meta analysis of the efficacy and safety of traditional Chinese patent medicine in the treatment of tic disorders in children

  • Published:2023-12-25 Online:2024-03-06

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摘要： 目的 系统评价中成药治疗儿童抽动障碍的有效性和安全性。方法 全面检索中国知网、万方数据库、维普网、中国生物医学数据库、Pubmed、Embase和Cochrane图书馆中有关中成药治疗儿童抽动障碍的随机对照试验。由两名独立的研究者根据预先设定的纳入排除标准筛选并评估文献质量，将纳入文献采用RevMan 5.3软件进行Meta分析。结果 最终纳入12项研究共3 088例患儿。Meta分析显示，在有效率方面，中成药有效率高于安慰剂组，差异有统计学意义[RR=2.06(1.63,2.62),P<0.000 01],中成药与盐酸硫必利的有效率比较，差异无统计学意义[RR=1.03(0.98,1.07),P=0.23]。在抽动严重程度方面，中成药较安慰剂可显著降低耶鲁综合抽动严重程度量表(YGTSS)总评分[MD=-7.84(-10.18,-5.51),P<0.000 01],中成药与盐酸硫必利比较，YGTSS总评分降低程度比较差异无统计学意义[MD=-0.32(-1.21,0.58),P=0.75]。不良事件方面，中成药在头晕、乏力和嗜睡的发生率低于盐酸硫必利。结论 中成药治疗儿童抽动障碍疗效突出且安全性较好，也仍需更多高质量随机对照研究加以证实。

关键词: 抽动障碍, 中成药, Meta分析, 儿童

Abstract: ObjectiveTo systematically evaluate the efficacy and safety of traditional Chinese patent medicine in the treatment of tic disorders in children.MethodsRandomized controlled trials of traditional Chinese patent medicine in the treatment of tic disorders in children were comprehensively searched in CNKI,Wanfang Database,VIP,China Biomedical Database,Pubmed,Embase and Cochrane Library.Two independent researchers screened and evaluated the quality of the literature based on pre-set inclusion and exclusion criteria,and made a meta-analysis of the included literature using RevMan 5.3 software.ResultsA total of 3 088 pediatric patients were ultimately included in 12 studies.Meta analysis showed that the effective rate of traditional Chinese patent medicine was higher than that of the placebo group,with a statistically significant difference ［RR=2.06 (1.63，2.62),P<0.000 01］.The effective rate of traditional Chinese patent medicine was not significantly different from that of tiapride hydrochloride ［RR=1.03 (0.98，1.07),P=0.23］.In terms of tic severity,traditional Chinese patent medicine could significantly reduce the total score of YGTSS compared with placebo ［MD=-7.84 (-10.18,-5.51),P<0.000 01］.Comparing traditional Chinese patent medicine with tiapride hydrochloride,there was no statistically significant difference in the reduction of the total score of YGTSS ［MD=-0.32 (-1.21,0.58),P=0.75］.In terms of adverse events,the incidence of dizziness,fatigue and sleepiness of traditional Chinese patent medicine was lower than that of tiapride hydrochloride.ConclusionTraditional Chinese patent medicine is effective and safe in the treatment of tic disorders in children,which still needs to be confirmed by more high-quality randomized controlled studies.

Key words:

Tic disorders, Traditional Chinese patent medicine, Meta analysis, Children