针刺治疗小儿抽动症随机临床对照试验的研究现状与分析  

Current Status and Analysis of Randomized Controlled Clinical Trials of Acupuncture in the Treatment of TiC in Children

作　　者：刘路 倪夕秀 田甜 李晓 王亚楠[1] 赵凌[1] Liu Lu;Ni Xixiu;Tian Tian;Li Xiao;Wang Yanan;Zhao Ling(School of Acupuncture-Moxibustion and Tuina,Chengdu University of Chinese Medicine,Chengdu 610072,China)

机构地区：[1]成都中医药大学针灸推拿学院,成都610072

出　　处：《世界科学技术-中医药现代化》2020年第8期2751-2757,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委员会优秀青年基金项目(81722050):针刺治疗慢性疼痛的中枢调控机制研究,负责人:赵凌;成都中医药大学一流学科建设项目(CZYJC1901):针刺治疗慢性偏头痛的疗效预测及适宜人群筛选的影像组学研究,负责人:赵凌

摘　　要：目的统计近十年来针刺治疗小儿抽动症的随机临床对照试验,分析其现状与存在的问题。方法检索中文数据库:维普网(VIP)、中国知网(CNKI)、万方数据(WANFANG DATA)、中国生物医学文献数据库(CBM),英文数据库:web of science和pub med。时间限定为2009年1月-2018年10月。纳入符合标准的文献33篇,采用Microsoft Excel提取信息。结果对针刺治疗小儿抽动症主穴使用频次进行统计,使用频次较高腧穴自高到低为:百会、合谷、神门、足三里、内关、印堂、风池、太冲、四神聪、三阴交、太溪,其中17篇文献使用随症配穴的方法,仅1篇文献使用随症配穴与辨证配穴相结合的方法。近十年来针刺治疗小儿抽动症随机临床对照试验样本量大部分为次小样本,且均未进行样本量估算。有完整诊断、纳入、排除标准文献仅占文献总量54.5%,诊断标准多样,无统一标准;72.7%的文献根据《耶鲁抽动症整体严重程度量表(YGTSS)》的减分率作为疗效的判定标准,仍有少部分文献使用自拟标准;3篇文献详细介绍分配隐藏的具体步骤,93.9%的文献未提及盲法使用情况;仅6篇文献设置随访期,观察针刺治疗小儿抽动症的远期疗效;54.5%的文献未提及不良反应,18.2%的文献报告了试验过程中患者的依从性。结论针刺治疗小儿抽动症的随机临床对照试验的研究设计及方法学上存在诸多问题,降低了临床研究的准确性、真实性及可信度,难以实现临床研究的重复性,影响了研究结论的科学性。为了使针刺治疗小儿抽动症的疗效得到普遍认可和推广,可以借鉴国外同类研究,设计更为严谨的试验方案,多开展多中心、前瞻性和大样本的随机对照试验研究,为今后临床治疗与试验研究提供科学指导。Objective To analyze the current situation of randomized controlled clinical trials(RCTs)of acupuncture treatment of TiC in children in recent 10 years.Methods Chinese databases:VIP,CNKI,WANFANG DATA,CBM and English databases:web of science and pub med were retrieved.The time limit was from January 2009 to October 2018.Thirty-three eligible literatures were included,and information was extracted by Microsoft Excel.Results Statistics were made on the frequency of main acupoints used in the treatment of children’s tic.The higher used acupoints were ranged from Baihui,Hegu,Shenmen,Zusanli,Neiguan,Yintang,Fengchi,Taichong,Sishencong,Sanyinjiao and Taixi,17 literatures used the method of matching acupoints with symptoms,and only 1 literature used the method of combining acupoints with syndrome differentiation;In the past ten years,the sample size of RCTs of acupuncture treatment for tic children was mostly sub-small sample size,and no sample size was estimated;Documents with complete diagnostic,inclusion and exclusion accounted for only 54.5%of the total literature.Diagnostic criteria were diverse and there were no unified criteria;72.7%of the literatures used the Yale Tourette’s Total Severity Scale(YGTSS)as the criterion for evaluating the curative effect,and a few literatures still used the self-designed criterion;Three papers detailed the steps of allocation concealment.93.9%of the papers did not mention the use of blind method;Only 6 articles were followed up to observe the long-term effect of acupuncture on children with tic;54.5%of the literature did not mention adverse reactions,and 18.2%reported patient compliance during the trial.Conclusion There are many problems in the design and methodology of RCTs of acupuncture in the treatment of TiC children,which reduces the accuracy,authenticity and credibility of clinical studies,makes it difficult to achieve the repeatability of clinical studies,and affects the scientificity of research conclusions.In order to get the worldwide recognization and promote the ef

关 键 词：针刺 小儿抽动症 多动秽语综合征 多发性抽动症 

分 类 号：R246.4[医药卫生—针灸推拿学]