针灸戒烟随机对照试验中临床结局指标的文献研究  

Literature Analysis of Clinical Outcome Indicators in Randomized Controlled Trials of Acupuncture for Smoking Cessation

作　　者：袁杨阳 章薇 匡泓俊 杨腊媛 袁楠 刘民权 付珊珊 钟峰 YUAN Yangyang;ZHANG Wei;KUANG Hongjun;YANG Layuan;YUAN Nan;LIU Minquan;FU Shanshan;ZHONG Feng(Graduate School,Hunan University of Chinese Medicine,Changsha,410208;The First Hospital of Hunan University of Chinese Medicine)

机构地区：[1]湖南中医药大学研究生院,湖南省长沙市410208 [2]湖南中医药大学第一附属医院

出　　处：《中医杂志》2022年第12期1179-1185,共7页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局中医药循证能力建设项目(2019XZZX-ZJ007);湖南中医药大学一流学科开放基金(2018ZYX09)。

摘　　要：目的分析针灸戒烟随机对照试验(RCT)的临床结局指标,为构建针灸戒烟临床试验的核心结局指标集提供基础。方法计算机检索中国知网(CNKI)、万方数据(WanFang)、维普数据库(VIP)、PubMed、Cochrane library、Web of Science 6个数据库,检索时限为1990年1月至2021年5月,收集数据库中收录的针灸戒烟的临床RCT,对结局指标相关资料(包括结局指标、疗程与随访情况)进行提取,将结局指标按照功能属性分类后进行频次的描述性分析,并对结局指标的组合使用情况进行分析。结果纳入46篇文献,其中中文24篇、英文22篇,涉及的结局指标为40种(227次),单个文献的结局指标为1~11个,平均每个研究结局指标4.93个,仅有19篇(中文7篇,英文12篇)研究明确指出试验的主要结局指标和次要结局指标。46个RCT的临床结局指标主要分为7类,分别为临床疗效评价(75次、33.0%)、症状或体征(73次、32.2%)、理化检查(46次、20.3%)、安全性事件(26次、11.5%)、中医证候(4次、1.8%)、经济学评估(2次、0.9%)、生活质量(1次、0.4%)。有6篇研究只使用了1类指标,12篇研究使用了2类指标,8篇研究使用了3类指标,14篇研究使用了4类指标,6篇研究使用了5类指标。纳入文献研究的疗程为3天~10周。纳入46篇文献的随访报告率为71.7%(33篇),随访时间≥3个月的中文文献10篇(62.5%),英文文献14篇(82.4%)。结论针灸戒烟RCT结局指标的选择较丰富,在症状体征、理化检查、生活质量等方面均有涉及,但仍存在结局指标主次不分、指标选择与组合差异性大、缺乏中医治疗特色指标的问题。Objective To analyze the outcome indicators in the randomized controlled trials(RCTs)of acupuncture for smoking cessation,so as to provide a basis for the establishment of the core outcome set of acupuncture for smoking cessation.Methods The RCTs of acupuncture for smoking cessation were collected through searching of the six electronic databases such as CNKI,Wanfang,VIP,PubMed,Cochrane Library and Web of Science from January 1990 to May 2021.The data on outcome indicators,treatment course and follow-up status were extracted.The outcome indicators were classified according to the functional attribute for descriptive analysis on frequency,and the combination of outcome indicators was analyzed.Results Finally,46 articles(24 in Chinese and 22 in English)were included,involving 40 outcome indicators with frequency of 227.With a minimum of one and a maximum of 11 outcome indicators per study,the average number was 4.93.Only 19 studies(7 in Chinese and 12 in English)clearly defined the primary and secondary outcomes.The outcome indicators in the 46 RCTs were mainly divided into 7 types,including clinical effect(75 times,33.0%),symptoms and signs(73 times,32.2%),physical and chemical examination(46 times,20.3%),safety events(26 times,11.5%),traditional Chinese medicine(TCM)syndromes(4 times,1.8%),economic evaluation(2 times,0.9%),and quality of life(1 time,0.4%).Six studies used only one type of the outcome indicators,while 12 studies used two types,and 8 studies used three types;14 studies used four types,and six studies used five types of outcome indicators.The treatment duration of the included studies ranged from 3 days to 10 weeks.The reporting rate of the follow-up was 71.7%(33/46),and the number of studies with follow-up≥3 months was 10 in Chinese(62.5%)and 14 in English(82.4%).Conclusion The outcome indicators in the RCTs of smoking cessation by acupuncture are varied,involving symptoms and signs,physical and chemical examination,quality of life and the others.However,there are still some problems,such as uncl

关 键 词：戒烟 针灸 临床结局指标 随机对照试验 文献研究 

分 类 号：R246.6[医药卫生—针灸推拿学]