基于数据挖掘分析中医药防控调节性近视临床研究中有效率的定义及其评判标准差异  

Analysis of Differences in the Definition and Evaluation Criteria of Effectiveness in RCT on TCM for the Prevention and Control of Pseudomyopia Based on Data Mining

作　　者：陈楠 曾铉玲 王天琳 杨星月 CHEN Nan;ZENG Xuanling;WANG Tianlin;YANG Xingyue(School of Acupuncture-Moxibustion and Tuina,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学针灸推拿学院,北京100029 [2]中国中医科学院广安门医院,北京100053

出　　处：《中国中医眼科杂志》2024年第3期221-226,共6页China Journal of Chinese Ophthalmology

基　　金：国家自然科学基金项目(81904063)。

摘　　要：目的分析中医药防控调节性近视临床随机对照试验(RCT)中有效率定义及其评判标准差异,为相关研究中有效率的应用提供理论支撑和更优选择。方法在中国知网、中国生物医学文献数据库、万方数据知识服务平台、维普资讯网、PubMed、Cochrane library和Embase共7个数据库中检索中医药防控调节性近视的RCT研究,检索时限为建库至2021年12月31日,将检索到的文献导入文献管理软件NoteExpress 3.6中,采用Excel 2016建立文献数据库,对纳入文献的干预措施、有效率定义参考标准、疗效判定分级、涉及的单项及组合指标进行频次描述分析。结果(1)干预措施分类:共纳入135篇研究,中医药疗法的研究共109篇(80.74%),中西医结合疗法的研究共26篇(19.26%)。(2)有效率的参考标准:频次排名前3位的是《中药新药临床研究指导原则(第三辑)》29篇(21.48%)、《中医病症诊断疗效标准》17篇(12.59%)、《常见疾病的诊断与疗效判定(标准)》16篇(11.85%),21篇(16.60%)有效率定义综合了2~3种参考标准,37篇(27.40%)未注明参考标准。(3)疗效判定分级:6篇(4.44%)研究将疗效分为5个疗效等级,80篇(59.26%)研究将疗效分为4个疗效等级,49篇(36.30%)研究将疗效分为3个疗效等级。(4)单项指标使用频次:使用频次排名前3位的指标依次为远视力68篇(50.37%)、临床症状51篇(37.78%)、视力43篇(31.85%)。(5)组合指标使用频次:使用频次排名前3位的指标依次为视力+屈光度+临床症状39篇(28.89%)、视力+屈光度36篇(26.67%)、视力+临床症状11篇(8.15%)。结论由于缺乏统一的规范化标准,中医药防控调节性近视临床研究应用的有效率定义的参考标准引用、分级标准、等级名称、构成等存在很多问题,有待进一步统一。OBJECTIVE To analyze the differences in the definition and evaluation criteria of effectiveness in randomized controlled trials(RCT)of Traditional Chinese Medicine(TCM)for the prevention and control of pseudomyopia.This analysis aims to provide theoretical support and improved choices for the application of effectiveness in related research.METHODS A systematic search was conducted in seven databases,including China National Knowledge Infrastructure(CNKI),China Biology Medicine(CBM),Wanfang Data,VIP Information,PubMed,Cochrane Library,and Embase,from the inception of the databases to December 31st,2021.The retrieved literature was imported into the reference management software NoteExpress 3.6,and an Excel 2016 spreadsheet was established to document intervention measures,reference standards for effectiveness definition,efficacy grading,and the involved single and combined indicators.Frequency and descriptive analyses were performed.RESULTS(1)Intervention measures classification:A total of 135 studies were included,including 109(80.74%)focused on TCM therapies,and 26(19.26%)investigated integrated TCM and Western Medicine approaches.(2)Reference standards for effectiveness:The top three reference standards for effectiveness were Guiding Principles for Clinical Research of New TCM(Third Edition)in 29 studies(21.48%),Diagnostic and Therapeutic Criteria of Tcm Syndromes in 17 studies(12.59%),and Diagnostic Criteria for Common Diseases and Efficacy Judgment(standards)in 16 studies(11.85%).In 21 studies(16.60%),the definition of effectiveness integrated two to three reference standards,while 37 studies(27.40%)did not specify reference standards.(3)Efficacy evaluation levels:Six studies(4.44%)categorized efficacy into five levels,80 studies(59.26%)into four levels,and 49 studies(36.30%)into three levels.(4)Frequency of single indicators:The top three indicators in terms of frequency of use were distant vision in 68 studies(50.37%),clinical symptoms in 51 studies(37.78%),and visual acuity in 43 studies(31.85%).(5)Freque

关 键 词：调节性近视 假性近视 中医药 结局指标 随机对照试验 文献研究 

分 类 号：R276.7[医药卫生—中医五官科学]