特发性肺纤维化随机对照试验结局指标应用现状分析  

Analysis of the Outcome Indicators in Randomized Controlled Trials of Idiopathic Pulmonary Fibrosis

作　　者：邸家琪 李宣霖[1] 曹嘉敏 杨曙光 余学庆[1,2] Dl Jiaqi;LI Xuanlin;CAO Jiamin;YANG Shuguang;YU Xueqing(Co-construction Collaborative Innovation Center for Chinese Medicine Prevention and Treatment of Respiratory Diseases by Henan Province and Education Ministry of P.R.China,Henan University of Chinese Medicine,Zhengzhou,450046;The First Affiliated Hospital of Henan University of Chinese Medicine)

机构地区：[1]河南中医药大学呼吸疾病中医药防治省部共建协同创新中心,河南郑州450046 [2]河南中医药大学第一附属医院

出　　处：《中医杂志》2021年第12期1040-1045,1058,共7页Journal of Traditional Chinese Medicine

基　　金：河南省特色学科中医学学科建设项目(STS-ZYX-2019029);河南省中医管理局国家中医临床研究基地科研专项(2018JDZX006);河南省科技攻关项目(182102311165)。

摘　　要：目的分析特发性肺纤维化(IPF)随机对照试验(RCT)结局指标的应用现状,为合理选择IPF临床研究结局指标提供参考。方法检索中国知网、万方数字化期刊全文数据、维普中文期刊数据库、中国生物医学文献数据库、PubMed、Web of Science数据库中明确诊断为IPF的RCT,检索时限为各数据库建库至2020年5月8日。筛选文献,提取资料,整理IPF临床试验的结局指标,并对其应用频次、频率进行描述性分析。结果纳入84篇RCT,共71种结局指标672频次,分属于7个指标域:理化检查指标25种,频次251次(37.35%);症状体征指标12种,频次92次(13.69%);远期预后指标11种,频次115次(17.11%);生活质量指标8种,频次58次(8.63%);安全性事件指标3种,频次105次(15.63%);中医症状/证候评分指标2种,频次4次(0.60%);其他指标10种,频次47次(6.99%)。结论目前IPF临床试验研究的结局指标存在种类繁多、部分指标无统一评判标准、使用不规范等问题。建议加强IPF研究顶层设计,构建IPF核心指标集,进而提升临床试验的质量。Objective To analyze the outcome indicators used in current randomized controlled trials(RCTs)of idiopathic pulmonary fibrosis(IPF),and to provide references for the rational use of outcome indicators in IPF clinical researches.Methods Databases including CNKI,Wanfang,VIP,Sinomed,PubMed and Web of Science were searched from the inception date to May 8 th,2020 for RCTs of IPF.Literature was screened and data was extracted.The frequency of outcome indicators in RCTs of IPF were descriptively analyzed.Results Totally 84 RCTs were included involving 71 outcome indicators with the frequency of 672 times.The outcome indicators were grouped into seven types,which include 25 physicochemical outcomes with frequency of 251 times(37.35%),12 symptom and syndrome outcomes with frequency of 92 times(13.69%),11 long-term prognostic outcomes with frequency of 115 times(17.11%),8 quality of life outcomes with frequency of 58 times(8.63%),3 safety outcomes with frequency of 105 times(15.63%),2 traditional Chinese medicine symptom/syndrome outcomes with frequency of four times(0.60%),and 10 other outcomes with frequency of 47 times(6.99%).Conclusion The outcome indicators are varied in current RCTs of IPF;some outcomes have no unified evaluation criteria;and there are problems of irregular use of the outcomes.Therefore,top-level researches on IPF should be designed,and core outcome set is constructed,so as to promote the quality of IPF RCTs.

关 键 词：特发性肺纤维化 随机对照试验 结局指标 核心指标集 

分 类 号：R563[医药卫生—呼吸系统]