首页|结缔组织病相关间质性肺病的随机对照试验结局指标现状分析

结缔组织病相关间质性肺病的随机对照试验结局指标现状分析

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目的 研究结缔组织病相关间质性肺病(CTD-ILD)的随机对照试验结局指标应用现状.方法 检索中国知网、维普网、万方数据知识服务平台、中国生物医学文献数据库、PubMed、EMbase、Cochrane Library、Web of Science核心合集数据库、Scoups等数据库,及ClinicalTrials.gov、中国临床试验注册中心中明确诊断为CTD-ILD的随机对照试验,检索时间为各数据库建库至2023年1月.筛选文献并提取相关资料,整理CTD-ILD采用的临床结局指标,对其应用频次和频率进行描述性分析,对其在临床试验中的价值及意义进行讨论.结果 共纳入相关文献36篇,包括5种不同类型的CTD-ILD,68种结局指标.参照功能属性将其分为7个指标域,其中理化检查指标种类与频次最高.结局指标使用频次率最高的为用力肺活量,不同结局指标的测量方法和参照标准不一致.结论 CTD-ILD发病机制复杂且不同CTD之间差异性较大.CTD-ILD的临床试验相对较少,且大多数研究规模较小,建议加强CTD-ILD临床研究设计,提高临床试验质量,综合考虑结局指标的应用现状,确保其在临床试验中的准确性和实用性.
Status analysis of outcome indicators in randomized controlled trials of connective tissue disease-interstitial lung disease
Objective To investigate the current status of outcome indicators application in randomized controlled trials for connective tissue dis-ease-interstitial lung disease(CTD-ILD).Methods Randomized controlled trials of definite diagnosis of CTD-ILD were searched in retrieve databases such as CNKI,VIP,Wanfang Data,China Biomedical Literature Database,PubMed,EMbase,Cochrane Library,Web of Science Core Collection Database,Scorps,as well as in ClinicalTrials.gov and China Clinical Trial Registration Center.The search period was from the establish-ment of each database to January 2023.Literature was screened and relevant data were extracted,clinical outcome indexes of CTD-ILD were sorted out,and its application frequency and frequency were descriptively analyzed,and its value and significance in clinical trials were discussed.Re-sults A total of 36 relevant literatures were included,including five different types of CTD-ILD and 68 outcome indicators.It was divided into sev-en index domains according to functional attributes,among which the type and frequency of physical and chemical examination indexes were the highest.The most frequently used outcome indicator was forced vital capacity,and the measurement methods and reference standards of different outcome indicators were inconsistent.Conclusion The pathogenesis of CTD-ILD is complex and there are great differences among different CTD.Clinical trials of CTD-ILD are relatively few,and most of the studies are small in scale.It is recommended to strengthen the clinical research design of CTD-ILD,improve the quality of clinical trials,and comprehensively consider the application status of outcome indicators to ensure its accuracy and practicability in clinical trials.

Connective tissue disease-interstitial lung diseaseRandomized controlled trialOutcome measuresCore indicators set

苏文文、梁艳霞、樊茂蓉

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中国中医科学院西苑医院肺病科,北京 100091

结缔组织病相关间质性肺病 随机对照试验 结局指标 核心指标集

国家重点研发计划战略性科技创新合作项目北京市卫生健康委研究型病房示范建设项目中国中医科学院科技创新工程项目中国中医科学院中央级公益性科研院所基本科研业务费专项

2022YFE0203000BCRW202108CI2021A01105ZZ15-WT-07-02

2024

10.20047/j.issn1673-7210.2024.13.13

中国医药导报
中国医学科学院

中国医药导报

CSTPCD
影响因子：1.759
ISSN：1673-7210
年,卷(期)：2024.21(13)
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