特发性肺纤维化无进展生存结局指标应用现状及思考

Current Application Status and Considerations of Progression-Free Survival Outcome Indicators in Idiopathic Pulmonary Fibrosis

目的:系统总结分析特发性肺纤维化(IPF)无进展生存(PFS)结局指标的应用现状,为临床合理应用提供参考。方法:计算机系统检索PubMed、EMbase、The Cochrane Library、国家知识基础设施数据库(CNKI)、中国生物医学文献数据库(CBM)、中国学术期刊数据库(CSPD)及中文科技期刊数据库(CCD)中有关IPF无进展生存结局指标的文献,检索时限为各数据库建库至2022年12月31日。筛选文献,提取资料,整理IPF防治研究中的PFS结局指标,对其应用频次,涵盖各项单一结局指标的差异进行分析。结果:纳入51篇文献,PFS存结局指标是临床常用的复合结局指标,主要涵盖肺功能、肺移植、6MWD(6分钟步行距离)、死亡、AE-IPF(特发性肺纤维化急性加重)等结局指标中的一项或多项。结论:目前IPF防治研究中PFS结局指标应用标准不统一,有待于进一步完善及规范、统一。

Objective:To systematically summarize and analyze the application status of progression-free survival(PFS)outcome indicators in idiopathic pulmonary fibrosis(IPF),and provide a reference for rational clinical use.Methods:A systematic computer search was conducted in PubMed,EMbase,The Cochrane Library,China National Knowledge Infrastructure(CNKI),Chinese Biomedical Literature Database(CBM),China Academic Journals Database(CSPD),and Chinese Science and Technology Journals Database(CCD)for literature related to PFS outcome indicators in IPF.The search period spanned from the establishment of each database until December 31,2022.Relevant literature was screened,data were extracted,and PFS outcome indicators in IPF prevention and treatment studies were organized.The frequency of application and the differences in various single outcome indicators were analyzed.Results:Fifty-one articles were included.The PFS outcome indicator is a commonly used composite endpoint indicator in clinical practice,mainly covering one or more of the following outcome indicators:lung function,lung transplantation,6-minute walk distance(6MWD),mortality,and acute exacerbation of idiopathic pulmonary fibrosis(AE-IPF).Conclusion:Currently,the application standards for PFS outcome indicators in IPF prevention and treatment research are not unified,indicating a need for further improvement,standardization,and unification.