临床试验资格的肺活量测定阈值：紧急重新评估的时间

IF 7.7 1区医学 Q1 RESPIRATORY SYSTEM

Thorax Pub Date : 2025-09-04 DOI:10.1136/thorax-2024-222652

Idan Bokobza, Melanie Le Sayec, Cara Bossley, Rossa Brugha, Jane Carolyn Davies, Charlotte Dawson, Lucy Holt, Dominic A Hughes, Yasmine Needham, Caroline Pao, Gary Ruiz, Shahideh Safavi, Clare Saunders, Nadia Shafi, Nicholas J Simmonds, Michael D Waller, Danie Watson, Gwyneth Davies

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引用次数: 0

摘要

呼吸临床试验的一个常见资格标准是预测的1秒用力呼气量（ppFEV1）在40%到90%之间，使用种族依赖的全球肺功能倡议(GLI)-2012肺活量测定参考方程。国际社会现在支持更新的“种族中立”全球方程式。我们量化了英国囊性纤维化登记处（n=8182）从glii -2012切换到glii - global对试验资格的影响。在未来的试验中，ppFEV1的最大资格阈值为90%，ppFEV1的变化将导致超过700人成为新的不合格。需要对固定的ppFEV1阈值进行紧急审查，并初步建议在实施GLI-Global时将范围扩大到30-95% ppFEV1，以确保所有种族的人都能公平获得。还有更广泛的需要审查使用固定ppFEV1肺活量测定法限制试验资格。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Spirometry thresholds for clinical trial eligibility: time for urgent re-evaluation

A common eligibility criterion in respiratory clinical trials is a per cent-predicted forced expiratory volume in 1 second (ppFEV1) between 40% and 90%, using the ethnicity-dependent Global Lung Function Initiative (GLI)-2012 spirometry reference equations. International societies now endorse the newer ‘race-neutral’ GLI-Global equations. We quantify the impact on trial eligibility of switching from GLI-2012 to GLI-Global for the UK Cystic Fibrosis Registry (n=8182). In a future trial with a maximum eligibility threshold of ppFEV1=90%, the changes in ppFEV1 would lead to over 700 people becoming newly ineligible. Urgent review of fixed ppFEV1 thresholds is required, with an initial recommendation to widen the range to 30–95% ppFEV1 when GLI-Global is implemented to ensure equitable access for people of all ethnicities. There is also a wider need to review the use of fixed ppFEV1 spirometry limits for trial eligibility.

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来源期刊

Thorax 医学-呼吸系统

CiteScore

16.10

自引率

2.00%

发文量

197

审稿时长

1 months

期刊介绍： Thorax stands as one of the premier respiratory medicine journals globally, featuring clinical and experimental research articles spanning respiratory medicine, pediatrics, immunology, pharmacology, pathology, and surgery. The journal's mission is to publish noteworthy advancements in scientific understanding that are poised to influence clinical practice significantly. This encompasses articles delving into basic and translational mechanisms applicable to clinical material, covering areas such as cell and molecular biology, genetics, epidemiology, and immunology.