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PET-CT 在 2 期临床试验中评估结核病治疗中的作用?

Does PET-CT Have a Role in the Evaluation of Tuberculosis Treatment in Phase 2 Clinical Trials?

机构信息

Immunovirology and Pathogenesis Program, The Kirby Institute, UNSW, Sydney.

Burnet Institute, Victoria, Australia.

出版信息

J Infect Dis. 2024 Apr 12;229(4):1229-1238. doi: 10.1093/infdis/jiad425.

Abstract

Positron emission tomography-computed tomography (PET-CT) has the potential to revolutionize research in infectious diseases, as it has done with cancer. There is growing interest in it as a biomarker in the setting of early-phase tuberculosis clinical trials, particularly given the limitations of current biomarkers as adequate predictors of sterilizing cure for tuberculosis. PET-CT is a real-time tool that provides a 3-dimensional view of the spatial distribution of tuberculosis within the lung parenchyma and the nature of lesions with uptake (ie, whether nodular, consolidative, or cavitary). Its ability to provide functional data on changes in metabolism, drug penetration, and immune control of tuberculous lesions has the potential to facilitate drug development and regimen selection for advancement to phase 3 trials in tuberculosis. In this narrative review, we discuss the role that PET-CT may have in evaluating responses to drug therapy in active tuberculosis treatment and the challenges in taking PET-CT forward as predictive biomarker of relapse-free cure in the setting of phase 2 clinical trials.

摘要

正电子发射断层扫描计算机断层成像(PET-CT)有可能像在癌症领域一样,彻底改变传染病研究。鉴于当前生物标志物作为结核病杀菌治愈的充分预测因子存在局限性,人们对其在早期结核病临床试验中作为生物标志物的兴趣日益浓厚。PET-CT 是一种实时工具,可提供肺部实质内结核病空间分布以及摄取部位(即结节性、实变或空洞性)病变性质的三维视图。它能够提供关于代谢、药物渗透和结核病变免疫控制变化的功能数据,有可能促进药物开发和方案选择,以推进结核病 3 期临床试验。在这篇叙述性综述中,我们讨论了 PET-CT 在评估活动性结核病治疗中药物治疗反应方面可能发挥的作用,以及在 2 期临床试验中作为无复发治愈的预测性生物标志物推进 PET-CT 所面临的挑战。

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