Thompson George R, Boulware David R, Bahr Nathan C, Clancy Cornelius J, Harrison Thomas S, Kauffman Carol A, Le Thuy, Miceli Marisa H, Mylonakis Eleftherios, Nguyen M Hong, Ostrosky-Zeichner Luis, Patterson Thomas F, Perfect John R, Spec Andrej, Kontoyiannis Dimitrios P, Pappas Peter G
Division of Infectious Diseases, Department of Internal Medicine, University of California-Davis Medical Center, Sacramento California, USA.
Division of Infectious Diseases, Department of Internal Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Open Forum Infect Dis. 2022 Mar 4;9(6):ofac112. doi: 10.1093/ofid/ofac112. eCollection 2022 Jun.
Invasive fungal infections continue to increase as at-risk populations expand. The high associated morbidity and mortality with fungal diseases mandate the continued investigation of novel antifungal agents and diagnostic strategies that include surrogate biomarkers. Biologic markers of disease are useful prognostic indicators during clinical care, and their use in place of traditional survival end points may allow for more rapid conduct of clinical trials requiring fewer participants, decreased trial expense, and limited need for long-term follow-up. A number of fungal biomarkers have been developed and extensively evaluated in prospective clinical trials and small series. We examine the evidence for these surrogate biomarkers in this review and provide recommendations for clinicians and regulatory authorities.
随着高危人群的扩大,侵袭性真菌感染持续增加。真菌疾病相关的高发病率和死亡率要求继续研究新型抗真菌药物和包括替代生物标志物在内的诊断策略。疾病的生物标志物在临床护理中是有用的预后指标,使用它们代替传统的生存终点可能允许更快地开展临床试验,所需参与者更少,试验费用降低,长期随访需求有限。许多真菌生物标志物已在前瞻性临床试验和小系列研究中得到开发和广泛评估。在本综述中,我们研究了这些替代生物标志物的证据,并为临床医生和监管机构提供建议。