Department of Pathology and Laboratory Medicine, University of California, Los Angeles, Los Angeles, CA, United States.
Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
J Appl Lab Med. 2023 May 4;8(3):598-634. doi: 10.1093/jalm/jfad007.
Procalcitonin (PCT), a peptide precursor of the hormone calcitonin, is a biomarker whose serum concentrations are elevated in response to systemic inflammation caused by bacterial infection and sepsis. Clinical adoption of PCT in the United States has only recently gained traction with an increasing number of Food and Drug Administration-approved assays and expanded indications for use. There is interest in the use of PCT as an outcomes predictor as well as an antibiotic stewardship tool. However, PCT has limitations in specificity, and conclusions surrounding its utility have been mixed. Further, there is a lack of consensus regarding appropriate timing of measurements and interpretation of results. There is also a lack of method harmonization for PCT assays, and questions remain regarding whether the same clinical decision points may be used across different methods.
This guidance document aims to address key questions related to the use of PCT to manage adult, pediatric, and neonatal patients with suspected sepsis and/or bacterial infections, particularly respiratory infections. The document explores the evidence for PCT utility for antimicrobial therapy decisions and outcomes prediction. Additionally, the document discusses analytical and preanalytical considerations for PCT analysis and confounding factors that may affect the interpretation of PCT results.
While PCT has been studied widely in various clinical settings, there is considerable variability in study designs and study populations. Evidence to support the use of PCT to guide antibiotic cessation is compelling in the critically ill and in some lower respiratory tract infections but is lacking in other clinical scenarios, and evidence is also limited in the pediatric and neonatal populations. Interpretation of PCT results requires guidance from multidisciplinary care teams of clinicians, pharmacists, and clinical laboratorians.
降钙素原（PCT）是降钙素的前体肽，是一种生物标志物，其血清浓度在细菌感染和脓毒症引起的全身炎症反应中升高。PCT 在美国的临床应用最近才受到关注，越来越多的美国食品和药物管理局（FDA）批准的检测方法和扩大的用途得到了扩展。人们对 PCT 作为结局预测因子和抗生素管理工具的使用感兴趣。然而，PCT 在特异性方面存在局限性，围绕其效用的结论也存在分歧。此外，关于测量的适当时间和结果的解释缺乏共识。PCT 检测方法也缺乏方法学协调，并且关于是否可以在不同方法之间使用相同的临床决策点仍存在疑问。
本指导文件旨在解决与 PCT 用于管理疑似脓毒症和/或细菌感染（特别是呼吸道感染）的成人、儿科和新生儿患者相关的关键问题。本文探讨了 PCT 在抗菌治疗决策和结局预测中的效用证据。此外，本文还讨论了 PCT 分析的分析和预分析注意事项以及可能影响 PCT 结果解释的混杂因素。
虽然 PCT 在各种临床环境中得到了广泛的研究，但研究设计和研究人群存在很大的差异。在危重病患者和某些下呼吸道感染中，支持使用 PCT 来指导抗生素停药的证据令人信服，但在其他临床情况下则缺乏证据，在儿科和新生儿人群中证据也有限。PCT 结果的解释需要来自临床医生、药剂师和临床实验室人员组成的多学科护理团队的指导。
