Unit of Infectious Diseases, Hospital Universitario '12 de Octubre', Instituto de Investigación Hospital '12 de Octubre' (i+12), School of Medicine, Universidad Complutense, Madrid, Spain; Spanish Network for Research in Infectious Diseases (REIPI RD16/0016), Instituto de Salud Carlos III, Madrid, Spain.
Unit of Infectious Diseases, Department of Internal Medicine, Hospital de Barcelona, Societat Cooperativa d'Installacions Assistencials Sanitàries (SCIAS), Barcelona, Spain.
Clin Microbiol Infect. 2018 Jun;24 Suppl 2:S2-S9. doi: 10.1016/j.cmi.2018.01.029. Epub 2018 Feb 7.
The field of new biological agents is increasing exponentially over the past years, thus making prevention and management of associated infectious complications a challenge for nonspecialized clinicians.
The present consensus document is an initiative of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Infections in Compromised Hosts (ESGICH) aimed at analysing, from an infectious diseases perspective, the safety of targeted and biological therapies.
Computer-based Medline searches with MeSH terms pertaining to each agent or therapeutic family.
The document is structured in sections according to the targeted site of action of each drug class: proinflammatory cytokines; interleukins, immunoglobulins and other soluble immune mediators; cell surface receptors and associated signaling pathways; intracellular signaling pathways; lymphoma and leukaemia cells surface antigens; and other targeted therapies. A common outline is followed for each agent: summary of mechanism of action, approved indications and common off-label uses; expected impact on the host's susceptibility to infection; available clinical evidence (i.e. pivotal clinical trials, postmarketing studies, case series and case reports); and suggested prevention and risk minimization strategies. The methodologic and practical difficulties of assessing the specific risk posed by a given agent are also discussed.
This ESGICH consensus document constitutes not only a comprehensive overview of the molecular rationale and clinical experience on the risk of infection associated with approved targeted therapies but also an attempt to propose a series of recommendations with the purpose of guiding physicians from different disciplines into this emerging framework.
近年来，新的生物制剂领域呈指数级增长，因此，对于非专业临床医生来说，预防和管理相关感染并发症是一项挑战。
本共识文件是欧洲临床微生物学和传染病学会（ESCMID）感染宿主研究组（ESGICH）的一项倡议，旨在从传染病学的角度分析靶向和生物治疗的安全性。
使用与每个药物或治疗家族相关的 MeSH 术语进行基于计算机的 Medline 搜索。
该文件按照每个药物类别的作用靶点进行分组：促炎细胞因子；白细胞介素、免疫球蛋白和其他可溶性免疫调节剂；细胞表面受体和相关信号通路；细胞内信号通路；淋巴瘤和白血病细胞表面抗原；以及其他靶向治疗。对每个药物采用相同的大纲：作用机制总结、批准的适应症和常见的超适应症用途；对宿主易感性感染的预期影响；可用的临床证据（即关键临床试验、上市后研究、病例系列和病例报告）；以及建议的预防和风险最小化策略。还讨论了评估特定药物带来的特定风险的方法学和实际困难。
本 ESGICH 共识文件不仅全面概述了与已批准的靶向治疗相关感染风险的分子原理和临床经验，还试图提出一系列建议，旨在指导来自不同学科的医生进入这一新兴框架。
