Division of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Section of Rheumatology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, USA.
J Pediatric Infect Dis Soc. 2020 Dec 31;9(6):716-737. doi: 10.1093/jpids/piaa098.
Immune-mediated lung injury and systemic hyperinflammation are characteristic of severe and critical coronavirus disease 2019 (COVID-19) in adults. Although the majority of severe acute respiratory syndrome coronavirus 2 infections in pediatric populations result in minimal or mild COVID-19 in the acute phase of infection, a small subset of children develop severe and even critical disease in this phase with concomitant inflammation that may benefit from immunomodulation. Therefore, guidance is needed regarding immunomodulatory therapies in the setting of acute pediatric COVID-19. This document does not provide guidance regarding the recently emergent multisystem inflammatory syndrome in children (MIS-C).
A multidisciplinary panel of pediatric subspecialty physicians and pharmacists with expertise in infectious diseases, rheumatology, hematology/oncology, and critical care medicine was convened. Guidance statements were developed based on best available evidence and expert opinion.
The panel devised a framework for considering the use of immunomodulatory therapy based on an assessment of clinical disease severity and degree of multiorgan involvement combined with evidence of hyperinflammation. Additionally, the known rationale for consideration of each immunomodulatory approach and the associated risks and benefits was summarized.
Immunomodulatory therapy is not recommended for the majority of pediatric patients, who typically develop mild or moderate COVID-19. For children with severe or critical illness, the use of immunomodulatory agents may be beneficial. The risks and benefits of such therapies are variable and should be evaluated on a case-by-case basis with input from appropriate specialty services. When available, the panel strongly favors immunomodulatory agent use within the context of clinical trials. The framework presented herein offers an approach to decision-making regarding immunomodulatory therapy for severe or critical pediatric COVID-19 and is informed by currently available data, while awaiting results of placebo-controlled randomized clinical trials.
免疫介导的肺损伤和全身炎症反应过度是成人严重和危重新冠病毒病 2019（COVID-19）的特征。尽管儿科人群中大多数严重急性呼吸综合征冠状病毒 2 感染在感染急性期导致轻微或轻度 COVID-19，但一小部分儿童在此阶段会出现严重甚至危急疾病，并伴有炎症，可能受益于免疫调节。因此，在急性儿科 COVID-19 中需要免疫调节治疗的指导。本文件不提供关于最近出现的儿童多系统炎症综合征（MIS-C）的指导。
一个由具有传染病、风湿病、血液学/肿瘤学和重症医学专业知识的儿科亚专科医生和药剂师组成的多学科小组被召集在一起。指导意见是根据最佳现有证据和专家意见制定的。
该小组根据临床疾病严重程度和多器官受累程度的评估，结合炎症过度的证据，制定了考虑使用免疫调节疗法的框架。此外，还总结了考虑每种免疫调节方法的已知理由以及相关风险和益处。
免疫调节疗法不建议用于大多数儿童患者，他们通常患有轻度或中度 COVID-19。对于患有严重或危急疾病的儿童，使用免疫调节药物可能有益。这些治疗方法的风险和益处各不相同，应根据具体情况进行评估，并征求适当专科服务的意见。在有条件的情况下，小组强烈赞成在临床试验的背景下使用免疫调节药物。本文提出的框架为严重或危急儿科 COVID-19 的免疫调节治疗决策提供了一种方法，同时参考了现有数据，等待安慰剂对照随机临床试验的结果。
