Allen Upton D
Division of Infectious Diseases, Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.
Pediatr Crit Care Med. 2005 May;6(3 Suppl):S80-6. doi: 10.1097/01.PCC.0000161949.08227.CE.
The main objectives of this review are to provide insight into the various factors that affect the risk of sepsis in immunocompromised children and to discuss special issues that should be considered when such patients are enrolled in clinical trials.
A literature review was conducted, and authoritative references were consulted when appropriate. This was supported by discussion among experts at an international consensus conference on pediatric sepsis.
The review discusses general issues as they relate to the factors that are associated with a predisposition to sepsis in children with cancers and non-human immunodeficiency virus (HIV)-related acquired immunodeficiencies. The host defects that are associated with specific infections are discussed, and an overview of the indicators of immune dysfunction in the previously well child is presented. Selected examples of patients with non-HIV-related acquired immunodeficiencies, including those with cancer or who have undergone solid-organ or hematopoietic stem-cell transplants are discussed. Special challenges that may affect clinical trials include the altered immune response as this relates to the definition of infection and disease and the assessment of outcomes and the heterogeneity of study populations due to the variable manifestations of immune deficiency states.
Knowledge of the factors that are associated with sepsis in immunocompromised patients is important when such patients are to be entered into clinical trials on sepsis. These factors do not necessarily operate in isolation and may occur concurrently or sequentially. With these considerations in mind, clinical trials involving immunocompromised children can go forward and will very likely lead to significant advances in the care of this understudied population.
本综述的主要目的是深入探讨影响免疫功能低下儿童发生脓毒症风险的各种因素,并讨论在将此类患者纳入临床试验时应考虑的特殊问题。
进行了文献综述,并在适当的时候查阅了权威参考文献。这得到了一次关于儿童脓毒症的国际共识会议上专家们讨论的支持。
本综述讨论了与癌症患儿和非人类免疫缺陷病毒(HIV)相关获得性免疫缺陷患儿脓毒症易感性相关因素的一般问题。讨论了与特定感染相关的宿主缺陷,并概述了既往健康儿童免疫功能障碍的指标。讨论了非HIV相关获得性免疫缺陷患者的选定实例,包括癌症患者或接受实体器官或造血干细胞移植的患者。可能影响临床试验的特殊挑战包括与感染和疾病定义以及结果评估相关的免疫反应改变,以及由于免疫缺陷状态表现多样导致的研究人群异质性。
当要将免疫功能低下患者纳入脓毒症临床试验时,了解与脓毒症相关的因素非常重要。这些因素不一定单独起作用,可能同时或相继出现。考虑到这些因素,涉及免疫功能低下儿童的临床试验可以推进,并且很可能会在对这一研究不足的人群的护理方面取得重大进展。