PDF(Pubmed)
Abstract：
Respiratory syncytial virus (RSV) is the most common etiology of bronchiolitis in young children. While most children clinically improve with care at home, RSV is the leading cause of hospitalization among infants aged 12 months or less. Common modalities of treatment for children with immune dysregulation include respiratory support and best supportive care, which may include immunoglobulin therapy. All immunoglobulin therapies adhere to Food and Drug Administration (FDA) - established standards for antibodies against measles, polio, and diphtheria, but there are no required standards for problematic respiratory viral pathogens, including RSV and others. ASCENIV is an approved IVIG that is manufactured from blending normal source plasma with plasma from donors that possess high antibody titers against RSV and other respiratory pathogens of concern. ASCENIV was developed, in part, to the unmet need that exists in immunocompromised patients who lack sufficient antibodies against problematic viral pathogens. ASCENIV is not a currently approved treatment for severe RSV and other viral infections. There is a lack of research regarding its potential benefits in the acute treatment period for RSV and in the pediatric population. Therefore, this case series was developed to describe real-world experiences of ASCENIV use in this less well studied clinical scenario. This case series reviews three pediatric patients ≤ 5 years of age with immune dysregulation and who were severely ill with RSV. Despite receiving best supportive care, and standard immunoglobulin therapy for some, the patients\' clinical status continued to decline. All patients received ASCENIV in an intensive care setting. Each patient had ultimately recovered due to the various medical interventions done. This case series demonstrated that ASCENIV (500mg/kg) administration may have contributed to the treatment outcomes of a less well studied age-cohort of patients. In addition, no adverse side effects were observed after ASCENIV administration. Further analysis of the benefits of ASCENIV for the acute and preventative treatment in patients younger than 12 years of age with immune dysregulation should continue to be explored.
摘要：
呼吸道合胞病毒（RSV）是幼儿毛细支气管炎的最常见病因。虽然大多数儿童在家中护理后临床改善，RSV是12个月或更小的婴儿住院的主要原因。免疫失调儿童的常见治疗方式包括呼吸支持和最佳支持治疗。其中可能包括免疫球蛋白治疗。所有免疫球蛋白疗法均遵守食品和药物管理局（FDA）-建立的麻疹抗体标准，脊髓灰质炎,白喉,但是对于有问题的呼吸道病毒病原体没有必要的标准，包括RSV和其他。ASCENIV是经批准的IVIG,其通过将正常来源的血浆与来自供体的血浆混合而制造,所述供体具有针对RSV和关注的其他呼吸道病原体的高抗体滴度。ASCENIV被开发出来,在某种程度上,对于缺乏针对有问题的病毒病原体的足够抗体的免疫受损患者中存在的未满足的需求。ASCENIV不是目前批准的严重RSV和其他病毒感染的治疗方法。缺乏关于其在RSV急性治疗期和儿科人群中的潜在益处的研究。因此,本病例系列旨在描述ASCENIV在这一研究较少的临床情景中使用的真实经验.本病例系列回顾了3名年龄≤5岁且患有严重RSV的儿科患者。尽管得到了最好的支持治疗,和一些标准的免疫球蛋白治疗，患者的临床状态持续下降。所有患者均在重症监护环境中接受ASCENIV。由于进行了各种医疗干预，每位患者最终都康复了。该病例系列表明，ASCENIV（500mg/kg）给药可能对研究较少的患者年龄队列的治疗结果做出了贡献。此外,ASCENIV给药后未观察到不良副作用.应继续研究ASCENIV对12岁以下免疫失调患者的急性和预防性治疗的益处。
