Revised indications for the use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the prevention of respiratory syncytial virus infections
Revised indications for the use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the prevention of respiratory syncytial virus infections
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DOI：
10.1542/peds.112.6.1447
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发表时间：
2003-12-01
期刊：
影响因子：
8
通讯作者：
Stark, AR
中科院分区：
文献类型：
--
作者：
Abramson, JS;Baker, CJ;Stark, AR
帕利珠单抗和呼吸道合胞病毒免疫球蛋白静脉注射液（RSV-IGIV）已获得美国食品药品监督管理局的许可，用于预防高危婴儿、24个月以下患有慢性肺病（以前称为支气管肺发育不良）的儿童和某些早产儿的严重呼吸道合胞病毒（RSV）感染。本报告总结了临床试验信息，随附政策声明中关于对某些有早产、慢性肺病或先天性心脏病病史的儿童进行RSV预防性治疗的指南是基于这些信息。根据最近完成的临床试验结果，帕利珠单抗适用于患有血流动力学显著性先天性心脏病的婴幼儿。RSV- IGIV不应用于患有血流动力学显著心脏病的儿童。帕利珠单抗是首选的大多数高危婴儿和儿童，因为易于肌肉注射。在RSV季节期间每月给予帕利珠单抗导致RSV所致住院率降低45%至55%。由于妊娠32至35周后出生的婴儿数量众多，且费用高昂，只有在存在2种或2种以上风险因素的情况下，才应考虑对这类早产儿进行免疫预防。
Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous ( RSV- IGIV) are licensed by the Food and Drug Administration for use in preventing severe respiratory syncytial virus ( RSV) infections in high- risk infants, children younger than 24 months with chronic lung disease ( formerly called bronchopulmonary dysplasia), and certain preterm infants. This report summarizes the clinical trial information on which the guidance in the accompanying policy statement for administering RSV prophylaxis to certain children with a history of preterm birth, chronic lung disease, or congenital heart disease is based. On the basis of results of a recently completed clinical trial, palivizumab is appropriate for infants and young children with hemodynamically significant congenital heart disease. RSV- IGIV should not be used in children with hemodynamically significant heart disease. Palivizumab is preferred for most high- risk infants and children because of ease of intramuscular administration. Monthly administration of palivizumab during the RSV season results in a 45% to 55% decrease in the rate of hospitalization attributable to RSV. Because of the large number of infants born after 32 to 35 weeks' gestation and because of the high cost, immunoprophylaxis should be considered for this category of preterm infants only if 2 or more risk factors are present.