Torchin H, Rousseau J, Marchand-Martin L, Truffert P, Jarreau P-H, Ancel P-Y
Inserm U1153, Obstetric, Perinatal and Paediatric Epidemiology, Sorbonne Paris cité, "Risks in pregnancy" University Hospital Department, 75014 Paris, France; Université Paris Descartes, 75006 Paris, France; Department of Neonatal Medicine, Cochin-Port Royal Hospital, AP-HP, 75014 Paris, France.
Inserm U1153, Obstetric, Perinatal and Paediatric Epidemiology, Sorbonne Paris cité, "Risks in pregnancy" University Hospital Department, 75014 Paris, France.
Arch Pediatr. 2018 Feb;25(2):89-94. doi: 10.1016/j.arcped.2017.12.009. Epub 2018 Feb 1.
Several countries, including France, have restricted the indications for monoclonal antibodies directed against respiratory syncytial virus (RSV) compared to the marketing authorization (MA). No new data concerning use of palivizumab on a national scale have been published since the 2007 update of the national guidelines.
To describe palivizumab administration for RSV prophylaxis during the first RSV season in infants born prematurely in France in 2011.
Infants from the national population-based cohort EPIPAGE-2 born at≤34 weeks' gestation, discharged home before 31 March 2012 and followed-up at 1year were included. The RSV season ran from 1 October 2011 to 31 March 2012. Prophylaxis was deemed "initiated" if the infant had received at least one dose of palivizumab during this period and "complete" if it had received at least five doses or as many doses as the number of exposed months. The reference documents were the MA and French Transparency Committee guidelines (TC).
Prophylaxis was indicated in 3586 of 3608 infants (99.7%) according to the MA and 1315 of 3608 (16.7%) according to the TC. A total of 1906 infants (26.6%) received at least one dose of palivizumab. The overall rate of conformity with TC indications was 85%, but was lower for infants born at 27-32 weeks' gestation. The rate of complete prophylaxis was 77.2%. The factors associated with prophylaxis initiation were low gestational age, low birthweight, high maternal educational level, type of neonatal unit, and date at discharge. Factors associated with complete prophylaxis were respiratory impairment, high educational level, and characteristics related to living conditions (absence of siblings at home, type of childcare).
Palivizumab administration in France generally conformed with TC guidelines, but could be further improved for infants born at 27-32 weeks' gestation without bronchopulmonary dysplasia.
与上市许可（MA）相比，包括法国在内的几个国家已限制了针对呼吸道合胞病毒（RSV）的单克隆抗体的适应症。自2007年国家指南更新以来，尚未发表关于帕利珠单抗在全国范围内使用的新数据。
描述2011年法国早产婴儿首个RSV季节期间帕利珠单抗用于RSV预防的情况。
纳入全国基于人群的队列研究EPIPAGE-2中出生时孕周≤34周、于2012年3月31日前出院并随访1年的婴儿。RSV季节为2011年10月1日至2012年3月31日。如果婴儿在此期间接受了至少一剂帕利珠单抗，则预防被视为“开始”；如果接受了至少五剂或与暴露月份数相同剂量，则预防被视为“完成”。参考文件为MA和法国透明度委员会指南（TC）。
根据MA，3608名婴儿中有3586名（99.7%）有预防指征；根据TC，3608名婴儿中有1315名（16.7%）有预防指征。共有1906名婴儿（26.6%）接受了至少一剂帕利珠单抗。总体符合TC指征的比例为85%，但对于孕周为27 - 32周出生的婴儿该比例较低。完全预防的比例为77.2%。与开始预防相关的因素为孕周小、出生体重低、母亲教育水平高、新生儿病房类型和出院日期。与完全预防相关的因素为呼吸功能损害、教育水平高以及与生活条件相关的特征（家中无兄弟姐妹、 childcare类型）。
法国帕利珠单抗的使用总体上符合TC指南，但对于孕周为27 - 32周且无支气管肺发育不良的婴儿，仍可进一步改进。
