DeVincenzo John P, Ambrose Christopher S, Makari Doris, Weiner Leonard B
a Children's Foundation Research Institute , Le Bonheur Children's Hospital , Memphis , TN , USA.
b Department of Pediatrics and Department of Microbiology , Immunology, and Biochemistry, University of Tennessee School of Medicine , Memphis , TN , USA.
Hum Vaccin Immunother. 2016 Apr 2;12(4):971-5. doi: 10.1080/21645515.2015.1115936. Epub 2016 Feb 18.
In July 2014, the Committee on Infectious Diseases (COID) updated their guidance on the use of palivizumab, recommending against use in preterm infants 29 to 35 weeks' gestational age (wGA). A primary data source cited to support this significant change was the low respiratory syncytial virus (RSV) hospitalization rate observed in the subpopulation of preterm (<37 wGA) infants evaluated from 2000 to 2005 through the New Vaccine Surveillance Network (NVSN). Here we critically appraise the preterm infant data from the NVSN in the context of data regarding the use of palivizumab in this same time period. Data from the NVSN, an analysis of Florida Medicaid data, and a national survey of US in-hospital palivizumab administration demonstrated that during 2001 to 2007, palivizumab was administered to 59% to 83% of preterm infants born at <32 wGA and 21% to 27% of all preterm infants (<37 wGA). When the NVSN data regarding incidence of RSV hospitalization in preterm infant subgroups were evaluated as a function of chronologic age, preterm infants <32 wGA showed a paradoxical increase in RSV hospitalization with older age, with the highest risk of RSV hospitalization occurring at 18 to 23 months of age. This pattern is most consistent with a reduction in RSV hospitalizations in <32 wGA infants in the first 12 to 18 months of life due to high palivizumab use at these young ages. The NVSN data were not designed to and cannot accurately describe RSV disease burden in preterm infants given the small size of the analyzed subpopulation and the high use of palivizumab during the study period.
2014年7月,传染病委员会(COID)更新了其关于使用帕利珠单抗的指南,建议不要在孕龄29至35周(wGA)的早产儿中使用。支持这一重大变化所引用的主要数据来源是通过新疫苗监测网络(NVSN)在2000年至2005年期间评估的早产(<37 wGA)婴儿亚组中观察到的低呼吸道合胞病毒(RSV)住院率。在此,我们结合同一时期帕利珠单抗使用的数据,对NVSN的早产儿数据进行批判性评估。来自NVSN的数据、对佛罗里达医疗补助数据的分析以及一项关于美国医院内帕利珠单抗使用情况的全国性调查表明,在2001年至2007年期间,出生时<32 wGA的早产儿中有59%至83%接受了帕利珠单抗治疗,所有早产儿(<37 wGA)中有21%至27%接受了治疗。当将NVSN关于早产儿亚组中RSV住院发生率的数据作为年龄的函数进行评估时,<32 wGA的早产儿RSV住院率随年龄增长出现反常增加,RSV住院风险最高发生在18至23个月龄。这种模式最符合由于在这些年幼时帕利珠单抗使用量高,<32 wGA婴儿在出生后的前12至18个月内RSV住院率降低的情况。鉴于所分析亚组规模较小且研究期间帕利珠单抗使用量高,NVSN的数据并非旨在也无法准确描述早产儿中RSV疾病负担。