Anderson Evan J, Carosone-Link Phyllis, Yogev Ram, Yi Jumi, Simões Eric A F
From the Departments of *Pediatrics and †Medicine, Emory University School of Medicine, Atlanta, Georgia; ‡Department of Pediatrics, Children's Hospital Colorado, Aurora, Colorado; §Department of Pediatrics, Ann and Robert H Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ¶Department of Pediatrics, The University of Colorado School of Medicine, Aurora, Colorado; and ‖Department of Epidemiology, Center for Global Health, Colorado School of Public Health, Aurora, Colorado.
Pediatr Infect Dis J. 2017 Aug;36(8):699-704. doi: 10.1097/INF.0000000000001533.
Infants with premature birth ≤35 weeks gestational age, chronic lung disease of prematurity and congenital heart disease are at an increased risk for lower respiratory tract infections and hospitalization from respiratory syncytial virus (RSV), which has been shown in randomized trials to be prevented by palivizumab. However, palivizumab effectiveness (PE) has not been studied in a large clinical setting.
A multicenter study among high-risk US and Canadian children younger than 24 months hospitalized with lower respiratory tract infection and whose nasopharyngeal aspirates were tested for human metapneumovirus (HMPV) and RSV were the subjects of the trial. We conducted a test-negative case-control study in these subjects to determine PE. We used an inverse propensity score weighted (IPSW) multiple logistic regression model to adjust PE.
Palivizumab was used in 434 (51%) of 849 eligible children. RSV was identified in 403 (47%) children. The unadjusted PE was 43% [95% confidence interval (CI), 34%-51%)]. After IPSW adjustment, the adjusted PE was 58% (95% CI, 43%-69%). Palivizumab prevented intensive care unit admissions (PE, 62%; 95% CI, 35%-78%). PE for 29-35 weeks gestational age and ≤6 months of chronologic age without chronic lung disease of prematurity or congenital heart disease was 74% (95% CI, 56%-85%).
Using a test-negative case-control design with RSV molecular detection, palivizumab is shown to prevent RSV hospitalizations and intensive care unit admissions in high-risk infants.
孕周≤35周的早产、患有早产儿慢性肺病和先天性心脏病的婴儿，发生下呼吸道感染以及因呼吸道合胞病毒（RSV）住院的风险增加，随机试验已表明帕利珠单抗可预防此类情况。然而，尚未在大型临床环境中研究帕利珠单抗的有效性（PE）。
一项针对美国和加拿大24个月以下因下呼吸道感染住院且对其鼻咽抽吸物进行人偏肺病毒（HMPV）和RSV检测的高危儿童的多中心研究作为该试验的对象。我们在这些受试者中进行了一项检测阴性病例对照研究以确定PE。我们使用逆倾向评分加权（IPSW）多元逻辑回归模型来调整PE。
849名符合条件的儿童中有434名（51%）使用了帕利珠单抗。403名（47%）儿童检测出RSV。未调整的PE为43%[95%置信区间（CI），34%-51%]。经过IPSW调整后，调整后的PE为58%（95%CI，43%-69%）。帕利珠单抗预防了重症监护病房入院（PE，62%；95%CI，35%-78%）。孕周29-35周且实际年龄≤6个月、无早产儿慢性肺病或先天性心脏病的PE为74%（95%CI，56%-85%）。
采用带有RSV分子检测的检测阴性病例对照设计，结果表明帕利珠单抗可预防高危婴儿因RSV住院和入住重症监护病房。
