免疫功能低下儿童呼吸道合胞病毒预防：加拿大帕利珠单抗 RSV 评估研究登记处十二个季节（2005-2017 年）的结果。
Respiratory Syncytial Virus Prophylaxis in Immunocompromised Children: Outcomes From the Canadian RSV Evaluation Study of Palivizumab Registry Over Twelve Seasons (2005-2017).
机构信息
From the Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
Medical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
出版信息
Pediatr Infect Dis J. 2020 Jun;39(6):539-545. doi: 10.1097/INF.0000000000002665.
BACKGROUND
Immunocompromised children are at increased risk for respiratory syncytial virus (RSV) infection with associated morbidity and mortality. Prophylaxis is usually provided to these children on a case-by-case basis.
METHODS
Immunocompromised children who received ≥1 injection of palivizumab were prospectively enrolled across 32 Canadian sites, between 2005 and 2017, during the RSV season. We assessed respiratory illness hospitalization (RIH) and RSV-related hospitalization (RSVH) hazard ratios (HRs) in immunocompromised children versus infants' prophylaxed for standard indications (SI: prematurity ≤35 weeks' gestation, bronchopulmonary dysplasia, and congenital heart disease) and complex medical disorders (CMD). Data were analyzed using t-tests, χ and Cox proportional hazards adjusted for confounders.
RESULTS
A total of 25,003 infants were recruited; 214 immunocompromised, 4283 CMD, 20,506 SI. On average, children received 4.4 ± 1.3 injections. A total of 16,231 children were perfectly adherent (58.4% immunodeficiency, 68.9% CMD, 64.2% SI; P < 0.0005). A higher proportion of immunocompromised children were aboriginal and exposed to smoking compared with CMD and SI. Immunocompromised children also had a higher median; gestational and enrollment age and birth weight compared with CMD and SI. Immunodeficient children had a higher RIH risk compared with SI (HR = 2.4, 95% confidence interval, 1.3-4.7, P = 0.009) but were similar to CMD (HR = 1.7, 95% confidence interval, 0.9-3.4, P = 0.118). RSVH in prophylaxed, immunocompromised children was similar to CMD (HR < 0.005, P = 0.955) and SI (HR < 0.005, P = 0.953).
CONCLUSIONS
Immunocompromised children who received palivizumab had an increased RIH hazard compared with the SI group. Similar RSVH hazard between the 3 groups suggests that immunocompromised children may benefit from palivizumab during the RSV season.
背景
免疫功能低下的儿童患呼吸道合胞病毒（RSV）感染的风险增加，相关发病率和死亡率也随之增加。这些儿童通常根据具体情况进行预防。
方法
2005 年至 2017 年 RSV 季节期间，在加拿大 32 个地点前瞻性招募了接受≥1 次帕利珠单抗注射的免疫功能低下儿童。我们评估了免疫功能低下儿童与因标准适应证（SI：早产≤35 周、支气管肺发育不良和先天性心脏病）和复杂医学疾病（CMD）进行预防的婴儿的呼吸道疾病住院（RIH）和 RSV 相关住院（RSVH）风险比（HR）。使用 t 检验、卡方检验和 Cox 比例风险模型调整混杂因素后进行数据分析。
结果
共招募了 25003 名婴儿；214 名免疫功能低下儿童、4283 名 CMD、20506 名 SI。平均而言，儿童接受了 4.4±1.3 次注射。共有 16231 名儿童完全依从（58.4%免疫缺陷、68.9%CMD、64.2%SI；P<0.0005）。与 CMD 和 SI 相比，免疫功能低下儿童中更多的是原住民和接触过吸烟的人。与 CMD 和 SI 相比，免疫功能低下儿童的中位胎龄、入组年龄和出生体重也更高。与 SI 相比，免疫缺陷儿童的 RIH 风险更高（HR=2.4，95%置信区间，1.3-4.7，P=0.009），但与 CMD 相似（HR=1.7，95%置信区间，0.9-3.4，P=0.118）。接受预防的免疫功能低下儿童的 RSVH 与 CMD（HR<0.005，P=0.955）和 SI（HR<0.005，P=0.953）相似。
结论
与 SI 组相比，接受帕利珠单抗治疗的免疫功能低下儿童的 RIH 风险增加。3 组之间 RSVH 风险相似表明，免疫功能低下儿童在 RSV 季节可能受益于帕利珠单抗。
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