Medical Outcomes and Research in Economics Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada;
Division of Infectious Diseases, Department of Pediatrics, University Medical Centre Utrecht, Utrecht, Netherlands;
Pediatrics. 2014 Jun;133(6):1031-7. doi: 10.1542/peds.2013-3916. Epub 2014 May 5.
Children with Down syndrome (DS) are at significant risk for respiratory syncytial virus (RSV) infection and related hospitalization. We compared hospitalization rates due to respiratory tract infection in children with DS aged <2 years who prospectively received palivizumab during the RSV season with a previously published, similar untreated DS birth cohort.
A total of 532 children with DS who prospectively received palivizumab were assembled from the prospective Canadian RSV Evaluation Study of Palivizumab registry between 2005 and 2012. The untreated group included 233 children with DS derived from a nationwide Dutch birth cohort from 2003 to 2005. Events during the RSV seasons were counted. Poisson regression analysis was performed to compare incidence rate ratios (95% confidence intervals [CIs]) between groups while controlling for observation length and known risk factors for severe RSV infection.
In total, 31 (23 untreated, 8 treated) RSV-related hospitalizations were documented. The adjusted risk of RSV-related hospitalizations was higher in untreated subjects than in palivizumab recipients (incidence rate ratio 3.63; 95% CI, 1.52-8.67). The adjusted risk of hospitalization for all respiratory tract infection (147 events; 73 untreated, 74 treated) was similar (incidence rate ratio untreated versus palivizumab 1.11; 95% CI, 0.80-1.55).
These results suggest that palivizumab is associated with a 3.6-fold reduction in the incidence rate ratio for RSV-related hospitalization in children with DS during the first 2 years of life. A randomized trial is needed to determine the efficacy of RSV immunoprophylaxis in this specific high-risk patient population.
唐氏综合征（Down syndrome，DS）患儿存在发生呼吸道合胞病毒（respiratory syncytial virus，RSV）感染和相关住院的重大风险。我们比较了在 RSV 季节期间前瞻性接受帕利珠单抗治疗的<2 岁 DS 患儿与先前发表的未经治疗的 DS 出生队列中因呼吸道感染而住院的发生率。
2005 年至 2012 年期间，前瞻性加拿大 RSV 评价研究帕利珠单抗注册中心共收集了 532 名前瞻性接受帕利珠单抗治疗的 DS 患儿。未治疗组包括 2003 年至 2005 年期间来自荷兰全国性出生队列的 233 名 DS 患儿。计数 RSV 季节期间的事件。进行泊松回归分析，以比较两组之间的发病率比（95%置信区间[CI]），同时控制观察长度和 RSV 严重感染的已知危险因素。
共记录到 31 例（23 例未治疗，8 例治疗）与 RSV 相关的住院病例。未治疗组的 RSV 相关住院风险高于帕利珠单抗治疗组（调整发病率比 3.63；95%CI，1.52-8.67）。所有呼吸道感染（147 例事件；73 例未治疗，74 例治疗）的住院风险相似（未治疗与帕利珠单抗的调整发病率比为 1.11；95%CI，0.80-1.55）。
这些结果表明，帕利珠单抗可使 DS 患儿在生命的前 2 年中 RSV 相关住院的发病率比降低 3.6 倍。需要进行随机试验以确定 RSV 免疫预防在这一特定高风险患者人群中的疗效。
