帕利珠单抗对黑山呼吸道合胞病毒(RSV)感染的预防效果

E. Lekic, Ljubinka Dragas, Drasko Nikcevic, Jasmina Lekic, Ana Dedic, L. Sulovic
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摘要

背景。呼吸道合胞病毒(RSV)是导致婴幼儿严重下呼吸道疾病的最常见病原体之一。新生儿、年幼婴儿和合并疾病的婴儿发生严重感染的风险会增加。目前预防严重 RSV 感染的方法是使用单克隆抗体帕利珠单抗进行免疫预防。该研究旨在评估在黑山共和国使用帕利珠单抗预防的效果,并与预防前进行比较。研究在黑山波德戈里察临床中心以前瞻性/回顾性单中心形式进行,时间跨度为2009-2019年。共有104名高风险婴儿参加了帕利珠单抗预防计划(2014-2019年RSV流行季节),168名高风险儿童未参加帕利珠单抗预防计划(2009-2013年RSV流行季节)。共有 51 名儿童(49.0%)因早产而接受预防治疗,33 名(31.7%)因支气管肺发育不良(BPD)而接受预防治疗,13 名(12.5%)因血流动力学显著性心脏病/缺陷(HSCHD)而接受预防治疗,7 名(6.8%)因 "其他 "适应症而接受预防治疗。在对照组中,大多数儿童患有早产(101 例,占 60.1%),其次是 BPD(59 例,占 35.1%)、HSCHD(3 例,占 1.8%)和 "其他"(5 例,占 3.4%)。预防组因感染 RSV 而再次入住儿科重症监护室 (PICU) 的比例明显降低(0.0 vs 16.1%,P<0.001)。使用帕利珠单抗预防治疗的高危儿童未出现致命后果,而对照组为2.4%。对高危新生儿采用 RSV 免疫预防以及其他新的保护性治疗策略,大大改善了黑山的婴幼儿护理工作。这是第一份关于黑山帕利珠单抗预防治疗的报告,证明了在临床环境中使用帕利珠单抗的有效性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effects of palivizumab prophylaxis on respiratory syncytial virus (RSV) infections in Montenegro
Background. Respiratory syncytial virus (RSV) is one of the most common pathogens causing severe lower respiratory tract disease in infancy and childhood. In newborns, young infants, and in infants with co-morbidities, the risk of severe infection is increased. Current protection against severe RSV infection is immunoprophylaxis with the monoclonal antibody palivizumab. The study aimed to assess the effects of palivizumab prophylaxis in the Republic of Montenegro in comparison to the pre-prophylaxis period. Methods. The study was conducted in prospective/retrospective single center format in Montenegro in the Clinical Center of Podgorica, for the period 2009-2019. Results. A total of 104 high-risk infants in the palivizumab prophylaxis program (2014-2019 RSV seasons) and 168 high-risk children without palivizumab prophylaxis (2009-2013 RSV seasons) were enrolled. A total of 51 children (49.0%) received prophylaxis for prematurity, 33 (31.7%) for bronchopulmonary dysplasia (BPD), 13 (12.5%) for hemodynamically significant heart disease/defect (HSCHD), and 7 (6.8%) for “miscellaneous” indications. In the control group most children had prematurity (101, 60.1%), followed by BPD (59, 35.1%), HSCHD (3, 1.8%), and “miscellaneous” (5, 3.4%) conditions. Readmission to the pediatric intensive care units (PICU) due to RSV infection was significantly lower in prophylaxis group (0.0 vs 16.1%, p<0.001). No lethal outcomes were observed in high-risk children with palivizumab prophylaxis compared to 2.4% in the control group. Conclusions. The introduction of RSV immunoprophylaxis as well as other new protective treatment strategies for high-risk newborns led to significant improvements in infant and childcare in Montenegro. This is the first report on palivizumab prophylaxis in Montenegro, demonstrating the effectiveness and safety of palivizumab use in clinical settings.
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