Navér L, Eriksson M, Ewald U, Linde A, Lindroth M, Schollin J
Department of Clinical Science, Division of Paediatrics, Karolinska University Hospital, Huddinge, Sweden.
Acta Paediatr. 2004 Nov;93(11):1470-3. doi: 10.1080/08035250410023197.
Palivizumab (Synagis) was registered in Sweden in 1999 for prophylaxis against respiratory syncytial virus (RSV) in premature infants. The high costs and the limited knowledge of the efficacy of this substance have led to debate about how and when it should be used. National guidelines for the use of palivizumab in Sweden were constructed in the year 2000. The aim of this study was to evaluate the guidelines.
A nation-wide prospective study was conducted during the two RSV seasons of the years 2000-2002. The paediatric departments in Sweden reported the use of palivizumab, the indication for its use, and the number of infants born preterm before 36 wk of gestation and less than 2 y old who were admitted to hospital for RSV infection.
During the two seasons, 218 (3.8%) children who were born before 36 wk of gestation, and 97 (5.4%) who were born before 33 wk, were hospitalized because of RSV infection. Five children were treated with mechanical ventilation. No death caused by RSV was reported. A total of 390 children were treated with palivizumab, and 16 (4.1%) of those who received prophylactic treatment were admitted to hospital with RSV infection.
We consider the comparatively restrictive Swedish recommendations to be safe and recommend that palivizumab should also be used very restrictively in the future. In our opinion, palivizumab in preterm children could be recommended only for those with chronic lung disease younger than 1 y of age, and with active treatment for their disease.
帕利珠单抗（Synagis）于1999年在瑞典注册，用于预防早产儿的呼吸道合胞病毒（RSV）感染。该药物成本高昂且疗效方面的知识有限，引发了关于其使用方式和时机的争论。瑞典于2000年制定了帕利珠单抗使用的国家指南。本研究旨在评估这些指南。
在2000 - 2002年的两个RSV流行季节进行了一项全国性前瞻性研究。瑞典的儿科部门报告了帕利珠单抗的使用情况、使用指征以及孕周小于36周且年龄小于2岁的早产儿因RSV感染入院的人数。
在这两个季节中，218名（3.8%）孕周小于36周出生的儿童以及97名（5.4%）孕周小于33周出生的儿童因RSV感染住院。5名儿童接受了机械通气治疗。未报告由RSV导致的死亡病例。共有390名儿童接受了帕利珠单抗治疗，其中16名（4.1%）接受预防性治疗的儿童因RSV感染入院。
我们认为瑞典相对严格的建议是安全的，并建议未来也应非常严格地使用帕利珠单抗。我们认为，仅对于1岁以下患有慢性肺病且正在接受积极治疗的早产儿，才可以推荐使用帕利珠单抗。
