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食品与药品管理局最近批准了一种肌注单克隆抗体制剂-Palivizumab。推荐应用该制剂是基于大量随机的研究证明:可降低55％因呼吸道合胞体病毒(RSV)感染而住院的高危儿科病人。患有慢性肺部疾病(CLD)的、以前已确诊为支气管肺发育异常的婴儿和儿童,以及未患过CLD的早产儿在接受Palivizumab治疗后,与安慰剂组相比较均减少了其住院病人的数量。Palivizumab和RSV静注免疫球蛋白(RSV-IGIV)都可达到保护高危儿童,以免因RSV感染而引发的严重并发症。Palivizumab之所以适宜于大多数高危儿童是因为:给药方便(肌注)、无麻疹-流行性腮腺炎—风疹疫苗和水痘疫苗的干扰,及无静脉注射人免疫球蛋白制剂相关的并发症。然而,RSV-Ⅰ-GIV还提供其它的保护:抵抗其它呼吸遭病毒性疾病以及适宜于某些高危儿童包括因潜在的免疫缺陷或人类免疫缺陷病毒感
The Food and Drug Administration recently approved an intramuscular monoclonal antibody formulation, Palivizumab. This formulation is recommended based on a number of randomized studies demonstrating that 55% of high-risk pediatric patients hospitalized for respiratory syncytial virus (RSV) infection can be reduced. Infants and children with chronic lung disease (CLD) previously diagnosed with bronchopulmonary dysplasia, and preterm infants not having CLD, received Palivizumab after treatment compared with placebo, reducing their inpatients quantity. Palivizumab and RSV intravenous immunoglobulin (RSV-IGIV) can protect children at high risk, so as to avoid serious complications caused by RSV infection. Palivizumab is suitable for most children at high risk because of: easy administration (intramuscular), no measles-mumps-rubella vaccine and varicella vaccine, and complications associated with intravenous immunoglobulin preparations. However, RSV-I-GIV provides additional protection against other respiratory diseases and suitable for certain high-risk children including those due to latent immunodeficiency or human immunodeficiency virus