Department of Pediatrics and Stollery Children's Hospital, University of Alberta, Edmonton, Canada.
World J Pediatr. 2010 Nov;6(4):296-300. doi: 10.1007/s12519-010-0230-z. Epub 2010 Nov 16.
Palivizumab has proven efficacy for prophylaxis of respiratory syncytial virus (RSV) in infants with prematurity or congenital heart disease. Despite a paucity of data, palivizumab is sometimes used to prevent progression when high-risk patients present with upper respiratory tract infection (URTI) due to RSV, or as therapy when any patients present with severe lower respiratory tract infection (LRTI) caused by RSV.
A systematic review of the literatures on the use of palivizumab as therapy for RSV was conducted. The primary outcomes were progression from URTI to LRTI and survival rates. Secondary outcomes were adverse events due to palivizumab, serum palivizumab level, and RSV concentration in respiratory secretions.
The search yielded 1 case report, 4 case series, and 2 randomized controlled trials (RCTs) with a total of 136 adults and children. The RCTs were not powered to look at clinical outcomes. By combining all reported clinical outcomes, 3 (12%) of 25 patients with URTI who were given palivizumab died of RSV and 5 of 88 patients with LRTI at the time of treatment died of RSV (6%). Palivizumab levels appeared to be adequate for at least 3 weeks of intravenous injection at 15 mg/kg. The therapy resulted in decreased RSV concentrations in tracheal secretions.
Larger RCTs will be required before palivizumab can be recommended as therapy for RSV in any clinical setting.
帕利珠单抗已被证明可有效预防早产儿或先天性心脏病婴儿的呼吸道合胞病毒(RSV)感染。尽管数据有限,但当高危患者因 RSV 引起上呼吸道感染(URTI)时,帕利珠单抗有时也被用于预防疾病进展,或者当任何患者因 RSV 引起严重下呼吸道感染(LRTI)时,帕利珠单抗也被用作治疗药物。
系统检索了帕利珠单抗治疗 RSV 的文献。主要结局是从 URTI 进展为 LRTI 和生存率。次要结局是帕利珠单抗引起的不良事件、血清帕利珠单抗水平和呼吸道分泌物中的 RSV 浓度。
搜索结果共包括 1 例病例报告、4 个病例系列和 2 个随机对照试验(RCT),共涉及 136 名成人和儿童。RCT 未设计用于观察临床结局。综合所有报告的临床结局,25 例 URTI 患者中有 3 例(12%)接受帕利珠单抗治疗后因 RSV 死亡,88 例 LRTI 患者中有 5 例(6%)在治疗时因 RSV 死亡。15mg/kg 的剂量静脉注射 15 毫克/千克,帕利珠单抗的血清水平至少在 3 周内维持在有效水平。治疗后,气管分泌物中的 RSV 浓度降低。
在任何临床环境中,推荐帕利珠单抗作为 RSV 治疗药物之前,需要进行更大规模的 RCT。