Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease

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• 作者：Timothy F Feltes ; Allison K Cabalka ; H.Cody Meissner ; Franco M Piazza ; David A Carlin ; Franklin H Top Jr. ; Edward M Connor ; Henry M Sondheimer ; for the Cardiac Synagis Study Group
• 刊名：The Journal of Pediatrics
• 出版年：2003
• 出版时间：October 2003
• 年：2003
• 卷：143
• 期：4
• 页码：532-540
• 全文大小：154 K

文摘

Objectives

To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD).

Study design

A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg palivizumab or placebo. Children were followed for 150 days. The primary efficacy end point was antigen-confirmed respiratory syncytial virus (RSV) hospitalization.

Results

Palivizumab recipients had a 45 % relative reduction in RSV hospitalizations (P = .003), a 56 % reduction in total days of RSV hospitalization per 100 children (P = .003), and a 73 % reduction in total RSV hospital days with increased supplemental oxygen per 100 children (P = .014). Adverse events were similar in the treatment groups; no child had drug discontinued for a related adverse event. Serious adverse events occurred in 55.4 % of palivizumab recipients and 63.1 % of placebo recipients (P<.005); none were related to palivizumab. Twenty-one children (3.3 % ) in the palivizumab group and 27 (4.2 % ) in the placebo group died; no deaths were attributed to palivizumab. The rates of cardiac surgeries performed earlier than planned were similar in the treatment groups.

Conclusions

Monthly palivizumab (15 mg/kg IM) was safe, well-tolerated, and effective for prophylaxis of serious RSV disease in young children with hemodynamically significant CHD.