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帕利珠单抗(赛诺菲)连续两个季节给药的安全性和免疫原性。

Safety and immunogenicity of palivizumab (Synagis) administered for two seasons.

作者信息

Null Donald, Pollara Bernard, Dennehy Penelope H, Steichen Jean, Sánchez Pablo J, Givner Laurence B, Carlin David, Landry Bernard, Top Franklin H, Connor Edward

机构信息

Primary Children's Medical Center, Salt Lake City, UT, USA.

出版信息

Pediatr Infect Dis J. 2005 Nov;24(11):1021-3. doi: 10.1097/01.inf.0000183938.33484.bd.

DOI:10.1097/01.inf.0000183938.33484.bd
PMID:16282947
Abstract

To evaluate the safety and immunogenicity of palivizumab, 55 children who received palivizumab in the IMpact-RSV trial received 5 monthly doses of 15 mg/kg palivizumab (Synagis) during the subsequent year. The single child with an antipalivizumab titer of >1/40 had no associated serious adverse events and had expected serum palivizumab trough concentrations. Second year palivizumab prophylaxis was safe and well-tolerated.

摘要

为评估帕利珠单抗的安全性和免疫原性,55名在呼吸道合胞病毒预防(IMpact-RSV)试验中接受帕利珠单抗治疗的儿童在随后一年中每月接受5剂15mg/kg的帕利珠单抗(商品名:Synagis)。抗帕利珠单抗滴度>1/40的唯一一名儿童未出现相关严重不良事件,且血清帕利珠单抗谷浓度在预期范围内。第二年使用帕利珠单抗进行预防是安全且耐受性良好的。

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