Makari Doris, Checchia Paul A, Devincenzo John
MedImmune; Gaithersburg, MD USA.
Texas Children's Hospital; Baylor College of Medicine; Houston, TX USA.
Hum Vaccin Immunother. 2014;10(3):607-14. doi: 10.4161/hv.27426. Epub 2013 Dec 6.
Palivizumab monthly injections throughout the RSV season prevent severe respiratory syncytial virus (RSV) disease in preterm infants ≤ 35 wGA. However, some RSV guidelines currently recommend stopping palivizumab after 3 months of age in the midst of the RSV season. This article evaluates the need for full-season dosing by reviewing the pharmacokinetic properties of palivizumab and RSV hospitalization (RSVH) risk as a function of chronologic age. Precise human palivizumab protective levels are not established. Clinical trials show significant interpatient variability in palivizumab serum trough concentrations. Partial season dosing is associated with increased risk of RSVH. For late-preterm infants, data suggest that the risk of RSVH remains elevated through at least 6 months of age. Monthly, full-season palivizumab dosing provides the only empirically proven protection from RSVH. In conclusion, late-preterm infants are at significant risk for RSVH through at least 6 months of age and would benefit from dosing throughout the RSV season.
在呼吸道合胞病毒(RSV)流行季节全程每月注射帕利珠单抗,可预防胎龄小于等于35周的早产儿发生严重的RSV疾病。然而,目前一些RSV指南建议在RSV流行季节期间,婴儿3月龄后停止使用帕利珠单抗。本文通过回顾帕利珠单抗的药代动力学特性以及按实足年龄计算的RSV住院(RSVH)风险,评估全季节给药的必要性。尚未确定确切的人帕利珠单抗保护水平。临床试验表明,患者间帕利珠单抗血清谷浓度存在显著差异。部分季节给药与RSVH风险增加相关。对于晚期早产儿,数据表明至少到6月龄时,RSVH风险仍会升高。每月全季节使用帕利珠单抗给药是唯一经实证证明可预防RSVH的方法。总之,晚期早产儿至少到6月龄时仍有发生RSVH的显著风险,在RSV流行季节全程给药会使其受益。