Mori Masaaki, Onodera Masafumi, Morimoto Akira, Kosaka Yoshiyuki, Morio Tomohiro, Notario Gerard F, Sharma Shringi, Saji Tsutomu
From the *Department of Pediatrics, Yokohama City University Medical Center, Yokohama; †Department of Human Genetics, National Center for Child Health and Development, Tokyo; ‡Department of Pediatrics, Jichi Medical University School of Medicine, Shimotsuke; §Department of Hematology and Oncology, Hyogo Prefectural Kobe Children's Hospital, Kobe; ¶Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; ‖Virology; **Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL; and ††Department of Pediatrics, Toho University Medical Center Omori Hospital, Tokyo, Japan.
Pediatr Infect Dis J. 2014 Nov;33(11):1183-5. doi: 10.1097/INF.0000000000000392.
A total of 27/28 (96%) immunocompromised Japanese children received ≥ 4 doses of palivizumab. No respiratory syncytial virus-associated hospitalizations occurred. Mean palivizumab trough concentrations were 59.0 and 91.8 μg/mL 30 days after the 1st and 4th doses, respectively. Of 28 subjects, 27 (96%) experienced ≥ 1 adverse event and 7 (25%) experienced ≥ 1 serious adverse event, none of which was considered related to palivizumab.
27/28(96%)名免疫功能低下的日本儿童接受了≥4剂帕利珠单抗。未发生与呼吸道合胞病毒相关的住院情况。在第1剂和第4剂给药后30天,帕利珠单抗的平均谷浓度分别为59.0和91.8μg/mL。在28名受试者中,27名(96%)经历了≥1次不良事件,7名(25%)经历了≥1次严重不良事件,其中无一被认为与帕利珠单抗有关。