Surveillance study on the tolerability and safety of Flebogamma® DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients
Surveillance study on the tolerability and safety of Flebogamma® DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients
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DOI：
10.1002/prp2.345
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发表时间：
2017-10-01
影响因子：
2.6
通讯作者：
Gompels, Mark
中科院分区：
文献类型：
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作者：
Alsina, Laia;Mohr, Andreas;Gompels, Mark
浓缩静脉注射免疫球蛋白（IVIG）与浓缩度较低的产品的耐受性和安全性的直接比较很少。在这项许可后、前瞻性、观察性、多中心研究中，在常规条件下根据批准的适应症接受研究IVIG产品治疗的成人和儿童患者中，对10%和5%浓度的Flebogamma（R）DIF IVIG进行了系统比较。分析了产品给药剂量、不良事件（AE）、体格评估、实验室检查和伴随治疗。10%和5%产品组的患者招募分别为34例（32例分析，其中13例为儿童，接受130次IVIG输注）和35例（34例分析，接受135次IVIG输注）。24例10%产品输注（18.5%; 95% CI：11.8，25.1）和3例5%产品输注（2.2%; 95% CI：-0.3，4.7）与潜在治疗相关AE相关（P
Direct comparisons of tolerability and safety of concentrated intravenous immunoglobulin (IVIG) versus less concentrated products are scarce. In this postauthorization, prospective, observational, multicenter study, a systematic comparison of 10% and 5% concentrations of Flebogamma (R) DIF IVIG was performed in both adult and pediatric patients treated with the studied IVIG products according to the approved indications under routine conditions. Dose of product administered, adverse events (AEs), physical assessments, laboratory tests, and concomitant therapy were analyzed. Patient recruitment in the 10% and 5% product groups was, respectively, 34 (32 analyzed, 13 of them children, receiving 130 IVIG infusions) and 35 (34 analyzed, receiving 135 IVIG infusions). Twenty-four infusions (18.5%; 95% CI: 11.8, 25.1) with the 10% product and 3 (2.2%; 95% CI: -0.3, 4.7) with the 5% product were associated with potentially treatment-related AEs (P