不同输注速率下新型 10%静脉用液体免疫球蛋白（普来可复）的耐受性。
Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates.
机构信息
Department of Pediatrics, University of South Florida, St. Petersburg, FL, USA.
出版信息
J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.
PURPOSE
The tolerability of L-proline-stabilized Privigen, a new 10% liquid immunoglobulin for intravenous administration, was assessed at high infusion rates in a Phase III, open-label, single-arm, multicenter study in 45 patients with primary immune deficiencies.
PATIENTS AND METHODS
Maximum infusion rates were not assigned prospectively. For analysis, patients were grouped according to maximum infusion rate in a low infusion rate group (8 mg/kg/min) and high infusion rate group (12 mg/kg/min).
RESULTS
Twenty-three patients, selected at the investigators' discretion for the high infusion rate group based on their good tolerability, tolerated Privigen at 12 mg/kg/min with no increase in temporally associated adverse events (AEs) above the level they had experienced at 8 mg/kg/min. The proportion of infusions with temporally associated AEs in these patients was 0.079 [97.5% confidence interval (CI) 0.114] compared to 0.211 (97.5% CI 0.267) in the low infusion rate group. The most frequent AE was headache. Thus, selected patients tolerate Privigen at high infusion rates.
目的
在一项评估新型 10％静脉用液体免疫球蛋白 L-脯氨酸稳定 Privigen 耐受性的 III 期、开放性、单臂、多中心研究中，45 例原发性免疫缺陷患者以高输注率接受了该药治疗。
患者和方法
未预先设定最大输注率。为了进行分析，根据低输注率组（8mg/kg/min）和高输注率组（12mg/kg/min）中患者的最大输注率对患者进行分组。
结果
根据研究者的判断，23 例患者由于较好的耐受性而被选择进入高输注率组，这些患者以 12mg/kg/min 的速度耐受 Privigen，与以 8mg/kg/min 的速度相比，与时间相关的不良事件（AE）没有增加。这些患者中与时间相关的 AE 发生率为 0.079（97.5％置信区间（CI）0.114），而低输注率组为 0.211（97.5％CI 0.267）。最常见的 AE 是头痛。因此，选择的患者可以耐受高输注率的 Privigen。
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