Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency
Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency
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DOI：
10.1007/s10875-006-9025-3
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发表时间：
2006-07-01
影响因子：
9.1
通讯作者：
Ehrlich, Hartmut J.
中科院分区：
文献类型：
--
作者：
Church, Joseph A.;Leibl, Heinz;Ehrlich, Hartmut J.
本临床研究旨在评价一种新型10%静脉注射免疫球蛋白在原发性免疫缺陷疾病患者中的疗效、药代动力学和安全性。61名患有原发性免疫缺陷疾病的成人和儿童每21-28天接受300-600毫克/公斤体重的剂量，持续12个月。没有证实的急性严重细菌感染报告。急性严重细菌感染年化率（主要终点）的95%置信区间为0-0.060。总共观察到四种预先确认的其他细菌感染，通常发生在原发性免疫缺陷疾病受试者中；没有严重、严重或导致住院。IgG的中位消除半衰期为35天。总IgG谷值中位数在9.6 ~ 11.2 g/L之间变化。在每次输注后72小时内测定与时间相关的不良反应，最常见的不良反应是头痛，与6.9%的输注相关。该研究达到了疗效的主要终点，并证明了新的10%静脉注射免疫球蛋白制剂的良好耐受性。
The present clinical study was designed to evaluate the efficacy, pharmacokinetics and safety of a new 10% liquid intravenous immune globulin in patients with primary immunodeficiency diseases. Sixty-one adults and children with primary immuno-deficiency diseases received doses of 300-600 mg/kg body weight every 21-28 days for 12 months. No validated acute serious bacterial infections were reported. The 95% confidence interval for the annualized rate of acute serious bacterial infections (primary endpoint) was 0-0.060. A total of four predefined validated other bacterial infections commonly occurring in primary immunodeficiency disease subjects were observed; none were serious, severe or resulted in hospitalization. The median elimination half-life of IgG was 35 days. Median total IgG trough levels varied from 9.6 to 11.2 g/L. Temporally associated adverse experiences were determined for 72 h after each infusion and the most common adverse experience was headache, which was associated with 6.9% of infusions. The study met the primary endpoint for efficacy and demonstrated excellent tolerability of the new 10% liquid intravenous imunoglobulin preparation.