Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions
Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions
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DOI：
10.1016/j.intimp.2014.09.015
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发表时间：
2014-12-01
影响因子：
5.6
通讯作者：
Costa-Carvalho, Beatriz T.
中科院分区：
文献类型：
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作者：
Bichuetti-Silva, Danielli C.;Furlan, Fernanda P.;Costa-Carvalho, Beatriz T.
静脉注射免疫球蛋白（WIG）越来越多地被推荐用于除原发性免疫缺陷疾病（PID）外的许多疾病。虽然有效和安全，但可能发生不良反应。我们对117例PID患者进行了一项为期2年的前瞻性观察研究，这些患者接受常规IVIG替代治疗，中位剂量为每3至4周600 mg/kg，以检查IVIG的不良反应；共进行静脉注射1765次（平均15次/例），男75例，女42例（年龄3个月~ 77岁），分3组：20岁（39.3%）。50例患者患有常见可变免疫缺陷（CVID）， 11例患有x连锁无球蛋白血症（XLA）， 55例患有其他免疫系统疾病。用药分别为Octagam（49.1%）、Tegeline（17.3%）、Imunoglobulin（18.6%）、Flebogama（12.9%）、Vigam（1.2%）、Kiovig（0.4%）。1765例输液中发生即刻输液相关不良反应38例（2.15%,IC95% 1.53% ~ 2.94%），不良反应分为轻度（81.6%）、中度（10.5%）和重度（7.9%）。反应时间从10到240分钟不等（平均= 85.7，中位数= 60）。不同年龄组的反应率相似。最常见的反应是不适、头痛和腹痛。报告的严重事件是喉咙紧绷和癫痫发作。暂时或完全中断WIG并对症用药后，所有症状均得到改善。38例输液反应中有16例发生急性感染（p = 0.09）。Tegeline (R)的反应危险因素高于Octagam (R) （p < 0.001）。这些结果表明IVIG输注可以被认为是一种安全的程序。反应发生率低，未见严重的即时输液相关不良反应。(C) 2014 Elsevier B.V.版权所有
Intravenous immunoglobulin (WIG) is increasingly recommended for many diseases apart from primary immunodeficiency diseases (PID). Although effective and safe, adverse reactions may occur. We conducted a 2-year prospective observational study in 117 patients with PID who received regular IVIG replacement therapy at a median dose of 600 mg/kg every 3 to 4 weeks to examine IVIG's adverse effects; 1765 infusions were performed (mean = 15/patient) in 75 males and 42 females (aged 3 months to 77 years) in 3 groups: = 20 years (39.3%). Fifty patients had common variable immunodeficiency (CVID), 11 had X-linked agammaglobulinemia (XLA), and 55 had other immune system disorders. The drugs administered were Octagam (R) (49.1%), Tegeline (R) (17.3%), Imunoglobulin (R) (18.6%), Flebogama (R) (12.9%), Vigam (R) (1.2%), and Kiovig (R) (0.4%). Immediate infusion-related adverse reactions occurred in the cases of 38 out 1765 infusions (2.15%, IC95% 1.53%-2.94%), which were classified as mild (81.6%), moderate (10.5%), or severe (7.9%). Time until reaction ranged from 10 to 240 min (mean = 85.7, median = 60). Reaction rates were similar across age groups. The most common reactions were malaise, headache, and abdominal pain. Reported severe events were tightness of the throat and seizure. All symptoms improved with temporary or complete WIG interruption and symptomatic medications. Sixteen of 38 reactions to infusions occurred in the presence of an acute infection (p = 0.09). Tegeline (R) represented a greater reaction risk factor than Octagam (R) (p < 0.001). These results indicate that IVIG infusion can be considered a safe procedure. Low reaction incidence and few severe immediate infusion-related adverse reactions were observed. (C) 2014 Elsevier B.V. All rights reserved.