Misbah S A, Chapel H M
Department of Immunology, John Radcliffe Hospital, Oxford, England.
Drug Saf. 1993 Oct;9(4):254-62. doi: 10.2165/00002018-199309040-00003.
The range of diseases in which intravenous immunoglobulin (IVIG) is effective has expanded significantly since its initial use in primary antibody deficiency. There are at present at least 17 preparations of IVIG in use worldwide with similar profiles of adverse effects. Infusion-related effects range in severity. Mild adverse reactions (headache, flushing, low backache, nausea, wheezing) are often associated with a fast infusion rate, and respond rapidly on slowing the infusion. Very rare episodes of life-threatening anaphylaxis may occur, particularly in those IgA-deficient patients with anti-IgA antibodies; such patients should receive an IgA-depleted preparation of IVIG. There are concerns with any blood product about safety in regard to viral transmission. The 4 outbreaks of non-A non-B hepatitis (probably hepatitis C) in the 1980s were associated with the use of particular batches of IVIG. The more recent exclusion of all anti-hepatitis C virus positive individuals from the donor pool, and the introduction of specific antiviral steps in the manufacture of IVIGs, should prevent further outbreaks. The human immunodeficiency virus (HIV) is effectively inactivated during the manufacturing process itself and HIV transmission has not been reported with IVIG. Rarely, haematological (Coombs' test positive haemolysis), neurological (aseptic meningitis) or renal (transient rises in serum creatinine) adverse effects may be seen when high doses of IVIG are used for immunomodulatory purposes. Haemolysis, due to passive transmission of blood group antibodies (anti-A, anti-D), may be prevented by selecting IVIG batches that give a negative cross-match between the recipient's red cells and IVIG.(ABSTRACT TRUNCATED AT 250 WORDS)
自静脉注射免疫球蛋白(IVIG)最初用于原发性抗体缺陷以来,其有效的疾病范围已显著扩大。目前全球至少有17种IVIG制剂在使用,它们的不良反应情况相似。与输注相关的效应严重程度不一。轻度不良反应(头痛、潮红、腰痛、恶心、喘息)通常与输注速度过快有关,减慢输注速度后反应迅速。极罕见的危及生命的过敏反应可能发生,尤其是在那些有抗IgA抗体的IgA缺乏患者中;此类患者应接受去除IgA的IVIG制剂。任何血液制品都存在病毒传播方面的安全性问题。20世纪80年代的4次非甲非乙型肝炎(可能是丙型肝炎)暴发与特定批次的IVIG使用有关。最近将所有抗丙型肝炎病毒阳性个体排除在献血者群体之外,以及在IVIG生产中引入特定的抗病毒措施,应可防止进一步暴发。人类免疫缺陷病毒(HIV)在生产过程中本身就会被有效灭活,且尚未有IVIG传播HIV的报道。很少见的情况是,当高剂量IVIG用于免疫调节目的时,可能会出现血液学(库姆斯试验阳性溶血)、神经学(无菌性脑膜炎)或肾脏(血清肌酐短暂升高)不良反应。由于血型抗体(抗A、抗D)的被动传播导致的溶血,可通过选择在受者红细胞与IVIG之间交叉配血呈阴性的IVIG批次来预防。(摘要截短于250字)