Hooper John A
BioCatalyst Research LLC, 217 Camelot Drive, Liberty, MO 64068, USA.
Immunol Allergy Clin North Am. 2008 Nov;28(4):765-78, viii. doi: 10.1016/j.iac.2008.06.002.
Since its first use in 1952, human immunoglobulin has been used to treat people who have inherited antibody deficiencies. This article summarizes IVIG clinical development in primary immunodeficient patients and manufacturing improvements introduced over time. Manufacturing improvements include purification procedures that have reduced the incidence of adverse events and improved clinical efficacy, as well as virus inactivation and removal steps that have increased safety from blood-borne infections. Current manufacturing procedures, IVIG production trends, and recent clinical trial results are also reviewed.
自1952年首次使用以来，人免疫球蛋白一直用于治疗遗传性抗体缺陷患者。本文总结了静脉注射免疫球蛋白（IVIG）在原发性免疫缺陷患者中的临床发展情况以及随着时间推移所引入的生产改进。生产改进包括降低不良事件发生率并提高临床疗效的纯化程序，以及提高血源感染安全性的病毒灭活和去除步骤。还回顾了当前的生产程序、IVIG生产趋势和近期临床试验结果。
