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海泽麦德皮下免疫球蛋白替代疗法,首款 20% SCIG 制剂:实用方法。

Subcutaneous immunoglobulin replacement therapy with Hizentra, the first 20% SCIG preparation: a practical approach.

机构信息

Department of Medical Biochemistry and Immunology, University Hospital of Wales, Cardiff, UK.

出版信息

Adv Ther. 2011 Jul;28(7):521-33. doi: 10.1007/s12325-011-0036-y. Epub 2011 Jun 14.

Abstract

To reduce the risk of infection in adults and children with primary immunodeficiencies, replacement therapy with IgG, which can be administered to patients intravenously or subcutaneously, is required. Although intravenous administration of IgG (IVIG) has been the therapy of choice in the US and widely used in Europe for many years, subcutaneous administration of IgG (SCIG) has recently gained considerable acceptance among patients and doctors. SCIG therapy achieves high and stable serum IgG levels, is well tolerated, and can be self-administered. Hizentra (IgPro20; CSL Behring, Berne, Switzerland) is the first, ready-to-use 20% liquid preparation of human IgG specifically formulated for subcutaneous infusions. The high concentration (20%) might allow shorter infusion times due to smaller infusion volumes, with potential improvement in the convenience of SCIG therapy. Hizentra is well tolerated and has been shown to protect adult and pediatric primary immunodeficiency patients against serious bacterial infections. In addition, it is easy to handle and can be stored at a temperature up to 25°C. In summary, Hizentra is an advance in the field of immunoglobulin replacement therapy, which might offer benefits for home therapy patients.

摘要

为降低原发性免疫缺陷症患者(包括成人和儿童)的感染风险,需要进行 IgG 替代疗法,可通过静脉注射或皮下注射给药。虽然静脉注射免疫球蛋白(IVIG)已成为美国的首选疗法,且多年来在欧洲被广泛应用,但皮下注射免疫球蛋白(SCIG)最近在患者和医生中得到了广泛认可。SCIG 疗法可实现高且稳定的血清 IgG 水平,具有良好的耐受性,并可由患者自行给药。欣可丽生(IgPro20;CSL Behring,伯尔尼,瑞士)是首款 20%人免疫球蛋白即用型预充式液体制剂,专为皮下输注配制。高浓度(20%)可能允许通过使用较小的输注体积来缩短输注时间,从而潜在地提高 SCIG 疗法的便利性。欣可丽生具有良好的耐受性,已被证明可预防成人和儿科原发性免疫缺陷症患者发生严重细菌感染。此外,它易于操作,且可在高达 25°C 的温度下储存。总之,欣可丽生是免疫球蛋白替代疗法领域的一项进步,可能为居家治疗患者带来益处。

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