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原发性免疫缺陷病的 IgG 替代治疗选择:皮下 IgG 与静脉内 IgG 及选择最佳剂量。

Choices in IgG replacement therapy for primary immune deficiency diseases: subcutaneous IgG vs. intravenous IgG and selecting an optimal dose.

机构信息

Immunology Research and Development, CSL Behring LLC, King of Prussia, Pennsylvania, USA.

出版信息

Curr Opin Allergy Clin Immunol. 2011 Dec;11(6):532-8. doi: 10.1097/ACI.0b013e32834c22da.

Abstract

PURPOSE OF REVIEW

Subcutaneous IgG (SCIG) is becoming more popular, but there is still uncertainty about efficacy and optimal dosing. This review discusses recent pharmacokinetic studies and applications of SCIG therapy, and its efficacy in the context of emerging understanding of the relationship between dosing and efficacy of both intravenous IgG (IVIG) and SCIG replacement therapy for primary immunodeficiency diseases.

RECENT FINDINGS

Three preparations of IgG have been licensed in the US in the past year. Their bioavailabilities are 65-70% of that of IVIG. Pooled analyses show that the efficacy of SCIG in preventing infections is proportional to the steady-state levels achieved, and similar to that of IVIG. Pharmacokinetic studies allow estimation of doses that will yield desired serum levels with both IVIG and SCIG, and when switching from one route to another.

SUMMARY

Pooled analyses show that at equivalent total doses, weekly SCIG results in steady-state levels 10-20% higher than troughs on monthly IVIG. For most patients, the choice between routes should be based on individual preference, and the regimen should be individualized to achieve the desired outcomes.

摘要

目的综述

皮下免疫球蛋白(SCIG)正变得越来越流行,但在疗效和最佳剂量方面仍存在不确定性。本综述讨论了 SCIG 治疗的最新药代动力学研究和应用,以及在深入了解静脉注射免疫球蛋白(IVIG)和 SCIG 替代治疗原发性免疫缺陷病的剂量与疗效之间关系的背景下,SCIG 治疗的疗效。

最近的发现

过去一年,美国有三种 IgG 制剂获得批准。它们的生物利用度是 IVIG 的 65-70%。汇总分析表明,SCIG 预防感染的疗效与达到的稳态水平成正比,与 IVIG 相似。药代动力学研究允许估计 IVIG 和 SCIG 的剂量,以达到所需的血清水平,并在从一种途径转换到另一种途径时进行估计。

总结

汇总分析表明,在等效总剂量下,每周 SCIG 可使稳态水平比每月 IVIG 的谷值高 10-20%。对于大多数患者,应根据个人偏好选择治疗途径,并且应根据个体情况制定方案以达到预期的效果。

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