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静脉注射用人免疫球蛋白(Privigen)治疗的慢性淋巴细胞白血病伴继发免疫缺陷患者血清 IgG 浓度与感染发生率的相关性。

Association between serum IgG concentrations and the incidence of infections in patients with chronic lymphocytic leukemia and secondary immunodeficiency under treatment with Privigen.

出版信息

Int J Clin Pharmacol Ther. 2024 Jun;62(6):241-249. doi: 10.5414/CP204473.

Abstract

OBJECTIVE

To investigate the association between serum immunoglobulin G (IgG) concentrations and the incidence of infections in patients with chronic lymphocytic leukemia (CLL) and secondary immunodeficiency receiving treatment with Privigen.

MATERIALS AND METHODS

Data was analyzed from a non-interventional study conducted in 31 centers in Germany and 1 in Austria. Adult CLL patients with hypogammaglobulinemia and recurrent infections were allowed to enter the study upon signing informed consent, if a prior decision for treatment with Privigen had been made. All infections requiring an antimicrobial treatment were subject to analysis. Patients were stratified according to their mean post-baseline serum IgG trough levels in a group with lower IgG trough levels (≤ 5.0 g/L), and a group with higher IgG trough levels (> 5.0 g/L).

RESULTS

Overall, 89 patients and 840 treatment cycles were analyzed. Up to 11 treatment cycles (average duration 29 days) were documented in each patient. In the group with higher IgG trough levels (> 5.0 g/L, N = 72), significantly fewer infections were observed than in the group with lower IgG trough levels (≤ 5.0 g/L, N = 17), including fewer severe and serious infections. The Privigen dosage was a major determinant of the post-baseline serum IgG levels. Overall tolerability of Privigen was assessed as very good or good in 91% of patients.

CONCLUSION

This analysis confirms the association of serum IgG trough levels with the incidence of infections and highlights the importance of careful monitoring of IgG levels during treatment of secondary immunodeficiencies in CLL patients.

摘要

目的

研究接受 Privigen 治疗的慢性淋巴细胞白血病(CLL)和继发性免疫缺陷患者的血清免疫球蛋白 G(IgG)浓度与感染发生率之间的关系。

材料和方法

对在德国 31 个中心和奥地利 1 个中心进行的非干预性研究的数据进行了分析。如果先前已决定使用 Privigen 进行治疗,则允许低丙种球蛋白血症和复发性感染的成年 CLL 患者在签署知情同意书后进入研究。所有需要进行抗菌治疗的感染均进行了分析。根据其平均基线后血清 IgG 谷底水平,患者分为两组:谷底 IgG 水平较低(≤5.0 g/L)组和谷底 IgG 水平较高(>5.0 g/L)组。

结果

总体而言,对 89 例患者和 840 个治疗周期进行了分析。每位患者的记录时间最长为 11 个治疗周期(平均持续时间 29 天)。在 IgG 谷底水平较高(>5.0 g/L,N=72)组中,观察到的感染明显少于 IgG 谷底水平较低(≤5.0 g/L,N=17)组,包括较少的严重和严重感染。Privigen 剂量是基线后血清 IgG 水平的主要决定因素。91%的患者总体上认为 Privigen 的耐受性非常好或好。

结论

这项分析证实了血清 IgG 谷底水平与感染发生率之间的关联,并强调了在 CLL 患者继发性免疫缺陷治疗过程中仔细监测 IgG 水平的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46d0/11112504/aebd0cb36ba9/intjclinpharmacol-62-241-01.jpg

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