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临床实践中接受免疫球蛋白治疗的恶性肿瘤和继发性免疫缺陷患者的管理:SIGNS研究的长期数据

Management of patients with malignancies and secondary immunodeficiencies treated with immunoglobulins in clinical practice: Long-term data of the SIGNS study.

作者信息

Reiser Marcel, Borte Michael, Huscher Dörte, Baumann Ulrich, Pittrow David, Sommer Claudia, Stangel Martin, Fasshauer Maria, Gold Ralf, Hensel Manfred

机构信息

PIOH - Praxis internistischer Onkologie und Hämatologie, Köln, Germany.

Paediatric Rheumatology, Immunology and Infectiology, Hospital St. Georg, Leipzig, Germany.

出版信息

Eur J Haematol. 2017 Aug;99(2):169-177. doi: 10.1111/ejh.12900. Epub 2017 Jun 21.

Abstract

OBJECTIVE

We aimed to describe the current management and outcomes of patients with secondary immunodeficiencies (SID) on intravenous (IV) or subcutaneous (SC) immunoglobulins (IG) as maintenance therapy to prevent infections.

METHODS

Non-interventional, prospective study (average follow-up 20.5 months).

RESULTS

Of the 307 SID patients (mean age 63.7±14.4 years, 52% males, in 31% IG newly initiated), 95.4% received IV IG (mean dosing interval 4.6 weeks, average dose 199 mg/kg per 4 weeks) and 4.6% were treated with SC IG (2.6 weeks, 343 mg/kg per 4 weeks). Median IG through level at first documentation was 5.8 g/L and did not differ between IV and SC treatment or between underlying malignancies. In 24.1% of patients, treatment was interrupted temporarily, over a mean of 11.6±6.3 months. In patients with newly initiated IG treatment the 82% overall infection rate prior to treatment dropped to 21% at 1 year.

CONCLUSIONS

Under clinical practice conditions, IG replacement therapy in SID patients was feasible, diminished infection rates and improved quality of life. Average IG doses were relatively low. Tolerability of IV IG treatment was excellent.

摘要

目的

我们旨在描述接受静脉注射(IV)或皮下注射(SC)免疫球蛋白(IG)作为维持治疗以预防感染的继发性免疫缺陷(SID)患者的当前管理情况和治疗结果。

方法

非干预性前瞻性研究(平均随访20.5个月)。

结果

307例SID患者(平均年龄63.7±14.4岁,52%为男性,31%为新开始使用IG)中,95.4%接受IV IG治疗(平均给药间隔4.6周,每4周平均剂量199mg/kg),4.6%接受SC IG治疗(2.6周,每4周343mg/kg)。首次记录时IG的中位谷浓度为5.8g/L,IV和SC治疗之间或潜在恶性肿瘤之间无差异。24.1%的患者治疗曾暂时中断,平均中断时间为11.6±6.3个月。在新开始IG治疗的患者中,治疗前82%的总体感染率在1年后降至21%。

结论

在临床实践条件下,SID患者的IG替代治疗是可行的,可降低感染率并改善生活质量。平均IG剂量相对较低。IV IG治疗的耐受性良好。

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