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接受皮下免疫球蛋白治疗的原发性免疫缺陷儿童的安全性、有效性及治疗满意度

Safety, efficiency, and treatment satisfaction in children with primary immunodeficiency receiving subcutaneous immunoglobulin treatment.

作者信息

Eltan Sevgi Bilgic, Keskin Ozlem, Deveci Mehmet Fatih

机构信息

Division of Pediatric Allergy and Immunology, Department of Pediatrics, Gaziantep University Faculty of Medicine, Gaziantep, Turkiye.

Department of Pediatrics, Gaziantep University Faculty of Medicine, Gaziantep, Turkiye.

出版信息

North Clin Istanb. 2022 Jul 20;9(3):228-234. doi: 10.14744/nci.2020.16870. eCollection 2022.

Abstract

OBJECTIVE

Patients with Inborn Errors of Immunity, also known as Primary Immunodeficiency (PID), are prone to recurrent bacterial infections and these patients often require lifelong IgG replacement therapy. The aim of this presentation is to evaluate the efficacy, safety, and patient satisfaction in PID patients receiving subcutaneous immunoglobulin (SCIG) treatment and to share our expe-riences.

METHODS

Twenty-one patients who were followed up with the diagnosis of PID by our Pediatric Allergy and Immunology Clinic and received regular intravenous immunoglobulin therapy (IVIG) befo-re starting SCIG treatment were included in the study.

RESULTS

A total of 21 patients were included in the study. 10 of the patients (47.6%) were female, 11 (52.4%) were male, and the mean age was 8.8±4.42 years. Five of the patients were Syrian patients living in the refugee camp. Threshold IgG levels of the patients were evaluated every 3 months. IgG levels were significantly higher than baseline IVIG levels at weeks 3, 6, and 12 of SCIG treatment, respectively. There was no significant difference between 3, 6 and 12 months of SCIG treatment. A statistically significant decrease was observed in the frequency of infections in patients who received SCIG treatment (p=0.003). During SCIG treatment, the total infection rate was 4.1/person/year. According to the TSQM-9 satisfaction questionnaire, the annual hospitalization rate was 0.9/patient/year for IVIG and 0.4/patient/year for SCIG (p>0.005), and 61.9% of patients were moderately satisfied, 14.2%. 19% were very satisfied and 4.7% were not satisfied with the treatment. When the satisfaction criteria were evaluated, it was observed that the patients mostly (71%) were satisfied with the absence of vascular access prob-lems and the comfort of self-application at home.

CONCLUSION

SCIG therapy causes high serum IgG levels and a reduced frequency of infections and can be a safe, effective, and well-tolerated treatment alternative in patients with PID with high patient satisfaction.

摘要

目的

免疫缺陷病患者,也称为原发性免疫缺陷(PID),易反复发生细菌感染,这些患者通常需要终身接受免疫球蛋白G替代疗法。本报告的目的是评估接受皮下免疫球蛋白(SCIG)治疗的PID患者的疗效、安全性和患者满意度,并分享我们的经验。

方法

本研究纳入了21例由我院儿科过敏与免疫门诊诊断为PID并在开始SCIG治疗前接受常规静脉注射免疫球蛋白治疗(IVIG)的患者。

结果

本研究共纳入21例患者。其中10例(47.6%)为女性,11例(52.4%)为男性,平均年龄为8.8±4.42岁。5例患者为居住在难民营的叙利亚患者。每3个月评估患者的免疫球蛋白G阈值水平。在SCIG治疗的第3周、第6周和第12周,免疫球蛋白G水平分别显著高于基线IVIG水平。SCIG治疗3个月、6个月和12个月之间无显著差异。接受SCIG治疗的患者感染频率有统计学意义的下降(p=0.003)。在SCIG治疗期间,总感染率为4.1/人/年。根据TSQM-9满意度问卷,IVIG的年住院率为0.9/患者/年,SCIG为0.4/患者/年(p>0.005),61.9%的患者中度满意,14.2%。19%的患者非常满意,4.7%的患者对治疗不满意。在评估满意度标准时,观察到患者大多(71%)对无血管通路问题和在家自我应用的舒适度感到满意。

结论

SCIG疗法可使血清免疫球蛋白G水平升高,感染频率降低,对于PID患者可能是一种安全、有效且耐受性良好的治疗选择,患者满意度高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9cfa/9464846/9afd49aa0f1e/NCI-9-228-g001.jpg

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