在原发性免疫缺陷疾病患者中使用皮下注射的免疫球蛋白制剂Hizentra的经验

A. Avedova, Y. Rodina, D. Yukhacheva, V. Burlakov, E. Deripapa, A. Shcherbina
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引用次数: 0

摘要

免疫球蛋白替代疗法是治疗抗体缺陷患者的金标准。我们的目的是研究皮下免疫球蛋白(SCIG)替代疗法对原发性免疫缺陷患者的疗效和安全性。这项研究得到了独立伦理委员会和Dmitry Rogachev国家儿童血液学、肿瘤学和免疫学医学研究中心学术委员会的批准。所有患者和/或其法定代理人均对该治疗给予知情同意。在我们的研究中,12名18岁以下患有各种形式原发性免疫缺陷的患者之前接受静脉注射免疫球蛋白,现在改为SCIG治疗,每周接受Hizentra输注。治疗方法:每周一次快速推注,剂量为0.1-0.15 g/kg。所有患者接受Hizentra治疗至少3个月。研究中没有患者出现严重感染。SCIG治疗3个月后血液中的免疫球蛋白G水平明显高于先前静脉注射免疫球蛋白治疗的水平。本品使用后没有出现严重的不良事件。我们的研究表明,Hizentra对于治疗各种形式的原发性免疫缺陷的儿童是有效和安全的。
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Experience with the use of Hizentra, an immunoglobulin preparation for subcutaneous administration, in patients with primary immunodeficiency diseases
   Immunoglobulin replacement therapy is the gold standard of treatment for patients with antibody deficiencies.   We aimed to investigate the efficacy and safety of replacement therapy with subcutaneous immunoglobulin (SCIG) Hizentra in patients with primary immunodeficiencies.   This study was approved by the Independent Ethics Committee and the Academic Council of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology. All patients and / or their legal representatives gave informed consent for this treatment. In our study, 12 patients under 18 years of age with various forms of primary immunodeficiencies who had previously received intravenous immunoglobulin were switched to SCIG treatment to receive weekly infusions of Hizentra. Therapy SCIG was administered weekly at a dose of 0.1–0.15 g/kg by rapid push infusion. All patients received Hizentra for at least 3 months. None of the patients included in the study developed severe infections. Immunoglobulin G levels in blood after 3 months of SCIG therapy were significantly higher compared to those achieved on previous intravenous immunoglobulin therapy. There were no severe adverse events associated with Hizentra administration. Our study demonstrated Hizentra to be effective and safe for the treatment of children with various forms of primary immunodeficiencies.
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来源期刊
Pediatric Hematology/Oncology and Immunopathology
Pediatric Hematology/Oncology and Immunopathology Medicine-Pediatrics, Perinatology and Child Health
CiteScore
0.40
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0.00%
发文量
49
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