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首页> 外文期刊>Clinical drug investigation >Correlations Among Subcutaneous Immunoglobulin Dosage, Immunoglobulin G Serum Pre-infusional Levels and Body Mass Index in Primary Antibody Deficiency Patients: A Pooled Analysis from the SHIFT/IBIS Studies
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Correlations Among Subcutaneous Immunoglobulin Dosage, Immunoglobulin G Serum Pre-infusional Levels and Body Mass Index in Primary Antibody Deficiency Patients: A Pooled Analysis from the SHIFT/IBIS Studies

机译：皮下免疫球蛋白剂量的相关性，免疫球蛋白G血清前动入水平和体重指数在原代抗体缺乏症患者中的综合性分析：来自转移/宜必思研究的汇总分析

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Background and Objective In recent years, two Italian non-interventional studies evaluated subcutaneous immunoglobulin (SCIG) treatment in patients affected by primary antibody deficiency (PAD). The SHIFT study considered patients who were treated with intravenous immunoglobulin (IVIG) or SCIG 16% (Vivaglobin (R)) and then replaced this therapy with weekly treatments of SCIG 20% (Hizentra (R)). The IBIS study evaluated patients previously taking a weekly SCIG 20% regimen, who instead began therapy with biweekly SCIG 20% to assess the correlation between the dose of immunoglobulin G (IgG) administered and the body mass index (BMI) of patients, determine if there is a need for dosage adjustments on a BMI basis, and identify the predictors of serum IgG trough levels in our cohort. Methods In this study, we analyzed the pooled data of 109 PAD patients enrolled in the SHIFT and IBIS studies. Only prospective phases were considered. Results The total monthly SCIG dose showed comparable trends among weight categories, except for underweight patients. When we considered the monthly SCIG dosage per kilogram of body weight, a significant decreasing trend according to BMI was observed. Data on IgG trough levels were available for 88 patients, with a mean IgG serum level of 8.4 +/- 1.6 g/L. A stepwise regression model revealed that the mean monthly dosage of SCIG 20% (p = 0.04248) and the mean monthly dosage of IgG per kilogram of body weight were the only two independent predictors associated with IgG trough levels. No association was found between BMI and IgG trough levels. Conclusions These findings support the concept that the cumulative monthly dose of SCIG and the dose of SCIG per kilogram of body weight affect IgG trough levels in PAD patients, irrespective of BMI.
机译：近年来的背景和目标，两种意大利非介入研究评估了受原发性抗体缺乏（垫）影响的患者的皮下免疫球蛋白（SCIG）治疗。换档研究认为，用静脉内免疫球蛋白（IVIG）或SCIG 16％（Vivaglobin）治疗的患者，然后用每周治疗突发20％（Hizentra（R））替换该疗法。 IBIS研究评估了以前服用每周突发的患者20％方案的患者，而是开始治疗双周突发20％以评估施用的免疫球蛋白G（IgG）的剂量与患者体重指数（BMI）之间的相关性，确定是否需要对BMI进行剂量调整，并识别我们的队列中血清IgG槽水平的预测因子。方法在本研究中，我们分析了109名患者入学患者和IBIS研究的汇总数据。只考虑了前瞻性阶段。结果每月突发剂量均显示重量类别的可比趋势，除了体重减轻患者。当我们考虑每千克体重每千克体重时，观察到根据BMI的显着降低的趋势。 IgG槽水平的数据可用于88名患者，平均IgG血清水平为8.4 +/- 1.6 g / L.逐步回归模型表明，突出的平均每月剂量20％（P = 0.04248）和每千克体重的IgG的平均每月剂量是与IgG槽水平相关的两个独立预测因子。 BMI和IgG槽水平之间没有发现任何关联。结论这些调查结果支持概念：无论BMI如何，每公斤体重累积每千克体重的累积量剂量和突出剂量的概念会影响垫子患者的IgG槽水平。

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  • 来源
    《Clinical drug investigation》 |2020年第3期|共8页
  • 作者

    Pecoraro Antonio; Ricci Silvia; Vultaggio Alessandra; Boggia Giorgio Maria; Spadaro Giuseppe;

  • 作者单位

    Univ Naples Feder II Ctr Basic Dept Translat Med Sciences Clin Immunol Res CISI Via S. Pansini 5;

    Univ Florence Meyer Children's Hosp Dept Hlth Sciences Div Pediat Immunol Viale G. Pieraccini;

    Dept BioMed Immunoallergol Unit Azienda Ospedaliero Universitaria Careggi Largo Brambilla 3 I;

    Med Affairs CSL Behring . Ghisallo 20 I-20151 Milan Italy;

    Univ Naples Feder II Ctr Basic Dept Translat Med Sciences Clin Immunol Res CISI Via S. Pansini 5;

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  • 正文语种 eng
  • 中图分类 药学;
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