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Response to the Letter to the Editor Regarding "Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials".对致编辑的信的回复，信的主题为“在临床试验中评估皮下注射免疫球蛋白（SCIG）的局部不良反应”
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Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies.对于原发性抗体缺陷患者，从静脉注射或16%皮下替代疗法转换为20%皮下免疫球蛋白疗法。
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Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig®]) in the Treatment of Patients With Primary Immunodeficiencies.新型皮下免疫球蛋白 16.5%（奥坦诺®）治疗原发性免疫缺陷病患者的临床疗效、安全性和耐受性。
Front Immunol. 2019 Feb 4;10:40. doi: 10.3389/fimmu.2019.00040. eCollection 2019.
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Response to the Letter to the Editor Regarding "Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials".对致编辑的信的回复，信的主题为“在临床试验中评估皮下注射免疫球蛋白（SCIG）的局部不良反应”
J Clin Immunol. 2017 Nov;37(8):739-740. doi: 10.1007/s10875-017-0438-y. Epub 2017 Sep 5.

本文引用的文献

1
Efficacy, safety, tolerability and pharmacokinetics of a novel human immune globulin subcutaneous, 20%: a Phase 2/3 study in Europe in patients with primary immunodeficiencies.新型20%皮下注射用人免疫球蛋白的疗效、安全性、耐受性及药代动力学：在欧洲针对原发性免疫缺陷患者开展的2/3期研究
Clin Exp Immunol. 2017 Jan;187(1):146-159. doi: 10.1111/cei.12866. Epub 2016 Oct 18.
2
Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America.北美原发性免疫缺陷病患者使用新型20%皮下注射用人免疫球蛋白的疗效、安全性及药代动力学
J Clin Immunol. 2016 Oct;36(7):700-12. doi: 10.1007/s10875-016-0327-9. Epub 2016 Aug 31.
3
Association of skin necrosis with subcutaneous immunoglobulin therapy.皮肤坏死与皮下免疫球蛋白治疗的关联。
Ann Allergy Asthma Immunol. 2014 Aug;113(2):232-3. doi: 10.1016/j.anai.2014.05.025. Epub 2014 Jul 2.
4
Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease.欣可来®用于原发性免疫缺陷病治疗的长期疗效、安全性和耐受性。
Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26.
5
Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy.静脉或皮下替代治疗剂量等效转换后，Hizentra(®) 在原发性免疫缺陷患者中的疗效和安全性。
Clin Immunol. 2011 Oct;141(1):90-102. doi: 10.1016/j.clim.2011.06.002. Epub 2011 Jun 12.
6
Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency.新型 20%皮下免疫球蛋白制剂 IgPro20 治疗原发性免疫缺陷症患者的疗效和安全性。
J Clin Immunol. 2010 Sep;30(5):734-45. doi: 10.1007/s10875-010-9423-4. Epub 2010 May 8.

Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials.

作者信息

Ballow Mark, Wasserman Richard L, Jolles Stephen, Chapel Helen, Berger Mel, Misbah Siraj A

机构信息

Department of Pediatrics, Division of Allergy & Immunology, The Johns Hopkins All Children's Hospital, Children's Research Institute, University of South Florida, 140 7th Ave South, St Petersburg, FL, 33701, USA.

Medical City Children's Hospital, Dallas, TX, USA.

出版信息

J Clin Immunol. 2017 Aug;37(6):517-518. doi: 10.1007/s10875-017-0410-x. Epub 2017 Jul 10.

DOI:10.1007/s10875-017-0410-x
PMID:28695366
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5940704/
Abstract
摘要