Safety and efficacy of a long-acting liposomal formulation of plasma-derived factor VIII in haemophilia A patients

SpiraJ.; PlyushchO.; AndreevaT.; ZorenkoV.; ZozulyaN.; VelichkoiI.; ZalepukhinaO.E.; YatuvR.; BaruM.

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Safety and efficacy of a long-acting liposomal formulation of plasma-derived factor VIII in haemophilia A patients

机译：血浆衍生因子VIII长效脂质体制剂在A型血友病患者中的安全性和有效性

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Haemophilia A patients are treated by infusion of factor VIII (FVIII) concentrates, either prophylactically in order to avoid spontaneous haemorrhages or on demand to treat bleeds. Prophylactic treatment of severe haemophilia patients has laxis (3 weekly injections with 90 IU/kg per week) calculated for the subjects enrolled in this study (6055 +- 386 IU/week). All subjects tolerated PEGLip-pdFVIII well: No serious adverse events were recorded, no inhibitory antibodies were developed and no changes in haematological or clinical chemistry parameters were found. Two patients experienced mild complement activation-related pseudoallergy (CARPA) with the first injection.

机译：A型血友病患者可通过预防性输注VIII因子（FVIII）浓缩物来治疗，以避免自发性出血或根据需要治疗出血。对重度血友病患者的预防性治疗有失调（每周3次注射，每周90 IU / kg），该研究的受试者计算为（6055±386 IU /周）。所有受试者均耐受良好的PEGLip-pdFVIII：未记录到严重的不良事件，未产生抑制性抗体，未发现血液学或临床化学参数发生变化。两名患者在第一次注射时经历了轻度补体激活相关的假性变态反应（CARPA）。

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《British Journal of Haematology》 |2012年第1期|共4页
作者
SpiraJ.; PlyushchO.; AndreevaT.; ZorenkoV.; ZozulyaN.; VelichkoiI.; ZalepukhinaO.E.; YatuvR.; BaruM.;
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正文语种 eng
中图分类血液及淋巴系疾病;
关键词
Factor VIII; Haemophilia A; Long-acting; PEGylated liposomes; Prophylaxis;

机译：因子VIII;A型血友病;长效;聚乙二醇脂质体;预防;

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1. Safety and efficacy of a long-acting liposomal formulation of plasma-derived factor VIII in haemophilia A patients [J] . SpiraJ., PlyushchO., AndreevaT., British Journal of Haematology . 2012,第1期

机译：血浆衍生因子VIII长效脂质体制剂在A型血友病患者中的安全性和有效性
2. Interim data on long-term efficacy, safety and tolerability of a plasma-derived factor VIII concentrate in 109 patients with severe haemophilia A [J] . NemesL., PollmannH., BeckerT. Haemophilia: the official journal of the World Federation of Hemophilia . 2012,第4期

机译：血浆衍生的VIII因子浓缩物对109例严重A型血友病患者的长期疗效，安全性和耐受性的中期数据
3. A Phase II clinical trial of a mixture of plasma-derived factor VIIa and factor X (MC710) in haemophilia patients with inhibitors: Haemostatic efficacy, safety and pharmacokinetics/pharmacodynamics [J] . ShirahataA., FukutakeK., TakamatsuJ., Haemophilia: the official journal of the World Federation of Hemophilia . 2013,第6期

机译：血浆来源的VIIa因子和X因子（MC710）混合物在患有抑制剂的血友病患者的II期临床试验：止血功效，安全性和药代动力学/药效学
4. Inactiwatlon of Animal Factor VIII by human Factor VIII Inhibitors: Inwestigation of Plasma from Patients with Inhibitors in congenital Hemophilia I and from Patients with acquired Hemophilia A [C] . V. Aumann, G. Lutze (Jr.), G. Lutze (Sen.), Hemophilie-Symposion . 2003

机译：人为因子VIII抑制剂的动物因子VIII的乙酰丁酮：先天性血友病药中抑制剂患者的血浆中的预防
5. Combined deficiency of factors V and VIII by chance coinheritance of parahaemophilia and haemophilia A, but not by mutations of either LMAN1 or MCFD2 [D] . 鈴木幸子 2019

机译：副血友病和A血友病的偶然一致性导致因子V和VIII的联合缺乏，但不是LMAN1或MCFD2的突变
6. Long-term efficacy and safety of a pasteurized plasma-derived factor VIII concentrate (Beriate® P) in patients with haemophilia A [O] . Robert Klamroth, Saskia Gottstein, Marija Orlovic, -1

机译：巴氏灭菌血浆衍生的凝血因子VIII浓缩物（Beriate®P）在A型血友病患者中的长期疗效和安全性
7. Safety and efficacy of a long-acting liposomal formulation of plasma-derived factor VIII in haemophilia A patients [O] . Jack Spira, Olga Plyushch, Tatiana Andreeva, 2012

机译：血浆衍生因子VIII在血友病患者中的长效脂质体制率的安全性和有效性

Safety and efficacy of a long-acting liposomal formulation of plasma-derived factor VIII in haemophilia A patients

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