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一种新型单克隆抗体纯化因子IX的临床经验:B型血友病患者的半衰期、回收率及安全性

Clinical experience of a new monoclonal antibody purified factor IX: half-life, recovery, and safety in patients with hemophilia B.

作者信息

Kim H C, McMillan C W, White G C, Bergman G E, Saidi P

机构信息

Department of Medicine, UMDNJ, Robert Wood Johnson Medical School, New Brunswick 08903.

出版信息

Semin Hematol. 1990 Apr;27(2 Suppl 2):30-5.

PMID:2094957
Abstract

Highly purified factor IX, produced by a monoclonal antibody immunoaffinity technique, contains a high concentration of factor IX with negligible amounts of other vitamin K-dependent coagulation factors. When infused in patients with hemophilia B, monoclonal factor IX concentrate yielded a mean half-life of 34.6 +/- 13.1 (+/- SD) hours and in vivo recovery of 0.67 +/- 0.14 U/dL rise per each U/kg of factor IX infused. Unlike prothrombin complex concentrate (PCC) infusion, monoclonal IX infusion was not associated with rises in factors II, VII, and X, but achieved in vivo recovery and half-life at least comparable to PCC. Long-term use of monoclonal IX as a home-care product provided excellent response in the control of bleeding episodes and was equivalent to previous patient experience with PCC. The results indicate that monoclonal IX concentrate raises factor IX levels effectively, while avoiding extraneous thrombogenic components.

摘要

通过单克隆抗体免疫亲和技术生产的高纯度凝血因子IX,含有高浓度的凝血因子IX,其他维生素K依赖的凝血因子含量可忽略不计。当给B型血友病患者输注时,单克隆凝血因子IX浓缩物的平均半衰期为34.6 +/- 13.1(+/-标准差)小时,每输注1 U/kg的凝血因子IX,体内回收率为每分升上升0.67 +/- 0.14 U。与输注凝血酶原复合物浓缩物(PCC)不同,输注单克隆IX与因子II、VII和X的升高无关,但体内回收率和半衰期至少与PCC相当。长期将单克隆IX作为家庭护理产品使用,在控制出血发作方面有出色的反应,并且与患者先前使用PCC的经验相当。结果表明,单克隆IX浓缩物可有效提高凝血因子IX水平,同时避免无关的血栓形成成分。

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Clinical experience of a new monoclonal antibody purified factor IX: half-life, recovery, and safety in patients with hemophilia B.一种新型单克隆抗体纯化因子IX的临床经验:B型血友病患者的半衰期、回收率及安全性
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引用本文的文献

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Secondary prophylaxis with factor IX concentrates: continuous infusion.使用凝血因子IX浓缩剂进行二级预防:持续输注。
Blood Transfus. 2008 Sep;6 Suppl 2(Suppl 2):s21-5. doi: 10.2450/2008.0033-08.
2
Pharmacokinetics of factor IX in patients with haemophilia B. Methodological aspects and physiological interpretation.
Eur J Clin Pharmacol. 1994;46(4):325-32. doi: 10.1007/BF00194400.