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【商业翻译】FDA Approves Drug For Common Bleeding Disor
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Humate-P (Antihemophilic Factor/von Willebrand Factor Complex), a drug designed for the treatment of excessive bleeding during and after surgery, has been approved by the FDA. Patients with mild, moderate or severe vWD (von Willebrand disease), an inherited disease which affects about 1% of people, are susceptible to excessive bleeding during and after surgery.
This is the second drug to be approved for patients with vWD, who experienced excessive bleeding during or after surgery, and for whom desmopressin does not work. Three months ago the FDA approved Aphanate. Unlike Aphanate, however, Humate-P is designed specifically for people with severe vWD who are undergo surgery.
Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA, said "This is an important advance for patients with vWD, including those who are severely affected by the disorder. Humate-P provides a preventive therapy that can make needed surgery not only possible, but also safer."
Humate-P had been approved for treating hemophilia A adults - to prevent bleeding.
The much needed clotting protein from human plasma from carefully screened US donors is purified - this is Humate-P. Measures are taken to lessen the risk of transfusion-transmitted diseases. Although chances of transmitting bloodborne diseases to the patient are tiny, they do exist.
The FDA examined reports on 35 vWD patients who underwent 28 major and 7 minor surgical procedures - they were all treated with Humate-P. Humate-P was found to be either excellent or good in 91% of the patients who avoided severe hemorrhage. 30% of patients did experience hemorrhaging, however, only 9% of those were classed as severe. 24% of patients experienced nausea and 17% experienced pain as a side-effect.
Humate-P is made by CSL Behring GmbH, Marburg, Germany. 本人认领此文. 如在24小时内未能提交译文, 其他战友自由认领. Humate-P (Antihemophilic Factor/von Willebrand Factor Complex), a drug designed for the treatment of excessive bleeding during and after surgery, has been approved by the FDA. Patients with mild, moderate or severe vWD (von Willebrand disease), an inherited disease which affects about 1% of people, are susceptible to excessive bleeding during and after surgery.
FDA批准了精制灭菌冻干人抗血友病因子（抗血友病因子/冯维勒布兰德因子复合物）用于治疗手术中及手术后过量出血。vWD（冯维勒布兰德氏病）是一种遗传性疾病，有1%的人患有此病，轻、中度或重度患者在手术中以及手术后易发生大出血。
This is the second drug to be approved for patients with vWD, who experienced excessive bleeding during or after surgery, and for whom desmopressin does not work. Three months ago the FDA approved Aphanate. Unlike Aphanate, however, Humate-P is designed specifically for people with severe vWD who are undergo surgery.
这是FDA批准的第二个用于vWD患者的药物，这类患者在术中或术后常发生大出血，且去氨基精加压素无效。三个月前，FDA批准了Aphanate，与之不同的是，精制灭菌冻干人抗血友病因子专用于需要进行手术的vWD患者。
Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA, said "This is an important advance for patients with vWD, including those who are severely affected by the disorder. Humate-P provides a preventive therapy that can make needed surgery not only possible, but also safer."
FDA生物制品评价和研究中心主管Jesse Goodman博士称，对于vWD患者，包括那些深受其累的患者来说，这是一个重要进步。作为预防措施，精制灭菌冻干人抗血友病因子不仅使必要的手术成为可能，也使其更安全。
Humate-P had been approved for treating hemophilia A adults - to prevent bleeding.
精制灭菌冻干人抗血友病因子被批准用于治疗血友病A成人患者—预防出血
The much needed clotting protein from human plasma from carefully screened US donors is purified - this is Humate-P. Measures are taken to lessen the risk of transfusion-transmitted diseases. Although chances of transmitting bloodborne diseases to the patient are tiny, they do exist.
这种必须的凝血蛋白，即精制灭菌冻干人抗血友病因子由美国仔细筛选的供体血浆中精制而来，并经处理以降低输血传播疾病的风险。尽管感染血液传播性疾病的机率很低，但这种可能性还是存在。
The FDA examined reports on 35 vWD patients who underwent 28 major and 7 minor surgical procedures - they were all treated with Humate-P. Humate-P was found to be either excellent or good in 91% of the patients who avoided severe hemorrhage. 30% of patients did experience hemorrhaging, however, only 9% of those were classed as severe. 24% of patients experienced nausea and 17% experienced pain as a side-effect.
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作者:admin@医学,生命科学 2011-03-15 17:11
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