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【drug-news】FDA警告：促红细胞生成素α可增加急性
The warning was based on preliminary data from a German functional-ability study that employed doses of epoetin alfa (marketed as Eprex) that were considerably higher than those recommended by the FDA for the treatment of anemia, according to an alert issued by MedWatch, the FDA's safety information and adverse-event reporting program.
For the study, 522 adult patients with MRI-confirmed ischemic stroke were randomized to receive either placebo or 40,000 units of epoetin alfa administered intravenously for 3 days. Recombinant tissue-type plasminogen activator (r-TPA) was also used when clinically indicated.
Although investigators sought to demonstrate therapeutic improvements in functional ability, results over the first 90 days showed higher mortality in patients taking epoetin alfa than in those taking placebo (16% vs 9%), with roughly 50% of deaths occurring during the first week of treatment. Approximately 4% of epoetin-treated patients died from intracranial hemorrhage, compared with 1% of those receiving placebo.
According to an early communication, further information concerning this matter should be available from the FDA within the next several weeks. In the interim, close monitoring of adverse events in other clinical trials is advised to ensure that the potential benefits of therapy outweigh the risks to enrollees.
Epoetin alfa is an erythropoiesis-stimulating agent (ESA) approved by the FDA for the treatment of anemia in chronic renal failure patients, zidovudine-treated HIV-infected patients, cancer patients on chemotherapy; and to reduce the need for allogenic blood transfusions in surgical patients.
Adverse events related to use of epoetin alfa should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 September 26, 2008 ; Use of high-dose epoetin alfa (Epogen, Amgen, Inc; Procrit, Ortho Biotech) in acute ischemic stroke patients has been linked to an increased risk for death, the US Food and Drug Administration (FDA) warned healthcare professionals today.
2008年9月26日;使用高剂量的红细胞生成素阿尔法（汀，安进公司; Procrit ，奥托生物技术）在急性缺血性中风患者已链接到的风险增加死亡，美国食品和药物管理局（ FDA ）警告医疗保健今天的专业人员。
The warning was based on preliminary data from a German functional-ability study that employed doses of epoetin alfa (marketed as Eprex) that were considerably higher than those recommended by the FDA for the treatment of anemia, according to an alert issued by MedWatch, the FDA's safety information and adverse-event reporting program.
这项警告是基于初步数据从德国功能性研究，采用剂量的红细胞生成素阿尔法（销售为Eprex ）被大大高于所建议的美国用于治疗贫血，根据警报发出的MedWatch的FDA的安全信息和不良事件的报告程序。
For the study, 522 adult patients with MRI-confirmed ischemic stroke were randomized to receive either placebo or 40,000 units of epoetin alfa administered intravenously for 3 days. Recombinant tissue-type plasminogen activator (r-TPA) was also used when clinically indicated.
在这项研究中， 522例成人MRI检查证实缺血性中风被随机分配接受安慰剂或40000单位的红细胞生成素静脉注射干扰素为3天。重组组织型纤溶酶原激活（注册商标，对苯二甲酸）也用于临床时表示。Although investigators sought to demonstrate therapeutic improvements in functional ability, results over the first 90 days showed higher mortality in patients taking epoetin alfa than in those taking placebo (16% vs 9%), with roughly 50% of deaths occurring during the first week of treatment. Approximately 4% of epoetin-treated patients died from intracranial hemorrhage, compared with 1% of those receiving placebo.
虽然调查表明寻求治疗的改进功能的能力，结果在头90天显示更高的死亡率在病人服用红细胞生成素阿尔法比那些服用安慰剂（ 16 ％比9 ％ ） ，大约有50 ％的死亡发生的第一周期间治疗。约有4 ％的红细胞生成素治疗的患者死于颅内出血，而1 ％的人接受安慰剂。According to an early communication, further information concerning this matter should be available from the FDA within the next several weeks. In the interim, close monitoring of adverse events in other clinical trials is advised to ensure that the potential benefits of therapy outweigh the risks to enrollees.
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作者:admin@医学,生命科学 2011-02-16 05:11
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