缺血性中风病患之高剂量Epogen/Procrit与较高的死亡率有关


  September 26, 2008 -- 美国食品药物管理局(FDA)今天对健康照护专业人士指出,急性缺血性中风病患使用高剂量的epoetin alfa (商品名Epogen,Amgen公司;商品名Procrit,Ortho Biotech公司)与死亡风险增加有关。
  
  根据FDA的安全信息与不良反应通报计画MedWatch所发出的警讯,此项警讯是根据一篇德国功能-能力研究的初步资料,使用的epoetin alfa (商品名Eprex)剂量高于FDA建议用于贫血的剂量。
  
  该研究中,522名以MRI确认的缺血性中风病患,被随机分组接受安慰剂或者40,000单位的epoetin alfa,以静脉注射给予3天;临床必要时也会给予重组组织型纤溶酶原激活剂(r-TPA)。
  
  虽然研究者试图证明可以改善功能与能力,最初的90天结果显示,使用epoetin alfa的病患比使用安慰剂的病患有较高的死亡率(16% vs. 9%),约有50%的死亡发生在治疗后的第一周内;将近4%的epoetin治疗病患死于颅内出血,使用安慰剂之病患则只有1%。
  
  根据初步沟通,FDA将在未来几周内提供此问题的后续信息;这段期间,建议对临床试验进行其它不良反应监测,以确保这些研究对象的治疗利益大于风险。
  
  Epoetin alfa是一种红血球生成刺激剂(ESA),FDA核准用于治疗慢性肾衰竭病患之贫血、以zidovudine治疗的HIV病患、接受化疗的癌症病患;减少手术病患对于异体输血的需求。
  
  有关使用epoetin alfa的不良反应须向FDA的MedWatch通报计画报告,可以打电话1-800-FDA-1088、传真1-800-FDA-0178、上网 http://www.fda.gov/medwatch、或写信到5600 Fishers Lane, Rockville, MD 20852-9787。

High-Dose Epogen/Procrit in Ischemic Stroke Patients Linked to Higher Death Rate

By Yael Waknine
Medscape Medical News

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.

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.

    
相关报导
tPA中风试验的汇整分析强调迅速治疗的重要性
2010/5/27 下午 02:17:00
周末中风的病患比较可能会接受 tPA
2010/1/22 下午 02:11:00
AHA/ASA科学建议委员会建议在中风之后3至4.5小时使用tPA
2009/6/2 下午 03:40:00

上一页
   1   2   3   4  




回上一页