FDA：抗贫血药促进肿瘤生长、升高死亡率

hxq2007

FDA To Review Data That Find Anemia Drugs Increase Death Risk, Tumor Growth In Cancer Patients
FDA回顾信息：对癌症患者应用抗贫血药物会促进肿瘤生长、升高死亡率。
FDA on Thursday said it will review new data on Amgen and Johnson & Johnson's anemia drugs Aranesp, Epogen and Procrit that found the drugs can increase the risk of death and tumor growth in women with breast or cervical cancers who are taking the drugs to treat anemia caused by chemotherapy, the Wall Street Journal reports.
星期四FDA在回顾分析了Amgen 和Johnson 两药厂的抗贫血药物Aranesp, Epogen（红细胞生成素） 和 Procri（重组红细胞生成素α）最新数据后，他发现乳腺癌和宫颈癌病人应用这些药物治疗贫血（由于化疗而引起），其结果却是这些药物会促进肿瘤生长、升高死亡率。
FDA said it \"may take\" additional action based on two new studies of the drugs -- known as erythropoiesis-stimulating agents -- submitted to the agency last month by Amgen and J&J, according to the Journal. Amgen manufactures all three drugs, and Procrit is marketed by J&J unit Ortho Biotech.
FDA说，按照杂志的要求，Amgen 和Johnson 两药厂根据红细胞生成刺激素的最近的两个试验会采取额外的措施——上个月已经把有关信息呈交给代理机构。不过，Amgen药厂制造的三种药物和Procrit已经上市。
According to FDA, the two new studies \"provide further evidence of the risks of anemia drugs,\" including \"more rapid tumor growth or shortened survival\" in patients with breast and cervical cancers, as well as patients with certain other cancers (Corbett Dooren, Wall Street Journal, 1/4).
根据FDA，这两个新的研究提供了进一步的证据，表明乳腺癌、宫颈癌及其他癌症病人应用这类抗贫血药物会有高度的风险，包括促进肿瘤生长、缩短生存率。
The first study involved 733 women who received chemotherapy before undergoing surgery to treat breast cancer.
第一个研究中共有733乳腺癌患者，他们在手术前接受化疗。
Among the patients who received Aranesp to treat their anemia, 14% had died after three years, compared with 9.8% of those who did not receive Aranesp.在这些病人中，应用Aranesp治疗贫血（化疗引起）的病人三年死亡率14%，而不用Aranesp的病人三年死亡率9.8%。
In addition, tumors grew faster in the patients who received Aranesp, according to the study.而且那些应用Aranesp的病人体内的肿瘤生长加快。
In a separate study, conducted by the National Cancer Institute's Gynecologic Oncology Group, researchers analyzed records of advanced cervical cancer patients who received chemotherapy and radiation. 在另外一个研究中（由国家肿瘤研究所妇产科肿瘤小组统筹规划），研究者分析了接受化疗和放疗的高分化子宫颈癌患者的记录。
The patients received either Procrit or blood transfusions as necessary. After three years, 58% of the patients who received Procrit were still living, compared with 66% of the patients who did not receive the drug.
患者应用Procrit或者输血来治疗贫血。那些应用Procrit的人三年生存率是58%，而不用Procrit的人三年生存率是66%。
According to the Los Angeles Times, FDA last year added a black box warning to the drugs' labels after six studies in recent years found that they can lead to increased risk of heart attack, stroke, heart failure and cancer tumor growth.
最近几年的六个研究发现这些抗贫血药物会促进心脏病发作、中风、心衰及肿瘤生长，依照Los Angeles Times，FDA于去年在这类药物标签上加上了黑箱警告。
Medicare, following the addition of the black box warning, placed limits on its reimbursements for anemia drugs (Costello, Los Angeles Times, 1/4). FDA said it was not aware of the new data when it issued the black box warnings in November 2007.
随之而来的是，医疗保险对应用这类药物的肿瘤患者的赔偿也做了限制。FDA说2007年11月当他发布黑箱警告时，他没有意识到这类药物会升高死亡率。
An FDA panel of cancer experts is expected to consider the new data during a meeting in March, the AP/***Money.com reports (AP/***Money.com, 1/3).
希望在今年三月份的会议上肿瘤专家FDA小组能够把升高死亡率这一点考虑进去。