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美国和欧洲重新评估癌症治疗用 ESA。

Reassessments of ESAs for cancer treatment in the US and Europe.

机构信息

VA Center for the Management of Complex Chronic Care, VA Chicago Healthcare System, Chicago, Illinois, USA.

出版信息

Oncology (Williston Park). 2010 Mar;24(3):260-8.

PMID:20394138
Abstract

Anemia is a widely prevalent complication among cancer patients. At the time of diagnosis, 30% to 40% of patients with non-Hodgkin lymphoma or Hodgkin lymphoma and up to 70% of patients with multiple myeloma are anemic; rates are higher among persons with myelodysplastic syndromes. Among patients with solid cancers or lymphomas, up to half develop anemia following chemotherapy. For almost 2 decades, erythropoiesis-stimulating agents (ESAs) were the primary treatment for cancer-related anemia. However, reassessments of benefits and risks of ESAs for cancer-associated anemia have occurred internationally. We reviewed guidelines and notifications from regulatory agencies and manufacturers, reimbursement policies, and utilization for ESAs in the cancer and chronic kidney disease settings within the United States, Europe, and Canada. In 2008 the US Food and Drug Administration (FDA) restricted ESAs from cancer patients seeking cure. Reimbursement is limited to hemoglobin levels < 10 g/dL. In the United States, ESA usage increased 340% between 2001 and 2006, and decreased 60% since 2007. The European Medicines Agency (EMEA) recommended that ESA benefits do not outweigh risks. In Europe between 2001 and 2006, ESA use increased 51%; since 2006, use decreased by 10%. In 2009, Canadian manufacturers recommended usage based on patient preferences. In Canada in 2007, approximately 20% of anemic cancer patients received ESAs, a 20% increase since 2004. In contrast to Europe, where ESA use has increased over time, reassessments of ESA-associated safety concerns in the United States have resulted in marked decrements in ESA use among cancer patients.

摘要

贫血是癌症患者中普遍存在的并发症。在诊断时,30%至 40%的非霍奇金淋巴瘤或霍奇金淋巴瘤患者以及多达 70%的多发性骨髓瘤患者存在贫血;骨髓增生异常综合征患者的贫血发生率更高。在患有实体瘤或淋巴瘤的患者中,多达一半的患者在化疗后会发生贫血。近 20 年来,促红细胞生成素刺激剂(ESAs)一直是治疗癌症相关贫血的主要方法。然而,国际上对 ESAs 治疗癌症相关性贫血的益处和风险进行了重新评估。我们对美国、欧洲和加拿大癌症和慢性肾脏病环境中 ESAs 的指南和监管机构及制造商通知、报销政策和使用情况进行了回顾。2008 年,美国食品和药物管理局(FDA)限制了寻求治愈的癌症患者使用 ESAs。报销仅限于血红蛋白水平<10g/dL。在美国,2001 年至 2006 年 ESA 使用率增加了 340%,自 2007 年以来下降了 60%。欧洲药品管理局(EMEA)建议 ESA 的益处并不超过风险。在欧洲,2001 年至 2006 年期间,ESA 的使用增加了 51%;自 2006 年以来,使用量减少了 10%。2009 年,加拿大制造商建议根据患者的偏好使用 ESA。2007 年加拿大约有 20%的贫血癌症患者使用 ESA,比 2004 年增加了 20%。与欧洲不同的是,ESA 的使用随着时间的推移而增加,而在美国对 ESA 相关安全性问题的重新评估导致癌症患者中 ESA 的使用明显减少。

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2
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引用本文的文献

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Medical costs and associated racial/ethnic and sex disparities in erythropoiesis-stimulating agent use: anemia management under the Medicare reimbursement policy.医疗费用及促红细胞生成素治疗的种族/民族和性别差异:医疗保险报销政策下的贫血管理。
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Erythropoiesis-Stimulating Agents in the Management of Anemia in Chronic Kidney Disease or Cancer: A Historical Perspective.促红细胞生成素在慢性肾脏病或癌症贫血管理中的应用:历史视角
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