據(jù)2月27日《美國醫(yī)學(xué)協(xié)會期刊》（JAMA）上的一則研究顯示，應(yīng)用一類叫作紅血球生成-刺激劑（ESAs）的藥物來治療癌癥病人的貧血與靜脈血栓栓塞性疾?。丛谙轮铎o脈或肺部血管內(nèi)血塊生成）及死亡風(fēng)險增加有關(guān),。
ESAs 中的erythropoietin 和 darbepoetin被廣泛用來治療癌癥病患的貧血癥,。根據(jù)文章中的背景資訊,，有研究指出，使用這些藥物可能會增加深靜脈血栓栓塞性疾?。╒TE）的風(fēng)險,，但是,，這些藥物是否與死亡風(fēng)險的增加有關(guān)則不清楚。
美國西北大學(xué)醫(yī)學(xué)院的Charles L. Bennett及其同僚對第三期臨床試驗進(jìn)行了審查,，以調(diào)查癌癥病患使用ESA來治療貧血的VTE發(fā)生率及相關(guān)的死亡情況。
研究人員找到了51項臨床試驗的1萬3611名病患并對其存活情況進(jìn)行了調(diào)查,。對這些數(shù)據(jù)的分析顯示,，癌癥病患在用ESA治療后,，其死亡風(fēng)險比對照（即安慰劑）組的受試者顯著要高。
研究人員對38項臨床試驗中的8172名病患的靜脈血栓栓塞性疾病進(jìn)行了評估,。研究人員發(fā)現(xiàn),，在接受ESA治療的病人中,，其發(fā)生VTE的風(fēng)險（在4610位接受ESA治療的病患中發(fā)生了334次VTE事件 vs. 在3562名對照組病患中出現(xiàn)173次VTE事件）會顯著增加（57%）。
生物谷推薦原始出處:
（JAMA）,，2008;299(8):914-924,，Charles L. Bennett,，Michael Henke
Venous Thromboembolism and Mortality Associated With Recombinant Erythropoietin and Darbepoetin Administration for the Treatment of Cancer-Associated Anemia
Charles L. Bennett, MD, PhD; Samuel M. Silver, MD, PhD; Benjamin Djulbegovic, MD, PhD; Athena T. Samaras, BA; C. Anthony Blau, MD; Kara J. Gleason, BS; Sara E. Barnato, MD; Kathleen M. Elverman; D. Mark Courtney, MD; June M. McKoy, MD, MPH, JD; Beatrice J. Edwards, MD; Cara C. Tigue, BA; Dennis W. Raisch, PhD; Paul R. Yarnold, PhD; David A. Dorr, MD, MS; Timothy M. Kuzel, MD; Martin S. Tallman, MD; Steven M. Trifilio, RPh; Dennis P. West, PhD; Stephen Y. Lai, MD, PhD; Michael Henke, MD
Context The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin are licensed to treat chemotherapy-associated anemia in patients with nonmyeloid malignancies. Although systematic overviews of trials have identified venous thromboembolism (VTE) risks, none have identified mortality risks with ESAs.
Objective To evaluate VTE and mortality rates associated with ESA administration for the treatment of anemia among patients with cancer.
Data Sources A published overview from the Cochrane Collaboration (search dates: January 1, 1985-April 1, 2005) and MEDLINE and EMBASE databases (key words: clinical trial, erythropoietin, darbepoetin, and oncology), the public Web site of the US Food and Drug Administration and ESA manufacturers, and safety advisories (search dates: April 1, 2005-January 17, 2008).
Study Selection Phase 3 trials comparing ESAs with placebo or standard of care for the treatment of anemia among patients with cancer.
Data Extraction Mortality rates, VTE rates, and 95% confidence intervals (CIs) were extracted by 3 reviewers from 51 clinical trials with 13 611 patients that included survival information and 38 clinical trials with 8172 patients that included information on VTE.
Data Synthesis Patients with cancer who received ESAs had increased VTE risks (334 VTE events among 4610 patients treated with ESA vs 173 VTE events among 3562 control patients; 7.5% vs 4.9%; relative risk, 1.57; 95% CI, 1.31-1.87) and increased mortality risks (hazard ratio, 1.10; 95% CI, 1.01-1.20).
Conclusions Erythropoiesis-stimulating agent administration to patients with cancer is associated with increased risks of VTE and mortality. Our findings, in conjunction with basic science studies on erythropoietin and erythropoietin receptors in solid cancers, raise concern about the safety of ESA administration to patients with cancer.
