Control of Plasma Uric Acid in Adults at Risk for Tumor Lysis Syndrome: Efficacy and Safety of Rasburicase Alone and Rasburicase Followed by Allopurinol Compared With Allopurinol Alone-Results of a Multicenter Phase III Study

Control of Plasma Uric Acid in Adults at Risk for Tumor Lysis Syndrome: Efficacy and Safety of Rasburicase Alone and Rasburicase Followed by Allopurinol Compared With Allopurinol Alone-Results of a Multicenter Phase III Study
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DOI:
10.1200/jco.2009.26.8896
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发表时间:
2010-09-20
影响因子:
45.3
通讯作者:
Seiter, Karen
Seiter, Karen
中科院分区:
医学1区
文献类型:
--
作者:
Cortes, Jorge;Moore, Joseph O.;Seiter, Karen

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目的探讨Rasburicase对小儿血液病患者血浆尿酸的控制作用。这项成人研究评估了单独使用毛糙酶与口服别嘌呤醇联合使用毛糙酶和单独使用别嘌呤醇控制血浆尿酸的安全性和疗效。患者和方法有高尿酸血症和肿瘤溶解综合征(TLS)风险的成人血液恶性肿瘤患者随机分配到rasburicase组(静脉注射0.20 mg/kg/d,第1-5天)、rasburicase加别嘌呤醇组(rasburicase 0.20 mg/kg/d,第1- 3天,随后口服别嘌呤醇300 mg/d,第3 -5天)或别嘌呤醇组(第1-5天,口服300 mg/d)。主要疗效变量是血浆尿酸缓解率,定义为达到或维持血浆尿酸的患者百分比
Purpose Rasburicase is effective in controlling plasma uric acid in pediatric patients with hematologic malignancies. This study in adults evaluated safety of and compared efficacy of rasburicase alone with rasburicase followed by oral allopurinol and with allopurinol alone in controlling plasma uric acid.Patients and Methods Adults with hematologic malignancies at risk for hyperuricemia and tumor lysis syndrome (TLS) were randomly assigned to rasburicase (0.20 mg/kg/d intravenously days 1-5), rasburicase plus allopurinol (rasburicase 0.20 mg/kg/d days 1 to 3 followed by oral allopurinol 300 mg/d days 3 to 5), or allopurinol (300 mg/d orally days 1 to 5). Primary efficacy variable was plasma uric acid response rate defined as percentage of patients achieving or maintaining plasma uric acid