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Abstract：
BACKGROUND: Tumor lysis syndrome is an oncologic emergency characterized by hyperuricemia. Previous studies have demonstrated that a fixed-dose strategy of rasburicase is as effective as the FDA approved weight-based dose. Albany Medical Center employs rasburicase 1.5 mg in patients with a uric acid (UA) between 8 and 12 mg/dL and 3 mg for UA above12 mg/dL.We aimed to evaluate the UA lowering effectiveness and provider adherence to the institutional protocol, as well as the cost-efficiency of this dosing strategy.
METHODS: This is a single center, retrospective, cohort study. The electronic medical record was used to identify patients receiving rasburicase and to collect baseline demographic and laboratory data. The fixed-dose strategies of rasburicase 1.5 mg and 3 mg were compared in their degree of UA reduction and clinical outcomes. Cost-savings of fixed-dosing was compared to the FDA-approved weight-based dose.
RESULTS: Mean UA reduction in the 1.5 mg group (n = 49) from baseline to 24 hours was 2.88 ± 0.88 mg/dL (p < 0.0001) and 4.83 ± 1.39 mg/dL (p < 0.0001) in the 3 mg group (n = 105). A subgroup analysis of patients who received per protocol initial doses of rasburicase showed a mean reduction in UA from baseline to 24 hours of 2.83 ± 0.62 mg/dL in the 1.5 mg group (n = 42) and 6.12 ± 1.87 mg/dL in the 3 mg group (n = 42). Using a low fixed-dose approach resulted in a cost-savings of $138,077.30 annually.
CONCLUSIONS: Low fixed-dose rasburicase was an effective treatment, with a dose of 1.5 mg being sufficient to reach a goal UA of less than 8 mg/dL for serum UA levels below 12 mg/dL, while a 3 mg dose is appropriate for levels above 12 mg/dL. Cost analysis indicates this strategy is more cost-efficient than the FDA-approved weight-based dose.
METHODS: This is a single center, retrospective, cohort study. The electronic medical record was used to identify patients receiving rasburicase and to collect baseline demographic and laboratory data. The fixed-dose strategies of rasburicase 1.5 mg and 3 mg were compared in their degree of UA reduction and clinical outcomes. Cost-savings of fixed-dosing was compared to the FDA-approved weight-based dose.
RESULTS: Mean UA reduction in the 1.5 mg group (n = 49) from baseline to 24 hours was 2.88 ± 0.88 mg/dL (p < 0.0001) and 4.83 ± 1.39 mg/dL (p < 0.0001) in the 3 mg group (n = 105). A subgroup analysis of patients who received per protocol initial doses of rasburicase showed a mean reduction in UA from baseline to 24 hours of 2.83 ± 0.62 mg/dL in the 1.5 mg group (n = 42) and 6.12 ± 1.87 mg/dL in the 3 mg group (n = 42). Using a low fixed-dose approach resulted in a cost-savings of $138,077.30 annually.
CONCLUSIONS: Low fixed-dose rasburicase was an effective treatment, with a dose of 1.5 mg being sufficient to reach a goal UA of less than 8 mg/dL for serum UA levels below 12 mg/dL, while a 3 mg dose is appropriate for levels above 12 mg/dL. Cost analysis indicates this strategy is more cost-efficient than the FDA-approved weight-based dose.
摘要：
背景：肿瘤溶解综合征是一种以高尿酸血症为特征的肿瘤急症。以前的研究表明，rasburicase的固定剂量策略与FDA批准的基于体重的剂量一样有效。奥尔巴尼医疗中心对尿酸（UA）在8至12mg/dL之间的患者使用rasburicase1.5mg，对UA在12mg/dL以上的患者使用3mg。我们旨在评估UA降低的有效性和提供商对机构协议的遵守情况，以及这种给药策略的成本效益。
方法：这是一个单一的中心，回顾性,队列研究。电子病历用于识别接受rasburicase的患者，并收集基线人口统计学和实验室数据。比较了rasburicase1.5mg和3mg的固定剂量策略的UA降低程度和临床结果。将固定给药的成本节省与FDA批准的基于体重的剂量进行比较。
结果：从基线到24小时，1.5mg组（n=49）的UA平均减少量为2.88±0.88mg/dL（p<0.0001），3mg组（n=105）的UA平均减少量为4.83±1.39mg/dL（p<0.0001）。根据方案初始剂量rasburicase的患者的亚组分析显示，从基线到24小时，在1.5mg组（n=42）和6.12±1.87mg/dL中，UA平均降低了2.83±0.62mg/dL在3mg组（n=42）。使用低固定剂量方法每年节省费用138,077.30美元。
结论：低固定剂量rasburicase是一种有效的治疗方法，对于低于12mg/dL的血清UA水平，1.5mg的剂量足以达到低于8mg/dL的目标UA，而3mg剂量适用于12mg/dL以上的水平。成本分析表明，该策略比FDA批准的基于体重的剂量更具成本效益。
方法：这是一个单一的中心，回顾性,队列研究。电子病历用于识别接受rasburicase的患者，并收集基线人口统计学和实验室数据。比较了rasburicase1.5mg和3mg的固定剂量策略的UA降低程度和临床结果。将固定给药的成本节省与FDA批准的基于体重的剂量进行比较。
结果：从基线到24小时，1.5mg组（n=49）的UA平均减少量为2.88±0.88mg/dL（p<0.0001），3mg组（n=105）的UA平均减少量为4.83±1.39mg/dL（p<0.0001）。根据方案初始剂量rasburicase的患者的亚组分析显示，从基线到24小时，在1.5mg组（n=42）和6.12±1.87mg/dL中，UA平均降低了2.83±0.62mg/dL在3mg组（n=42）。使用低固定剂量方法每年节省费用138,077.30美元。
结论：低固定剂量rasburicase是一种有效的治疗方法，对于低于12mg/dL的血清UA水平，1.5mg的剂量足以达到低于8mg/dL的目标UA，而3mg剂量适用于12mg/dL以上的水平。成本分析表明，该策略比FDA批准的基于体重的剂量更具成本效益。
