Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy, Baltimore, Maryland.
Children's Research Institute, Children's National Health System, Silver Spring, Maryland.
Pediatr Blood Cancer. 2018 Oct;65(10):e27236. doi: 10.1002/pbc.27236. Epub 2018 Jun 15.
The American Society of Clinical Oncology guidelines recommend rasburicase for the treatment of pediatric patients with hyperuricemia at risk of tumor lysis syndrome (TLS) using a weight-based dose of 0.1-0.2 mg/kg once daily for 1-7 days. However, there has been a trend in practice due to recent data showing benefit using a fixed-dose approach. The purpose of this study was to evaluate the efficacy and safety between fixed and weight-based dosing of rasburicase in a pediatric population.
This was a retrospective chart review of 48 patients from January 1, 2007 to August 31, 2016 at Children's National Health System. Patients less than 18 years old with a documented diagnosis of a malignancy and baseline uric acid level were included; patients less than 30 kg at the time of rasburicase administration were excluded.
The primary endpoint of this study was the treatment success of normalization of uric acid level (<5 mg/dl) within 24 hr of rasburicase administration. Eighty-three percent of patients had success with normalization of uric acid post rasburicase dose. Eighty-five percent of patients had success in the weight-based group compared to eighty-one percent in the fixed-dose group (P = 0.715). Mean percent reduction of uric acid at 24 hr was relatively similar between both groups (94% vs. 89%).
Our results suggest that a fixed-dose strategy of rasburicase is both safe and effective in reducing uric acid levels in the pediatric patient population. A fixed dose of rasburicase 6 mg is a cost-effective treatment option for TLS.
美国临床肿瘤学会指南建议使用基于体重的拉布立酶剂量（0.1-0.2mg/kg，每日一次，持续 1-7 天）治疗有肿瘤溶解综合征（TLS）风险的高尿酸血症儿科患者。然而，由于最近的数据显示固定剂量方案有益，因此在实践中出现了一种趋势。本研究的目的是评估在儿科人群中使用固定剂量和基于体重的拉布立酶剂量的疗效和安全性。
这是一项回顾性图表审查，纳入了 2007 年 1 月 1 日至 2016 年 8 月 31 日期间在儿童国家卫生系统的 48 名患者。纳入标准为有恶性肿瘤诊断和基线尿酸水平记录的小于 18 岁患者；排除拉布立酶给药时体重小于 30kg 的患者。
本研究的主要终点是在拉布立酶给药后 24 小时内尿酸水平正常化（<5mg/dl）的治疗成功率。83%的患者在拉布立酶给药后尿酸水平正常化成功。与固定剂量组的 85%相比，基于体重的组中有 81%的患者成功（P=0.715）。两组在 24 小时内尿酸降低的平均百分比相似（94%与 89%）。
我们的结果表明，在儿科患者人群中，拉布立酶的固定剂量策略既安全又有效，可以降低尿酸水平。拉布立酶 6mg 的固定剂量是 TLS 的一种具有成本效益的治疗选择。
