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评估单剂量固定剂量7.5毫克的拉布立酶治疗成年癌症患者高尿酸血症的效果。

Evaluation of a single fixed dose of rasburicase 7.5 mg for the treatment of hyperuricemia in adults with cancer.

作者信息

Reeves David J, Bestul Daniel J

机构信息

Department of Pharmaceutical Services, William Beaumont Hospital, Royal Oak, Michigan 48073, USA.

出版信息

Pharmacotherapy. 2008 Jun;28(6):685-90. doi: 10.1592/phco.28.6.685.

DOI:10.1592/phco.28.6.685
PMID:18503395
Abstract

STUDY OBJECTIVE

To determine the efficacy of a single 7.5-mg dose of rasburicase compared with single doses of 0.15 mg/kg for the prevention or treatment of hyperuricemia associated with tumor lysis syndrome.

DESIGN

Prospective, open-label study using a historical control group.

SETTING

Large, nonprofit community teaching hospital.

PATIENTS

Seventeen hospitalized patients with cancer and hyperuricemia or a risk for hyperuricemia in the prospective group, and 23 control subjects with cancer who received a weight-based dose of rasburicase.

INTERVENTION

Patients in the prospective group received a single 7.5-mg dose of rasburicase and were followed for a minimum of 96 hours. Control subjects received a single 0.15-mg/kg dose of rasburicase.

MEASUREMENTS AND MAIN RESULTS

Uric acid levels were measured in all patients at baseline, at 12 and 24 hours after dosing, and then daily. In all patients receiving 7.5 mg, uric acid levels returned to normal at 12 and 24 hours. Mean uric acid levels were similar between the 7.5-mg and 0.15-mg/kg groups at 12 hours (1.9 vs 0.99 mg/dl, p=0.12) and at 24 hours (1.34 vs 1.69 mg/dl, p=0.64). Mean reductions in uric acid levels in the 7.5-mg and 0.15-mg/kg groups were, respectively, 82% and 91% at 12 hours (p=0.04) and 87% and 79% at 24 hours (p=0.35). If 26 doses of rasburicase were administered every year, a 7.5-mg dose would save $41,000/year compared with a 0.15-mg/kg dose ($15,750/10 patients treated).

CONCLUSIONS

A single 7.5-mg intravenous dose of rasburicase appeared to have effects similar to those of a single 0.15-mg/kg intravenous dose for the treatment or prevention of hyperuricemia associated with tumor lysis syndrome. This low fixed dose also has the potential to reduce costs.

摘要

研究目的

确定单剂量7.5毫克的拉布立酶与单剂量0.15毫克/千克的拉布立酶相比,在预防或治疗与肿瘤溶解综合征相关的高尿酸血症方面的疗效。

设计

采用历史对照组的前瞻性开放标签研究。

地点

大型非营利性社区教学医院。

患者

前瞻性组中有17名住院癌症患者伴有高尿酸血症或有高尿酸血症风险,23名接受按体重给药的拉布立酶的癌症对照患者。

干预措施

前瞻性组患者接受单剂量7.5毫克的拉布立酶,并至少随访96小时。对照患者接受单剂量0.15毫克/千克的拉布立酶。

测量指标及主要结果

在基线、给药后12小时和24小时以及之后每天对所有患者测量尿酸水平。在所有接受7.5毫克剂量的患者中,尿酸水平在12小时和24小时恢复正常。7.5毫克组和0.15毫克/千克组在12小时时的平均尿酸水平相似(1.9对0.99毫克/分升,p = 0.12),在24小时时也相似(1.34对1.69毫克/分升,p = 0.64)。7.5毫克组和0.15毫克/千克组在12小时时尿酸水平的平均降低分别为82%和91%(p = 0.04),在24小时时分别为87%和79%(p = 0.35)。如果每年使用26剂拉布立酶,7.5毫克剂量与0.15毫克/千克剂量相比(每治疗10名患者花费15,750美元),每年可节省41,000美元。

结论

单剂量7.5毫克静脉注射拉布立酶在治疗或预防与肿瘤溶解综合征相关的高尿酸血症方面似乎具有与单剂量0.15毫克/千克静脉注射拉布立酶相似的效果。这种低固定剂量还有降低成本的潜力。

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