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Recombinant urate oxidase (Rasburicase) for the treatment of hyperuricemia in pediatric patients with hematologic malignancies: Results of a compassionate prospective multicenter study in Korea
Cited 22 time in
Web of Science
Cited 25 time in Scopus
- Authors
- Issue Date
- 2005-08-27
- Publisher
- Wiley-Blackwell
- Citation
- Pediatr Blood Cancer. 2006 Apr;46(4):439-45.
- Keywords
- Adolescent ; Child ; Child, Preschool ; Drug Administration Schedule ; Female ; Hematologic Neoplasms/*complications ; Humans ; Hyperuricemia/*complications/*drug therapy ; Infant ; Infant, Newborn ; Korea/epidemiology ; Male ; Prospective Studies ; Recombinant Proteins/administration & dosage/therapeutic use ; Renal Dialysis ; Treatment Outcome ; Urate Oxidase/administration & dosage/adverse effects/*therapeutic use ; Uric Acid/blood
- Abstract
- BACKGROUND: Hyperuricemia accompanying tumor lysis syndrome is a serious complication in neoplasia with rapid proliferation and destruction. To confirm the efficacy of recombinant urate oxidase (rasburicase) and its safety profile, a phase IV compassionate use prospective study was performed in Korean pediatric patients with hematologic malignancies. PROCEDURE: Rasburicase was administered at 0.2 mg/kg/day once daily for 3-5 days (twice daily allowed during the first 72 hr) by intravenous route for hyperuricemia (uric acid > 7.5 mg/dl). The study period was 5 weeks and consisted of a baseline assessment within 48 hr before the administration of rasburicase, 3-5 days of assessment during treatment and a follow-up assessment at 4 weeks after its final administration. RESULTS: The uric acid endpoint (< or =7.0 mg/dl) was reached in 97.3% (36/37) of the patients and uric acid levels were significantly reduced in all patients (P < 0.001). Drug related toxicities were mild and reversible without any grade 4 or serious adverse event associated with rasburicase. CONCLUSION: This study confirms that rasburicase is a safe and effective agent for the treatment of hyperuricemia associated with hematologic malignancies in pediatric patients.
- ISSN
- 1545-5009 (Print)
- Language
- English
- URI
- http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16123985
https://hdl.handle.net/10371/28902
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