博士 / 中國醫藥大學 / 藥學系博士班 / 102 / Deferiprone and Deferasirox are oral iron chelators for thalassemia major in clinical treatment. In this study, the pharmacokinetic evaluation of deferasirox and deferiprone with monotherapy, combined or concurrent therapy for treatment of thalassemia was performed using LC/MS/MS method. For this open-label, randomized trial, fourteen Chinese thalassemia patients were recruited and randomly allocated to receive different treatment regimens. Four treatment regimens were included: (A) monotherapy with a single oral dose of deferasirox 30 mg/kg, (B) combined therapy with deferasirox and deferiprone (deferasirox 30 mg/kg for the first dose, deferirpone 40 mg/kg was followed after 7 hours, and deferirpone 40 mg/kg was followed after another 7 hours), (C) monotherapy with deferiprone 80 mg/kg/day, separated into two doses and administered every 7 hours and (D) concurrent therapy with deferasirox 30 mg/kg and deferiprone 80 mg/kg (administered within ten minutes). Descriptive statistics were used to evaluate the pharmacokinetic parameters, AUC0-t, AUC0-inf, Cmax, Tmax and T1/2. Our study had several novel findings. As for the pharmacokinetics of deferasirox, the pharmacokinetic parameters of treatment A and B were significantly higher than that of treatment D (except AUC0-inf and T1/2). As for deferiprone, the pharmacokinetic parameters of treatment B were very close to that of treatment C, but lower than that of treatment D. No adverse events were found in all of the patients during study duration. From the findings of this study, combined therapy with deferasirox and deferiprone (regimen B) at recommended dose didn’t increase adverse events and was well tolerated by all of the thalassemia patients. Combined therapy seems to be more efficient and safer than concurrent therapy, and has the potential to replace the combined therapy of deferoxamine injection and deferasirox (or deferiprone) tablet that is presently used.
| Identifer | oai:union.ndltd.org:TW/102CMCH5551006 |
| Date | January 2014 |
| Creators | Ta-Shu Song, 宋達樞 |
| Contributors | 侯曼貞 |
| Source Sets | National Digital Library of Theses and Dissertations in Taiwan |
| Language | zh-TW |
| Detected Language | English |
| Type | 學位論文 ; thesis |
| Format | 239 |
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