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首页> 外文期刊>Drug Design, Development and Therapy >Development of fludarabine formulations in the treatment of chronic lymphocytic leukemia
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Development of fludarabine formulations in the treatment of chronic lymphocytic leukemia

机译：氟达拉滨制剂在慢性淋巴细胞性白血病治疗中的开发

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Abstract: Fludarabine is an antineoplastic agent used in the treatment of hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and indolent B-cell lymphoma. Because of its immunosuppressive effects, fludarabine has been added to reduced intensity conditioning regimens. The oral formulation of fludarabine has become widely available. Pharmacokinetic studies have shown that an oral dose of 40 mg/m2/d would provide systemic drug exposure similar to the standard intravenous (IV) dose of 25 mg/m2/d. The oral dose can be taken once daily without any dietary restrictions. Dose adjustments are mandatory in patients with renal impairment to avoid increased toxicity. Several noncomparative trials in previously untreated and treated patients with CLL have shown that treatment with the oral formulation demonstrates similar efficacy compared to historical control groups treated with the IV formulation. The tolerability profile of oral fludarabine seems similar to that of the IV formulation. Myelosuppression and infectious complications are the most frequently reported adverse events. Gastrointestinal toxicity is more frequent with the oral formulation, but is usually of mild or moderate severity. Although oral fludarabine makes treatment more convenient, health care workers must be aware of the compliance behavior of each patient.
机译：摘要：氟达拉滨是一种抗肿瘤药，用于治疗血液系统恶性肿瘤，特别是慢性淋巴细胞性白血病（CLL）和惰性B细胞淋巴瘤。由于其免疫抑制作用，氟达拉滨已被添加到降低强度的调节方案中。氟达拉滨的口服制剂已被广泛使用。药代动力学研究表明，口服剂量为40 mg / m2 / d可使全身药物暴露与标准静脉内（IV）剂量25 mg / m2 / d相似。口服剂量可以每天服用一次，没有任何饮食限制。肾功能不全的患者必须调整剂量，以避免增加毒性。在先前未经治疗和接受过治疗的CLL患者中进行的几项非比较试验表明，与静脉注射制剂治疗的历史对照组相比，口服制剂治疗具有相似的疗效。口服氟达拉滨的耐受性似乎与静脉注射制剂相似。骨髓抑制和感染性并发症是最常报告的不良事件。口服制剂胃肠道毒性更常见，但严重程度通常为轻度或中度。尽管口服氟达拉滨使治疗更加方便，但医护人员必须意识到每个患者的依从行为。

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