普瑞巴林在不同肾功能受试者体内的药代动力学研究。
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Randinitis EJ, Posvar EL, Alvey CW, Sedman AJ, Cook JA, Bockbrader HN
普瑞巴林在不同肾功能受试者体内的药代动力学研究。
临床药物学杂志，2003 03;43(3):277-83。
- PubMed ID
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12638396 (PubMed视图］
- 摘要
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本研究的目的是确定普瑞巴林在不同肾功能程度受试者中的单剂量药代动力学，确定普瑞巴林清除率与估计肌酐清除率(CLcr)之间的关系，并测量血液透析对普瑞巴林血浆水平的影响。结果形成肾功能下降患者推荐普瑞巴林给药方案的基础。入选38名受试者以确保广泛的肾功能(CLcr < 30 mL/min, n = 8;30-50, n = 5;50-80, n = 7;> 80, n = 6)。同时纳入12例需要血液透析的肾损害患者。在这项开放标签的平行组研究中，每名受试者接受50 mg普瑞巴林胶囊(两粒25 mg胶囊)。普瑞巴林浓度的测量采用以前验证过的液相色谱方法。普瑞巴林药代动力学参数采用已建立的非隔室方法进行评价。普瑞巴林在所有受试者中都被迅速吸收。 Total and renal pregabalin clearance were proportional (56% and 58%, respectively) to CLcr. As a result, area under the plasma concentration-time profile (AUC) and terminal elimination half-life (t1/2) values increased with decreasing renal function. Pregabalin dosage adjustment should be considered for patients with CLcr < 60 mL/min. A 50% reduction in pregabalin daily dose is recommended for patients with CLcr between 30 and 60 mL/min compared to those with CLcr > 60 mL/min. Daily doses should be further reduced by approximately 50% for each additional 50% decrease in CLcr. Pregabalin was highly cleared by hemodialysis. Supplemental pregabalin doses may be required for patients on chronic hemodialysis treatment after each hemodialysis treatment to maintain steady-state plasma pregabalin concentrations within desired ranges.
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