Multiple-dose pentoxifylline及其代谢物在肾功能不全的药物动力学。
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Paap厘米,辛普森KS,霍顿MW, Schaefer KL,莱斯曼HB,袋
Multiple-dose pentoxifylline及其代谢物在肾功能不全的药物动力学。
Jul-Aug安Pharmacother。1996; 30 (7 - 8): 724 - 9。doi: 10.1177 / 106002809603000702。
- PubMed ID
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8826548 (在PubMed]
- 文摘
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目的:描述pentoxifylline (PTF)和代谢物处置经过多次口服剂量每天2和3次给患者肾脏功能障碍。设计:非盲、随机、交叉、平行组设计。设置:以社区为基础的临床研究中心。患者群体:主题与肾功能分层基础上24小时尿肌酸间隙(Clcr):组I = Clcr > 80毫升/分钟(n = 9);第二组= Clcr 30 - 80毫升/分钟(n = 6);和组3 = Clcr < 30毫升/分钟(n = 10)。方法:PTF出价400毫克或tid管理在天1 - 7和400毫克投标或tid是14到20天给药1周惨败。定时采集的血液样本在天1日7日和20。血样分析PTF及其代谢物(m i、M-IV mv)气液色谱法。主要结果测量:最大血浆浓度(Cmax),最大浓度的时间(达峰时间),平均稳态血浆浓度(CavgSS),和在稳态血浆浓度时间曲线下的面积(AUCSS)是由视觉和模型独立的方法。 ANOVA, paired t-test, and linear regression were used with significance level set at p < 0.05. RESULTS: The ratio of PTF AUCSS (tid):AUCSS (bid) and M-I AUCSS (bid and tid) were not significantly different between the groups. Significant differences were found in M-IV and M-V Cmax, AUCSS, CavgSS, and AUCSS ratios (M-IV:PTF and M-V:PTF) between renal function groups (p < 0.05 for all). A change in dosage regimen from tid to bid resulted in significant changes in M-IV and M-V CavgSS for subjects with normal renal function and in those with moderate dysfunction, although not in subjects with severe renal dysfunction. CONCLUSIONS: Renal dysfunction did not cause significant accumulations of PTF or M-I after multiple bid and tid dosing, however, M-IV and M-V had significant accumulation in patients with renal impairment. Dosage reduction to 400 mg bid for patients with moderate renal impairment and 200-400 mg/d for severe renal impairment, as well as close clinical monitoring, seem prudent until the complex pharmacologic interactions of PTF and its metabolites can be further delineated.
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- 药物