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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Anidulafungin does not require dosage adjustment in subjects with varying degrees of hepatic or renal impairment.
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Anidulafungin does not require dosage adjustment in subjects with varying degrees of hepatic or renal impairment.

机译：对于具有不同程度的肝或肾功能不全的受试者，阿尼芬净不需要剂量调整。

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摘要

Two open-label studies assessed the effects of hepatic and renal impairment on anidulafungin pharmacokinetics. A single 50-mg dose was administered intravenously to subjects with varying degrees of hepatic or renal insufficiency or with end-stage renal disease; all were matched to normal healthy controls. Anidulafungin was well tolerated. AUC, CL, C(max), t(max), t(1/2), and V(ss) between renally impaired subjects and controls were not significantly different (P>.05), and no measurable amounts of drug were found in dialysate. The same pharmacokinetic parameters were also not affected (P>.05) by mild or moderate hepatic insufficiency, with respective mean AUCs of 50.6 +/- 11.7 microg x h/mL and 68.6 +/- 14.5 microg x h/mL, compared to 70.0 +/- 13.4 microg x h/mL in controls. Statistically significant decreases (P<05) of AUC (33% change) and C(max) (36% change) in severely hepatically impaired subjects compared to controls--most likely secondary to ascites and edema--were not clinically relevant. Anidulafungin can be safely administered to patients with any degree of hepatic or renal impairment without dosage adjustment and without regard to hemodialysis schedules.
机译：两项开放标签研究评估了肝和肾功能不全对阿尼芬净药代动力学的影响。向患有不同程度的肝或肾功能不全或患有终末期肾脏疾病的受试者静脉内单剂量50 mg;全部与正常健康对照匹配。 Anidulafungin的耐受性良好。肾功能不全的受试者与对照组之间的AUC，CL，C（max），t（max），t（1/2）和V（ss）没有显着差异（P> .05），并且没有可测量的药物量在透析液中发现。轻度或中度肝功能不全也不会影响相同的药代动力学参数（P> .05），相比之下，平均AUC分别为50.6 +/- 11.7 microg xh / mL和68.6 +/- 14.5 microg xh / mL，而70.0 + /-对照中13.4 microg xh / mL。与对照组相比（最有可能继发于腹水和水肿的患者），与肝功能严重受损的受试者相比，AUC（33％改变）和C（max）（36％改变）的AUC统计学显着降低（P <05）没有临床意义。安迪芬净可以安全地施用于任何程度的肝或肾功能不全的患者，而无需调整剂量，也无需考虑血液透析的时间表。

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