Padoin C, Tod M, Brion N, Louchahi K, Le Gros V, Petitjean O
CREPIT 93, Hôpital Avicenne, Bobigny, France.
Biopharm Drug Dispos. 1995 Apr;16(3):169-76. doi: 10.1002/bdd.2510160302.
The pharmacokinetics of orally administered amoxicillin were investigated in 12 healthy volunteers in a crossover design. They received either a placebo or a saline-polyethylene glycol solution (SPG) for 4 d, the last dose being given simultaneously with 1 g amoxicillin; blood samples were drawn for the next 12 h. Amoxicillin kinetics were similar in the two treatments but small differences in some pharmacokinetic parameters reached significance. The mean +/- SD area under the curve was lower with SPG (43.8 +/- 6.8 against 47.8 +/- 8.2 mg h L-1, p < 0.05) but the treatments were equivalent according to Westlake's test (95% confidence interval = 14.95%). Analysis of SPG against placebo amoxicillin absorption kinetics after fitting the data to a Weibull model revealed a longer duration of the absorption, a slower rate of absorption, and a different shape of the curve. No clinical consequences are expected from these minor variations but possible mechanisms could be relevant to other drugs.
采用交叉设计在12名健康志愿者中研究了口服阿莫西林的药代动力学。他们接受了4天的安慰剂或盐溶液-聚乙二醇溶液（SPG），最后一剂与1g阿莫西林同时服用；在接下来的12小时内采集血样。两种治疗中阿莫西林的动力学相似，但一些药代动力学参数的微小差异具有统计学意义。SPG治疗组的曲线下面积均值±标准差较低（43.8±6.8对比47.8±8.2mg·h·L⁻¹，p<0.05），但根据韦斯特莱克检验，两种治疗相当（95%置信区间=14.95%）。将数据拟合到韦布尔模型后，对SPG与安慰剂阿莫西林吸收动力学的分析显示，吸收持续时间更长、吸收速率更慢且曲线形状不同。预计这些微小变化不会产生临床后果，但可能的机制可能与其他药物有关。
