Abstract：
This randomized controlled trial compared two dosing regimens of the polyvalent immunoglobulin available for hepatitis A post-exposure prophylaxis in Australia. Participants were randomized to receive either 270 IU (standard dose) or 3.375 IU/kg (dose by weight). Quantitative serial serum hepatitis A antibody concentrations were measured at baseline and then on days 1, 3, 7, 28, and 50. Fifteen participants completed the trial. Serum hepatitis A antibody concentrations were not different between the study groups at any time point. Pharmacokinetic parameters estimated from participant data were not different between the study groups. The hepatitis A antibody level of all participants exceeded 10 mIU/mL at day 50. While no difference between dosing regimens was found in this study, further research should examine dosing at the lower limit of current Australian recommendations before making policy decisions.
摘要：
这项随机对照试验比较了澳大利亚用于甲型肝炎暴露后预防的多价免疫球蛋白的两种给药方案。参与者随机接受270IU（标准剂量）或3.375IU/kg（重量剂量）。在基线和然后在第1、3、7、28和50天测量定量系列血清甲型肝炎抗体浓度。15名参与者完成了试验。在任何时间点，研究组之间的血清甲型肝炎抗体浓度没有差异。根据参与者数据估计的药代动力学参数在研究组之间没有差异。在第50天，所有参与者的甲型肝炎抗体水平超过10mIU/mL。虽然在这项研究中没有发现给药方案之间的差异，在做出政策决定之前,进一步的研究应检查当前澳大利亚建议的下限剂量.
