Multicenter randomized trial of postoperative corticosteroid therapy for biliary atresia
Multicenter randomized trial of postoperative corticosteroid therapy for biliary atresia
复制标题
DOI：
10.1007/s00383-013-3377-6
复制
发表时间：
2013-11-01
影响因子：
1.8
通讯作者：
Muraji, Toshihiro
中科院分区：
文献类型：
--
作者：
Nio, Masaki;Muraji, Toshihiro
我们的目的是评估葛西门肠造口术治疗胆道闭锁 (BA) 后对两种不同皮质类固醇剂量的早期反应。在全国 BA 登记处的 3 型 BA 婴儿中进行了一项前瞻性随机试验。 69 名婴儿随机接受 4 毫克/公斤/天（A 组，n = 35）或 2 毫克/公斤/天泼尼松龙（B 组，n = 34）。术后第7天开始皮质类固醇治疗，并在第30天逐渐减少剂量。比较各组第31天和第60天的肝功能检查结果。各组之间的平均胆红素、AST、ALT和GGT水平没有显着差异。然而，手术时 < 70 天婴儿的总胆红素和直接胆红素水平在各组之间存在显着差异。 A 组的 4 名患者和 B 组的 5 名患者退出了研究。 PE 后第一个月的并发症在各组之间相当。初始 4 mg/kg/天的剂量并没有显着改善肝功能，只是手术时 < 70 天的婴儿亚组的胆红素水平较低。任一剂量的皮质类固醇均未出现明显并发症。
We aimed to evaluate early response to two different corticosteroids doses after Kasai portoenterostomy for biliary atresia (BA).A prospective, randomized trial was performed in infants from the nationwide BA registry with type 3 BA. Sixty-nine infants were randomized to receive either 4 mg/kg/day (group A, n = 35) or 2 mg/kg/day prednisolone (group B, n = 34). The corticosteroids were started on postoperative day 7, and the dose was tapered toward day 30. Results of liver function tests on days 31 and 60 were compared between the groups.Mean bilirubin, AST, ALT, and GGT levels did not significantly differ between the groups. However, the levels of total and direct bilirubin of infants < 70 days old at surgery significantly differed between the groups. Four patients from group A and five from group B, dropped out of the study. Complications during the first month after PE were comparable between the groups.An initial 4 mg/kg/day dose did not significantly improve liver function, except that bilirubin levels were lower in the subgroup of infants < 70 days old at surgery. There were no significant complications with either dose of corticosteroids.