Effect of Adjuvant Steroid Therapy in Type 3 Biliary Atresia

医学 胆道闭锁 随机对照试验 黄疸 肝移植 胃肠病学 存活率 类固醇 外科 内科学 临床终点 移植 激素
作者
Xuexin Lu,Jingying Jiang,Zhen Shen,Gong Chen,Ying Wu,Xianmin Xiao,Weili Yan,Shan Zheng
出处
期刊:Annals of Surgery [Ovid Technologies (Wolters Kluwer)]
卷期号:277 (6): e1200-e1207 被引量:10
标识
DOI:10.1097/sla.0000000000005407
摘要

To evaluate the efficacy and side effects of additional postoperative steroid therapy for type 3 BA versus the current routine care.Whether steroid therapy post-Kasai portoen-terostomy improves the outcomes of BA remains controversial. Clinical evidence from 2 randomized trials in the UK and USA do not support the routine use of steroid in the treatment of BA.In this open-label randomized controlled trial, patients with type 3 BA were randomized to routine postoperative treatment with or without 10 to 12 weeks of adjuvant steroid treatment. The primary outcome was the postoperative jaundice clearance rate with native liver at 6 months. The secondary outcomes included postoperative jaundice clearance rate at 3, 12, and 24 months, survival with native liver at 12 and 24 months, and SAEs within 3 months.Overall, 200 participants were randomized and allocated into either steroid or control group (n = 100/group). The proportion of participants that are jaundice free without liver transplantation was significantly higher in the steroid group than in the control group at 6 months (54.1% vs 31.0%, P = 0.0015). The native liver survival rate was higher postoperatively in the steroid group than in the control group at 12 (66.3% vs 50.0%, P = 0.02) and 24 (57.1% vs 40.0%, P = 0.02) months. The survival time with native liver was significantly longer in the steroid group than in the control group (median survival, steroid vs control: not reached vs 1.21 years, P = 0.02). There were no significant differences between the 2 groups in the mean occurrence of SAEs within 3 months (steroid vs control: 0.63 vs 0.45, P = 0.20).Postoperative adjuvant steroid intervention improved bile drainage and survival with native liver in type 3 BA patients, without increasing early-stage SAEs.
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