Efficacy and Safety of Steroid Therapy for Posttransplant Hyperbilirubinemia Caused by Early Allograft Dysfunction: A Randomized Controlled Trial

Efficacy and Safety of Steroid Therapy for Posttransplant Hyperbilirubinemia Caused by Early Allograft Dysfunction: A Randomized Controlled Trial
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类固醇治疗对早期同种异体移植物功能障碍引起的移植后高胆红素血症的疗效和安全性:随机对照试验

DOI:
10.12659/msm.915128
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发表时间:
2019-03-14
影响因子:
3.1
通讯作者:
He, Xiaoshun
He, Xiaoshun
中科院分区:
医学4区
文献类型:
--
作者:
Yang, Jie;Yang, Lei;He, Xiaoshun

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背景:高胆红素血症是肝移植后常见的事件。高胆红素血症通常由早期同种异体移植物功能障碍引起。糖皮质激素被广泛用于免疫抑制,但很少有研究分析类固醇治疗对移植后高胆红素血症的影响。本研究的目的是评估糖皮质激素是否有利于治疗早期同种异体移植物功能障碍引起的高胆红素血症。材料/方法术后高胆红素血症患者(排除伴有胆道并发症和排斥反应的患者)按2:1的比例随机分为类固醇组和对照组。类固醇组采用糖皮质激素联合熊去氧胆酸治疗,对照组仅采用熊去氧胆酸治疗。主要终点是胆红素降低,次要终点是安全性。结果2016年6月1日至2018年4月30日,40例患者入组类固醇治疗组,20例入组对照组。两组间供体、受体及手术资料相似。激素组在干预结束后第一天(9.25±1.30 mg/dL vs. 3.11±1.45 mg/dL, p=0.005)和2周后(15.01±1.20 mg/dL vs. 8.88±1.98 mg/dL, p=0.007)胆红素水平下降显著大于对照组。类固醇组没有更高的并发症发生率,但其术后住院时间确实比对照组短。结论小剂量类固醇治疗早期移植物功能障碍所致高胆红素血症有效、安全,可改善肝功能。
Background Hyperbilirubinemia is a common event that occurs after liver transplantation. Hyperbilirubinemia is usually caused by early allograft dysfunction. Glucocorticoid is widely used for immunosuppression, but few studies have analyzed the effects of steroid therapy on posttransplantation hyperbilirubinemia. The aim of this study was to assess whether glucocorticoid was beneficial in treating hyperbilirubinemia caused by early allograft dysfunction. Material/Methods Patients with postoperative hyperbilirubinemia (those with conditions such as biliary complications and rejections were excluded) were randomly assigned, in a 2: 1 ratio, to the steroid and control groups. Patients in the steroid group were treated with glucocorticoid combined with ursodeoxycholic acid, whereas patients in the control group were only treated with ursodeoxycholic acid. The primary endpoint was decrease in bilirubin and the secondary endpoint was safety. Results From 1st June 2016 to 30th April 2018, 40 patients were enrolled into the steroid group, and 20 were enrolled into the control group. Donor, recipient, and operative data were similar between the 2 groups. The decrease in bilirubin levels in the steroid group was significantly greater than that in the control group on the first day after the intervention was finished (9.25±1.30 mg/dL vs. 3.11±1.45 mg/dL, p=0.005), and after 2 weeks (15.01±1.20 mg/dL vs. 8.88±1.98 mg/dL, p=0.007). The steroid group did not have a higher complication rate but it did have a shorter postoperative hospital stay than in the control group. Conclusions Low-dose steroid therapy was effective and safe for treating hyperbilirubinemia caused by early graft dysfunction, and it improved liver function.