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地塞米松治疗肝切除术后高胆红素血症患者:一项开放标签、随机对照试验。

Dexamethasone for postoperative hyperbilirubinemia in patients after liver resection: An open-label, randomized controlled trial.

机构信息

Department of Liver Surgery & Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University; Key Laboratory for Carcinogenesis and Cancer Invasion, Chinese Ministry of Education; Shanghai, China.

Department of Liver Surgery & Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University; Key Laboratory for Carcinogenesis and Cancer Invasion, Chinese Ministry of Education; Shanghai, China.

出版信息

Surgery. 2019 Mar;165(3):534-540. doi: 10.1016/j.surg.2018.09.002. Epub 2018 Oct 19.

Abstract

BACKGROUND

Although prophylactic glucocorticoids have been used before liver resection to minimize liver dysfunction, it is unknown whether treatment with glucocorticoids will accelerates recovery from hyperbilirubinemia after liver resection.

METHODS

In this open-label, randomized, controlled trial, patients with hyperbilirubinemia (>2.5 × and ≤5 × the upper limit of normal) within 7 days after hepatic resection were assigned randomly to the dexamethasone or control groups. For the dexamethasone group, 10 mg, 10 mg, and 5 mg dexamethasone were administered intravenously on days 0, 1, and 2, respectively, after randomization. For the control group, patients received standard treatment only. The primary outcome was time to recovery from hyperbilirubinemia defined as the period from the day of randomization to the day when serum bilirubin decreased to ≤1.5 times that of the upper limit of normal. Secondary outcomes were the prevalence of postoperative complications, postoperative hospital stay, and hospital expense.

RESULTS

Between March 2016 and December 2017, 76 participants were enrolled (38 in each group). Median time to recovery from hyperbilirubinemia was less in the dexamethasone group than in the control group (2 vs 4 days, P < .001). Serum bilirubin levels were less in the dexamethasone group on days 1-3 after randomization (P < .05). The prevalence of infection, posthepatectomy liver failure, postoperative hospital stay, and hospital expense were not different between the groups.

CONCLUSION

Dexamethasone accelerated recovery from hyperbilirubinemia and decreased serum bilirubin levels without causing more side effects in patients after hepatectomy.

摘要

背景

虽然预防性糖皮质激素已被用于肝切除术前以最小化肝功能障碍,但尚不清楚糖皮质激素治疗是否会加速肝切除术后高胆红素血症的恢复。

方法

在这项开放标签、随机、对照试验中,肝切除术后 7 天内胆红素升高(>2.5×且≤5×正常值上限)的患者被随机分为地塞米松组或对照组。对于地塞米松组,在随机分组后第 0、1 和 2 天分别静脉给予 10 mg、10 mg 和 5 mg 地塞米松。对于对照组,患者仅接受标准治疗。主要结局是从高胆红素血症恢复的时间,定义为从随机分组之日起至血清胆红素降至≤1.5 倍正常值上限之日的时间。次要结局是术后并发症、术后住院时间和住院费用的发生率。

结果

2016 年 3 月至 2017 年 12 月,共纳入 76 名参与者(每组 38 名)。地塞米松组从高胆红素血症恢复的中位时间短于对照组(2 天与 4 天,P<0.001)。随机分组后第 1-3 天,地塞米松组的血清胆红素水平较低(P<0.05)。两组间感染、肝切除术后肝功能衰竭、术后住院时间和住院费用的发生率无差异。

结论

地塞米松可加速肝切除术后高胆红素血症的恢复,降低血清胆红素水平,且不会增加副作用。

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