High dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis is safe and effective
High dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis is safe and effective
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DOI：
10.1016/j.jhep.2007.12.023
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发表时间：
2008-05-01
影响因子：
25.7
通讯作者：
Chapman, Roger W.
中科院分区：
文献类型：
--
作者：
Cullen, Susan N.;Rust, Christian;Chapman, Roger W.
背景/目标：熊去氧胆酸（UDCA）已被证明可以改善原发性硬化性胆管炎（PSC）的血清肝脏试验，但对照试验显示对肝脏组织学的影响不一致，并且没有显示生存益处。本试验，随机剂量范围试验试图确定是否进一步丰富的胆汁酸池与UDCA将导致一个改善的结果为PSC patients.Methods：31例PSC患者被随机分配到治疗与10 mg/kg（低剂量），20 mg/kg（标准剂量）或30 mg/kg（高剂量）每日UDCA 2年。每12周对患者进行一次评估，并在试验开始和结束时进行肝活检。结果：服用UDCA的所有组的血清肝脏检查均有所改善。通过马约风险评分评价的1 - 4年生存概率，所有患者均趋于改善，高剂量组显著改善（p <0.02）。所有患者中只有3例（10%）的Ludwig评分显示在试验期间组织学恶化。结论：高剂量UDCA耐受性良好，与生存概率的改善相关。还观察到组织学分期稳定/改善的趋势。这种治疗似乎对PSC有效，值得进一步评价。(C)2008年欧洲肝脏研究协会。出版社：Elsevier B.V. All rights reserved.
Background/Aims: Ursodeoxycholic acid (UDCA) has been shown to improve serum liver tests in primary sclerosing cholangitis (PSC), but controlled trials have shown inconsistent effects on liver histology, and did not reveal a survival benefit. This pilot, randomised dose-ranging trial attempted to determine whether further enrichment of the bile acid pool with UDCA would lead to an improvement in outcome for PSC patients.Methods: Thirty-one patients with PSC were randomised to treatment with either 10 mg/kg (low dose), 20 mg/kg (standard dose) or 30 mg/kg (high dose) daily of UDCA for 2 years. Patients were assessed every 12 weeks and underwent liver biopsy at the beginning and end of the trial.Results: Serum liver tests improved in all groups taking UDCA. Survival probability at 1-4 years as evaluated by the Mayo risk score tended to improve for all patients and significantly improved for the high dose group (p < 0.02). Only 3 (10%) of all patients had a Ludwig score showing histological deterioration over the trial period.Conclusions: High dose UDCA is well-tolerated and is associated with an improvement in survival probability. A trend towards stability/improvement in histological stage was also observed. This treatment appears to be effective for PSC and deserves further evaluation. (C) 2008 European Association for the Study of the Liver. Published by Elsevier B.V.. All rights reserved.