A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis
A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis
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DOI：
10.1016/j.jhep.2010.08.030
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发表时间：
2011-05-01
影响因子：
25.7
通讯作者：
Spenard, Jean
中科院分区：
文献类型：
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作者：
Ratziu, Vlad;de Ledinghen, Victor;Spenard, Jean
背景与目的：非酒精性脂肪性肝炎(NASH)是一种发病率和死亡率均较高的肝病。熊去氧胆酸(UDCA)可能具有抗氧化、抗炎和抗纤维化的特性，并可能减轻NASH的肝损伤。到目前为止，还没有研究评估大剂量UDCA(HD-UDCA)对NASH患者的有效性和安全性。方法：我们进行了一项为期12个月的随机、双盲、安慰剂对照的多中心试验，以评估HD-UDCA(每天28-35 mg/kg)对126例经活检证实的NASH和丙氨酸氨基转移酶(ALT)水平升高的患者的有效性和安全性。主要的研究终点是与安慰剂相比，接受HD-UDCA治疗的患者的ALT水平从基线水平下降。二次研究的终点是ALT复常者的比例、肝纤维化和肝脏炎症标志物的相对降低以及安全性和耐受性。结果：12个月后，HD-UDCA组的平均ALT水平较基线显著降低28.3%，而安慰剂组为-1.6%(P
Background & Aims: Nonalcoholic steatohepatitis (NASH) is a prevalent liver disease associated with increased morbidity and mortality. Ursodeoxycholic acid (UDCA) may have antioxidant, anti-inflammatory, and antifibrotic properties and may reduce liver injury in NASH. To date, no studies have assessed the efficacy and safety of high-dose UDCA (HD-UDCA) in patients with NASH.Methods: We conducted a 12-month, randomized, double-blind, placebo-controlled multicenter trial to evaluate the efficacy and safety of HD-UDCA (28-35 mg/kg per day) in 126 patients with biopsy-proven NASH and elevated alanine aminotransferase (ALT) levels. The primary study end point was reduction in ALT levels from baseline in patients treated with HD-UDCA compared with placebo. Secondary study end points were the proportion of patients with ALT normalization, relative reduction in the scores of serum markers of fibrosis and hepatic inflammation, and safety and tolerability.Results: HD-UDCA significantly reduced mean ALT levels -28.3% from baseline after 12 months compared with -1.6% with placebo (p