Ursodeoxycholic acid for treatment of nonalcoholic steatohepatitis: Results of a randomized trial
Ursodeoxycholic acid for treatment of nonalcoholic steatohepatitis: Results of a randomized trial
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DOI：
10.1002/hep.20092
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发表时间：
2004-03-01
期刊：
影响因子：
13.5
通讯作者：
Colin, P
中科院分区：
文献类型：
--
作者：
Lindor, KD;Kowdley, KV;Colin, P
没有有效的药物治疗可用于所有非酒精性脂肪性肝炎（NASH）患者。基于开放标签临床研究，熊去氧胆酸（UDCA）被认为是有益的。我们将166例肝活检证实为NASH的患者随机分为两组，分别接受13 - 15 mg/kg/d UDCA或安慰剂治疗2年。终点包括治疗2年时肝脏检查结果和肝脏组织学的变化。治疗组在入组时的年龄、性别、NASH风险因素、血清肝生化和基线肝组织学方面相当。共有126例患者完成了2年的治疗。在研究结束时，107例患者的治疗前和治疗后肝活检可供审查。UDCA耐受性良好，研究期间体重稳定。UDCA和安慰剂治疗组的血清肝生化均稳定或改善。UDCA组和安慰剂组治疗期间发生的脂肪变性、坏死性炎症或纤维化程度的变化无显著差异。总之，对于NASH患者，UDCA 13 - 15 mg/kg/d治疗2年，尽管安全且耐受性良好，但并不优于安慰剂。
No effective medical therapy is available for all patients with nonalcoholic steatohepatitis (NASH). Ursodeoxycholic acid (UDCA) has been suggested to be of benefit based on open label clinical studies. We randomized 166 patients with liver biopsy proven NASH to receive between 13 and 15 mg/kg/d of UDCA or placebo for 2 years. End points included changes in liver test results and liver histology at 2 years of therapy. The treatment groups were comparable at entry with regard to age, gender, risk factors for NASH, serum liver biochemistries, and baseline liver histology. A total of 126 patients completed 2 years of therapy. Pre- and posttreatment liver biopsies were available in 107 patients for review at the end of the study. UDCA was well tolerated and body weight was stable during the study duration. Serum liver biochemistries were stable or improved in both the UDCA and placebo-treated groups. Changes in the degree of steatosis, necroinflammation, or fibrosis that occurred with therapy were not significantly different between the UDCA and placebo groups. In conclusion, 2 years of therapy with UDCA at a dose of 13 to 15 mg/kg/d, although safe and well tolerated, is not better than placebo for patients with NASH.