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首页> 外文期刊>Journal of Hepatology: The Journal of the European Association for the Study of the Liver >The combination of ursodeoxycholic acid and methotrexate for primary biliary cirrhosis is not better than ursodeoxycholic acid alone.
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The combination of ursodeoxycholic acid and methotrexate for primary biliary cirrhosis is not better than ursodeoxycholic acid alone.

机译：熊去氧胆酸和甲氨蝶呤的组合治疗原发性胆汁性肝硬化并不比单独的熊去氧胆酸好。

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BACKGROUND/AIMS: Many therapies have been tried in primary biliary cirrhosis. It has been suggested that a combination of ursodeoxycholic acid and methotrexate may offer advantages. Because the benefit and safety of this combination is uncertain, we conducted this prospective, randomized, double-blind, controlled trial. METHODS: Twenty-five patients with well-defined primary biliary cirrhosis were randomly assigned to receive either ursodeoxycholic acid (500 mg/day) plus methotrexate (10 mg/week) or ursodeoxycholic acid plus placebo for a period of 48 weeks. Clinical, biochemical and histologic evolution were assessed. RESULTS: In both groups the clinical response was similar and heterogeneous. In patients of ursodeoxycholic acid alone group, biochemical and histologic changes were comparable to those of patients of ursodeoxycholic acid plus methotrexate at 48 weeks. The addition of methotrexate was not associated with substantial adverse affects. CONCLUSIONS: The use of methotrexate in combination with ursodeoxycholic acid was not followed by an additive benefit over ursodeoxycholic acid alone, nor was substantial toxicity added. Unless larger and longer controlled trials with clinical, biochemical and histologic controls show it to be a safe and effective therapy for primary biliary cirrhosis, ursodeoxycholic acid+methotrexate should not be used as a proven and accepted treatment.
机译：背景/目的：在原发性胆汁性肝硬化中已经尝试了许多疗法。已经提出，熊去氧胆酸和甲氨蝶呤的组合可以提供优点。由于这种组合的益处和安全性尚不确定，因此我们进行了这项前瞻性，随机，双盲，对照试验。方法：25例明确的原发性胆汁性肝硬化患者被随机分配接受熊去氧胆酸（500毫克/天）加甲氨蝶呤（10毫克/周）或熊去氧胆酸加安慰剂，为期48周。临床，生化和组织学演变进行了评估。结果：两组的临床反应均相似且异质。在单独的熊去氧胆酸患者中，在48周时的生化和组织学变化与熊去氧胆酸加甲氨蝶呤的患者相当。甲氨蝶呤的添加与大量不良反应无关。结论：甲氨蝶呤与熊去氧胆酸联合使用并没有比单独的熊去氧胆酸产生额外的好处，也没有增加实质性毒性。除非通过临床，生化和组织学对照进行的更大，更长期的对照试验表明，它是治疗原发性胆汁性肝硬化的安全有效方法，否则熊去氧胆酸+甲氨蝶呤不应该被用作公认且可接受的治疗方法。

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