Rolandi E, Franceschini R, Cataldi A, Cicchetti V, Carati L, Barreca T
Department of Internal Medicine, University of Genoa, Italy.
Eur J Clin Pharmacol. 1991;40(5):473-6. doi: 10.1007/BF00315225.
The effects of ursodeoxycholic acid (UDCA, 450 mg daily) in patients with histologically proven chronic active hepatitis (CAH) have been evaluated in a randomized, double-blind, placebo-controlled study. Twenty-six patients with serum alanine aminotransferase (ALT) values at least twice the normal upper limit in two of three pre-treatment tests received UDCA or a placebo for twelve weeks. In all UDCA-treated patients, serum aspartate amino-transferase (AST), ALT, gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase (AP) fell significantly after 4 weeks of treatment. There was a further decrease at the end of therapy, as well as a small but significant fall in total serum bilirubin. Conversely, 4 weeks after suspension of therapy, serum enzyme levels had increased, reaching values not much lower than those recorded before treatment. Total serum protein, albumin and gamma-globulin did not change after UDCA treatment. In the placebo group no significant variation in the test results were found. The results indicate that UDCA therapy in CAH, as has been observed in primary biliary cirrhosis and primary sclerosing cholangitis, is able to improve several indices of liver damage, without producing any toxic adverse effects.
在一项随机、双盲、安慰剂对照研究中，评估了熊去氧胆酸（UDCA，每日450毫克）对组织学确诊的慢性活动性肝炎（CAH）患者的疗效。26例在三次治疗前检测中有两次血清丙氨酸氨基转移酶（ALT）值至少为正常上限两倍的患者接受了UDCA或安慰剂治疗12周。在所有接受UDCA治疗的患者中，治疗4周后血清天冬氨酸氨基转移酶（AST）、ALT、γ-谷氨酰转肽酶（GGT）和碱性磷酸酶（AP）均显著下降。治疗结束时进一步下降，总血清胆红素也有小幅但显著下降。相反，治疗暂停4周后，血清酶水平升高，达到不比治疗前记录的值低多少的水平。UDCA治疗后总血清蛋白、白蛋白和γ-球蛋白没有变化。在安慰剂组中，未发现检测结果有显著变化。结果表明，正如在原发性胆汁性肝硬化和原发性硬化性胆管炎中所观察到的那样，CAH患者接受UDCA治疗能够改善肝脏损伤的多项指标，且不会产生任何毒性不良反应。
