Lotterer E, Stiehl A, Raedsch R, Foelsch U R, Bircher J
Division of Clinical Pharmacology, University of Göttingen, Federal Republic of Germany.
J Hepatol. 1990 May;10(3):284-90. doi: 10.1016/0168-8278(90)90134-d.
In an open, exploratory study, the safety of ursodeoxycholic acid (UDCA) in the treatment of primary biliary cirrhosis (PBC) was investigated. Seven patients in stages I to III and two patients in stage IV were treated for 1 year with 1 g/day of UDCA. Clinical symptoms, and alkaline phosphatase, gamma-glutamyltransferase, alanine aminotransferase (GOT) and aspartate aminotransferase (GTP) levels improved significantly within three months and remained at the lower levels for the period of observation. Results of the galactose elimination capacity (4.7 +/- S.D. 1.4 mg/min per kg) and the aminopyrine breath test (0.60 +/- 0.33% dose/kg per mmol CO2) remained unchanged for 1 year. In all patients total serum bile acids increased and quantitatively UDCA became the most important bile acid. In patients in stages I to III this increase, however, was modest, whereas in patients in stage IV, total serum bile acids reached levels of 140 and 157 mumol/l and UDCA, levels of 90 and 103 mumol/l, respectively. It is concluded that UDCA appears to be safe only in stages I to III and that prognostic stratification based on bile acid levels or on the histological stage of the disease should be an important aspect of controlled clinical trials.
在一项开放性探索性研究中，对熊去氧胆酸（UDCA）治疗原发性胆汁性肝硬化（PBC）的安全性进行了调查。7例处于I至III期的患者和2例IV期患者接受了为期1年的治疗，每日服用1克UDCA。临床症状以及碱性磷酸酶、γ-谷氨酰转移酶、丙氨酸转氨酶（GOT）和天冬氨酸转氨酶（GTP）水平在三个月内显著改善，并在观察期内维持在较低水平。半乳糖清除能力（4.7±标准差1.4毫克/分钟/千克）和氨基比林呼气试验（0.60±0.33%剂量/千克/毫摩尔二氧化碳）的结果在1年内保持不变。所有患者的血清总胆汁酸均升高，并且从数量上看，UDCA成为最重要的胆汁酸。然而，在I至III期患者中，这种升高幅度较小，而在IV期患者中，血清总胆汁酸分别达到140和157微摩尔/升，UDCA水平分别达到90和103微摩尔/升。得出的结论是，UDCA似乎仅在I至III期是安全的，并且基于胆汁酸水平或疾病组织学分期的预后分层应成为对照临床试验的一个重要方面。
