Turner I B, Myszor M, Mitchison H C, Bennett M K, Burt A D, James O F
Department of Medicine, Medical School, University of Newcastle upon Tyne, United Kingdom.
J Gastroenterol Hepatol. 1994 Mar-Apr;9(2):162-8. doi: 10.1111/j.1440-1746.1994.tb01237.x.
Forty-six patients with primary biliary cirrhosis from a single centre were studied in a randomized placebo-controlled trial to determine the effectiveness of ursodeoxycholic acid (UDCA) over a 2 year period. The two groups were well-matched at baseline. For each parameter, by calculating the difference between the median changes with time between the UDCA group and the placebo group, it was found that from entry, with respect to placebo, there were differences between median changes (MCD) favouring the UDCA group in bilirubin (MCD 5 mumol/L [95% confidence interval (CI) 1 to 12] at 1 year and 5 mumol/L (95% CI 1 to 9) at 2 years), alkaline phosphatase MCD 242 iu/L (95% CI 107 to 360) at 1 year and 268 iu/L (95% CI 146 to 424) at 2 years and aspartate aminotransferase MCD 26 iu/L (95% CI 12 to 41) at 1 year and 37 iu/L (95% CI 16 to 64) at 2 years. Within the UDCA group, there was long-term fall in alkaline phosphatase [median fall 116 iu/L (95% CI 93 to 378) at 2 years and aspartate aminotransferase [median fall 18 iu/L (95% CI 6 to 47) at 2 years; however, the major change in bilirubin was a modest rise over 2 years in the placebo group [median rise 2 mumol/L (95% CI 1 to 9)]. Changes in albumin, prothrombin ratio and immunoglobulins were generally minor and not significant.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项随机安慰剂对照试验中，对来自单一中心的46例原发性胆汁性肝硬化患者进行了研究，以确定熊去氧胆酸（UDCA）在2年期间的疗效。两组在基线时匹配良好。对于每个参数，通过计算UDCA组和安慰剂组随时间的中位数变化之间的差异，发现从入组开始，与安慰剂相比，UDCA组在胆红素方面的中位数变化（MCD）存在差异（1年时MCD为5 μmol/L [95%置信区间（CI）1至12]，2年时为5 μmol/L [95% CI 1至9]），碱性磷酸酶1年时MCD为242 iu/L（95% CI 107至360），2年时为268 iu/L（95% CI 146至424），天冬氨酸转氨酶1年时MCD为26 iu/L（95% CI 12至41），2年时为37 iu/L（95% CI 16至64）。在UDCA组中，碱性磷酸酶有长期下降[2年时中位数下降116 iu/L（95% CI 93至378）]，天冬氨酸转氨酶[2年时中位数下降18 iu/L（95% CI 6至47）]；然而，安慰剂组胆红素的主要变化是2年内有适度上升[中位数上升2 μmol/L（95% CI 1至9）]。白蛋白、凝血酶原比值和免疫球蛋白的变化通常较小且无统计学意义。（摘要截断于250字）
