Mitchison H C, Palmer J M, Bassendine M F, Watson A J, Record C O, James O F
Department of Medicine, University of Newcastle upon Tyne, United Kingdom.
J Hepatol. 1992 Jul;15(3):336-44. doi: 10.1016/0168-8278(92)90065-w.
The results of a 3-year, placebo-controlled trial of prednisolone treatment in primary biliary cirrhosis (PBC) are presented. The active (n = 19) and placebo (n = 17) arms were initially well matched for age, menopausal status and disease severity. At 3 years hepatic symptoms were relatively improved in the prednisolone group. Hepatic mortality was 3/19 (prednisolone), 5/17 (placebo) (p = n.s.). For all liver blood tests the trend favoured prednisolone treatment, though the differences were only significant for alkaline phosphatase and protein. All immunoglobulins fell significantly. Quantitative ELISA determination of antimitochondrial antibody showed a significant fall in the prednisolone group compared with placebo (p less than 0.001 at 1 year, p less than 0.05 at 3 years). Deterioration in histology (appearance of cirrhosis) was more common in the placebo group. Overall hepatic function (hepatic mortality, doubling in bilirubin, 6 milligrams fall in albumin, de novo appearance of cirrhosis or symptoms of portal hypertension) was significantly worse in the placebo group (p less than 0.01). After 3 years no significant differences could be detected in bone mineral content (single photon absorptiometry of radius and femur) between the two groups or in comparison with other PBC patients. Thus, after 3 years, prednisolone treatment was associated with a better overall hepatic outcome and little evidence of increased bone loss.
本文展示了一项为期3年的泼尼松龙治疗原发性胆汁性肝硬化（PBC）的安慰剂对照试验结果。活性药物组（n = 19）和安慰剂组（n = 17）在年龄、绝经状态和疾病严重程度方面最初匹配良好。3年后，泼尼松龙组的肝脏症状相对改善。肝脏死亡率为3/19（泼尼松龙组），5/17（安慰剂组）（p =无显著性差异）。对于所有肝脏血液检查，趋势有利于泼尼松龙治疗，尽管差异仅在碱性磷酸酶和蛋白质方面显著。所有免疫球蛋白均显著下降。抗线粒体抗体的定量ELISA测定显示，与安慰剂组相比，泼尼松龙组显著下降（1年时p < 0.001，3年时p < 0.05）。组织学恶化（肝硬化出现）在安慰剂组更常见。安慰剂组的总体肝功能（肝脏死亡率、胆红素翻倍、白蛋白下降6毫克、新发肝硬化或门静脉高压症状）显著更差（p < 0.01）。3年后，两组之间或与其他PBC患者相比，骨矿物质含量（桡骨和股骨的单光子吸收测定法）未发现显著差异。因此，3年后，泼尼松龙治疗与更好的总体肝脏结局相关，几乎没有骨质流失增加的证据。
