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原发性胆汁性肝硬化(下称PBC)是以肝内小胆管破坏,伴进行性胆汁郁积,并最后导致肝硬化和肝细胞衰竭为特征。免疫反应似乎参与了胆管损伤的发病机理,80％病例显示对胆管抗原有细胞免疫反应,30～50％的病例在周围血中有针对肝细胞的细胞毒淋巴细胞。也有研究指出95％的患者存在高浓度的循环免疫复体。由此,期望免疫抑制药物可能对本病有些效益。于是,作者等设计在世界多个中心作以硫唑嘌呤和安慰剂治疗PBC的双盲随机试验。病例和方法:本组患者的临床表现和组织学改变均可诊断或符合PBC,血清碱性磷酸酶活力亦都大于正常上限两倍。各中心按性别随机给予硫唑嘌呤或乳糖(安慰剂),两者剂型外观完全一样。体重40kg以下者,每周服药300mg;体重每增加10kg,每周剂量增加100mg,最大剂量为每周700mg。开始2周,给服一半
Primary biliary cirrhosis (PBC) is characterized by the destruction of small intrahepatic bile ducts, with progressive cholestasis, and eventually liver cirrhosis and hepatocellular failure. The immune response appears to be involved in the pathogenesis of biliary tract injury, with 80% of cases showing cellular immune responses to biliary antigens and 30 to 50% of cases having cytotoxic lymphocytes against hepatocytes in the peripheral blood. There are also studies have shown that 95% of patients present with high concentrations of circulating immune complex. Thus, expectant immunosuppressive drugs may be some benefit of the disease. Thus, the authors designed a double-blind, randomized trial of PBC with azathioprine and placebo at multiple centers around the world. Cases and Methods: The clinical manifestations and histological changes in this group of patients can be diagnosed or consistent with PBC, serum alkaline phosphatase activity is also greater than twice the upper limit of normal. The centers were randomized to azathioprine or lactose (placebo) by sex, and both formulations looked exactly the same. Weight 40kg the following, weekly medication 300mg; weight for each additional 10kg, the weekly dose increase of 100mg, the maximum dose of 700mg per week. Start 2 weeks, to serve half