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我们通过临床试验来比较不同剂量的D-青霉胺对原发性胆汁性肝硬化病人的疗效及安全性。将56例原发性胆汁性肝硬化病人随机分为两组,一组每日接受250mg,另一组每日接受750mg D-青霉胺。这两组病人治疗前都经过临床检验及肝活体组织检查确定诊断,用药后继续随访临床检验并一年一次复查肝活检。结果两组病例在临床表现及肝脏组织学特征上都没有区别,治疗期间两组病例肝功试验结果也没有明显的改变。最初的三年中,750mg治疗组胆红素每年增高11%,与250mg组每年升高18%没有显著
We compare the efficacy and safety of different doses of D-penicillamine in patients with primary biliary cirrhosis through clinical trials. Fifty-six patients with primary biliary cirrhosis were randomized into two groups, one receiving 250 mg daily and the other receiving 750 mg D-penicillamine daily. The two groups of patients before treatment have been clinically verified and liver biopsy to confirm the diagnosis, follow-up after treatment with clinical tests and once a year to review the liver biopsy. Results There was no difference between the two groups in clinical manifestations and liver histological features. There was no significant change in the results of liver function test between the two groups during treatment. In the first three years, the bilirubin level in the 750 mg treatment group increased by 11% per year and was not significantly increased by 18% per year with the 250 mg group