CYCLOSPORINE-A TREATMENT IN PRIMARY BILIARY-CIRRHOSIS - RESULTS OF A LONG-TERM PLACEBO CONTROLLED TRIAL
CYCLOSPORINE-A TREATMENT IN PRIMARY BILIARY-CIRRHOSIS - RESULTS OF A LONG-TERM PLACEBO CONTROLLED TRIAL
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DOI：
10.1016/0016-5085(93)90422-9
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发表时间：
1993-02-01
期刊：
影响因子：
29.4
通讯作者：
ANDERSEN, PK
中科院分区：
文献类型：
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作者：
LOMBARD, M;PORTMANN, B;ANDERSEN, PK
背景：原发性胆汁性肝硬化（PBC）的有效治疗导致进展缓慢和生存率提高仍然难以捉摸。环孢菌素A（CyA），这一直是如此有效地防止人类同种异体移植排斥反应，已显示出承诺在少数患者在早期study.Methods：349例PBC患者随机接受CyA，3 mg · kg-1·d-1，或安慰剂在一项多中心研究，随访6年。结果：考克斯多变量分析显示，从进入死亡或移植的时间显着延长（高达50%）在CyA治疗组。肝脏相关死亡率也显著降低。然而，单变量生存分析显示两组之间无统计学差异。CyA治疗组的生化肝脏指标恶化较慢，但9%的患者血清肌酐浓度升高>150 μmol/L，其中一半患者需要永久停药。减少剂量的CyA需要在11%，因为hypertension.Conclusions：CyA有一定的治疗潜力，在原发性胆汁性肝硬化，提供血压和肾功能密切监测。
Background:Effective treatment for primary biliary cirrhosis (PBC) resulting in slower progression and improved survival remains elusive. Cyclosporin A (CyA), which has been so effective in preventing human allograft rejection, has shown promise in small numbers of patients in early studies.Methods:Three hundred forty-nine patients with PBC were randomized to receive CyA, 3 mg · kg−1· day−1, or placebo in a multicenter study with follow-up for 6 years. The end point was death or liver transplantation.Results:Cox multivariate analysis showed time from entry to death or transplantation was significantly prolonged (by up to 50%) in the CyA-treated group. Liver-related mortality was also significantly lower. However, a univariate analysis of survival showed no statistical differences between the two groups. Biochemical liver indices deteriorated more slowly in the CyA-treated group, but serum creatinine concentration was elevated >150 (μmol/L in 9%, necessitating permanent discontinuation in half of these. A reduction in the dose of CyA was required in 11% because of hypertension.Conclusions:CyA has some therapeutic potential in primary biliary cirrhosis, providing blood pressure and renal function are closely monitored.