Lombard M, Portmann B, Neuberger J, Williams R, Tygstrup N, Ranek L, Ring-Larsen H, Rodes J, Navasa M, Trepo C
Institute of Liver Studies, King's College Hospital, London, England.
Gastroenterology. 1993 Feb;104(2):519-26. doi: 10.1016/0016-5085(93)90422-9.
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.
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.
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 mumol/L in 9%, necessitating permanent discontinuation in half of these. A reduction in the dose of CyA was required in 11% because of hypertension.
CyA has some therapeutic potential in primary biliary cirrhosis, providing blood pressure and renal function are closely monitored.
原发性胆汁性肝硬化（PBC）的有效治疗方法仍未找到，该方法应能减缓疾病进展并提高生存率。环孢素A（CyA）在预防人体同种异体移植排斥反应方面效果显著，早期研究显示其在少数患者中具有治疗前景。
在一项为期6年的多中心研究中，349例PBC患者被随机分为两组，分别接受3mg·kg-1·d-1的CyA或安慰剂治疗。研究终点为死亡或肝移植。
Cox多因素分析显示，CyA治疗组从入组到死亡或移植的时间显著延长（最长达50%）。与肝脏相关的死亡率也显著降低。然而，单因素生存分析显示两组之间无统计学差异。CyA治疗组肝脏生化指标恶化较慢，但9%的患者血清肌酐浓度升高>150μmol/L，其中一半患者需要永久停药。11%的患者因高血压需要减少CyA剂量。
在密切监测血压和肾功能的情况下，CyA对原发性胆汁性肝硬化具有一定的治疗潜力。
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