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首页> 外文期刊>Transplantation: Official Journal of the Transplantation Society >A long-term comparison of tacrolimus (FK506) versus cyclosporine in liver transplantation: a report of the United States FK506 Study Group.
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A long-term comparison of tacrolimus (FK506) versus cyclosporine in liver transplantation: a report of the United States FK506 Study Group.

机译：他克莫司（FK506）与环孢霉素在肝移植中的长期比较：美国FK506研究小组的报告。

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BACKGROUND: The long-term (5 year) efficacy and safety of tacrolimus (FK506) and cyclosporine were compared in primary liver transplant recipients who participated in a 1-year randomized, multicenter trial and a 4-year follow-up extension study. METHODS: A total of 529 patients (263 tacrolimus group, 266 cyclosporine group) were randomized to study drug. Patients were evaluated at 3-month intervals. Patient and graft survival rates, incidence of adverse events, and changes in laboratory and clinical profiles were determined. RESULTS: Cumulative 5-year patient and graft survival rates were comparable for the tacrolimus (79.0%, 71.8%) and cyclosporine (73.1%, 66.4%) groups. However, patient half-life survival was longer for tacrolimus-treated patients (25.1+/-5.1 years versus 15.2+/-2.5 years; P=0.049). Improved patient survival with tacrolimus was also observed for hepatitis C-positive patients (78.9% tacrolimus group versus 60.5% cyclosporine group; P=0.041). Both treatments were associated with a low incidence of late acute rejection, late steroid-resistant rejection, and death or graft loss related to rejection. Both treatments demonstrated an acceptable safety profile with maintenance of adequate renal and liver function and a low incidence of malignancy/lymphoproliferative disease and serious infections. CONCLUSIONS: Tacrolimus is a safe and effective long-term maintenance immunosuppressive agent in primary liver transplantation.
机译：背景：比较了他克莫司（FK506）和环孢素的长期（5年）疗效和安全性，这些参与者参加了为期1年的随机，多中心试验和为期4年的随访扩展研究的原发性肝移植受者。方法：总共529例患者（他克莫司组263例，环孢素组266例）被随机分组​​研究药物。每三个月对患者进行一次评估。确定患者和移植物的存活率，不良事件的发生率以及实验室和临床特征的变化。结果：他克莫司（79.0％，71.8％）和环孢霉素（73.1％，66.4％）组的5年累积患者和移植物存活率相当。然而，他克莫司治疗的患者的半衰期存活时间更长（25.1 +/- 5.1年，而15.2 +/- 2.5年; P = 0.049）。他克莫司对丙型肝炎阳性患者的生存率也有所改善（他克莫司组为78.9％，而环孢霉素组为60.5％; P = 0.041）。两种治疗均与晚期急性排斥反应，晚期类固醇耐药性排斥反应以及与排斥反应相关的死亡或移植物丢失的发生率低相关。两种治疗均显示出可接受的安全性，并具有足够的肾和肝功能，恶性/淋巴增生性疾病和严重感染的发生率低。结论他克莫司是一种安全有效的长期维持免疫抑制剂，用于原发性肝移植。

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