Pelletier S J, Vanderwall K, Debroy M A, Englesbe M J, Sung R S, Magee J C, Fontana R J, Punch J D
Department of Surgery, University of Michigan, Ann Arbor, Michigan 48109-0331, USA.
Transplant Proc. 2005 Mar;37(2):1214-6. doi: 10.1016/j.transproceed.2004.12.153.
Steroids are a mainstay in liver transplantation for induction and maintenance immunosuppression but are associated with significant adverse effects. While prior studies have successfully limited the use of steroids, whether complete steroid avoidance will improve outcomes remains unclear. To further evaluate the need for steroids, consenting patients who underwent liver transplantation between June 2002 and May 2004 were entered into a prospective, randomized trial to receive either standard therapy (tacrolimus, mycophenolate mofetil, steroid induction/maintenance) or complete steroid avoidance (standard therapy without steroid induction/maintenance). Clinically suspected rejection was confirmed by biopsy and treated with pulse steroid therapy. Outcomes were compared on an intention to treat basis. Of the 72 patients enrolled, 36 (50%) were randomized to the steroid avoidance group with a mean follow up of 412 +/- 41 days. Donor and recipient characteristics were similar between groups. The steroid avoidance group was more likely to have significant infections (52% vs 28%, P = .03). There was a trend toward an increased rate of acute rejection (25% vs 14%, P = .23). Twelve of 36 recipients (33%) enrolled in the steroid avoidance group later received steroids. The incidence of recurrent hepatitis C was similar between groups. The 1-year patient (90% vs 83%, P = .44) and graft survivals (90% vs 81%, P = .27) were similar between groups. These data suggest complete steroid avoidance in liver transplantation results in acceptable patient and graft survival. However, the potential long-term benefits of steroid avoidance, including a decrease in severity of recurrent hepatitis C, remain under investigation.
类固醇是肝移植中诱导和维持免疫抑制的主要药物，但会产生显著的不良反应。虽然先前的研究已成功限制了类固醇的使用，但完全避免使用类固醇是否会改善预后仍不清楚。为了进一步评估类固醇的必要性，2002年6月至2004年5月期间接受肝移植的自愿患者被纳入一项前瞻性随机试验，接受标准治疗（他克莫司、霉酚酸酯、类固醇诱导/维持）或完全避免使用类固醇（无类固醇诱导/维持的标准治疗）。临床疑似排斥反应通过活检确诊，并用脉冲类固醇疗法治疗。在意向性治疗的基础上比较结果。在72名入组患者中，36名（50%）被随机分配到避免使用类固醇组，平均随访412±41天。两组之间的供体和受体特征相似。避免使用类固醇组更易发生严重感染（52%对28%，P = 0.03）。急性排斥反应发生率有增加趋势（25%对14%，P = 0.23）。避免使用类固醇组的36名受体中有12名（33%）后来接受了类固醇治疗。两组之间丙型肝炎复发率相似。两组之间1年患者生存率（90%对83%，P = 0.44）和移植物生存率（90%对81%，P = 0.27）相似。这些数据表明，肝移植中完全避免使用类固醇可使患者和移植物生存率达到可接受水平。然而，避免使用类固醇的潜在长期益处，包括丙型肝炎复发严重程度的降低，仍在研究中。
