Lladó Laura, Xiol Xavier, Figueras Joan, Ramos Emilio, Memba Roberto, Serrano Teresa, Torras Jaume, Garcia-Gil Agustin, Gonzalez-Pinto Ignacio, Castellote Jose, Baliellas Carme, Fabregat Joan, Rafecas Antoni
Department of Surgery, Liver Transplant Unit, Hospital Universitari de Bellvitge, IDIBELL, 08907 Barcelona, Spain.
J Hepatol. 2006 Apr;44(4):710-6. doi: 10.1016/j.jhep.2005.12.010. Epub 2006 Jan 24.
BACKGROUND/AIMS: The purpose of this study was to evaluate the efficacy of a steroid-free immunosuppression protocol.
From 2001 to 2004, 198 liver-transplant patients were randomized to receive immunosuppression with Basiliximab and cyclosporine, with (St Group) or without (NoSt Group) prednisone. The primary end points were acute rejection, and patient and graft survival. The secondary end points were infection, metabolic complications, and hepatitis C-virus recurrence.
Overall rejection rate was 15%, with no differences (St: 13% vs NoSt: 18%; P=0.33). Infection rate was similar in both groups (St: 51% vs NoSt: 47%; P=0.56), but diabetic patients in the St Group had a significantly higher rate of bacterial infections (St: 54% vs NoSt: 14%; P=0.005). The six-month protocol biopsies showed hepatitis C recurrence in 90% of patients, without differences between groups. Hypertension was more frequent in the St Group (St: 44% vs NoSt: 25%; P=0.006). De novo diabetes rate was higher in the St Group (month 1: St: 29% vs NoSt: 18%; P=0.06), with higher glycatedHb (5.1+/-1.1 vs 4.4+/-0.8; P=0.002). Six-month survival rates were similar (St: 89% vs NoSt: 94%, P=0.62).
Immunosuppression without steroids is safe and reduces infection and metabolic complications.
背景/目的：本研究旨在评估无类固醇免疫抑制方案的疗效。
2001年至2004年，198例肝移植患者被随机分为接受巴利昔单抗和环孢素免疫抑制治疗组，其中一组（St组）加用泼尼松，另一组（NoSt组）不加用泼尼松。主要终点为急性排斥反应、患者及移植物存活率。次要终点为感染、代谢并发症及丙型肝炎病毒复发。
总体排斥率为15%，两组无差异（St组：13% vs NoSt组：18%；P = 0.33）。两组感染率相似（St组：51% vs NoSt组：47%；P = 0.56），但St组糖尿病患者细菌感染率显著更高（St组：54% vs NoSt组：14%；P = 0.005）。6个月方案活检显示90%的患者出现丙型肝炎复发，两组间无差异。St组高血压更为常见（St组：44% vs NoSt组：25%；P = 0.006）。St组新发糖尿病率更高（第1个月：St组：29% vs NoSt组：18%；P = 0.06），糖化血红蛋白更高（5.1±1.1 vs 4.4±0.8；P = 0.002）。6个月存活率相似（St组：89% vs NoSt组：94%，P = 0.62）。
无类固醇免疫抑制是安全的，可减少感染和代谢并发症。
