Boillot O, Baulieux J, Wolf P, Messner M, Cherqui D, Gugenheim J, Pageaux G, Belghiti J, Calmus Y, Le Treut Y, Neau-Cransac M, Samuel D
Hôpital Edouard Herriot, Lyon, Hôpital Croix-Rousse, Lyon, France.
Clin Transplant. 2001 Jun;15(3):159-66. doi: 10.1034/j.1399-0012.2001.150303.x.
We studied the outcome of 345 liver transplant patients who received tacrolimus-based immunosuppressive therapy either as a dual regimen (with corticosteroids, n=172) or as a triple regimen (with corticosteroids and azathioprine, n=173) for 3 months after transplantation (3-month cohort). A further analysis was conducted for the first 195 patients randomised (dual n=100, triple n=95) who were followed up for 12 months after transplantation (12-month cohort). For the 3-month cohort, patient survival was 90.7% (dual) and 91.9% (triple), graft survival after 3 months was 88.4% (dual therapy) and 89.6% (triple therapy). Acute rejections were experienced by 67/172, 39.0% of patients on dual therapy and by 60/173, 34.7% of patients on triple therapy; corticosteroid-resistant rejections were reported in 9 patients (5.2%) in either treatment group. The overall safety profile was similar for the two treatment groups. Significant differences, however, were found for thrombocytopenia (dual 13/172, 7.6%, triple 37/173, 21.4%, p<0.001) and leukopenia (dual 4/172, 2.3%, triple 24/173, 13.9%, p<0.001). For the 12-month cohort, patient survival was 85.6% (dual) and 88.4% (triple) after 1 year. Graft survival was 81.7% (dual) and 85.2% (triple) 12 months after transplantation. Acute rejections were reported for 38/100, 38.0% of patients on dual therapy and 36/95, 37.9% of patients on triple therapy, corticosteroid-resistant rejections were 7/100, 7.0% (dual) and 7/95, 7.4% (triple) of patients. In the 12-month cohort, no significant differences in the safety profiles of the treatment groups were found. We conclude that both tacrolimus-based dual and triple drug regimens provide effective and safe immunosuppression following orthotopic liver transplantation.
我们研究了345例接受以他克莫司为基础的免疫抑制治疗的肝移植患者的预后情况。这些患者在移植后3个月采用双药方案（联合皮质类固醇，n = 172）或三药方案（联合皮质类固醇和硫唑嘌呤，n = 173）进行治疗（3个月队列）。对随机分组的前195例患者（双药方案组n = 100，三药方案组n = 95）进行了进一步分析，这些患者在移植后随访12个月（12个月队列）。对于3个月队列，患者生存率为90.7%（双药方案组）和91.9%（三药方案组），3个月后的移植物生存率为88.4%（双药治疗）和89.6%（三药治疗）。双药治疗组中67/172例（39.0%）患者发生急性排斥反应，三药治疗组中60/173例（34.7%）患者发生急性排斥反应；两个治疗组均有9例患者（5.2%）报告发生对皮质类固醇耐药的排斥反应。两个治疗组的总体安全性概况相似。然而，在血小板减少症方面发现了显著差异（双药方案组13/172例，7.6%；三药方案组37/173例，21.4%，p<0.001）以及白细胞减少症方面（双药方案组4/172例，2.3%；三药方案组24/173例，13.9%，p<0.001）。对于12个月队列，1年后患者生存率为85.6%（双药方案组）和88.4%（三药方案组）。移植12个月后的移植物生存率为81.7%（双药方案组）和85.2%（三药方案组）。双药治疗组中38/100例（38.0%）患者报告发生急性排斥反应，三药治疗组中36/95例（37.9%）患者报告发生急性排斥反应，对皮质类固醇耐药的排斥反应在双药方案组患者中占7/100例（7.0%），在三药方案组患者中占7/95例（7.4%）。在12个月队列中，未发现治疗组在安全性概况方面存在显著差异。我们得出结论，以他克莫司为基础的双药和三药方案在原位肝移植后均能提供有效且安全的免疫抑制作用。
