Reduced-Dose Tacrolimus with Mycophenolate Mofetil vs. Standard-Dose Tacrolimus in Liver Transplantation: A Randomized Study

被引：136

作者：

Boudjema, K. ^{[1
]}

Camus, C. ^{[2
]}

Saliba, F. ^{[3
]}

Calmus, Y. ^{[4
]}

Salame, E. ^{[5
]}

Pageaux, G. ^{[6
]}

Ducerf, C. ^{[7
]}

Duvoux, C. ^{[8
]}

Mouchel, C. ^{[9
,10
]}

Renault, A. ^{[9
,10
]}

Compagnon, P. ^{[1
]}

Lorho, R. ^{[11
]}

Bellissant, E. ^{[9
,10
]}

机构：

[1] Univ Rennes 1, Serv Chirurg Hepatobiliaire & Digest, Hop Pontchaillou, Ctr Hosp Univ, Rennes, France

[2] Univ Rennes 1, Serv Malad Infect & Reanimat Med, Hop Pontchaillou, Ctr Hosp Univ, Rennes, France

[3] Univ Paris 11, Ctr Hepatobiliaire, Serv Hepatogastroenterol, Hop Paul Brousse,AP HP, Villejuif, France

[4] Univ Paris 05, Unite Fonct Transplantat Hepat, Hop Cochin, AP HP, Paris, France

[5] Univ Caen, Dept Chirurg Digest & Transplantat Hepat, Hop Cote de Nacre, Ctr Hosp Univ, F-14032 Caen, France

[6] Univ Montpellier I, Serv Hepatogastroenterol & Transplantat Hepat, Hop St Eloi, Ctr Hosp Univ, Montpellier, France

[7] Univ Lyon 1, Serv Chirurg Digest & Transplantat, Hop Croix Rousse, Hosp Civils Lyon, F-69365 Lyon, France

[8] Univ Paris 12, Hop Henri Mondor, AP HP, Serv Hepatogastroenterol, F-94010 Creteil, France

[9] Univ Rennes 1, Serv Pharmacol Clin, Hop Pontchaillou, Ctr Hosp Univ, Rennes, France

[10] Univ Rennes 1, Ctr Invest Clin, INSERM 0203, Hop Pontchaillou,Ctr Hosp Univ, Rennes, France

[11] Univ Rennes 1, Serv Malad Foie, Hop Pontchaillou, Ctr Hosp Univ, Rennes, France

来源：

AMERICAN JOURNAL OF TRANSPLANTATION | 2011年 / 11卷 / 05期

关键词：

Diabetes mellitus; graft rejection; hypertension; immunosuppression; mycophenolate mofetil; renal insufficiency; tacrolimus; CHRONIC-RENAL-FAILURE; CALCINEURIN INHIBITORS; DIABETES-MELLITUS; CYCLOSPORINE; RECIPIENTS; FK506; IMPACT; RISK;

D O I：

10.1111/j.1600-6143.2011.03486.x

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

We conducted a multicenter randomized study in liver transplantation to compare standard-dose tacrolimus to reduced-dose tacrolimus with mycophenolate mofetil to reduce the occurrence of tacrolimus side effects. Two primary outcomes (censored criteria) were monitored during 48 weeks post-transplantation: occurrence of renal dysfunction or arterial hypertension or diabetes (evaluating benefit) and occurrence of acute graft rejection (evaluating risk). Interim analyses were performed every 40 patients to stop the study in the case of increased risk of graft rejection. One hundred and ninety-five patients (control: 100; experimental: 95) had been included when the study was stopped. Acute graft rejection occurred in 46 (46%) and 28 (30%) patients in control and experimental groups, respectively (HR = 0.59; 95% CI: [0.37-0.94]; p = 0.024). Renal dysfunction or arterial hypertension or diabetes occurred in 80 (80%) and 61 (64%) patients in control and experimental groups, respectively (HR = 0.68; 95% CI: [0.49-0.95]; p = 0.021). Renal dysfunction occurred in 42 (42%) and 23 (24%) patients in control and experimental groups, respectively (HR = 0.49; 95% CI: [0.29-0.81]; p = 0.004). Leucopoenia (p = 0.001), thrombocytopenia (p = 0.017) and diarrhea (p = 0.002) occurred more frequently in the experimental group. Reduced-dose tacrolimus with mycophenolate mofetil reduces the occurrence of renal dysfunction and the risk of graft rejection. This immunosuppressive regimen could replace full-dose tacrolimus in adult liver transplantation.

引用

页码：965 / 976

页数：12

共 27 条

[1] Posttransplant diabetes mellitus in liver transplant recipients: Risk factors, temporal relationship with hepatitis C virus allograft hepatitis, and impact on mortality [J].