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Randomized Trial of Ciclosporin with 2-h Monitoring *** with Trough Monitoring in Liver Transplantation:DELTA Study

journal of Clinical and Translational Hepatology 2023年第4期11卷 839-849页

作者： Bastian N.Ruijter Akin Inderson Aad Pvan den Berg Herold j.Metselaar j.roen dubbeld Maarten E.Tushuizen Robert j.Porte Wojciech Polak Danny van der Helm Marjolein van Reeven Mar Rodriguez-Girondo Bart van Hoek Department of Gastroenterology and Hepatology LUMC Transplantation CenterLeiden University Medical CenterLeidenThe Netherlands Department of Gastroenterology and Hepatology University Medical Center GroningenGroningenThe Netherlands Department of Gastroenterology and Hepatology Erasmus MC Transplant InstituteErasmus Medical CenterRotterdamThe Netherlands Department of Surgery LUMC Transplantation CenterLeiden University Medical CenterLeidenThe Netherlands Department of Surgery Section HPB Surgery and Liver TransplantationUniversity of GroningenUniversity Medical Center GroningenGroningenThe Netherlands Department of Surgery Division of HPB and Transplant SurgeryErasmus MC Transplant InstituteErasmus Medical CenterRotterdamThe Netherlands Department of Biomedical Data Sciences Leiden University Medical CenterLeidenThe Netherlands.

Background and Aims:Previous trials comparing cyclosporine and tacrolimus after liver transplantation(LT)showed conflicting *** used trough monitoring for cyclosporine(C0),leading to less accurate dosing than with 2-h monitoring(C2).Only one larger trial compared C2 with tacrolimus based on trough level(T0)after LT,with similar treated biopsy-proven acute rejection(tBPAR)and graft loss,while a smaller trial had less tBPAR with C2 compared to ***,it is still unclear which calcineurin inhibitor is preferred after *** aimed to demonstrate superior efficacy(tBPAR),tolerability,and safety of C2 or T0 after first ***:Patients after first LT were randomized to C2 or ***,patient-and graft survival,safety and tolerability were the main endpoints,with analysis by Fisher test,Kaplan-Meier survival analysis and log-rank ***:In intention-totreat analysis 84 patients on C2 and 85 on T0 were *** incidence of tBPAR C2 vs.T0 was 17.7%vs.8.4%at 3 months(p=0.104),and 21.9%vs.9.7%at 6 and 12 months(p=0.049).One-year cumulative mortality C2 vs.T0 was 15.5%vs.5.9%(p=0.049)and graft loss 23.8%vs.9.4%(p=0.015).Serum triglyceride and LDL-cholesterol was lower with T0 than with *** of diarrhea in T0 vs,C2 was 64%vs.31%(p≤0.001),with no other differences in safety and ***:In the first year after LT immunosuppression with T0 leads to less tBPAR and better patient-/re-transplant-free survival as compared to C2.

关键词： Adverse effects Ciclosporin Liver transplantation Outcome Randomized controlled trial Rejection Survival Renal function Tacrolimus

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