ABSTRACT
BACKGROUND/AIMS: The purpose of this study was to evaluate the efficacy of a steroid-free immunosuppression protocol. METHODS: 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. RESULTS: 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). CONCLUSIONS: Immunosuppression without steroids is safe and reduces infection and metabolic complications.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Cyclosporine/therapeutic use , Hepatitis C/drug therapy , Hepatitis C/etiology , Immunosuppression Therapy/methods , Immunosuppressive Agents/therapeutic use , Liver Transplantation/adverse effects , Prednisone/therapeutic use , Recombinant Fusion Proteins/therapeutic use , Adult , Aged , Antibodies, Monoclonal/immunology , Basiliximab , Cyclosporine/immunology , Diabetes Mellitus/etiology , Diabetes Mellitus/physiopathology , Drug Therapy, Combination , Female , Graft Rejection , Graft Survival , Hepacivirus/immunology , Hepatitis C/mortality , Hepatitis C/surgery , Humans , Hypertension/etiology , Hypertension/physiopathology , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/immunology , Liver/chemistry , Liver/pathology , Liver/virology , Liver Transplantation/immunology , Liver Transplantation/mortality , Male , Middle Aged , Prednisone/immunology , Prospective Studies , Recombinant Fusion Proteins/immunology , Recurrence , Steroids/immunology , Steroids/therapeutic use , Survival Rate , Treatment OutcomeABSTRACT
The best system for organ allocation is still a controversial issue. The aim of this study was to study the accuracy of four different scores to predict mortality on the waiting list and, thus, their usefulness to determine organ allocation. We retrospectively compared two groups of patients, those who died on waiting list (group D) and those who successfully underwent transplantation (group T) during the same time period. Four scores, at the time of entering the waiting list and just before liver transplantation or death, were evaluated. The evaluated scores were as follows: (1) the Child-Pugh classification; (2) the Model for End-Stage Liver Disease (MELD) score; (3) the Freeman scale; and (4) the Guardiola et al index. The mortality rate on waiting list was 15.9%. All studied scores, except Freeman scale, were higher in group D at the time of entrance on waiting list (MELD, 17.4 +/- 8 v 12.3 +/- 6, P = .02; Child, 9.9 +/- 2 v 7.7 +/- 2, P = .002; Freeman, 9.7 +/- 4 v 7.3 +/- 3.9, P = .09; Guardiola, 2.6 +/- 0.9 v 1.7 +/- 0.7, P = .001). C-statistics of all scores were similar and in all cases lower than 0.8 (MELD, 0.75; Child, 0.78; Freeman, 0.65; Guardiola, 0.79). None of the studied scores have an excellent accuracy to predict prognosis of patients on waiting list, mainly in case of populations with high proportion of hepatocellular carcinoma. Although the MELD score is rapidly available, standardized, and objective, it does not reflect the severity of patients with cancer or metabolic disorders.
