Is Minimal, [Almost] Steroid-Free Immunosuppression a Safe Approach in Adult Liver Transplantation? Long-term Outcome of a Prospective, Double Blind, Placebo-Controlled, Randomized, Investigator-Driven Study
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Citações na Scopus
47
Tipo de produção
article
Data de publicação
2014
Editora
LIPPINCOTT WILLIAMS & WILKINS
Indexadores
Título da Revista
ISSN da Revista
Título do Volume
Autores
LERUT, Jan P.
LAI, Quirino
STOUFFS, Valentine
ORLANDO, Giuseppe
JURI, Juan Manuel Rico
CICCARELLI, Olga
SEMPOUX, Christine
ROGGEN, Francine M.
REYCK, Chantal De
Autor de Grupo de pesquisa
Editores
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Organizadores
Citação
ANNALS OF SURGERY, v.260, n.5, p.886-892, 2014
Resumo
Objective: To investigate the safety of minimal immunosuppression (IS) in liver transplantation (LT). Background: The lack of long-term follow-up studies, including pathologic data, has led to a protean handling of IS in LT. Methods: Between February 2000 and September 2004, 156 adults were enrolled in a prospective, randomized, double-blind, placebo-controlled minimization trial comparing tacrolimus placebo (TAC-PLAC) and TAC short-term steroid (TAC-STER) IS. All patients had a minimum clinical, biochemical, and histological follow-up of 5 years. Results: Five-year actual patient and graft survival rates in TAC-PLAC and TAC-STER groups were 78.1% and 82.1% (P = 0.89) and 74.2% and 76.9% (P = 0.90), respectively. Five-year biopsies were available in 112 (89.6%) of 125 survivors. Twelve patients refused a biopsy because of their excellent evolution; tissue material was insufficient in 1 patient; 11 had normal liver tests; and 2 patients had developed alcoholic and secondary biliary cirrhosis. Histology was normal in 44 (39.3%) patients; 35 (31.3%) had disease recurrence. The remaining biopsies showed nonspecific chronic hepatitis (14.3%), mild inflammatory infiltrates (10.7%), and steatosis (3.5%). All findings were equally distributed between both groups. In each group, 3 patients (4.8%) presented with acute cellular rejection after the first year and only 1 (0.9%) TAC-PLAC patient developed chronic rejection after IS withdrawal because of pneumonitis. Arterial hypertension, diabetes mellitus, renal insufficiency, hypercholesterolemia, gout, and obesity were equally low in both groups. Conclusions: Excellent long-term results can be obtained under minimal IS and absence of steroids. TAC-based monotherapy is feasible in most adult liver recipients until 5 years of follow-up.
Palavras-chave
immunosuppression, liver transplantation, long-term, pathology, steroids
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