We analyzed the relation between FK506 trough levels (ELISA: patients
1-41, IMx: patients 42-70) and rejection and/or viral infection episod
es, retrospectively, in the first 70 consecutive cases of living relat
ed liver transplantation. Twenty patients (28.6%) had rejection episod
es. Of the 13 patients who had evidence of rejection during the first
3 months, 6 patients without infection and 7 patients with viral infec
tion showed low concentrations of FK506 (<5 ng/ml), Twelve patients we
re treated and improved with high dose steroid administration and an i
ncrease in the FK506 dosage. One patient died of refractory rejection.
Nine patients had evidence of rejection after the first 3 months, In
3 patients, weaning from FK506 initiated the rejection episodes, Five
patients repeated rejection and 4 patients required a third immunosupp
ressant (azathioprine). Viral infection included CMV (11 cases), EBV (
13 cases), HZV (3 cases), and HSV (1 case). Excess immunosuppression m
ight have been the cause, but no clear correlation was found. We propo
se that the optimal dosage of FK506 obtained by monitoring the trough
levels using the IMx method should maintain a 10-20 ng/ml level during
the first month, and a 5-10 ng/ml level at the second and third month
s.