A nine-month chronic XXXX study of tegafur- @entity5537 mixture (UFT) in @entity235 .

@entity137 @entity146 @entity235 @entity16229 @entity5537 @entity1487
In order to evaluate the long-term-safety of UFT which contained tegafur [ @entity16229 , @entity16229 ] and @entity5537 in molar ratio of 1:4, a nine-month chronic @entity137 study was performed in @entity235 . In doses of 9.7 (as @entity16229 : 3 mg/kg), 16.2 (as @entity16229 : 5 mg/kg) and 24.3 (as @entity16229 :7.5 mg/kg) mg/kg, UFT was administered orally in both sexes of @entity235 once a day for 9 months and withdrawn for 1 month. Three control drugs, @entity16229 , @entity5537 and @entity1487 , were also included in present experiment at doses of 7.5, 420.0 and 5.0 mg/kg, respectively. In this study, the two types of @entity146 and symptoms were observed in UFT, @entity16229 and @entity1487 . The first type was the acute and/or dynamic signs and the other type was the chronic and/or static signs. Slight decrease in food consumption was observed in males at the dose levels of 24.3 mg/kg of UFT group and in both sexes of @entity1487 group. In the ECG test, high T-wave was observed in some males treated with UFT, @entity16229 and @entity1487 . Histopathologically, micro-vacuolizations were observed in various portions of the cerebrum in both survived and dead animals treated with UFT, @entity16229 and @entity1487 . After one month recovery period, significant changes were not observed in various examinations, but morphological changes in the cerebrum had been remained. In conclusion, it seemed that the maximum safety dose of UFT in @entity235 were the 9.7 mg/kg for males and less than 9.7 mg/kg for females.
