passages: 1165
passages: document
passages: The prophylactic effect of itraconazole capsules and fluconazole capsules for systemic fungal infections in patients with acute myeloid leukemia and myelodysplastic syndromes : a Japanese multicenter randomized , controlled study . We performed a randomized , controlled study comparing the prophylactic effects of capsule forms of fluconazole ( n = 110 ) and itraconazole ( n = 108 ) in patients with acute myeloid leukemia ( AML ) or myelodysplastic syndromes ( MDS ) during and after chemotherapy . There were 4 cases with possible systemic fungal infection in the itraconazole group , and there were 8 possible and 3 probable cases in the fluconazole group . Adverse events did not significantly differ in the 2 groups . In patients with MDS or in the remission-induction phase of chemotherapy , the numbers of cases with probable or possible infections were lower in the itraconazole group than in the fluconazole group , whereas no difference was seen in patients with AML or in the consolidation phase of therapy . In patients with neutrophil counts of > 0.1 x 10 ( 9 ) /L lasting for more than 4 weeks , the frequency of infection in the fluconazole group ( 5 of 9 patients ) was significantly higher than in the itraconazole group ( 0 of 7 patients ; P = .03 ) . Our results suggest that both drugs were well tolerated in patients with AML or MDS who received chemotherapy and that the efficacy of itraconazole for prophylaxis against systemic fungal disease is not inferior to that of fluconazole .
entities: 1166
entities: Intervention_Pharmacological
entities: itraconazole
entities: 1167
entities: Intervention_Pharmacological
entities: fluconazole
entities: 1168
entities: Intervention_Pharmacological
entities: fluconazole
entities: 1169
entities: Intervention_Pharmacological
entities: itraconazole
entities: 1170
entities: Intervention_Pharmacological
entities: itraconazole
entities: 1171
entities: Intervention_Pharmacological
entities: fluconazole
entities: 1172
entities: Outcome_Adverse-effects
entities: Adverse events
entities: 1173
entities: Outcome_Physical
entities: probable or possible infections
entities: 1174
entities: Outcome_Physical
entities: frequency of infection
entities: 1175
entities: Participant_Condition
entities: patients with acute myeloid leukemia and myelodysplastic syndromes :
entities: 1176
entities: Participant_Condition
entities: Japanese
entities: 1177
entities: Participant_Condition
entities: patients with acute myeloid leukemia ( AML ) or myelodysplastic syndromes ( MDS ) during and after chemotherapy .
entities: 1178
entities: Participant_Condition
entities: patients with AML or MDS who received chemotherapy