84334
document
Antifungal prophylaxis during remission induction therapy for acute leukemia fluconazole versus intravenous amphotericin B . BACKGROUND Fungal infection is a frequent and often fatal complication in patients undergoing remission induction therapy for acute leukemia . Although candidiasis is the most common infection , mold infections are increasing in frequency . Fluconazole ( FLU ) is a new antifungal agent that has been used successfully to treat Candida infections and has modest activity against aspergillosis in animal models . Subtherapeutic doses of amphotericin B ( AMB ) have been considered effective as prophylaxis in these patients . This study was designed to compare the efficacy and toxicity of these agents as antifungal prophylaxis . METHODS Adults with acute leukemia undergoing remission induction chemotherapy randomly were assigned to receive antifungal prophylaxis with AMB ( 0.5 mg/kg three times weekly ) or FLU ( 400 mg daily ) . Trimethoprim-sulfamethoxazole was administered as an antibacterial prophylaxis . Prophylaxis was continued until the patient achieved complete remission or was treated for 8 weeks without antileukemic response . Prophylaxis was discontinued if the patient experienced a possible or proven fungal infection or a serious toxicity . RESULTS Overall , 58 % of the 36 patients assigned to AMB successfully completed prophylaxis compared with 80 % of the 41 patients assigned to FLU ( < 0.05 ) . Proven , probable , or possible fungal infections occurred in 31 % and 17 % of the patients , respectively . The risk of discontinuing prophylaxis due to fungal infection or toxicity increased with time in the study and was significantly greater for AMB ( P = 0.02 ) . CONCLUSIONS At the dose used in this study , AMB was no more effective and was more toxic than FLU for prophylaxis of fungal infections in patients undergoing remission induction chemotherapy for acute leukemia .
84335
Intervention_Pharmacological
versus intravenous amphotericin B
84336
Intervention_Pharmacological
Fluconazole ( FLU )
84337
Intervention_Pharmacological
amphotericin B ( AMB )
84338
Intervention_Pharmacological
antifungal prophylaxis with AMB ( 0.5 mg/kg three times weekly
84339
Intervention_Pharmacological
FLU
84340
Intervention_Pharmacological
Trimethoprim-sulfamethoxazole
84341
Intervention_Pharmacological
AMB
84342
Intervention_Pharmacological
FLU
84343
Intervention_Pharmacological
AMB
84344
Intervention_Pharmacological
FLU
84345
Outcome_Other
efficacy and toxicity
84346
Outcome_Physical
Proven , probable , or possible fungal infections
84347
Outcome_Physical
fungal infection
84348
Outcome_Physical
toxicity
84349
Outcome_Physical
fungal infections
84350
Participant_Condition
acute leukemia
84351
Participant_Condition
acute leukemia
84352
Participant_Sample-size
36 patients
84353
Participant_Sample-size
41 patients