ADMINISTRATION OF LIPID-EMULSION VERSUS CONVENTIONAL AMPHOTERICIN-B IN PATIENTS WITH NEUTROPENIA

OBJECTIVE: To evaluate the usefulness of a 20% lipid emulsion as a del ivery system for amphotericin B (1 mg/mL) administered over 1 hour to patients with neutropenia with hematologic malignancies compared with amphotericin B (0.1 mg/mL) administered in dextrose 5% solution over t he same time. DESIGN: A prospective, comparative, randomized, labeled study. SETTING: Hematology unit, pharmacy service, university general hospital. PARTICIPANTS: Twenty patients with neutropenia with hematolo gic malignancies and proven or suspected fungal infections, 10 in the fat emulsion group (group 1) and 10 in the dextrose 5% group (group 2) . MAIN OUTCOME MEASURES: Clinical tolerance (i.e,, fever, shaking chil ls, nausea, blood pressure, pulse rate) and biologic tolerance (i.e., urea, creatinine, sodium, potassium). RESULTS: Clinical tolerance was comparable in both groups although amphotericin B in fat emulsion was better tolerated. Medication for symptoms related to the administratio n of amphotericin B was given in 6 cases in group 1 and in 8 cases in group 2, There was a statistically significant difference in the urea concentrations between the 2 groups (p = 0.023); there was an observed increase between the initial and the final serum urea (56.8 mg/d in g roup 1, 79.8 mg/dL in group 2), Statistically significant differences in creatinine serum concentrations (84.9 mu mol/L in group 1, 123.8 mu mol/L, in group 2) (p = 0.047) were found. No differences were found in the antifungal efficacy of the treatment. However, as amphotericin B was started in the majority of cases (75%) as empiric treatment for fever unresponsive to antibiotic therapy, it is difficult to compare t he efficacy of both preparations. CONCLUSIONS: The clinical tolerance of lipid-emulsion infusions is similar to that of conventionally admin istered amphotericin B therapy. Renal toxicity appears to be decreased when the drug is administered in a fat emulsion. This type of prepara tion permits the reduction of the volume and the time of administratio n for amphotericin B therapy.