Administration of lipid-emulsion versus conventional amphotericin B in patients with neutropenia.
OBJECTIVE
To evaluate the usefulness of a 20% lipid emulsion as a delivery 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 the same time.


METHODS
A prospective, comparative, randomized, labeled study.


METHODS
Hematology unit, pharmacy service, university general hospital.


METHODS
Twenty patients with neutropenia with hematologic malignancies and proven or suspected fungal infections, 10 in the fat emulsion group (group 1) and 10 in the dextrose 5% group (group 2).


METHODS
Clinical tolerance (i.e., fever, shaking chills, 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 administration 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 group 1, 79.8 mg/dL in group 2). Statistically significant differences in creatinine serum concentrations (84.9 mumol/L in group 1, 123.8 mumol/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 the efficacy of both preparations.


CONCLUSIONS
The clinical tolerance of lipid-emulsion infusions is similar to that of conventionally administered amphotericin B therapy. Renal toxicity appears to be decreased when the drug is administered in a fat emulsion. This type of preparation permits the reduction of the volume and the time of administration for amphotericin B therapy.
Pascual
B
B
Department of Pharmacy, Hospital Valle de Hebron, Barcelona, Spain.
Ayestaran
A
A
Montoro
J B
JB
Oliveras
J
J
Estibalez
A
A
Julia
A
A
Lopez
A
A
D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005947:Glucose / Q000008:administration & dosage* / Q000009:adverse effects; D006402:Hematologic Diseases / Q000150:complications*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000150:complications / Q000188:drug therapy; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D012996:Solutions
D000935:Antifungal Agents; D005217:Fat Emulsions, Intravenous; D012996:Solutions; D000666:Amphotericin B; D005947:Glucose