Background: To evaluate the efficacy and pharmacological safety of 2 therapeutic trials with fluconazole in candida esophagitis in AIDS patients.
Methods: A total of 75 episodes of candida esophagitis in 70 AIDS patients were included in an open prospective study. In group I 36 patients were included who received 200 mg of fluconazole orally the first day followed by 100 mg daily for 4 weeks. In group II (34 patients) the length of treatment was reduced to 10 days with the same daily doses. Therapeutic response was evaluated by esophagoscopy, biopsy and fungal culture.
Results: The protocol was completed at 68 episodes with a cure being obtained in all but 2 patients in group II. No significant differences in clinical response were found between the 2 groups. The incidence of oropharyngeal colonization at the end of treatment was greater in patients from group I than from group II (43% vs 11%). Fluconazole was well tolerated in all the patients. A slight alteration of the hepatic enzymes was observed in 29 cases (40%) with a lower incidence in the shorter time group (p less than 0.001), however, treatment was discontinued only in 1 patient because of severe asymptomatic hepatic dysfunction to which a relation with the drug is unclear.
Conclusions: Fluconazole in an efficient and safe agent in the treatment of candida esophagitis in AIDS patients. A 10 day treatment is a useful as longer treatment and has a lower risk of adverse effects.