A comparative study of itraconazole in various dose schedules in the treatment of pulmonary aspergilloma in treated patients of pulmonary tuberculosis.

Abstract

Introduction:The optimal dose, duration, and efficacy of itraconazole in Indian patients of pulmonary aspergilloma (PA) are not clearly defined. Therefore, a study was carried out, to resolve these issues in diagnosed cases of PA complicating old treated patients of pulmonary tuberculosis.Materials and Methods:The study patients randomly received itraconazole either in a fixed dose schedule of 200 mg (group I), 200 mg twice daily (group II) or a variable dose schedule (group III), for 12 months. All the patients were followed up for the entire duration of the study for clinical, radiological, and immunological response. The side effects were recorded as and when reported by the patients and managed symptomatically.Results:A total of 60 patients were enrolled, 20, in each group. There were no intergroup differences with regard to age, sex, body weight, smoking status, alcohol intake, symptoms, Potassium hydroxide (KOH) mount, fungal culture, pattern of radiological lesions or anti-aspergillus antibodies (anti-Asp-Ab) titers. The radiological response was poor in group I patients, as compared to the other groups, at two months (P < 0.05). The dose of itraconazole was increased in five of the patients in group I due to poor response. A higher number of group II patients suffered side effects and the dose of itraconazole had to be decreased in three of these patients, but none of the patients on a variable dose schedule required a change in dose schedule.Conclusion:Thus, a weight-based variable dose schedule of itraconazole was found to be a more effective and safer modality in the management of PA than a fixed dose schedule.