Treatment of patients with isoniazid-resistant pulmonary tuberculosis using an adjuvant therapy
The purpose of the study was to assess the efficacy of glutamyl-cysteinyl-glycine disodium (Glu) as adjuvant therapy in patients with isoniazid resistant pulmonary tuberculosis. Methods. This was a randomized placebo-controlled blind study. The study involved 67 patients who was randomly assigned to the treatment with Glu and antituberculosis cchemotherapy (group 1; n = 23), or placebo (group 2; n = 10), or antituberculosis chemotherapy (group 3; n = 34). All patients were positive for M. tuberculosis (MBT). The treatment included a standard intensive chemotherapy in a hospital (DOTS strategy) during 5 months (2S 3-5HRZE/5RSE). Glu was administered intramuscularly in the dose of 60 mg once daily during 10 days followed by 60 mg once daily every other day during 20 days; the total course included 20 doses. Results. Single-drug resistant MBT was detected in 26.1%, 20.0%, and 8.8% of patients in groups 1, 2, and 3, respectively. Multiple drug resistance was detected in 73.9%, 77.8%, and 91.2%, respectively. Sputum conversion was achieved in 26.1%, 52.2%, and 21.7% of group 1 patients in one, two and three months of the treatment, respectively. Sputum conversion in group 2 was achieved over 3 months of the treatment only (n = 3 at 3 months, n = 4 at 4 months, and n = 2 at 5 months); two patients were still MBT-positive to the end of the treatment. In group 3, sputum conversion was achieved in 18 patients (53.0 %) at 3 months, in 6 patients (18%) at 4 months, and in 5 patients (14.7%) at 5 months; 5 patients remained MBT-positive to the end of the treatment. Median time to sputum conversion was 62, 114, and 100 days in groups 1, 2, and 3, respectively. Conclusion. The adjuvant treatment with Glu in patients with isoni-azid-resistant pulmonary tuberculosis was associated with earlier sputum conversion. This strategy can shorten the duration of the intensive treatment.