Alternative treatment regimens for pulmonary tuberculosis
To evaluate the effectiveness of other modes of treatment of pulmonary tuberculosis (or treatment regimens with separate use of drugs), in which various anti-tuberculosis drugs are used on different days, a randomized controlled clinical trial was conducted in 1,269 patients with positive results in sputum smear tests.
The patients were randomly assigned to the following groups:
Alternative scheme 1 (2RE (3) HZ (3) (alt) / 4RH (2)), 407 patients: rifampicin + ethambutol once a day and isoniazid + pyrazinamide the next day for the first 2 months treatment, then rifampicin + isoniazid 2 times a week for 4 months;
Alternative regimen 2 (3RE (3) HZ (3) (alt) / 3RH (2)), 415 patients: similar to separate regimen 1, except for the duration of each phase of treatment - in this scheme it was 3 months;
Mode 3 (2REHZ (3) / 4RH (2)) (control group), 418 patients: rifampicin + ethambutol + isoniazid + rifampicin 3 times a week during the first 2 months of treatment, then rifampicin + isoniazid 2 times a week for 4 months.
All patients underwent a clinical and bacteriological examination monthly for 2 years, then once in 6 months for the next 3 years (the total duration of observation of the patients was 5 years).
A favorable treatment result, defined as the absence of mycobacteria in the smears during the last 2 months of treatment, was observed in 91% of patients in group 1, 94% of patients in group 2 and 89% of patients in the a group of witnesses. At the end of the 5-year follow-up period, sputum smears remained negative in 91% of patients in group 1, 93% of patients in group 2 and 90% of patients in the control group.
Adverse effects were observed in 10% of patients in the 1st group, 15% in the 2nd group and 14% of patients in the control group. The NLR of the gastrointestinal tract was recorded much less frequently in patients receiving alternate treatment regimens (p = 0.01).
Thus, alternative treatment regimens for pulmonary tuberculosis (or treatment regimens with separate use of drugs) are not less effective than standard treatment regimens for this disease, but less likely to cause adverse drug reactions.