[Randomized control study on domestic fixed-dose combinations in the initial treatment of smears positive...

To explore the feasibility of domestic fixed-dose combinations as antituberculosis therapy applied in the National Tuberculosis Program.

A randomized control trial was conducted and 422 smear-positive pulmonary tuberculosis patients were randomly distributed into 2 groups. The trial group was treated daily with rifampicin, isoniazid and pyrazinamide tablets (including 120 mg rifampicin, 80 mg isoniazid and 250 mg pyrazinamide) in the first 2 months and rifampicin and isoniazid tables (including 300 mg rifampicin, 150 mg isoniazid) in the subsequent 4 months. The control group was treated by full 6-month standard regimens (2HRZE/4H3R3).

The demographic data and the disease status were similar between the 2 groups before treatment. The rate of conversion from positive to negative cases in the trial group after therapy was 91.6% at 2 months, 97.2% at 3 months, and 97.7% at 6 months, while that of the control group was 87.3%, 97.5%, and 98.0% respectively. The difference in the conversion rates between the two groups was not statistically significant (chi2 = 2. 05, chi2 = 0.03, chi2 = 0.04, P > 0.05). The incidence of skin rash as an adverse effect was less common in the trial group as compared to the control group (Fisher's exact P = 0.024 33) .

Domestic fixed-dose combinations as supplementary anti-tuberculous therapy could be used in the National Tuberculosis Program, but further study is needed for widespread application.