Abstract: Objective To assess antituberculosis efficacy and adverse events of domestic four-drug fixed-dose combination in smear positive pulmonary tuberculosis under the management of directly observed treatment short-course (DOTS).  Method Two hundreds and twenty-five new patients with smear positive pulmonary tuberculosis were randomly divided into a treatment group (2yinuonikang/4yifu capsule) and a control group (2HRZE/4HR) to observe rates of sputum negative conversion in short time, chest X-ray improvement and advert events.  Result The sputum negative conversion rates in the treatment group and the control were 94.6% and 93.8% at the 2nd month, and 99.1% and 96.5% at the end of treatment. Chest radiography showed remarkable improvement of lesions. The foci absorption rate in the treatment group and the controls were 98.2% and 97.4%, respectively, and the cavity closure rates were 72.2% in the treatment group and 56.4% in the controls. Hepatic dysfunction was seen among 4 cases in the treatment group and 3 cases in the controls.  Conclusion Domestic four-drug fixed-dose combination shows an excellent therapeutic efficacy, safety and good compliance in antituberculous chemotherapy which could be recommended widely in tuberculosis control in China.

Key words: tuberculosis, pulmonary/ drug therapy, antitubercular agents, fixed-dose combination