Abstract: Objective To investigate the effiacy and safety of the treatment regimen containing the second-line anti-tuberculosis drugs. Methods154 patients with drug resistant pulmonary tuberculosis (PTB) (at least resistant to rifampicin) from different centers were assigned randomly to a study group which were treated by a regimen containing the second line antituberculosis drugs, and a control group which received a regimen recommended by NTP. Sputum smear conversion and X-ray changes were evaluated. Results154 PTB patients with rifampicin-resistance were enrolled, and 114 patients completed, 40 patients were dropped out(26 from the control group and 14 from the study group) without statistically significant difference(P>0.05). The rates of sputum smear negative conversion in the study group and in the control were 81.7% and 70.0% without statistically significant difference（P>0.05）. The rates of sputum smear negative conversion were 90.3% and 90.0％ respectively in the study group and the control group for patients with limited focus on chest X-ray（P>0.05）, However, we found that the rates of sputum negative conversion were significantly higher in the study group( 77.5%) compared with the control (52.2%) for patients with extensive foci on chest X-ray（P<0.05）. The absorption of foci on chest X-ray cannot be seen significant difference between two groups. 17 patients were seen side effects in the study group, and 8 in the control group wihout significant difference (P>0.05). ConclusionThe regimen which included the second-line anti-tuberculosis drugs had the same safety as which recommended by NTP, and perhaps it is more effective for untreated patients with drug resistance, and those with extensive foci on chest X-ray.

Key words: pulmonary tuberculosis/drug therapy, clinical protocols, rifampin, drug resistance, bacterial