[Study on the efficacy and safety of short-term treatment including fluoroquinolones anti-tuberculosis drugs for rifampicin resistant pulmonary tuberculosis].

OBJECTIVE: To evaluate the efficacy and safety of short-term treatment including fluoroquinolones anti-tuberculosis drugs for rifampicin resistant pulmonary tuberculosis (TB) in those areas carrying out the 'TB control project'.

METHODS: TB cases involved in this study were from TB drug resistance surveillance in Heilongjiang province, Zhejiang province and Shenzhen city from 2004 to 2006. TB cases with rifampicin resistant were randomly divided into the treatment group (including fluoroquinolones anti-tuberculosis drugs group) and the control group (re-treatment regimen group). The treatment group was treated with 3RFT AM Ofx Pto PAS-INH/5RFT Ofx Pto PAS-INH while the control group was treated with 3 H3R3Z3E3S3/5 H3R3E3. Efficacy of short-term treatment was analyzed by per-protocol analysis (PP analysis) and intention-to-treat analysis (ITT analysis) while drug adverse reactions was also observed.

RESULTS: (1) 154 patients with rifampicin resistant pulmonary tuberculosis were recruited among them, 25 (16.2%) were only resistant to rifampicin, 114 (74.0%) to MDR-TB and 15 (9.8%) to others (resistant R+S, resistant R+E and resistant R+E+S). 114 TB cases completed the full course of treatment,with 71 in the treatment group and 43 in the control group. (2) Sputum negative conversion rate of the treatment group and the control group were 78.9% and 65.1% (chi2CMH = 4.558, P = 0.011) respectively, by per-protocol analysis. Sputum negative conversion rate of the treatment group and the control group were 65.9% and 40.6% (chi2CMH = 0.272, P = 0.001) respectively, by intention-to-treat analysis. The sputum negative conversion rate of the treatment group was higher than in the control group when treating rifampicin resistant pulmonary tuberculosis and MDR-TB patients. (3) Three patients withdrew in each of the two groups because of adverse effects to the drugs. Rates of adverse reaction to drugs appeared to be 23.9% (17/71) and 18.6% (8/43) in the treatment and in the control groups, with no statistically significant difference between the two groups.

CONCLUSION: The efficacy of treatment including fluoroquinolones anti-tuberculosis drugs group seemed better than the re-treatment regimen group in treating patients with rifampicin resistant pulmonary tuberculosis and those MDR-TB patients.