Abstract:

A retrospective analysis was conducted in 167 patients with re-treatment smear-positive pulmonary tuberculosis (PTB), who received anti-TB treatment at the Center for Tuberculosis Control and Prevention of Yingkou City Center for Disease Control and Prevention from March 2014 to December 2015. Out of those 167 patients, 116 patients received treatment of fixed-dose combination (FDC) anti-TB drugs; among 116 patients, 51 patients were treated by using levofloxacin combined with FDC (namely “combination treatment group”) while 65 patients were treated by using FDC. Out of 51 patients, 2 patients were confirmed to be drug-resistant PTB and their treatment regiments were changed and then excluded from this study, so finally 49 patients with smear-positive PTB were remaining in the combination treatment group. Another forty-nine patients with smear-positive PTB were randomly selected from 65 patients, who received FDC treatment, by using random number table method and as the “FDC treatment group”. The patients in the FDC treatment group received FDC treatment (3 isoniazid+rifampicin+pyrazinamide+ethambutol/6 isoniazid+rifampicin+ethambutol), while the patients in the combination treatment group received treatment of FDC combined with levofloxacin. In the combination treatment group, the sputum negative conversion rate, lesion absorption rate and cavity reduction rate of the patients at 2 months, 5 months and 8 months of treatment were 75.5% (37/49), 81.6% (40/49), 83.7% (41/49), 77.6% (38/49), 73.5% (36/49) respectively, the rates were much higher than those in the FDC treatment group (51.0% (25/49), 63.3% (31/49), 65.3% (32/49), 57.1% (28/49), 53.1% (26/49)). The difference of those rates between the two groups was statistically significant (χ² values were 6.32, 4.14, 4.35, 4.64, 4.39; P values were 0.012, 0.042, 0.037, 0.030, 0.036). The incidence of adverse reactions in the combination treatment group was 18.4% (9/49), and it was no significant difference compared with that in the FDC treatment group (26.5% (13/49)) (χ²=1.10, P=0.896). So this study showed that the treatment outcomes obviously improved by using FDC combined with levofloxacin in smear-positive pulmonary tuberculosis patients and it might be valuable to expand this chemotherapy method at the grassroots level.

Key words: Tuberculosis, pulmonary, Drug combinations, Ofloxacin, Drug therapy, combination, Comparative effectiveness research