Abstract: ObjectiveTo evaluate the efficacy and safety of long course chemotherapy regimens combined with immunopotentiator in the treatment of multi-drug resistant pulmonary tuberculosis. MethodsDuring 18 months treatment, 203 patients with multi-drug resistant pulmonary tuberculosis were randomized 1∶1 to a treatment group (rifapentine,pasiniazide,levofloxacin,ethambutol,ethionamide,amikacin, clarithromycin and M. vaccae for 3 months, followed by rifapentine, pasiniazide, levofloxacin, ethambutol, ethionamide, clarithromycin and M. vaccae for 6 months, and rifapentine, pasiniazide, levofloxacin, ethambutol, clarithromycin for 9 months), and a control group (the same chemotherapy regimen alone,without M. vaccae). ResultsAt the end of the treatment, the sputum negative conversion rate (smear negative, culture negative) was 74.5% (73/98) in the treatment group, and was 72.5% (66/91) in the control group.There was no statistically significant difference between groups(χ²＝0.09, P=0.759 9). The marked effective rates of chest X-ray in the treatment group and the control group were 72.4% (71/98) and 47.3% (43/91) with statistically significant difference(χ²＝12.52, P=0.000 4),and the effective rates were 90.8% (89/98) and 82.4% (75/91) without statistically significant difference(χ²＝2.90, P=0.088 6, P>0.05) between two groups. The cavity closure rates were 33.3% (27/81) and 22.1% (17/77) without statistically significant difference(F=1.52，P=0.1294, P>0.05). CD3 count was improved statistically significant difference after 3 months and 6 months treatment in the treatment group, and the difference of CD8 in treatment group was also higher than that of control group after 6 months treatment. CD4, CD8, CD4/CD8, NK, IL-2R were similar in two groups at any stage of treatment without statistically significant difference. The symptom of cough, expectoration, chest pain, hypodynamia were improved in the treatment group better than those in control group. ConclusionsOur study showed regimens combined with immunopotentiator were very effective in bactericidal activity and bacteriostatic activity for the treatment of multi-drug resistant pulmonary tuberculosis. It had also an activity to lesion absorption and the improvement in symptoms.

Key words: tuberculosis，multidrug-resistant/therapy, pulmonary tuberculosis/therapy, Mycobacterium bovis, randomized controlled trial