Abstract:

Objective: To evaluate the clinical efficacy, adverse drug reactions, and 1-year and 2-year follow-up recurrence for the 4-month treatment program with Mycobacterium vaccae Vaccine immune intervention in the smear-negative pulmonary tuberculosis treatment, and provide a basis for shortening the course of treatment. Methods: The consecutive cases diagnosed as smear negative pulmonary tuberculosis in Shaodong County and Yueyang County of Hunan province from November 2014 to April 2016 were enrolled in the study. They were enrolled in the ‘DAP epidemiological research system’ according to the inclusion order. They were randomly assigned to the observation group and the control group. Among them, 184 cases in the observation group were treated with 2H-R-Z-E/2H-R combined with Mycobacterium vaccae Vaccine, and 180 cases in the control group were treated with 2H-R-Z-E/4H-R. The clinical efficacy and adverse drug reactions at the end of the intensive treatment and the end of the treatment course were compared between the two groups, as well as the recurrence after 1 and 2 years of follow-up. Results: A total of 364 patients were enrolled, including 292 males (80.2%) and 72 females (19.8%), with an average age of (54±17) years. At the end of the intensive period and the end of the course of treatment, the symptom improvement rates of the observation group were 86.1% (130/151) and 96.0% (145/151), respectively; the control group were 86.5% (128/148) and 95.3% (141/148), respectively. There was no significant difference between the two groups (χ ²=0.010, P=0.921; χ ²=0.103, P=0.749). The absorption rates of chest X-ray lesions in the observation group were 19.0% (35/184) and 41.3% (76/184), respectively; in the control group, they were 18.9% (34/180) and 41.7% (75/180) respectively, and the difference was not statistically significant (χ ²=0.100, P=0.920; χ ²=0.005, P=0.944). The CD4 ⁺ T lymphocyte counts of the observation group were (643.3±207.1) cells/μl and (698.5±208.9) cells/μl; the control group were (600.5±183.2) cells/μl and (625.2±177.9) cells/μl, there was no statistically significant difference between the two groups (t=1.023, P=0.309; t=1.766, P=0.081). At the end of the course of treatment, the successful treatment rate of both groups was 100.0% (184/184,180/180). After the course of treatment, the 1-year and 2-year follow-up cumulative recurrence rate in the observation group was 0.6% (1/174) and 1.2% (2/167); the control group was 1.2% (2/172) and 1.8% (3/164) respectively, the difference was not statistically significant (Fisher exact Probability method, P values were 0.621 and 0.683 respectively). During the course of treatment, the incidence of adverse drug reactions in the two groups were 19.6% (36/184) and 28.3% (51/180) respectively, and the difference was statistically significant (χ²=3.846, P<0.05). Conclusion: The clinical efficacy of the 4-month regimen combined with Mycobacterium vaccae Vaccine immunotherapy was not inferior to the 6-month standard regimen in patients with smear-negative pulmonary tuberculosis. And the incidence of adverse drug reactions is low.

Key words: Mycobacterium vaccae Vaccine, Pulmonary tuberculosis, Ultra-short course chemotherapy, Clinical features