[The immunotherapeutic effect of Mycobacterium vaccae vaccine on initially treated pulmonary tuberculosis]

To evaluate the effect and safety of Mycobacterium vaccae vaccine (M. vaccae vaccine) on initially treated pulmonary tuberculosis.

342 cases of initially treated pulmonary tuberculosis with smear and culture positive were divided into immunotherapy (M, 171 cases) group and control (C, 171 cases) group at random pair. The group M were treated by chemotherapy with a regimen of 2HRZE/2HR and immunotherapy with M. vaccae vaccine for 6 months. The group C were treated only by chemotherapy with a regimen of 2HRZE/4HR.

The sputum smear-negative conversion rates in group M 1, 2 and 6 months after treatment were 36.8%, 80.1% and 98.2% respectively; those in group C were 19.9%, 54.4% and 98.8% respectively. The sputum culture-negative conversion rates in group M 1, 2 and 6 months after treatment were 47.4%, 85.9% and 99.4% respectively; those in group C were 19.3%, 67.8% and 98.8% respectively. The sputum-negative conversion rates of group M were significantly higher than those of group C after 1 and 2 months treatment (P < 0.01), but there were no statistically significant differences between the two groups at the end of 6 months after treatment (P > 0.05). Compared with group C, group M were better in improving of X-ray manifestation, increasing of the percentage of CD(3) and CD(4) T cell and the ratio CD(4)/CD(8) and closing of cavity (P < 0.01). The side effects of M. vaccae vaccine were rare and slight. The bacteriological relapse rates in group M, C were 3.0%, 5.6% respectively (P > 0.05).

As an adjunct to chemotherapy, immunotherapy with M. vaccae vaccine is helpful for patient with initially treated pulmonary tuberculosis, and it is possible to further shorten the duration of short-course chemotherapy with a combination of chemotherapy and M. vaccae vaccine.