[A clinical study on vaccine of Mycobacterium vaccae in treating pulmonary tuberculosis]

To study the effect of vaccine of Mycobacterium vaccae on cell-mediated immunity and on treating patients with pulmonary tuberculosis.

Seventy cases of pulmonary tuberculosis with smear positive and initial treatment were classified randomly into group I (35 cases) and group II (35 cases), receiving 2HRZS/4HR and 2HRZS/4HR plus vaccine of Mycobacterium vaccae regimens respectively. Thirty-one multi-drug resistant pulmonary tuberculosis cases were classified into group III, receiving 4 - 6 sensitive antituberculous drugs and vaccine of Mycobacterium vaccae. Improvement of clinical symptoms, resolution of pulmonary lesions, negative conversion of sputum and changes of immunological functions were observed.

No significant difference in improvement of symptoms was found in group I and group II (P > 0.05), and the improvement rate of clinical symptoms in group III was found more than 50%. X-ray resolution rates in 4th month were 83% and 89%, and cavity reducing rates 40% and 50% respectively in group I and group II, and no significant differences were found (P > 0.05). X-ray resolution rate was 29%, cavity reducing rate 7% and no deteriorated case was found in group III. Sputum negative conversion rates in 1st, 2nd, 3rd and 4th month were 23%, 51%, 83% and 97% respectively in group I, while 31%, 77%, 89% and 100% in group II, and 3%, 16%, 29% and 32% in group III. Significant difference was found between group I and group II in sputum negative conversion rate in 2nd month after treatment (P < 0.05). After treatment, values of lymphocyte transformation test (LTT), CD(3), CD(4) and CD(4)/CD(8) of the above 3 groups were all higher than that before the treatment (P < 0.05), level of tumor necrosis factor decreased in group II and IL-2, IL-6 increased in group III.

Vaccine of Mycobacterium vaccae is a good immunotherapy preparation, which promotes sputum negative conversion and activation of cell-mediated immunity.