Arshad Javaid, Musarrat Shah, Abdul Samad Wazir, Fazli Maula.
Immunotherapy with Mycobacterium vaccae in the treatment of newly diagnosed Pulmonary Tuberculosis in Pakistan.
Pak J Chest Med Jan ;7(Suppl):23-32.

In this study, 48 patients newly diagnosed as sputum smear positive pulmonary tuberculosis were randomised to receive an injection of killed Mycobacterium vaccae as Immunotherapy, or of saline as placebo, on day 3 or 4 of the routine course of chemotherapy. Patients were between 18 to 50 years old and included both sexes (25 Male + 23 Female). All patients received 8 month of Anti T.B. drugs. Sputum was tested for AFB on registration, two weeks, 1,2 and 8 months after starting treatment. Sputum culture for AFB were done at the time of registration and after two weeks. Venous blood was taken for blood complete, E.S.R. and L.F.Ts. All the investigations including CXR were repeated at 1,2 and 8 months of treatment. Both the groups were well matched for age, sex, weight, ESR, radiological score and the sputum A.F.B. status. Not surprisingly in a disease for which there is good chemotherapy, the final outcome at the end of treatment did not reach statistical significance (P>0.05) between the two arms of the study in respect of clearance of sputum AFB, culture negativity, increase in body weight, reduction in E.S.R and radiological regression. So far at the post treatment follow visits two patients in the control group have relapsed and are on retreatment regimen where as no patient has relapsed in M. Vaccae group. A degree of drug resistance was shown by the bacilli culture from 8 out of 37 (21.6%) and one of them (2.7%) has multi drug resistance. All the patients received the full course of ATT and were cured.

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