Pc. Onyebujoh et al., Immunotherapy with Mycobacterium vaccae in patients with newly diagnosed pulmonary tuberculosis: a randomised controlled trial, LANCET, 354(9173), 1999, pp. 116-119
Citations number
16
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Background Mycobacterium vaccae, an environmental saprophyte, has immunogen
ic properties that enhance the host immune response. Immunotherapy with M v
accae has been suggested to shorten short-course antituberculosis chemother
apy. We tested the hypothesis that the addition of M vaccae to standard sho
rt-course antituberculosis chemotherapy would decrease the time to achieve
a negative sputum culture.
Methods Patients with newly diagnosed tuberculosis were randomly assigned a
n injection of saline (placebo) or M vaccae on day 8. All patients received
antituberculosis chemotherapy with rifampicin, isoniazid, pyrazinamide, an
d ethambutol. Sputum samples were checked by microscopy and culture every w
eek for the first 8 weeks and monthly until the end of chemotherapy at 6 mo
nths. The primary outcome was the time to a negative sputum culture in the
first 8 weeks. Intention-to-treat analysis was used and time to sputum clea
rance was assessed by log-rank test and Cox's proportional-hazards regressi
on.
Findings 172 patients received M vaccae and 175 patients received placebo.
At 8 weeks, 70 patients in the M vaccae group and 65 patients in the placeb
o group had a negative culture; there was no difference between groups in t
he time to a negative culture (p=0.83). There was no interaction between HI
V status and treatment.
Interpretation M vaccae immunotherapy has no benefit when added to standard
antituberculosis chemotherapy.