The effect of the addition of dialyzable leukocyte extract (DLE)(transfer factor) to tuberculostatic drugs in the treatment of superinfected fistulating tuberculosis of bones and joints was evaluated in a controlled study. Eleven patients whose disease had persisted for a mean of 20 +/- 4.8 years and had proved to be resistant to antibiotics and tuberculostatic drugs were treated with an additional combined tuberculostatic drug regimen consisting of isoniazide, ethambutol, and rifampin for a control period of 2 years; after this therapy had failed as judged by the persistence of the superinfected fistulae and of the symptoms, DLE was added to the regimen. The result of this therapeutic approach was evaluated after another 2 years. Through this therapy, a closure of the fistulae was achieved in 9 out of the 11 patients (P less than 0.001) with a concomitant decrease of symptoms. DLE may prove beneficial in the treatment of patients with superinfected fistulating tuberculous osteomyelitis.

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