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Phase II trial of recombinant interferon-alpha2b in patients with advanced intractable multidrug-resistant pulmonary
Setting:
Multidrug-resistant tuberculosis patients without human immunodeficiency virus (HIV) infection, with Mycobacterium tuberculosis resistant to almost all of the available drugs.
Objective:
Limited phase II trial with recombinant interferon-alpha2b in five chronic multidrug-resistant tuberculosis patients.
Methods:
Three million units of r-IFN-alpha2b were administered subcutaneously every week for 12 weeks. Before and after treatment, and during a 30-month follow-up period, the patients underwent clinical and radiological examination, together with bacteriological, immunological and routine laboratory testing.
Results:
Two of the five patients became long-term sputum smear and culture negative after r-IFN-alpha2b therapy; one of the patients showed clinical improvement and negative smear after therapy, but remained culture positive. The other two patients showed no response.
Conclusion:
The results of this trial suggest that r-IFN-alpha2b should be evaluated further in multidrug-resistant tuberculosis in prospective controlled trials.