Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial

摘要: It has been postulated that deficient or incomplete clinical and/or microbiological response to tuberculosis treatment is associated with cell-mediated immunological dysfunction involving monocytes and macrophages. A phase 2 safety trial was conducted by treating patients either recombinant human granulocyte-macrophage colony-stimulating factor (rhu-GM-CSF) a placebo, both in combination anti-tuberculosis chemotherapy. Thirty-one documented pulmonary were treated rifampin/isoniazid for six months, plus pyrazinamide the first two months. At beginning of treatment, rhu-GM-CSF (125µg/M2) randomly assigned 16 injected subcutaneously twice weekly four weeks; other 15 received placebo. The accompanied hospital weeks, then monthly on an out patient basis, 12 Clinical outcomes similar groups, no difference acid-fast bacilli (AFB) clearance sputum at end fourth week treatment. Nevertheless, trend faster conversion negative observed group until eighth (p=0.07), after which all converted AFB negative. Adverse events local skin inflammation increase leukocyte count each injection, returning normal 72 hours injection. Three developed SGOP SGPT > 2.5 times values. All included GM-CSF culture except one who had primary TB resistance. None discontinue group. We conclude adjuvant immunotherapy could be safely explored 3 have active tuberculosis.