OBJECTIVE: To study and evaluate the efficacy and safety of recombinant human interleukin-2 (IL-2) in the treatment of pulmonary tuberculosis. METHODS:Two hundred and nine cases with re-treated Mycobacterium tuberculosis-positive pulmonary tuberculosis were randomly divided into a trial group (106 cases, treated with 3PaZ (TH)L(2)VE(AK) + IL-2/4PaL(2)V) and a control group (103 cases, treated with 3PaZ(TH)L(2)VE(AK)/4PaL(2)V). The efficacy of 203 cases was available for evaluation when the course was completed (trial group 103 cases, control group 100 cases). RESULTS: The sputum smear-negative conversion rates at the 1st and the 2nd month of therapy were 33.3% and 69.4% in the trial group, and 7.2% and 44.9% in the control group (P < 0.01). At the completion of the therapy, the X-ray resolution rates were 64.1% and 36.0% respectively for the trial and the control groups, the difference being significant (P < 0.001). There were significant differences in CD(4) T cells, the ratio of CD(4)/CD(8) and NK cells between the two groups (P < 0.01). The level of soluble interleukin-2 receptor (sIL-2R) was significantly different between the two groups after treatment for 3 months (P < 0.05). IL-2 associated side effects were rare and mild. CONCLUSION: As an effective and relatively safe biological agent, IL-2 can be added to the standard chemotherapy for pulmonary tuberculosis.
RCT Entities:
OBJECTIVE: To study and evaluate the efficacy and safety of recombinant humaninterleukin-2 (IL-2) in the treatment of pulmonary tuberculosis. METHODS: Two hundred and nine cases with re-treated Mycobacterium tuberculosis-positive pulmonary tuberculosis were randomly divided into a trial group (106 cases, treated with 3PaZ (TH)L(2)VE(AK) + IL-2/4PaL(2)V) and a control group (103 cases, treated with 3PaZ(TH)L(2)VE(AK)/4PaL(2)V). The efficacy of 203 cases was available for evaluation when the course was completed (trial group 103 cases, control group 100 cases). RESULTS: The sputum smear-negative conversion rates at the 1st and the 2nd month of therapy were 33.3% and 69.4% in the trial group, and 7.2% and 44.9% in the control group (P < 0.01). At the completion of the therapy, the X-ray resolution rates were 64.1% and 36.0% respectively for the trial and the control groups, the difference being significant (P < 0.001). There were significant differences in CD(4) T cells, the ratio of CD(4)/CD(8) and NK cells between the two groups (P < 0.01). The level of soluble interleukin-2 receptor (sIL-2R) was significantly different between the two groups after treatment for 3 months (P < 0.05). IL-2 associated side effects were rare and mild. CONCLUSION: As an effective and relatively safe biological agent, IL-2 can be added to the standard chemotherapy for pulmonary tuberculosis.