ABSTRACT
Objective To observe the effect of integrated therapy of Chinese medicine and chemical drugs on adverse reaction and curative effect of initial treatment of secondary pulmonary tuberculosis. Methods Totally 1404 patients with secondary pulmonary tuberculosis and TCM lung consumption diagnostic criteria (syndrome of lung yin deficiency, qi-yin deficiency, yin-deficiency caused excessive fire) were chosen for single blind, randomized, controlled, multicenter clinical trials. Trial group was given 2HRZE/4HR, 1 time/day with Chinese medicine 2 or 3 times/day, and control group was given 2HRZE/4HR only for six months. The adverse reactions and clinical symptoms were observed to evaluate clinical efficacy and safety. Results In terms of reducing liver damage and other adverse reactions, the ratio of trial group had statistical difference with that of control group (P<0.001). In symptom scores of lung yin deficiency syndrome treated for 2, 4, 6 months, yin-deficiency caused excessive fire syndrome treated for 6 months, qi-yin deficiency syndrome treated for 4, 6 months, the differences between the two groups were significant (P<0.001). TCM syndrome curative effect between the two groups was statistical different (P<0.001). Safety evaluation result between the two groups was statistical different by tratified analysis (P<0.001). Conclusion Integrated therapy of Chinese medicine and chemical drugs can improve the symptoms and reduce adverse reactions caused by chemical drugs. It can enhance the curative effect and safety.