Cohort Study And Economic Evaluation Of Combination Treatment Including Traditional Chinese Medicine Or Immunomodulator For Retreatment Pulmonary Tuberculosis

Objective To observe the therapeutic effects and adverse reactions of traditional Chinese medicine (TCM) and immunomodulator in adjuvant treatment of retreatment pulmonary tuberculosis, and to evaluate cost-effectiveness and find out a best therapeutic scheme.Methods A total of 307 patients with recrudescent and sputum bacilli positive who were treated in inpatient and outpatient department of integrated Chinese and western medicine hospital of Zhejiang province, were divided into three groups,99 cases in control group,105 cases in TCM group, and 103 cases in immunomodulator group. Three groups of patients received intensive treatment for 3 months, after that received consolidation treatment for 5 months. Cases in control group were treated by a regimen of 3HL2ZV/5HL2V (H:isoniazid, L2:rifapentine, Z:pyrazinamide, V: levofloxacin), cases in the TCM group were treated by a regimen of 3HL2ZV/5HL2V and Kangfuxin liquid (10 mL every time,3 times per day, oral administration), cases in the immunomodulator group were treated by a regimen of 3HL2ZV/5HL2V and Mycobacterium vaccine (22.5μg every time,1 time every 2 weeks, intramuscular injection). The changes were observed at 2 weeks,3 and 8 months after treatment, including changes of Clinical efficacy, sputum smear from positive to negative, lesions and cavities on radiography. Adverse drug reactions were observed and recorded among three groups during the whole treatment course. The cost-effectiveness in three groups was evaluated by pharmacoeconomic method.Results The sputum negative conversion rates of three groups at the end of 8 months were 93.3%,92.2%,80.8% respectively. The rates of focus absoption at the end of 3 months were 82.9%,78.6%,50.5%. The cavity closure rate of the TCM group was higher than that of the control group at the end of 8 months (P<0.05). The disappearance ratios of clinical symptoms in TCM group, immunomodulator group and control group were 65.4%(287/439),33.3%(259/416) and 24.7%(84/339) respectively. The percentages in TCM group and immunomodulator group were significantly higher than that in control group (P<0.05), and there was no significant difference between TCM group and immunomodulator group (P>0.05). The incidences of adverse drug reactions in control group, TCM group and immunomodulator group were 45.5%(45/99),33.3%(35/105) and 38.8%(40/103), respectively. There was no significant difference in the incidences of adverse drug reactions among three groups (P>0.05). The costs in TCM group, immunomodulator group and control group were 10 485.5,8734.4,7832.3 yuan, respectively. The increment costs of cost-effectiveness in TCM group and immunomodulator group were 212.3 and 79.1 yuan.Conclusion TCM and immunomodulator in adjuvant treatment of retreatment pulmonary tuberculosis could achieve good results and clinical efficacy. Both TCM and immunomodulator could accelerate sputum bacilli negative conversion and focus absoption, improve cavity closure rate, and reduce adverse reactions. According to cost-effectiveness analysis, the cost in immunomodulator group could be controlled more effectively than that in TCM group, so immunomodulator was the best drug in adjuvant treatment of retreatment pulmonary tuberculosis, which should be recommended for a wider use in clinical practice.