Randomized Controlled Clinical Trial Of Fixed-dose Combination And Assembled Drugs To Pulmonary Tuberculosis

Objective:To investigate the feasibility of fixed-dose combination (FDC) in Hunan tuberculosis control by a comparison study between FDC and assembled drugs in anti-tuberculosis chemotherapy.Methods:Selected the cases with new smear positive pulmonary tuberculosis using a cluster sampling technique, and divided them into two groups:the experimental group (EG) treated with 2HRZ+E/4HR and the control group (CG) treated with 2H3R3Z3E3/4H3R3. We compared the therapeutic effect, drug adverse reactions and patients'adherence to treatment between the two groups. EpiData 3.0 was used to build up the data-base, and all data were analyzed by SPSS 13.0 and SAS 9.13.Results:534 cases were enrolled in this study.269 cases were in EQ while 265 in CG. The negative conversion rates of sputum at the 2nd month in EG and CG was 95.5% and 92.8% respectively, and the cure rates were 96.3% and 93.2% in each group. In the end of treatment chest radiography showed that the absorption rates of infection focus in EG and CG were 86.6% and 83.4% respectively, and the cavity closure rates were 87.3% and 63.6% in each group. The non-inferiority test indicated that the four rates mentioned above in EG were not inferior to those in CG The total rates of drug adverse reactions in EG and CG was 27.1% and 30.9%, which showed no significant difference, but the occurance rate of digestive reactions in EG (12.3%) was lower than CG (18.9%). The total duration of drug adverse reactions in CG was significantly longer than EQ as well as digestive reactions, liver function lesion and neural symptoms (P<0.05). The rates of treatment interruption in EG and CG were similar (4.1% vs 6.0%), but the duration of interruption in CG was significantly longer than EG (P<0.05). The proportion of patients with high adherence in EG (42.6%) were higher than CG (14.2%) (P<0.05).Conclusion:The efficacy of FDC and assembled drugs in treating new smear-positive pulmonary tuberculosis were similar. Drug adverse reactions were not more common while FDC were used, furthermore the occurance rate of digestive reactions in patients treated with FDC was lower than assembled drugs, and the duration of adverse reactions and interruption due to FDC were shorter than assembled drugs. Patients' medication adherence significantly improved with FDC. Overall FDC could be widely used in Hunan TB control.