A Study Of Fixed-dose Combinations In Treating Tuberculosis Patients

Objective:To research the effects and safety of fixed-dose combinations(FDC) in treatment of tuberculosis,and to provide evidence for the use of FDC in tuberculosis.Methods:Case-control study was conducted in six counties of Zhanjiang Municipality in Guangdong province,with the case group using FDC and control group using the blister pack. The clinical manifestation,treatment outcome and adverse reaction were compared.Results:(1)The incidence of clinic symptoms such as cough,chest pain,fatigue,night sweating, fever and emptysis gradually declined in both groups after treatment,and there was no significant difference between the two groups(P＞0.05).(2)The negative conversion rates of sputum at the end of 2nd and 3rd month were 95.7%and 99.2%in the FDC group and the control group were 96.2%and 98.4%respectively.Chest radiography showed the improvement rate are similar in the two groups.The cavity closure rates at the end of the course of treatment in the FDC group was 78.2%,higher than that in the control group(61.2%).The cavity shrink in the control group was more than that in the FDC group.(3) In the FDC group and the control group, the rate of adverse reactions was 21.5%and 20.0%respectively,with no significant difference between the two groups(P＞0.05).In the body weight of 30～37kg group,the rate of adverse reactions in the control group was higher than that in the FDC group.The rate of adverse reactions had no significant difference between different weight,but it increased along with the weight rise in the control group.In the first two months,the adverse reactions of digestive system in the control group was much more than the FDC group.The abnormity rate of Blood Routine was similar in the two groups.The abnormity rate of AST in FDC group was higher than that in the control group.The discontinuation as a result of adverse reactions in FDC group was higher than than in the control group.Conclusion:The treatment outcome and adverse reaction of 4FDCs were similar as blister pack drug in treating smear-positive tuberculosis.While the discontinuation as a result of adverse reactions in the FDC group was higher than that in the control group,which must be noticed.