Comparison analysis on Fixed-dose Combination and blister pack drug in treating tuberculosis patients

Abstract

Abstract: Objective To study the effects and safety of fixed-dose combinations(FDC) in treatment of tuberculosis,and to explore good medication and measure which is fitted for anti-tuberculosis chemotherapy in Shenzhen. Methods Two hundred new smear-positive pulmonary tuberculosis patients(PTB) randomly selected from Luohu district and Nanshan district were allocated into two groups with 100 into FDC treatment group and 100 into controlled group.DOT was adopted in both groups.The following issues were compared between the two groups including drug dosage,clinical manifestation,treatment outcome and adverse reaction. Results (1) The incidence of clinic symptoms such as night sweating,fever,cough,emptysis,chest pain,dyspnea and fatigue were gradually declined at the end of 1st,2nd,3rd and 6th month in both groups,but there was no significant difference between the two groups(P<0.05).(2) The negative conversion rates of sputum at the end of 2nd month were 88% and 84% in the FDC group and the control group and 98% and 97% at the end of 6th month.Chest radiography showed remarkable improvement.The cavity closure rates at the end of 6th month were 58.3% in the FDC group and 48.6% in the control group.No significant difference was found between them(P<0.05).(3) In FDC group and control group,the rate of adverse reactions was 25% and 18%,abnormity rate of WBC was 18% and 11%,abnormity rate of was 16% and 9% and abnormity rate of BIL was 19% and 15%.There was no significant difference between the two groups.(4) The relation efficient between weight and dosage of RFP in the FDC group and the control group were 0.804 and 0.781 respectively.The per dose/kg of INH,RFP,PZA and EMB in FDC group was lower than those in the control group and there was significant difference between them(P<0.05). Conclusion The treatment outcome and adverse reaction FDC are similar as blister pack drug in treating smear-positive TB.While the dosage of FDC is lower than blister pack,the expanded use of FDC is promising.

Key words: Fixed-dose combination, Pulmonary tuberculosis/drug therapy

Tan Weiguo¹,Yang Yingzhou,Wu Qingfang,et al.. Comparison analysis on Fixed-dose Combination and blister pack drug in treating tuberculosis patients[J]. Chinese Journal of Antituberculosis, 2007, 29(2): 117-121.

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