Operational research of use Fixed-Dose Combination in national tuberculosis programme in China

Abstract

Abstract: Objective To explore the feasibility of treating new smear positive TB patient with Fixed-Dose Combination(FDC) in NTP in China,to provide evidence for the decision-maker to develop the policy on FDC use and supply. Methods Case-control study was conducted in 17 DOT counties in 4 provinces,with the case group using FDC and control group using the blister pack.The treatment outcome,side-effect and patient’s compliance were compared and the demand of the drug was calculated according to the weight of the patients in different area. Results For the new smear positive patients treated with FDC,the conversion rate at the end of 2nd and 3rd month were respectively 91.1% and 95.0% and the cure rate was 94.6%,the conversion rate at the end of 2nd and 3rd month in control group were respectively 90.2% and 92.9% and cure rate was 89.4%.Cure rate was higher in case group than control group(P<0.05).90 of 484 occurred side-effect of all kinds of drug and its frequency was 18.6% in case group.89 of 482 occurred side-effect of all kinds of drug and its frequency was 18.5%in control group. 37 of the total number of patient stopped the treatment due to the side-effect and among which 10(2.1%) was in case group and 27(5.8%) was in control group(P<0.05).According to the survey in different time of the treatment,patient’s compliance was different.The percentage of the patient with the weight was different between provinces.The number of drug tablets used in FDC was fewer than that of blister pack. Conclusion By using FDC,the cure rate of new smear positive patient has achieved the target of NTP,as the defaulted cases due to severe adverse side effect was less in case group than the control group and the number of drug tablet was fewer in case group than in control group.Therefore,FDC can play an important role in reducing MDR-TB and the cost of the drugs.The use of FDC should be further expanded in next step.

Key words: Pulmonary tuberculosis/drug therapy, Fixed-Dose Combination(FDC), Feasibility research

Cheng Shiming¹,Zhong Qiu,Zheng Jinfeng.et al.. Operational research of use Fixed-Dose Combination in national tuberculosis programme in China[J]. Chinese Journal of Antituberculosis, 2007, 29(2): 111-116.

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