| ObjectivesTo determine the diagnosis,treatment,management and epidemic situation of drug-resistant tuberculosis patients in Shenzhen in order to provide evidences for policy makers on tuberculosis control.To study between Fixed-dosed combination and assembled drugs in Anti-tuberculosis Chemotherapy, evaluate the effects,safety,patients'acceptability and technique measures.MethodsResearching on the management status of drug resistance of mycobacterium tuberculosis by drug resistance monitoring from 1999-2005.Randomized non-inferiority study and community-controlled study was conducted to explore the treatment effects,adverse effects,patients'adherence and medical personnel acceptability and economy feasibility. Epi Data 3.10 was used to build up the data-base, and all data were analyzed by SPSS 13.0.ResultsThe result of drug-resistance from 1999 to 2005: rate of total DR is 28.5%,rate of initial total DR is 27.4%,rate of acquired total DR is 40.7%, rate of MDR-TB is 5.1%. DOTS-PLUS strategy was implemented in resident population, the cure rate was 68.75%.The negative conversion rates of sputum at the 2nd month and 6nd month in the FDC group and the control group were 88% and 84% vs 98% and 97% respectively;Chest radiography showed remarkable improvement.The cavity closure rates at the 6nd month were 58.33% in the FDC group and 48.65% in the control group.No significant difference could be found between them.The resolution of pulmonary lesion at the 6nd month in the FDC group and the control group were 78% and 65% respectively,the resolution rate of FDC was higher than controlled group(P<0.05);No significant difference could be found between the rate of clinical symptoms adverse reactions and laboratory test result. No significant difference could be found between the relapse rates of two groups within two years.The rates of complement treatment between fixed-dosed combination group and assembled drugs group were 95.3% and 92.6%, there is no difference, but the cure rate of FDC was higher than controlled group. No significant difference could be found between two groups about adverse reactions.Compared with controlled group, less patients in treatment group complained about the procedure of taking medicine, the size and number of pills (P<0.05).Stopping treatment rates because of liver damage in two groups are similar (8.9% and 5.8% respectively, P>0.05);More monitoring doctors in treatment group felt inconvenience in pills distribution, quantity management of pills and patients supervision. In their viewpoint, there was almost no advantage in increasing patients'adherence (P<0.05);The cost-effective of the controlled group showed a remarkable advantage over FDC. No significant difference could be found between the relapse rates of two groups within two years.ConclusionsThe treatment outcomes,adverse reactions and satefy between fixed-dosed combination and assembled drugs were nearly similar,there was no significant difference. National fixed-dose combination can improve the patients'compliance,acceptability and cure rate of chemotherapy, the expanded use of FDC is promising in Shenzhen.But acceptability of doctors and cost-effective analysis are inferior to controlled group due to manufacture technique, market and some other factors.Assembled drugs has the advantage of price in tuberculosis control which could be recommended for wider use in developing district.The rate of drug resistance in Shenzhen was high, especially the rate of secong-line drugs resistance was much higher, so the use of second-line drugs should be standarded. DOTS could not solute multidrug-resistant tuberculosis problem, investment should be increased. Implementing DOTS-PLUS strategy in whole population is the key to reduce epidemic situation of multidrug-resistant tuberculosis.
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