| Background: Pulmonary tuberculosis is a chronic which is causedby Mycobacterium tuberculosis and spread through the respiratory tract,infectious disease of the lung. As morbidity and mortality of pulmonarytuberculosis is rising, the prevention and treatment of pulmonarytuberculosis is facing new challenges. Because the fixed-dose combinationdrugs (FDCs) has the advantages of improving medication compliance,with convenient drug management, reduce drug resistance, IUATLD andWHO recommended FDCs for the drug of choice for the treatment oftuberculosis. Few trials have been conducted to assess the efficacy andsafety of the FDCs for the treatment of newly diagnosed smear-positivepulmonary tuberculosis in the past ten years, however not all of trials havethe same conclusion.Objective: In order to avoid the different areas of study limitations,we used systematic review to evaluate the efficacy and safety of FDCs treatment of newly diagnosed smear-positive pulmonary tuberculosis. Weaimed to provide more reliable scientific evidence and basis for theapplication of FDCs and elimination of pulmonary tuberculosis.Methods: The studies related to the efficacy and safety of FDCs inthe treatment of newly diagnosed smear-positive pulmonary tuberculosis,and randomized clinical controlled trials (RCT) or clinical controlled trials(CCT) published in the openly journals either in Chinese or English weresearched by computer, then searched references of included studiesadditionally. Compare the efficacy and safety of FDCs and single drugcombination, FDCs and plate combination drug treatment of newlydiagnosed smear-positive pulmonary tuberculosis. Trial screening, dataexaction and quality assessment of included trials were conducted bymethod recommended by Cochrane Collaboration.Results:①According to the strict including and excluding criteria,21papers were finally selected, including14Chinese papers and7Englishpapers.②The efficacy results show: Comparison of FDCs and single drugcombination treatment of newly diagnosed smear-positive pulmonarytuberculosis,2-month sputum negative conversion rate was statisticallysignificant with RR=1.04and95%CI1.01to1.06(P=0.003);6-monthsputum negative conversion rate was no statistically significant withRR=1.00and95%CI0.99to1.02(P=0.066); relapse rate was nostatistically significant with RR=1.73and95%CI0.94to3.19(P=0.79). Comparison FDCs and plate combination drug treatment of newlydiagnosed smear-positive pulmonary tuberculosis,2-month sputumnegative conversion rate was no statistically significant with RR=1.02and95%CI1.00to1.04(P=0.083);6-month sputum negative conversion ratewas statistically significant with RR=1.02and95%CI1.01to1.03(P=0.005).③The safety show: Comparison of FDCs and single drugcombination treatment of newly diagnosed smear-positive pulmonarytuberculosis, adverse reactions of total incidence was no statisticallysignificant with RR=0.92and95%CI0.78to1.08(P=0.317); skin adversereaction rate was no statistically significant with RR=1.04and95%CI0.85to1.27(P=0.725); gastrointestinal adverse reaction rate was no statisticallysignificant with RR=0.68and95%CI0.41to1.13(P=0.136); liver and galladverse reaction rate was no statistically significant with RR=0.94and95%CI0.62to1.43(P=0.776); adverse reaction discontinuation rate wasstatistically significant with RR=2.03and95%CI1.22to3.38(P=0.007).Comparison of FDCs and plate combination drug treatment of newlydiagnosed smear-positive pulmonary tuberculosis, adverse reactions of totalincidence was no statistically significant with RR=0.90and95%CI0.80to1.03(P=0.119); skin adverse reaction rate was no statistically significantwith RR=1.02and95%CI0.73to1.43(P=0.918); gastrointestinal adversereaction rate was no statistically significant with RR=0.87and95%CI0.75to1.01(P=0.059); liver and gall adverse reaction rate was no statistically significant with RR=1.21and95%CI0.98to1.48(P=0.073); adversereaction discontinuation rate was no statistically significant with RR=1.22and95%CI0.52to2.86(P=0.625).④The sensitivity analysis suggestedthat the results of all indicators are stable and reliable. There arepublication bias of skin adverse reaction rate and liver and gall adversereaction rate between FDCs and plate combination drug treatment of newlydiagnosed smear-positive pulmonary tuberculosis.Conclusion: FDCs was more effective than single drug combinationand plate combination drug when it is used to treat newly diagnosedsmear-positive pulmonary tuberculosis. There was no statisticallysignificant on adverse reaction discontinuation rate, when comparison ofFDCs and single drug combination.FDCs won’t increase the incidence of adverse reactions, but compared withthe single drug combinations are more prone to discontinuation, so need tostrengthen supervision and early detection of adverse reaction and takemeasures to prevent the withdrawal. There are publication bias of skinadverse reaction rate and liver and gall adverse reaction rate between FDCsand plate combination drug treatment of newly diagnosed smear-positivepulmonary tuberculosis, so more multi-center, multi-nation and strictdesigned randomized controlled clinical trials are still expected to providesufficient evidences for FDCs on treating newly diagnosed smear-positivepulmonary tuberculosis. |
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