抗结核FDC与板式组合药间歇疗法临床对比观察

目的对抗结核固定剂量复合剂FDC与板式组合药间歇疗法进行临床对比观察,为抗结核FDC临床应用提供科学依据。方法将符合病例纳入条件的初治肺结核患者分为治疗组和对照组,治疗组用抗结核FDC,对照组用板式组合药,两组均采用隔日间歇疗法方案（2H3R3Z3E3/4H3R3）。用对照研究的方法观察两组2、3、6月末痰菌阴转、疗程末X线改变及不良反应发生等情况。结果新涂阳患者2、3、6月末痰菌阴转率2组差异均无统计学意义（均P〉0.05）;疗程末X线实变阴影显著吸收率及空洞闭合率2组差异均无统计学意义（均P〉0.05）;不良反应诸症状发生率和实验室检测血常规异常、肝功能异常及肾功能异常2组差异均无统计学意义（均P〉0.05）。结论在结核病防治规划中,国产抗结核FDC替代传统板式组合药是可行的,应进一步推广使用。

Clinical comparative observation on anti tuberculosis FDC and plate combination intermittent therapy

Objective]To carry out the clinical comparative observation on anti tuberculosis fixed dose combination（ FDC） and plate combination intermittent therapy,provide a scientific basis for clinical application of anti tuberculosis FDC. Methods]The initially-treated tuberculosis patients who met inclusion criteria were divided into the treatment group and the control group. The treatment group was given the anti tuberculosis FDC,while the control group received the plate combination drug,and two groups were treated with alternate-day intermittent therapy scheme（ 2H3R3Z3E3 /4H3R3）. A comparative study was applied to observe the sputum negative conversion rate at the end of 2,3,and 6 months,X-ray change at the end of treatment course,and the incidence rates of adverse reactions between two groups.Results]In new smear-positive patients,there were no significant differences in the sputum negative conversion rate at the end of 2,3 and 6 months between two groups（ all P〈0. 05）. At the end of treatment course,the differences in the absorption rate of lung consolidation shadow and the cavity closure rate between two groups were not significant（ all P〈0. 05）. There were no significant differences in the incidence rates of adverse reactions,and the abnormal rates of blood routine examination,liver function and renal function between two groups（ all P〈0. 05）.Conclusion]In the tuberculosis control program,the domestic anti tuberculosis FDC can instead of plate combination intermittent therapy,and it is worth popularizing.