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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。
OBJECTIVE: To compare the clinical efficacy of intermittent tuberculosis TBF with intermittent tablet-combination therapy and provide a scientific basis for the clinical application of anti-tuberculosis FDC. Methods The patients with newly diagnosed pulmonary tuberculosis who were included in the cases were divided into treatment group and control group. Anti-TB FDC was used in the treatment group and plate combination was used in the control group. Interventional intermittent therapy (2H3R3Z3E3 / 4H3R3) was used in both groups. With the method of control study, the sputum negative conversion at the end of two, three, and six months was observed in both groups. The change of X-ray and the adverse reactions at the end of the course of treatment were observed. Results There was no significant difference in sputum negative conversion rate between the two groups at the end of 2,3,6 months (all P> 0.05). There was no significant difference between the two groups (All P> 0.05). There was no significant difference between the two groups in incidence of adverse reactions and laboratory abnormalities in blood tests, liver dysfunction and renal dysfunction (all P> 0.05). Conclusion In the planning of tuberculosis prevention and treatment, domestic anti-tuberculosis FDC is feasible to replace the traditional plate-type combination medicine and should be further popularized.