北京市抗结核固定剂量复合制剂效果观察

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目的评价北京市使用抗结核固定剂量复合制剂(FDC)治疗活动性肺结核的效果,为其进一步推广使用提供理论参考。方法从结核病信息管理系统中,导出2012—2015年现住址为北京市且已结案的活动性肺结核患者病案,按年龄、性别、诊断分类、登记分类等信息匹配,比较使用FDC与使用散装抗结核药患者在治疗第2个月末痰菌阴转率,以及疗程结束后患者的转归等,以评价FDC的效果。结果本研究共纳入6 102例研究对象,FDC组与对照组,各3 051例,两组涂阳(痰涂片抗酸杆菌检查阳性)患者均为947例,治疗第2个月末两组痰菌阴转率分别为85.74%(812/947)、85.53%(810/947),差异无统计学意义(χ~2=4.657 9,P=0.097 4)。涂阴培阳(痰结核菌涂片检查结果为阴性培养检查为阳性)患者治疗第2个月末痰菌阴转率分别为93.82%(167/178)、86.67%(143/165),精确概率法分析差异无统计学意义(P=0.074 0)。肺结核患者疗程结束后,涂阳患者治愈率分别为92.08%(872/947)、85.53%(810/947),FDC组治愈率高于对照组(U=3.144,P<0.001)。且FDC组的治疗成功率(95.71%,2 920/3 051)高于对照组(92.95%,2 836/3 051)(χ~2=21.618 9,P<0.005)。结论抗结核FDC的总体效果要优于散药,在综合评估患者适应证的前提下,FDC值得进一步推广使用。 Objective To evaluate the effect of using anti-tuberculosis fixed-dose combination (FDC) in treating active tuberculosis in Beijing and to provide theoretical reference for its further popularization and utilization. Methods From 2012 to 2015, the cases of active pulmonary tuberculosis patients whose current address was Beijing and whose case was settled from 2012 to 2015 were analyzed. The data were matched by age, sex, diagnostic classification and registration classification. The comparison between FDC using bulk anti-tuberculosis Drug patients in the treatment of sputum negative conversion rate at the end of the second month, and after the end of the treatment of patients, etc., to evaluate the effect of FDC. Results A total of 6 102 study subjects, FDC group and control group, were enrolled in this study, with 3 051 cases each. There were 947 smear positive smear positive sputum smear tests in both groups. After the treatment, the two groups of sputum The negative rates of bacteria were 85.74% (812/947) and 85.53% (810/947), respectively, with no significant difference (χ ~ 2 = 4.657 9, P = 0.097 4). The results showed that the sputum negative conversion rates of smear-negative and-sputum-positive sputum (sputum TB test was negative culture test) were 93.82% (167/178) and 86.67% (143/165) respectively at the end of the second month of treatment, the exact probability There was no significant difference in the statistic analysis (P = 0.074 0). The cure rate of smear positive patients was 92.08% (872/947) and 85.53% (810/947) respectively after TB treatment. The cure rate of FDC group was higher than that of control group (U = 3.144, P <0.001). The success rate of treatment in FDC group (95.71%, 2 920/3 051) was higher than that in control group (92.95%, 2836/3 051) (χ ~ 2 = 21.618 9, P <0.005). Conclusion The overall effect of anti-tuberculosis FDC is better than that of bulk medicine. FDC should be further popularized under the premise of comprehensive evaluation of patients indications.
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