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目的评价国产抗结核药物固定剂量复合制剂(FDC)每日服药和隔日服药两种不同方式的临床应用效果,为FDC的推广使用提供参考依据。方法以保定市23个市县为研究现场,采用成组比较的分析方法,将FDC治疗的新发肺结核患者分为每日组和隔日组。每日组1 429例,隔日组1 317例。观察两组临床治疗完成率、新涂阳患者第2、3、6个月末痰菌阴转率、疗程末X线实变阴影及空洞改变和不良反应。结果 FDC治疗完成率:每日组为94.47%,隔日组为93.85%,差异无统计学意义(χ2=0.48,P>0.05);第2、3、6个月末新涂阳患者痰菌阴转率:每日组分别为89.69%、95.04%和96.95%,隔日组分别为90.45%、94.09%和95.91%,差异均无统计学意义(χ2=0.08、0.21、0.38,均P>0.05);每日组疗程末X线胸片实变阴影有效吸收率及空洞改善率分别为94.28%和89.45%,隔日组分别为93.61%和90.81%,差异均无统计学意义(χ2=0.38、0.21,均P>0.05);总不良反应症状发生率、血常规、肝功能及肾功能异常率,两组差异均无统计学意义(均P>0.05)。结论国产FDC每日服药方式与隔日服药方式疗效相似。
Objective To evaluate the clinical effects of two kinds of daily administration and daily administration of fixed-dose combination anti-tuberculosis drugs (FDC), which provide a reference for the promotion and use of FDC. Methods A total of 23 cities and counties in Baoding city were selected as the study site, and the new-onset pulmonary tuberculosis patients treated with FDC were divided into daily group and every other day group by the method of group comparison. There were 1 429 cases in the daily group and 1 317 cases in the alternate group. The completion rates of clinical treatment in two groups were observed. The sputum negative conversion rates at the end of the 2nd, Results The completion rate of FDC treatment was 94.47% in the daily group and 93.85% in the second day group, with no significant difference (χ2 = 0.48, P> 0.05). At the end of 2,3,6 months, sputum negative conversion Rates: 89.69%, 95.04% and 96.95% in the daily group and 90.45%, 94.09% and 95.91% in the other day groups, respectively, with no significant difference (χ2 = 0.08,0.21,0.38, all P> 0.05) At the end of each day, the effective absorption rate and cavity improvement rate of solid shadow at the end of X-ray were 94.28% and 89.45%, respectively, 93.61% and 90.81% respectively on the second day after treatment, the difference was not statistically significant (χ2 = 0.38,0.21, (All P> 0.05). There was no significant difference between the two groups (P> 0.05). The incidences of total adverse reactions, blood tests, liver function and renal dysfunction rates were not statistically significant. Conclusion The daily FDC method of domestic FDC is similar to that of every other day.