抗结核固定剂量复合剂每日与隔日不同服药方式治疗新发肺结核疗效观察

Clinical observation of different ways of taking medicine with daily or alternate day of fixed-dose combination of anti-tuberculosis drugs on new cases of pulmonary tuberculosis

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 effect of daily or alternate day taking domestic fixed-dose combinations（FDC） of anti-tuberculosis（TB）drugs, provide the reference for the popularization and application of FDC.[Methods]23 cities and counties of Baoding were the study sites, and the croup comparison analysis method was adopted. New pulmonary TB patients treated by FDC were divided into daily group and alternate day group, 1 429 cases in daily group, and 1 317 cases in alternate day group.The completion rates of clinical treatment, sputum negative conversion rates after 2,3,6 months treatment, shadow and cavity changing of X-ray at the end of treatment, and adverse reactions of the two groups were observed.[Results]Treatment completion rate of FDC was 94.47% in daily group and 93.85% in alternate day group, the differences between the two groups was not statistically significant（χ2= 0.48, P〉0.05）. The sputum negative conversion rates of new smear-positive patients after 2,3,6 months treatment were 89.69%,95.04% and 96.95% in daily group, and 90.45%, 94.09% and 95.91% in alternate day group, the differences between the two groups were not statistically significant（χ2=0.08,0.21,0.38, all P〉0.05）. The effective absorption rate of shadow and improvement rate of cavity in chest X-ray films at the end of treatment were 94.28% and 89.45% in daily group,and 93.61% and 90.81% in alternate day group, the differences between the two groups were not statistically significant（χ2=0.38,0.21, all P 〉0.05）. The differences of total incidence rate of adverse reaction symptom, abnormal rates of blood routine, liver function and renal function between two groups were not statistically significant（all P 〉 0. 05）.[Conclusion] The curative effect of taking homemade FDC daily or alternate day is similar.