关键词: 结核, 肺/药物疗法, 抗结核药, 复方合剂, 临床方案, 治疗结果

Abstract: Objective To evaluate the clinical effect of alternate day therapy with domestic fixed-dose combinations (FDC) of anti-tuberculosis drugs, and to provide the reference for the popularization and application of alternate day therapy with anti-tuberculosis FDC.  Methods According to the principle of the pilot study (the counties of pilot group and control group had similar landform, population, the overall economic status, equipment and staff level of tuberculosis (TB) control institute), 1225 new pulmonary TB cases in 12 counties of Baoding were enrolled in “alternate day therapy with anti-TB FDC pilot group” (referred to as “FDC group”), and 1225 new pulmonary TB cases located in the other 11 counties of Baoding were enrolled in “anti-TB drugs blister pack drug group” (referred to as“blister pack group”), who were sampled by probability proportional to size(PPS) method among 2328 cases. The completion rates of clinical treatment, the sputum negative conversion rates after 2, 3, 6 months treatment, X-ray change of shadow and cavity at the end of treatment, and the adverse reactions of the two group were observed and compared. Chi-square test was used for categorical data, 0.05 was set as the criteria of statistical significance. Results Treatment completion rate was 94.53% (1158/1225) in FDC group and 90.94% (1114/1225) in blister pack group, and there was significant difference between two groups (χ²=11.73, P<0.01). The sputum negative conversion rates after 2, 3, 6 months treatment were 91.29% (262/287), 94.08% (270/287) and 97.56% (280/287) in FDC group, and were 89.05% (244/274), 93.07% (255/274) and 96.72% (265/274) in blister pack group, the differences between the two groups had no statistical significance (χ²=0.79, 0.24, 0.36, P>0.05). The effective absorption rate of shadow and cavity improvement rate in chest X-ray films at the end of treatment were 93.06% (845/908) and 89.60% (181/202) in FDC group, and were 91.99% (781/849) and 88.95% (169/190) in blister pack group, the difference between the two groups had no statistical significance (χ²=0.73, 0.04, P>0.05). The total rate of adverse reaction was 21.35%(237/1110) in FDC group and 22.62% (235/1039) in blister pack group, no significant difference was observed (χ²=0.50, P<0.05). There was no significant difference of abnormal blood routine, abnormal liver function and renal dysfunction between FDC group and blister pack group (χ²=1.16, 0.00, 0.21, P>0.05). Conclusion FDC shows similar efficacy in the treatment of TB as blister pack drug, and can improve the treatment completion rate, which can be used as replacement of traditional blister pack drugs.

Key words: Tuberculosis, pulmonary/drug therapy, Antitubercular agents, Drug combinations, Clinical protocols, Tteatment outcome