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目的探讨抗结核固定剂量复合制剂(FDC)药品在西部地区推广应用的可行性,评价FDC药品治疗新涂阳肺结核病患者的临床效果。方法将纳入的新涂阳肺结核病患者分为FDC组和对照组,观察并比较两组患者的治疗效果、脱失及依从性等情况;应用Epi Data 3.0建立数据库,采用Spss 13.0软件进行统计学分析。结果 2个月末痰菌阴转率FDC组和对照组分别为91.69%和86.97%(χ2=1.38),疗程末痰菌阴转率分别为95.05%和90.99%(χ2=0.96),治愈率分别为93.34%和89.99%(χ2=0.67),失败率分别为0.70%和0.96%(χ2=0.83),疗效差异无统计学意义(均P>0.05);治疗脱失率FDC组和对照组分别为3.75%和6.67%,差异有统计学意义(χ2=16.92,P<0.05)。结论抗结核FDC与对照组对新涂阳肺结核病患者的治疗效果相同,FDC药品有利于提高患者治疗依从性,脱失率明显低于对照组,有利于医务人员对患者的治疗管理和督导,适宜在西部地区推广使用。
Objective To investigate the feasibility of promoting the application of anti-tuberculosis fixed-dose combination (FDC) drugs in the western region and evaluate the clinical effect of FDC on patients with new smear-positive pulmonary tuberculosis. Methods The new smear-positive pulmonary tuberculosis patients were divided into FDC group and control group. The therapeutic effect, withdrawal and compliance of the two groups were observed and compared. Epi Data 3.0 was used to establish the database and the data were analyzed by Spss 13.0 software analysis. Results The sputum negative conversion rate in the two months was 91.69% in the FDC group and 86.97% in the control group (χ2 = 1.38). The negative sputum conversion rates at the end of the treatment were 95.05% and 90.99%, respectively (χ2 = 0.96) (Χ2 = 0.67), respectively. The failure rates were 0.70% and 0.96% respectively (χ2 = 0.83), with no significant difference in the curative effect between the two groups (all P> 0.05) 3.75% and 6.67% respectively, with significant difference (χ2 = 16.92, P <0.05). Conclusions The anti-tuberculosis FDC and the control group have the same treatment effect on patients with new smear-positive pulmonary tuberculosis. The FDC medicine is beneficial to improve the treatment compliance and the rate of losing off is obviously lower than that of the control group, which is beneficial to the medical staff’s treatment management and supervision, Suitable for promotion and use in the western region.