抗结核药物固定剂量复合制剂隔日疗法临床效果分析  

Analysis of clinical effect of alternate day therapy with fixed-dose combinations of anti-tuberculosis drugs

作　　者：张雁[1] 张进国[2] 房登楼[1] 张永强[1] 张保宗 

机构地区：[1]河北省保定市疾病预防控制中心结核病防治科,071000 [2]河北省保定市易县疾病预防控制中心结核病门诊 [3]河北省石家庄人民医学高等专科学校2013届临床二班

出　　处：《中国防痨杂志》2014年第1期41-45,共5页Chinese Journal of Antituberculosis

摘　　要：目的 评价国产抗结核药物固定剂量复合制剂（FDC）隔日疗法的临床应用效果,为抗结核FDC隔日疗法的推广应用提供参考依据.方法 根据两组试点市（县）地貌、人口数、总体经济状况、结核科仪器设备和工作人员水平等基本接近的原则,“抗结核药物FDC隔日疗法试点组”（简称“FDC组”）为保定市12个市（县）中纳入的初治活动性肺结核患者,共计1225例;“抗结核药物板式组合药对比观察试点组”（简称“组合药组”）为保定市另11个市（县）中纳入的初治活动性肺结核患者2328例,通过人口容量比率概率法抽取1225例患者.对两组临床治疗完成率,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,以及不良反应等情况,用对照研究的方法进行对比观察.用统计软件包SPSS 13.0进行处理与分析,计数资料的比较采用x2检验,以P＜0.05为差异有统计学意义.结果 治疗完成率抗结核FDC组为94.53％（1158/1225）,组合药组为90.94％（1114/1225）,两组比较差异有统计学意义（x2＝11.73,P＜0.01）;2、3、6个月末痰菌阴转率抗结核FDC组分别为91.29％（262/287）、94.08％（270/287）、97.56 ％（280/287）,组合药组分别为89.05％ （244/274）、93.07％ （255/274）、96.72％（265/274）,两组比较差异均无统计学意义（x2值分别为0.79、0.24、0.36,P值均＞0.05）;FDC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93.06％（845/908）、89.60％（181/202）,组合药组分别为91.99％（781/849）、88.95％（169/190）,两组比较差异均无统计学意义（x2值分别为0.73、0.04,P值均＞0.05）;总不良反应发生率抗结核FDC组为21.35％（237/1110）,组合药组为22.62％（235/1039）,两组比较差异无统计学意义（x2 =0.50,P＞0.05）;实验室检测结果血常规异常、肝功能异常及肾功能异常方面,抗结核FDC组和板式组合药组相比,差异均无统计�Objective To evaluate the clinical effect of alternate day therapy with domestic fixed-dose combi- nations （FIX2） of anti tuberculosis drugs, and to provide the reference for the popularization and application of alter- nate day therapy with anti-tuberculosis FIX]. 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 antbTB FIX] pilot group＂ （referred to as ＂FE 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＂ （re- ferred 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 treat- ment, 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 sig nificance. Results Treatment completion rate was 94.53% （1158/1225） in FIX; group and 90.94% （1114/1225） in blister pack group, and there was significant difference between two groups （X2 = 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 FIX; 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 （x2 = 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 FIX; g

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 

分 类 号：R978.3[医药卫生—药品]