提高抗结核药品固定剂量复合剂在省市级结核病定点医院推广使用的实施性研究  

Implementation study on promoting the use of anti-tuberculosis fixed-dose combination in provincial and prefecture tuberculosis designated hospitals

作　　者：王倪[1] 黄飞[1] 竺丽梅[2] 曾谊 张瑞梅[4] 耿红 刘学法 郑建刚[7] 宗佩兰[8] 曾忠 李进岚[10] 蔡翠 郭晓红 钟引 刘莉 谢艳[15] 杜芳芳 周林[1] 成诗明 Wang Ni;Huang Fei;Zhu Limei;Zeng Yi;Zhang Ruimei;Geng Hong;Liu Xuefa;Zheng Jiangang;Zong Peilan;Zeng Zhong;Li Jinlan;Cai Cui;Guo Xiaohong;Zhong Yin;Liu Li;Xie Yan;Du Fangfang;Zhou Lin;Cheng Shiming(National Center for Tuberculosis Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China;Department of Chronic Communicable Disease,Jiangsu Provincial Center for Disease Control and Prevention,Jiangsu Province,Nanjing 210009,China;Department of Tuberculosis,the Second Hospital of Nanjing,Nanjing 211131,China;the First Department of Tuberculosis,Xuzhou Infectious Disease Hospital,Xuzhou 221004,China;Department of Prevention and Control,Shandong Public Health Clinical Center,Ji’nan 250013,China;Department of Prevention,Weifang NO.2 People’s Hospital,Weifang 261041,China;Department of Tuberculosis,Jiangxi Provincial Center for Disease Control and Prevention,Nanchang 330029,China;Department of Tuberculosis,Jiangxi Chest Hospital,Nanchang 330006,China;Department of Tuberculosis,Ganzhou NO.5 People’s Hospital,Ganzhou 341000,China;Department of Tuberculosis,Guizhou Center for Disease Control and Prevention,Guiyang 550004,China;Guiyang Public Health Treatment Center,Tuberculosis Diagnosis and Treatment Quality Control Center,Guiyang 550004,China;Department of Tuberculosis,Liupanshui NO.3 People’s Hospital,Liupanshui 553001,China;Department of Tuberculosis,Sichuan Center for Disease Control and Prevention,Chengdu 610041,China;Major Infectious Disease Management Department,Public Health Clinical Center of Chengdu,Chengdu 610066,China;Department of Tuberculosis,Zigong Center for Disease Control and Prevention,Zigong 643000,China;Chinese Antituberculosis Association,Beijing 100042,China)

机构地区：[1]中国疾病预防控制中心结核病预防控制中心,北京102206 [2]江苏省疾病预防控制中心慢性传染病防制所,南京210009 [3]南京市第二医院结核科,南京211131 [4]徐州市传染病医院结核一科,徐州221004 [5]山东省公共卫生临床中心预防控制科,济南250013 [6]潍坊市第二人民医院预防科,潍坊261041 [7]江西省疾病预防控制中心结核病防治所,南昌330029 [8]江西省胸科医院结核科,南昌330006 [9]赣州市第五人民医院,赣州341000 [10]贵州省疾病预防控制中心结核病防治所,贵阳550004 [11]贵阳市公共卫生救治中心结核病诊疗质量控制中心,贵阳550004 [12]六盘水市第三人民医院结核科,六盘水553001 [13]四川省疾病预防控制中心结核病防治所,成都610041 [14]成都市公共卫生临床医疗中心重大传染病管理部,成都610066 [15]自贡市疾病预防控制中心结核病防治所,自贡643000 [16]中国防痨协会,北京100042

出　　处：《中国防痨杂志》2022年第9期927-933,共7页Chinese Journal of Antituberculosis

基　　金：中国防痨协会抗结核FDC推广项目(CATA-20210410)。

摘　　要：目的:评价在国家结核病防治规划实施中,省市级结核病定点医院推广使用抗结核药品固定剂量复合剂(FDC)使用的可行性。方法:按照典型抽样的方法,在全国选择5个省,每省一个省级和一个地市级结核病定点医院作为研究现场,采取观察性研究方法,对新诊断的利福平敏感或无耐药检测结果的肺结核患者,根据FDC的纳入标准和排除标准进行治疗观察,分析使用抗结核FDC患者的纳入和退组情况。结果:2021年4月1日至7月31日,10个机构登记新诊断的利福平敏感或无耐药检测结果的肺结核患者3558例,抗结核FDC使用率为71.9%(2559/3558),其中最高为94.5%(346/366),最低为45.6%(215/472);12.1%(431/3558)的患者因禁忌证未使用抗结核FDC,有禁忌证的患者占登记患者数的比例最高为43.9%(207/472),最低为2.3%(5/215)。使用抗结核FDC的患者中22.3%(571/2562)在疗程中途停止使用抗结核FDC,各机构中最高为44.8%(155/346),最低为3.6%(13/365);退组患者中54.5%(311/571)由于发生不良反应调整方案;各机构中发生不良反应退组的患者占使用抗结核FDC患者的比例,最高为27.2%(94/346),最低为0.3%(1/300);治疗第1个月的退组率为7.9%(203/2559),治疗第6个月的退组率为0.4%(8/1996),退组率随疗程呈明显下降趋势(χ^(2)_(趋势)=14.277,P<0.05)。结论:抗结核FDC适宜在省市级结核病定点医院使用,加大对医务人员的培训是进一步提高抗结核FDC使用率和降低FDC中断治疗率的关键。Objective:To evaluate the feasibility of the use of anti-tuberculosis(TB)fixed dose combination(FDC)in provincial and prefecture TB designated hospitals under the national TB programme.Methods:According to the typical sampling methods,we selected 5 provinces,and one provincial and one prefecture TB designated hospital were determined in each of the provinces.The observational study method was adopted and the newly diagnosed tuberculosis patients who are rifampicin sensitive or without drug resistance test results were included.According to the inclusion and exclusion criteria,to analyze the inclusion and withdrawal of the patients.Results:A total of 3558 pulmonary TB patients were registered from April 1.to July 31,2021.The inclusion rate was 71.9%(2559/3558),from 45.6%(215/472)to 94.5%(346/366).12.1%(431/3558)patients who did not use FDC due to contraindications.The proportion of patients with contraindications in the number of registered patients was from 2.3%(5/215)to 43.9%(207/472).22.3%(571/2559)stopped using FDC in the middle of the treatment,from 3.6%(13/365)to 44.8%(155/346).54.5%(311/571)were stopped due to adverse reactions,the proportion of patients with adverse reactions and withdrawal from the group among patients using FDC was from 0.3%(1/300)to 27.2%(94/346).The withdrawal rate was 7.9%(203/2559)at the end of the first month of treatment,and 0.4%(8/1996)at the end of the six month of treatment.The withdrawal rate decreased significantly with the course of treatment(χ^(2)_(trend)=14.277,P<0.05).Conclusion:FDC is feasible for use at provincial and prefecture TB designated hospitals.Strengthen the training of medical staff is the key to further improve the usage of FDC and could also reduce the treatment interruption.

关 键 词：结核 肺 药物疗法 可行性研究 

分 类 号：R521[医药卫生—内科学] R749.053[医药卫生—临床医学]