18个月化疗方案对耐多药肺结核患者的治疗效果分析  

Effect of 18 Months Regimen in the Treatment of Multidrug-resistant Pulmonary Tuberculosis

作　　者：李琦[1] 姜晓颖[1] 高孟秋[1] 刘宇红[1] 杨坤云 阚晓红 梁建琴 田明 刘锦程 崔文玉 刘文 余德美 谭守勇[10] 唐神结[1] 刘玉琴 梁煊 邱丽华[13] 邵世峰[14] 高飞 接力 蔡宝云[1] 卜建玲[1] 马丽萍[1] 刘智[17] 徐麟 杜娟 操敏[1] 高静韬[1] 舒薇[1] 李亮[1] Li Qi;Jiang Xiaoying;Gao Mengqiu;Liu Yuhong;Yang Kunyun;Kan Xiaohong;Liang Jianqin;Tian Ming;Liu Jincheng;Cui Wenyu;Liu Wen;Yu Demei;Tan Shouyong;Tang Shenjie;Liu Yuqin;Liang Xuan;Qiu Lihua;Shao Shifeng;Gao Fei;Jie Li;Cai Baoyun;Bu Jianling;Ma Liping;Liu Zhi;Xu Lin;Du Juan;Cao Min;Gao Jingtao;Shu Wei;Li Liang(Clinical Center on Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China)

机构地区：[1]首都医科大学附属北京胸科医院,中国疾病预防控制中心结核病防治临床中心,101149 [2]湖南省结核病防治所耐药专科 [3]安徽省胸科医院科教科 [4]中国人民解放军总医院第八医学中心全军结核病研究 [5]成都市公共卫生临床中心 [6]陕西省结核病防治院 [7]长春市传染病医院 [8]枣庄市王开传染病医院 [9]西安市结核病胸部肿瘤医院结核内科 [10]广州市胸科医院 [11]黑龙江省传染病防治院 [12]沈阳市第五人民医院 [13]山东省胸科医院五病区(疑难结核病 [14]天津市海河医院 [15]内蒙古自治区第四人民医院 [16]新疆维吾尔自治区胸科医院结核二科 [17]深圳市第三人民医院肺病三科 [18]宁夏回族自治区第四人民医院呼吸一科 [19]贵州医科大学附属医院呼吸科

出　　处：《结核病与胸部肿瘤》2019年第3期173-180,共8页Tuberculosis and Thoracic Tumor

摘　　要：目的分析由6种药物组成、疗程为18个月的化疗方案对耐多药肺结核患者的治疗效果,为缩短耐多药肺结核患者的化疗疗程提供依据。方法纳入2009年7月至2015年12月在首都医科大学附属北京胸科医院等20家结核病专科医院确诊为耐多药肺结核的681例患者,按照所采用的化疗方案将患者分为观察组(18个月方案组,515例)和对照组(24个月方案组,166例)。收集治疗中结核分枝杆菌培养、血常规、肝肾功能、心电图检查等结果,观察药物不良反应,评估两组患者的治疗转归(治疗成功、失败、死亡、丢失等)。采用SPSS 22.0软件进行数据的统计学分析,计量资料采用t检验或χ^2检验,计数资料采用χ^2检验;两组患者治疗前有差异的临床指标与治疗成功率间的关系采用logistic回归分析,以P<0.05为差异有统计学意义。结果观察组的治疗成功率(64.66%,333/515)高于对照组(54.22%,90/166)(χ^2=5.818,P=0.002),病死率(2.33%,12/515)低于对照组(5.42%,9/166)(χ^2=4.015,P=0.045)。而两组的失败率(17.06%,92/515;23.49%,39/166)、丢失率(11.46%,59/515;11.45%,19/166)、药物不良反应的总发生率(24.85%,128/515;25.90%,43/166)差异均无统计学意义(χ^2=2.561,P=0.109;χ^2=0.000,P=0.997;χ^2=0.095,P=0.757)。logistic回归分析显示年龄≥50岁[β=0.549,Sx=0.204,Wold χ^2=7.262,P=0.007,OR(95%CI)=1.731(1.161~2.579)]和使用乙胺丁醇[β=0.485,Sx=0.190,Wold χ^2=6.516,P=0.011,OR(95%CI)=1.625(1.114~2.359)]是影响治疗成功率的风险因素。结论采用6种药物组成、疗程为18个月的化疗方案能够达到24个月化还歹案的疗效,并获得较好的治疗成功率,且未增加药物不良反应发生率,具有临床可行性。Objective We observed and analyzed the effect of 18 months regimen containing 6 drugs in the treatment of multidrug-resistant pulmonary tuberculosis(MDR-PTB)with the purpose to provide evidence for shortening the treatment course of MDR-TB.Methods Six hundred and eighty-one confirmed MDR-TB patients were enrolled from 20 TB specialized hospitals in China from July,2009 to December,2015 among which 515 were treated with the 18 months regimen containing 6 drugs(observation group)and 166 were treated with 24 months regimen containing 5 drugs(control group).Results of TB bacilli culture,complete blood count,hepatic and renal function,electrocardiograph,etc were collected throughout the treatment.The treatment outcome(success,death,failure and lost to follow-up)and adverse effect were assessed at the end of treatment.Data were analyzed using SPSS 22.0 software.Measurement data were analyzed by t test or z test.Enumeration data were analyzed by Chi-square test.The clinical indicator with significant difference before treatment were further analyzed by logistic regression to identify the risk factors associated with treatment success rate.P<0.05 was considered significant difference statistically.Results The treatment success rate(64.66%,333/515)in the observation group was higher than that of the control group(54.22%,90/166)(χ^2=5.818,P=0.002)and the death rate in the observation group(2.33%,12/515)was lower than that of the control group(5.42%,9/166)(χ^2=4.015,P=O.045).The rate of failure(17.86%(92/515)vs 23.49%(39/166))(χ^2=2.561,P=0.109)and lost to follow-up((11.46%,59/515)vs 11.45%(19/166)(χ^2=0.000,P=0.991))were similar between the two groups.The total incidence of adverse reactions in the observation group(24.85%,128/515)was close to that of the control group(25.90%,43/166)(χ^2=0.095,P=0.757).Analysis using logistic regression showed that>50 age(β=0.549,sx=0.204,Wald χ^2=7.262,P=0.007,OR(95%CI)=1.731(1.161-2.579)and selection of ethambutol.(β=0.485,sx=0.190,Wald χ^2=6.516,P=0.011,OR(95%CI)=1.625(1.119-2.

关 键 词：结核 抗多种药物性 药物疗法 联合 方案评价 疗效比较研究 

分 类 号：R47[医药卫生—护理学]