化疗加免疫长疗程方案治疗耐多药结核病的随机对照研究  

A Controlled Clinical Study of Long Course Chemotherapy Regimens Containing Immunopotentiator in the Treatment of Multi- Drug Resistant Pulmonary Tuberculosis

作　　者：初乃惠[1] 罗永艾[2] 朱莉贞[1] 傅瑜[3] 叶志忠[4] 肖和平[5] 王巍[6] 苑松林[7] 张侠[8] 卢水华[9] 马丽萍[1] 聂玉生 陈威[11] 陈晓红 刘志成 李凫坚[14] 王丽花[15] 尚好珍[16] 

机构地区：[1]北京市结核病胸部肿瘤研究所 [2]重庆医科大学附属第一医院 [3]中国CDC结核病防治临床中心 [4]厦门市第一医院 [5]上海市肺科医院 [6]中国人民解放军总医院第二附属医院 [7]天津市海河医院 [8]南京市胸科医院 [9]复旦大学公共卫生学院 [10]山西省阳泉市第三人民医院 [11]沈阳市胸科医院 [12]福建省福州肺科医院 [13]武汉结核病院 [14]杭州市红十字会医院 [15]山西省太原市结核病医院 [16]新乡医学院一附院

出　　处：《结核病与胸部肿瘤》2008年第2期108-113,共6页Tuberculosis and Thoracic Tumor

基　　金：国家“十五”科技攻关计划资助项目（2001BA705804）

摘　　要：目的评价化疗加免疫长疗程方案治疗耐多药肺结核的疗效和安全性。方法对203例耐多药肺结核患者，采用1：1随机、平行对照的方法，分为治疗组和对照组，两组患者除采用对氨基水杨酸异烟肼、利福喷丁、左旋氧氟沙星、丙硫异烟胺、克拉霉素和阿米卡星治疗外．治疗组患者加用免疫调节剂母牛分枝杆菌菌苗（M．vaccae，微卡），对照组患者不加用母牛分枝杆菌菌苗，疗程共18个月。结果治疗结束时（18个月）治疗组和对照组痰抗酸菌涂片阴性同时痰结核分枝杆菌培养阴性（涂阴培阴）分别为74．5％（73／98）和72．5％（66／91），（X^2=0．09，P=0．7599）。两组比较差异无统计学意义。X线影像结果表明，两组的病灶显效率分别为72．5％（71／98）和47．3％（43／91），差异有统计学意义（F=12．52，P=0．0004，P〉0．05）;有效率分别为90．8％（89／98）和82．4％（75／91），差异无统计学意义（X2=2．90，P=0．0886，P〉0．05）;空洞闭合率分别为33．3％（27／81）和22．1％（17／77），差异无统计学意义（秩和检验F=1．52，P=0．1294，P〉0．05）。免疫学指标CD8在治疗6月时治疗组高于对照组，CD3治疗后与治疗前免疫指标差值在3个月和9个有统计学差异外，其余CD4，CD4／CD8，NK细胞，IL-2R各治疗阶段，治疗组与对照组近似，无统计学差异。临床症状咳嗽、咳痰、胸痛、呼吸困难、乏力等症状有改善，治疗组改善程度均大于对照组。结论本研究所设计的方案对耐多药肺结核病均有明确的疗效，具有有效的杀菌、抑菌作用，加用免疫调节剂在促进病灶吸收、症状改善方面有一定的作用。Objective To evaluate the curative effect and safety of a regimen containing immunopotentiator in the treatment of multi-drug resistant pulmonary tuberculosis. Method During 18 months treatment, 189 patients with multi-drug resistant pulmonary tuberculosis were divided into a treatment group （rifapentine,pasiniazide,levofloxacin,ethambutol,ethionamide,amikacin, clarithromycin, M. vaccae for 3 months, rifapentin, pasiniazide, levofloxacin, ethambutol, ethionamide, clarithromycin, M. vaccae for 6 months, rifapentin, pasiniazide, levofloxacin, ethambutol, clarithromycin, for 9 months）, and a control group （rifapentine , pasiniazide, levofloxacin, ethambutol, ethionamide, amikacin , clarithromycin,for 3 months, rifapentin, pasiniazide, levofloxacin, ethambutol, ethionamide, clarithromycin, for 6 months, rifapentin, pasiniazide, levofloxacin, ethambutol, clarithromycin for 9 months） with proportion 1 ： 1 random, and parallel compared method. Results At the end of the treatment, the sputum negative conversion rate （smear negative, culture negative） of the treatment group was 74.49% （73/98）,and of the control group was 72.93% （66/91）, X^2=0.09, P=-0.7599,respectively. The remarkable effective rates in chest X-ray of the treatment group and the control group were 72.45% （71/98） and 47.25% （43/91）, X^2= 12.52, P=-0.0004, ,respectively and the effective rates were 90.82% （89/98） and 82.42% （75/91）, X^2=2.90, P=-0.0886, respectively. The cavity closure rates were 33.33% （27181） and 22.08% （17/77）, F= 1.52, P=-0.1294, respectively. CD8 was improved after 6 months treatment in treatment group, being significantly different in two groups. CD8, CD4/ CD8, NK, IL-2R were similar in two groups. The symptoms of cough, expectoration, chest pain, hypodynamia were improved. Conelusion Regimens containing immunopotentiator or not were very effective in killing baciterum and bacteriostasis for the treatment of multi-drug resistant pulmonary tuberculosis, with good safety and tolerance. It ca

关 键 词：结核 肺 抗药性 多药 母牛分枝杆菌菌苗 

分 类 号：R979.5[医药卫生—药品] R969.4[医药卫生—药学]