中文摘要：

目的 评价中药与免疫调节剂辅助治疗复治肺结核的疗效与经济性,寻找最佳治疗方案.方法 选取2010年1月-2012年12月浙江省中西医结合医院住院及门诊复治肺结核痰菌阳性患者307例,采用随机数字表法将患者分为3组,对照组99例、中药组105例、免疫组103例.3组治疗方案均为强化期3个月,巩固期5个月.对照组：3HL2ZV/5HL2V（H：异烟肼,L2：利福喷汀,Z：吡嗪酰胺,V：左氧氟沙星）;中药组：3HL2ZV/5HL2V＋康复新液10 ml/次,3次/d,口服;免疫组：3HL2ZV/5HL2V＋母牛分枝杆菌菌苗22.5 μg/次,1次/2周,肌肉注射.观察3组疗效、症状改善及不良反应发生情况,并采用成本-效果分析法进行经济学评价.结果 对照组、中药组、免疫组痰菌转阴率分别为80.8%（80/99）、93.3%（98/105）、92.2%（95/103）;其中中药组较对照组升高（P＜0.016 7）.3组病灶吸收率及空洞关闭率比较,差异均无统计学意义（P＞0.05）.对照组、中药组、免疫组症状消失率分别为24.8%（84/339）、65.4%（287/439）、62.3%（259/416）;其中中药组、免疫组较对照组均增高（χ2值分别为126.376和105.844,P＜0.016 7）;中药组与免疫组比较,差异无统计学意义（χ2=0.289,P＞0.016 7）.对照组、中药组、免疫组不良反应发生率分别为45.5%（45/99）、33.3%（35/105）、38.8%（40/103）,差异无统计学意义（χ2=3.149,P＞0.05）.平均治疗成本中药组、免疫组和对照组分别为10 485.5、8 734.4、7 832.3元.增量成本-效果中药组和免疫组分别为212.3、79.1元.结论 中药能加速痰结核分枝杆菌阴转,不增加不良反应.从成本-效果分析,免疫组较中药组更能有效地控制成本.

英文摘要：

Objective To evaluate the curative effect and cost -effectiveness of traditional Chinese medicine （TCM） and immunomodulator in adjuvant treatment of retreatment pulmonary tuberculosis, and to find out a best therapeutic scheme. Methods A total of 307 patients with reerudescent and sputum bacilli positive who were treated in inpatient and outpa- tient department of integrated Chinese and Western Medicine Hospital of Zhejiang Province, were randomly divided into three groups by random number table method, 99 cases in control group, 105 cases in TCM group, and 103 cases in immunomodulator group. Three groups of patients received intensive treatment for 3 months, then received consolidation treatment for 5 months. Cases in control group were treated by a regimen of 3HL2ZV/JHLEV （ H： isoniazid, L2 ： rifapentine, Z： pyrazinamide, V： levofloxacin） , cases in the TCM group were treated by a regimen of 3HLEZV/5HLEV and Kangfuxin liquid （ 10 ml every time, 3 times per day, oral administration） , cases in the immunomodulator group were treated by a regimen of 3 HL2ZV/5 HL2 V and Mycobacterium vaccine （2. 5 μg every time, 1 time every 2 weeks, intramuscular injection） . Clinical efficacy and adverse reactions were observed and recorded among three groups. The cost - effectiveness in three groups was evaluated by pharmacoeco- nomic method. Results The sputum bacilli negative conversion rate in control group, TCM group and immunomodulator group were 80. 8% （80/99）, 93.3 % （98/105）, 92. 2% （95/103） respectively, the rate in TCM group was higher than that of the control group （ P 〈 0. 016 7 ）. There was no significant difference in focus absoption rate and cavity closure rate among threegroups （P 〉 0. 05） . The clinical symptoms disappear percentages in control group, TCM group and immunomodulator group were 24. 8% （84/339）, 65.4% （287/439） and 62. 3% （259/416） respectively, the percentages in TCM group and immunomod- ulator group were significantly higher than that in