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中国防痨杂志 ›› 2021, Vol. 43 ›› Issue (4): 328-334.doi: 10.3969/j.issn.1000-6621.2021.04.006

• 论著 • 上一篇    下一篇

优化方案治疗复治药物敏感肺结核的疗效评价

戈启萍, 杜建, 舒嶶, 马艳, 马丽萍, 赵彩燕, 陈瑜晖, 张立杰, 黄学锐, 韩喜琴, 陈盛玉, 王飞, 李波, 曹文利, 刘倩颖, 陈东进, 石莲, 王鑫, 黎友伦, 杨尚鹏, 彭章丽, 吴超, 欧阳兵, 王芙蓉, 李钋, 吴湘, 席秀娥, 冷学艳, 张海晴, 李华, 李鹃, 杨澄清, 张朋, 崔洪哲, 谢莉, 刘宇红, 李亮(), 高微微()   

  1. 101149 首都医科大学附属北京胸科医院 北京市结核病胸部肿瘤研究所 中国疾病预防控制中心结核病防治临床中心(戈启萍、杜建、舒嶶、张立杰、黄学锐、韩喜琴、谢莉、刘宇红、李亮、高微微);中国中医科学院中医临床基础医学基础所(马艳);河南省疾病预防控制中心结核病防治科(马丽萍);哈尔滨市胸科医院结核科(赵彩燕);广东省结核病控制中心门诊部(陈瑜晖);天津市结核病控制中心门诊科 (陈盛玉);浙江省疾病预防控制中心结核病防治所(王飞);北京结核病控制研究所门诊部 (李波);北京老年医院感染疾病科(曹文利);解放军总医院第八医学中心结核科(刘倩颖);北京京煤集团总医院结核科(陈东进);沈阳市胸科医院结核科(石莲);黑龙江省疾病预防控制中心结核病防治所(王鑫);重庆医科大学附属第一医院呼吸科(黎友伦);湖北省荆州市传染病医院结防所(杨尚鹏);贵州省遵义医学院附属医院呼吸与危重症医学科结核病区(彭章丽);江苏省镇江市第三人民医院结核科(吴超);昆明市第三人民医院结核一科(欧阳兵);内蒙古自治区第四医院内五科(王芙蓉);包头市第三医院结核科(李钋);湖北省荆门市疾病预防控制中心结核病防治所(吴湘);河南省新乡医学院第一附属医院结核科(席秀娥);河北省秦皇岛市第三医院结核科(冷学艳);江苏省徐州市传染病医院结核科(张海晴);山西省临汾市第三医院结核科(李华);广西壮族自治区疾病预防控制中心结核病防治所(李鹃);武汉市结核病防治所呼吸与危重症医学科Ⅱ病区(杨澄清);河北省唐山市第四医院结核科(张朋);吉林省延边结核病防治所防治科(崔洪哲)
  • 收稿日期:2021-01-26 出版日期:2021-04-10 发布日期:2021-04-09
  • 通信作者: 李亮,高微微 E-mail:liliang@tb123.org;gwwjys@sina.com
  • 基金资助:
    “十一五”国家传染病重大专项(2008ZX10003-015);“十二五”国家传染病重大专项(2013ZX10003009-001-006);“十二五”国家传染病重大专项(2013ZX10003009-001-007);“十三五”国家传染病重大专项(2018ZX10722302-003);“十三五”国家传染病重大专项(2018ZX10722302-003-002)

Treatment effect analysis of the optimized regimen for re-treated drug-susceptible pulmonary tuberculosis patients

GE Qi-ping*, DU Jian, SHU Wei, MA Yan, MA Li-ping, ZHAO Cai-yan, CHEN Yu-hui, ZHANG Li-jie, HUANG Xue-rui, HAN Xi-qin, CHEN Sheng-yu, WANG Fei, LI Bo, CAO Wen-li, LIU Qian-ying, CHEN Dong-jin, SHI Lian, WANG Xin, LI You-lun, YANG Shang-peng, PENG Zhang-li, WU Chao, OUYANG Bing, WANG Fu-rong, LI Po, WU Xiang, XI Xiu-e, LENG Xue-yan, ZHANG Hai-qing, LI Hua, LI Juan, YANG Cheng-qing, ZHANG Peng, CUI Hong-zhe, XIE Li, LIU Yu-hong, LI Liang(), GAO Wei-wei()   

  1. *Department of Tuberculosis, Beijing Chest Hospital,Capital Medical University,Beijing 101149,China
  • Received:2021-01-26 Online:2021-04-10 Published:2021-04-09
  • Contact: LI Liang,GAO Wei-wei E-mail:liliang@tb123.org;gwwjys@sina.com

摘要:

目的 评价优化方案治疗复治药物敏感肺结核患者的临床疗效及安全性。方法 采取多中心、随机、开放、平行、对照的前瞻性队列研究,中心单位统一发放随机号随机分组,选取复治涂阳培阳或涂阴培阳肺结核患者共381例为研究对象,其中优化治疗方案组(简称“优化方案组”)244例和标准化治疗方案组(简称“标准方案组”)137例。采用SPSS 19.0软件进行数据统计,计数资料采用χ2检验,当理论频数<1时,采用Fisher确切概率法检验,以P<0.05为差异有统计学意义。比较两组方案治疗成功率及不良反应发生等情况。结果 疗程结束,优化方案组治愈175例,完成治疗30例,治疗成功率为84.0%(205/244);标准方案组治愈92例,完成治疗10例,治疗成功率为74.5%(102/137),两组比较差异有统计学意义(χ2=5.128,P=0.024)。优化方案组和标准方案组不良反应发生率分别为25.8%(63/244)和21.2%(29/137),两组比较差异无统计学意义(χ2=1.037,P=0.309);严重不良反应发生率分别为2.5%(6/244)和4.4%(6/137),两组差异无统计学意义(χ2=0.525,P=0.469)。结论 优化方案可提高复治药物敏感肺结核患者治疗成功率,且不增加药物不良反应的发生率。

关键词: 结核,肺, 抗结核药, 再治疗, 临床方案

Abstract:

Objective To analyze the treatment efficacy and safety of optimized regimen for re-treated patients with drug-susceptibility pulmonary tuberculosis. Methods This was a multi-center, randomized, open, parallel, controlled prospective cohort study for retreated drug-susceptible pulmonary tuberculosis. All of 381 subjects with either positive smear and positive culture, or with negative smear but culture positive were enrolled in the study. Two hundred and forty-four cases were randomly enrolled in the optimized regimen group and 137 cases in the standard regimen. SPSS 19.0 software was used for data statistics, and chi square test was used for data analysis. When the theoretical frequency is less than 1, Fisher exact probability test was used. The difference is statistically significant (P<0.05). Treatment outcome and side effect during treatment were compared between the two groups. Results At the end of treatment, the success rate was 84.0% (205/244, 175 cases cured and 30 cases completed treatment) in the optimized regimen group and 74.5% (102/137, 92 cases cured and 10 cases completed treatment) in the standard treatment group. The treatment success rate of optimized regimen group was significantly higher than that of the standard regimen group (χ2=5.128, P=0.024). There was no significant difference between the two groups in the incidence of both side effects (25.8% (63/244) in optimized regimen group and 21.2% (29/137) in standard regimen group respectively; χ 2=1.037,P=0.309);and severe side effects (2.5% (6/244) vs. 4.4% (6/137); χ2=0.525, P=0.469). Conclusion The optimized regimen can increase treatment success patients with re-treated drug-susceptible pulmonary TB without increasing the side effects.

Key words: Tuberculosis, pulmonary, Antitubercular agents, Retreatment, Clinical protocols