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中国防痨杂志 ›› 2018, Vol. 40 ›› Issue (6): 564-569.doi: 10.3969/j.issn.1000-6621.2018.06.004

• 论著 • 上一篇    下一篇



  1. 中国疾病预防控制中心结核病预防控制中心(李仁忠、阮云洲、苏伟、王黎霞)
  • 收稿日期:2018-03-12 出版日期:2018-06-20 发布日期:2018-07-24
  • 通信作者: 代晓琦;
  • 基金资助:

Analysis on effects of isoniazid treatment in patients with rifampicin mono-/poly-drug-resistant tuberculosis

Xiao-qi DAI,Ren-zhong LI(),Yun-zhou RUAN(),Wei SU,Zhong-dong WANG,Li-xia. WANG   

  1. *Tuberculosis Control Division of Qingdao Municipal Center for Disease Control and Prevention, Qingdao Institute of Preventive Medicine, Qingdao 266033, China
  • Received:2018-03-12 Online:2018-06-20 Published:2018-07-24
  • Contact: Xiao-qi DAI;

摘要: 目的



收集2011年1月1日至2011年12月31日中国卫生部-盖茨基金会结核病防治合作项目——医院与疾控系统合作管理耐多药肺结核试点研究项目(简称“医防合作子项目”)的 4个调查现场,确诊并符合纳入标准的50例利福平单耐/多耐药肺结核患者的资料,剔除14例丢失、未评估、无法使用有效治疗方案的患者资料,对其余36例患者的临床资料进行研究,其中11例(30.56%)患者在接受治疗后3~4个月时加用了异烟肼(治疗方案:3~6Am-Lfx-H-PZA-EMB/9~12 Lfx-H-PZA-EMB;简称“异烟肼组”),25例(69.44%)未加用异烟肼[治疗方案:6 PZA-Am (Cm)-Lfx(Mfx)-PAS(EMB)-Pto/18 PZA-Lfx(Mfx)-PAS(EMB)-Pto;简称“标准组”]。患者基本情况采用描述性分析,计数资料采用Fisher精确概率检验,检验水准为α=0.05。





关键词: 结核, 肺, 异烟肼, 结核, 抗多种药物性, 治疗结果, 疗效比较研究

Abstract: Objective

To analyze the therapeutic effects of isoniazid for the patients with rifampicin mono-resistant tuberculosis (RMR-TB) and rifampicin poly-drug-resistant tuberculosis (RPR-TB), and to provide re-ference basis for developing the effective treatments as well as the prevention and control measures to those patients.


The four research sites, where a comprehensive China-Gates Collaborative TB Project was implemented, were involved in this study. During the project implementation period (from January 1, 2011 to December 31, 2011), a total of 50 patients, who were confirmed to have RMR or RPR pulmonary TB and met the recruitment criteria, were enrolled and the relevant information were collected from those patients. And then based on the collected information, 14 patients were excluded due to incompletely information on treatment, such as lost during treatment or unevaluated or failed on forming an effective treatment regimen, while the remaining 36 patients’ clinical data and information were analyzed. Among them, 11 patients (30.56%) were treated with isoniazid which was added in their treatment regimens after 3 or 4 months of treatment (3-6 Am-Lfx-H-PZA-EMB/9-12 Lfx-H-PZA-EMB), which was called “isoniazid group”; 25 cases (69.44%) were not supplemented with isoniazid (6 PZA-Am (Cm)-Lfx(Mfx)-PAS(EMB)-Pto/18 PZA-Lfx(Mfx)-PAS(EMB)-Pto), which was called “standard group”. Descriptive analysis was used for the patients’ basic information. The categorical variables were studied by using Fisher exact test, α=0.05.


The incidence of adverse drug reactions in the isoniazid group (54.55% (6/11)) was lower than that in the standard group (60.00% (15/25)), but there was no statistically significant difference between the two groups (Fisher exact test, P=1.000). The treatment success rate in the isoniazid group and the standard group was 90.91% (10/11) and 48.00% (12/25)) respectively; the treatment failure rate was 0.00% (0/11) and 44.00% (11/25) respectively in the isoniazid group and the standard group; the mortality was 9.09% (1/11) in the isoniazid group and 8.00% (2/25) in the standard group. The difference of treatment success rate and failure rate between the two groups was statistically significant (Fisher exact test, P=0.025, P=0.015).


By adding isoniazid into the patients’ treatment regimens, the number of adverse drug reactions of the patients does not increase, and the treatment outcomes of the patients with isoniazid is better than that of patients without isoniazid. In order to improve the treatment outcomes of the patients, it is suggested that isoniazid should be timely added into the patients’ treatment regimens if isoniazid resistance is not confirmed or if the patients are determined to have RMR-TB/RPR-TB.

Key words: Tuberculosis, pulmonary, Isoniazide, Tuberculosis, multidrug-resistant, Treatment outcome, Comparative effectiveness research