Email Alert | RSS    帮助

中国防痨杂志 ›› 2014, Vol. 36 ›› Issue (7): 570-575.doi: 10.3969/j.issn.1000-6621.2014.07.010

• 论著 • 上一篇    下一篇

91例耐多药肺结核患者抗结核药物不良反应发生情况分析

苏伟 阮云洲 赵津 成君 张灿有 王黎霞 李仁忠   

  1. 102206 北京,中国疾病预防控制中心结核病预防控制中心耐药防治部
  • 收稿日期:2014-03-14 出版日期:2014-07-10 发布日期:2014-08-07
  • 通信作者: 李仁忠 E-mail:lirenzhong@chinatb.org
  • 基金资助:

    “十一五”国家重大科技专项(2008ZX10003-007)

Analysis of adverse drug reactions in 91 multidrug-resistant tuberculosis patients

SU Wei, RUAN Yun-zhou, ZHAO Jin,CHENG Jun,ZHANG Can-you,WANG Li-xia, LI Ren-zhong   

  1. National Center for Tuberculosis Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China
  • Received:2014-03-14 Online:2014-07-10 Published:2014-08-07
  • Contact: LI Ren-zhong E-mail:lirenzhong@chinatb.org

摘要: 目的 分析耐多药肺结核患者应用标准化治疗方案治疗出现药物不良反应的发生情况,并评价其对治疗的影响。方法 通过专家咨询,中国疾病预防控制中心结核病预防控制中心设计了《耐多药肺结核患者抗结核药物不良反应情况调查表》(内容包括患者姓名、性别、登记分类等基本情况,以及开始治疗时间、不良反应发生的种类、发生的时间、可能影响的药物、不良反应的处理等);由统一培训的研究人员与临床医生,在开展耐多药肺结核规范化治疗的河南省濮阳市、黑龙江省大庆市、浙江省衢州市和天津市4个地区,对2010年3月1日至2012年2月29日期间留取痰标本并确诊纳入治疗的91例耐多药肺结核患者病案进行回顾性调查分析。结果 91例应用耐多药肺结核规范化治疗方案的患者,89.0%(81/91)发生过不良反应,出现的不良反应以胃肠道反应、肝脏毒性和关节痛或肌肉痛发生率最高,分别占35.4%(52/147)、17.7%(26/147)和13.6%(20/147)。55.1%(81/147)的不良反应维持原治疗方案,32.7%(48/147)的不良反应需要更换或停用导致不良反应的药物,有7.5%(11/147)的不良反应导致治疗中断。因不良反应停用或更换药物比例最高的是对氨基水杨酸(PAS),占37.5%(18/48),停用或更换药物比例最少的是卡那霉素注射剂(Km),仅占6.3%(3/48)。结论 耐多药肺结核治疗过程中极易发生不良反应,但绝大多数不良反应不需处理;应重视对不良反应发生的监测和处理,不要轻易停药甚至停止治疗,保证患者的治疗效果。

关键词: 结核, 肺/药物疗法, 抗药性, 多种, 细菌, 药物不良反应, 治疗结果

Abstract: Objective To analyze the adverse drug reactions(ADR) of the standardized treatment of multidrug-resistant tuberculosis(MDR-TB),and to evaluate the impact on treatment. Methods  We designed the questionnaire of MDR-TB ADR through expert consultation, and retrospectively investigated MDR-TB patients’ medical records with standardized ADR questionnaire in He’nan Puyang city, Heilongjiang Daqing city, Zhejiang Quzhou city and Tianjin municipality. A total of 91 MDR-TB patients confirmed during March 1, 2010 to February 29, 2012 were enrolled in the analysis.  Results 89.0%(81/91) of 91 MDR-TB patients had adverse reactions(ADR). The most common ADR was gastrointestinal reaction which accounted for 35.4%(52/147), followed with hepatotoxicity,which accounted for 17.7%(26/147). After the ADR treatment, 55.1%(81/147) of patients maintained the original treatment regimen, 32.7%(48/147) patients changed or stopped ADR-induced drugs,only 7.5%(11/147) cases stopped MDR-TB treatment for ADR. The highest percentage of changed or stopped drug is amino acid (PAS), which accounted for 37.5%(18/48), the least percentage is kanamycin injections (Km), which accounted for 6.3%(3/48).  Conclusion ADR is common during the treatment course of MDR-TB, but the vast majority of ADR do not need to be dealt with. Attention should be paid to monitoring and management of ADR, drugs should not be stopped easily or even stopping treatment.

Key words: Tuberculosis, pulmonary/drug therapy, Drug resistance, multiple, bacterial, Drug-related adverse reactions, Treatment outcome