不同来源药物治疗耐多药肺结核过程中严重不良反应发生情况分析  

Analysis of adverse drug reactions in 195 multidrug-resistant tuberculosis patients

作　　者：代晓琦 阮云洲[1] 徐彩红[1] 苏伟[1] 王黎霞[1] 李仁忠[1] 

机构地区：[1]中国疾病预防控制中心结核病预防控制中心,北京102206

出　　处：《疾病监测》2016年第11期968-971,共4页Disease Surveillance

基　　金：中美新发和再发传染病合作项目(No.3);中国国家卫生和计划生育委员会-盖茨基金会结核病防治合作项目(No.51914)~~

摘　　要：目的分析耐多药肺结核患者治疗过程中药物严重不良反应发生情况,探讨不同来源(国产和进口)药物严重不良反应发生方面的差异,评价抗结核药物严重不良反应对治疗的影响。方法 2015年9 12月,由经过培训的调查人员使用统一的调查表,对7个研究地区的195例患者的病案信息进行回顾性调查。结果研究中使用国产和进口药物患者基本情况相似,具有可比性;使用国产和进口药物患者中因不良反应引起停用相关药物率分别为16.28%和15.15%(χ2=0.04,P=0.84),终止治疗率分别为8.53%和6.06%,差异无统计学意义(χ2=0.37,P=0.54);两组严重不良反应发生率分别为23.26%和21.21%,差异无统计学意义(χ2=0.10,P=0.75);严重不良反应发生次数前3位,使用国产药物的患者中为肝脏毒性、胃肠反应、关节痛和肌肉痛,使用进口药物的患者中为胃肠反应、精神症状、过敏反应。结论在耐多药肺结核治疗过程中,易发生药物不良反应,但大部分患者通过调整方案仍可继续治疗。国产药物在目前使用低剂量的情况下,与高剂量进口药物安全性相近。若为保证耐多药肺结核治疗有效性,加大国产药物剂量是否会引起不良反应发生情况增加,有待进一步研究。Objective To understand the incidence of the adverse drug reactions（ ADR） in multidrug resistant tuberculosis（ MDR-TB） patients during anti TB treatment and compare the difference in adverse drug reaction between domestic anti TB drug and imported anti TB drug. Methods During September-December in 2015,a retrospective questionnaire survey was conducted among 195 M DR-TB patients. Results The basic information of the patients were similar,regardless they used domestic anti TB drugs or imported anti TB drugs. The suspension rate was 16. 28% for domestic anti TB drugs and 15. 15%for imported anti TB drugs（ χ~2= 0. 04,P = 0. 84）,and 8. 53% of the patients who taken domestic anti TB drugs stopped treatment,so did 6. 06% of the patients who taken imported anti TB drugs（ χ~2= 0. 37,P = 0. 54）,the differences had no significance. The ADR rates were 23. 26% and 21. 21%,respectively,in 2 groups,the difference had no significance（ χ~2= 0. 10,P = 0. 75）. The first 3 ADRs were hepatotoxicity,gastrointestinal reaction,joint and muscle aches in domestic anti TB drug users, and gastrointestinal reaction, mental symptoms and anaphylaxis in imported anti TB drug users.Conclusions Though ADR is common in the treatment of M DR-TB,most treatment can continue if appropriate adjustment is made on therapeutic regimen. The safety of the domestic drugs at lowdosage was similar to that of the imported drugs at high dosage. Further studies are needed on whether ADR would increase if increased dosages of the domestic drugs are used to ensure the effect of M DR-TB treatment.

关 键 词：结核 肺 抗药性 多种 细菌 药物不良反应 治疗 

分 类 号：R521[医药卫生—内科学]