结核病与肺部健康杂志 ›› 2015, Vol. 4 ›› Issue (1): 49-53.doi: 10.3969/j.issn.2095-3755.2015.01.011

• 论著 • 上一篇    下一篇

94例肺结核患者抗结核药物所致不良反应的分析

薛浩,张红军,印伟,周志芹   

  1. 224002 江苏省盐城市疾病预防控制中心开发区分中心(薛浩、张红军、周志芹),慢性传染病防制科(印伟)
  • 收稿日期:2014-11-06 出版日期:2015-03-14 发布日期:2015-03-14
  • 通信作者: 薛浩,Email:41597303@qq.com

Analysis of the adverse drug reactions caused by anti-tuberculosis drugs in 94 cases of pulmonary tuberculosis patients

XUE Hao*,ZHANG Hong-jun,YIN Wei,ZHOU Zhi-qin   

  1. *The Center of Development Area, Yancheng Center for Disease Control and Prevention of Jiangsu Province,Yancheng 224002,China
  • Received:2014-11-06 Online:2015-03-14 Published:2015-03-14
  • Contact: XUE Hao,Email: 41597303@qq.com

摘要: 目的 分析2012年盐城市肺结核患者应用抗结核药物所致不良反应的发生情况。方法 对盐城市各结核病防治机构收治的3842例肺结核患者中的抗结核药物所致不良反应者进行及时处理的同时,填报抗结核药物不良反应个案表,主要包括性别、年龄、不良反应发生日期、持续时间、严重程度、类别、实验室检查、处理措施和结果、治疗转归等内容,并且进行统计学处理。结果 共报告发生抗结核药物不良反应94例,发生率为2.45%(94/3842);男66例,女28例,男∶女=2.4∶1。研究发现:(1)<20岁、20~岁、30~岁、40~岁、50~岁、60~岁、70~95岁年龄组的不良反应发生率分别为1.64%(2/122)、2.14%(11/513)、2.82%(9/319)、3.06%(17/556)、2.94%(22/748)、2.28%(19/835)、1.87%(14/749);其中男性和女性的不良反应发生率分别为2.38%(66/2772)和2.62%(28/1070),差异无统计学意义(χ2=0.1800,P>0.05);高峰年龄组分别为50~岁和30~岁年龄组,达3.06%(17/556)和3.60%(4/111)。(2)患者不良反应中,肝损害者占72.34%(68/94),肝损害合并胃肠道反应者占31.91%(30/94),≥2种不良反应者占40.43%(38/94)。(3)不良反应平均发生时间、持续时间分别为(35.4±28.7)d、(21.2±21.0)d,发生在服药60 d内者占87.23%(82/94),发生在30 d内者占50.00%(47/94)。有87.50%(7/8)的单纯过敏反应发生在10 d内;72.72%(8/11)的单纯胃肠道反应发生在20 d内;28.57%(10/35)、88.57%(31/35)的单纯肝损伤分别发生在30 d、60 d内。(4)有93.62%(88/94)的患者治愈或完成疗程,63.83%(60/94)的患者改变了治疗方案或服药方式。结论 盐城市抗结核药物所致不良反应处于低水平状态,以肝损害居多,常伴随胃肠道反应发生,30~59岁年龄组不良反应发生率较高,男性高峰年龄组比女性要高。

Abstract: Objective To analyze the anti-tuberculosis adverse drug reactions (ADRs) occurred in the patients with pulmonary tuberculosis (PTB) in Yancheng city in 2012. Methods When timely treating the anti-tuberculosis ADRs in 3842 cases of PTB patients, all institutions of tuberculosis prevention and control in Yancheng city should fill in the case table of the anti-tuberculosis ADRs,which mainly included sex,age,ADRs occurrence date,duration,severity,type,laboratory examination,measures and results, treatment outcome, and so on. And then we carried on statistical analysis. Results A total of 94 cases of the anti-tuberculosis drugs ADRs were occurred and reported. The incidence rate was 2.45%(94/3842).Male and female were 66 and 28 cases respectively. The rate was 2.4∶1.This study has following findings. First, in terms of the ADRs rate, less than 20,20-29,30-39,40-49,50-59,60-69 and 70-95 age groups were 1.64%(2/122),2.14%(11/513),2.82%(9/319),3.06%(17/556),2.94%(22/748),2.28%(19/835),1.87%(14/749)respectively. The ADRs of male and female incidence were 2.38% (66/2772) and 2.62% (28/1070).There was no statistically significant difference (χ2=0.1800,P>0.05).The peak of male and female were in 50-59 (3.06%;17/556) and 30-39 (3.60%;4/111) age group respectively. Second, liver damage rate was 72.34% (68/94).Hepatic injury complicated with gastrointestinal reactions accounted for 31.91% (30/94). Two or more ADRs accounted for 40.43% (38/94).Third, the mean times of occurrence and duration were (35.4±28.7)d,(21.2±21.0)d. There were 87.23% (82/94)and 50.00% (47/94)of ADRs occurred within 60 days and 30 days respectively. There was 87.50% (7/8) of simple allergic reaction occurred within 10 days. There was 72.72% (8/11) of simple gastrointestinal reaction occurred within 20 days. There were 28.57% (10/35), 88.57% (31/35) of simple liver damage occurred within 30 days and 60 days respectively. Forth, there were 93.62% (88/94) of ADRs cured or completed treatment and 63.83% (60/94) of ADRs changed treatment or medication way. Conclusion The anti-tuberculosis ADRs in Yancheng city was in the low level. The liver damage, which often occurred with gastrointestinal reaction, was in a majority. The incidence rate of the ADRs was higher in 30-59 age group. The peak age group of male was higher than female.