【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(χ~2=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60d内者占87.23%(82/94),发生在30d内者占50.00%(47/94)。有87.50%(7/8)的单纯过敏反应发生在10d内;72.72%(8/11)的单纯胃肠道反应发生在20d内;28.57%(10/35)、88.57%(31/35)的单纯肝损伤分别发生在30d、60d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。更多还原

【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 antituberculosis 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(χ~2=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.更多还原