94例肺结核患者抗结核药物所致不良反应的分析  

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

作　　者：薛浩[1] 张红军[1] 印伟[2] 周志芹 

机构地区：[1]江苏省盐城市疾病预防控制中心开发区分中心,224002 [2]江苏省盐城市疾病预防控制中心慢性传染病防制科,224002

出　　处：《结核病与肺部健康杂志》2015年第1期49-53,共5页Journal of Tuberculosis and Lung Health

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.Objective To analyze the anti-tuberculosis adverse drug reactions （ADRs） occurred in the pa- tients 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 re- spectively. Second, liver damage rate was 72.34% （68/94）. Hepatic injury complicated with gastrointestinal reac- tions 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 oc- curred 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 da

关 键 词：结核 肺/药物疗法 抗结核药 药物毒性 发病率 

分 类 号：R978.3[医药卫生—药品]