抗结核板式药物治疗肺结核不良反应对照研究  

Comparison Study on Adverse Drug Reactions of the Plate Combination Anti-tuberculosis Drugs in Anti-tuberculosis Chemotherapy

作　　者：谢靖[1] 丁守华[1] 刘林飞[1] 张远涛[1] 

机构地区：[1]江苏省淮安市疾病预防控制中心结防科,江苏淮安223001

出　　处：《实用预防医学》2013年第11期1288-1291,共4页Practical Preventive Medicine

基　　金：江苏省预防医学科研课题(Y201005)

摘　　要：目的研究抗结核板式组合药治疗肺结核不良反应发生情况,为抗结核板式组合药在结核病临床应用提供资料。方法随机按2:1配比将487例初治涂阳肺结核患者分成板式药组332例和传统药组155例,观察两组患者治疗期间不良反应并进行比较。结果 487例肺结核患者不良反应发生率33.47%,板式药组、传统药组药物不良反应发生率分别为36.54%、27.10%,板式药组药物不良反应发生率、胃肠道不适发生率高于传统药组(P<0.05);强化期板式药组不良反应发生率为25.90%,老年患者中板式药组不良反应发生率53.62%,均高于传统药组,且差异有统计学意义(P<0.05);板式药物与传统抗结核药对肝损伤差异无统计学意义(P>0.05)。结论板式抗结核药物不良反应发生率要高于传统散装抗结核药,尤其是胃肠道副反应发生率,临床使用板式抗结核药物时应加强不良反应监测,特别是强化期老年服药患者。Objective To explore the occurrence of adverse drug reactions （ADRs） of the plate combination anti-tuberculosis drugs,so as to provide evidence for the usage of anti-tuberculosis drugs in clinic.Methods Totally,487 new smear positive pulmonary tuberculosis patients were randomly allocated into two groups with a ratio of 2 to 1,the plate combination drug group（332 cases） and the traditional drug group（155 cases）.The occurrence of ADRs was observed and compared between the two groups.Results The total occurrence rate of ADRs was 33.47％,with 36.54％ for the plate combination drug group and 27.10％ for the traditional chug group.Compared with the traditional group,the total ADRs rate and the gastrointestinal reactions rate were higher in the plate combination drug group （P ＜ 0.05）.For the plate combination drug group,the occurrence rate of ADRs at the intensify stage was 25.90％,and that in the elderly patients was 53.62％,both higher than those in the traditional group （P ＜ 0.05）.No remarkable differences were found in hepatic injury between the two groups（P ＞0.05）.Conclusions The occurrence rate of ADRs,especially the occurrence rate of gastrointestinal reactions,is higher in the plate combination drug group than in the traditional group.ADR inspection should be intensified in the clinic,especially on the elderly and patients during the intensify stage.

关 键 词：肺结核 板式药物 药物不良反应 

分 类 号：R521.5[医药卫生—内科学]