内蒙古自治区抗结核药物不良反应监测结果分析

The results of anti-tuberculosis drug adverse drug reaction monitoring in Inner Mongolia

目的了解内蒙古自治区结核病防治规划下的一线抗结核药品不良反应发生情况及其对结核病防治工作的影响。方法采用队列研究方法观察评价内蒙古的东部、中部、西部地区的10个旗县,自2008年6月1日至2009年1月,所有接受免费治疗初治涂阳及初治涂阴肺结核患者为调查入选对象。所有入选病例观察半年,总共监测完成858例。对化疗中出现的异常临床表现和肝肾功能、血尿常规检查进行观察分析,将异常结果进行关联性评价,判断其"肯定"和"很可能"相关者为药品不良反应。EPiData3.1建立数据库,spss进行数据分析。结果本次研究有271例出现了1种或1种以上异常表现的可疑不良反应,占31.59%,其中轻度反应144例,占不良反应发生的53.14%,中度反应125例,占46.13%,重度反应2例,占0.73%。共有126例因不良反应而停换药,占14.7%,其中终止治疗15例,占研究对象的1.74%。女性不良反应发生率高于男性(x^2=14.072,P=0.0001,P<0.01,差异有统计学意义);体重<50kg的患者不良反应发生率高于>50kg的患者(x^2=7.438,P=0.006,P<0.01,差异有统计学意义);不同民族不良反应发生率无差异;有并发症患者的不良反应发生率(45.33%)高于无并发症患者的不良反应发生率(30.27%),(x^2=7.189,P=0.007,P<0.01,差异有统计学意义)。结论内蒙古自治区结核病防治规划采用的一线抗结核药品标准化疗方案中不良反应发生率相对较高,在一定程度上影响了化疗工作顺利进行,应重视抗结核药物所致的不良反应,加强对相关专业人员的培训和对患者的宣教,在化疗过程中密切监测以便及时发现不良反应,今后需进一步完善我区抗结核药物不良反应的呈报系统。

Objective Learn incidence of the dverse drug reaction（ADR）of first-line anti-tuberculosis and its impact on Tuberculosis（TB）prevention and treatment,under the prevention and control program in Inner Mongolia.Methods Cohort study used to evaluate 10 counties in the eastern,central,western region of Inner Mongolia.Since June 1,2008 to January 2009,all received free treatment smear positive and smear negative TB patients were selected.All elected cases were observed for six months,completed total of 858 cases monitoring.To observed and analyzed abnormal liver and kidney functions,blood and urine routine examination in clinical chemotherapy,relevancy evaluation of abnormal results,determine its ＂positive＂ and ＂very likely＂ relevant persons for drug adverse reactions.Use EPiData3.1 database,data analysis used SPSS system.Results In this study,271 patients had had more than 1 or one kind of suspected adverse reactions,accounting for 31.59%,144 cases of which mild reaction,accounted adverse reactions for 53.14%,125 patients with moderate reaction,accounting for 46.13%,2 cases of severe reaction,accounting for 0.73%.A total of 126 cases drug wiithdrawal or change dressings due to ADR, accounting for 14.7%,15 cases in which stop treatment,accounting for 1.74%.The adverse reactions rate of women was higher than men（x^2=14.072,P0.01）; adverse reactions rate of weight less than 50 kg patients was higher than patients over 50 kg（x^2=7.438,P=0.006,P0.01,have significant difference）;Adverse reactions rates in patients with complications（45.33%）was higher than in patients without complications（30.27%）（x^2=7.189,P=0.007,P0.01,have significant difference）。Conclusion Relatively high incidence dverse drug reaction（ADR）of first-line anti-tuberculosis and its impact on Tuberculosis（TB） prevention and treatment,under the prevention and control program in Inner Mongolia,affected the smooth progress of chemotherapy,should pay attention to anti-TB drugs-induced adverse reactions,strengthen the training of relevant professionals and the propaganda of patients,close monitoring during chemotherapy in order to detect adverse reactions.The future of our region need to further improve the anti-tuberculosis drug adverse reaction reporting system.