河北省2012-2014年抗感染药品不良反应发生情况及影响因素分析

发布时间：2018-03-11 17:25

本文选题：不良反应　切入点：抗感染药品　出处：《河北医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:药品不良反应(Adverse drug reaction ADR)是指合格药品在正常用法用量下出现的与用药目的无关的有害反应。虽然我国的不良反应体系成立较晚,但目前我国的药品不良反应监测体系已经逐步完善。2012年河北省药品不良监测体系基本建立,在药品不良反应报告收集方面取得了很大进展,报告县级覆盖率达到100%,报告数达到42586例,每百万人口平均不良反应报告数达到592.7份,符合世界卫生组织的推荐数量。有资料显示,每年的药品不良反应报告中抗感染药品发生的不良反应例数较多,尤其是抗生素类的不良反应。本研究通过收集河北省药品监测评价中心抗感染药品应用情况数据分析全省2012年-2014年抗感染药品不良反应发生情况,尤其是严重不良反应与患者因素、地域因素以及用药因素等之间的关系,提出相应的预防措施,降低药品不良反应的发生率。方法:收集河北省各地市2012、2013、2014年医疗机构上报的抗感染药品不良反应报告数据,对数据中患者性别、年龄、严重级别、时间分布、医院级别、药物分类等内容进行描述性分析。利用Microsoft Excel软件(Microsoft Excel 2010)对数据进行审核、整理。用X2检验对研究对象的性别、年龄、严重级别、医院级别、药物分类、地域分布等差异进行比较,用条件Logisitic回归分析计算相对危险估计值(Oddratio,OR)及其可信区间,所有P值基于双侧检验,统计学检验水准а均设定为0.05。结果:河北省2012年-2014年共收到抗感染药品不良反应病例报告33434例(男性14546例,女性15332例),其中严重病例报告740例,占报告总数的0.02%,其中2012年严重报告100例,2013年严重报告209例,2014年严重报告431例,严重药品不良反应/事件报告呈逐年上升的趋势。在11个地市中,保定市上报6288例病例报告,上报报告数量明显高于其它地市。在不同级别医疗机构中,三级医疗机构上报严重药品不良反应/事件报告178例,占比5.67%;发生药品不良反应的抗感染药物主要由抗生素类和全合成抗感染类构成。与注射给药途径相比口服给药途径更易引起不良反应。单因素分析发现,严重药品不良反应的发生与患者的年龄、体重、既往药品不良反应史、吸烟史、药物分类、给药途径、医院分级、地域8个因素有关。多因素分析结果显示老年患者、既往有药品不良反应史、抗生素类药物、注射给药途径、三级医疗机构、经济发达地区6个因素是不良反应的危险因素。年龄方面,老年患者更易出现不良反应(OR=2.178);既往药品不良反应史患者易发生药品不良反应;药物分类方面,合成抗感染类药品相比抗生素类更不易发生药品不良反应(OR=0.236);给药途径方面,注射给药途径更易发生药品不良反应(OR=0.556);医院分级方面,三级医疗机构更易发生药品不良反应(OR=0.928);地域方面,经济发达的城市相比较经济欠发达城市更易发生药品不良反应(OR=0.471)。结论:1医务人员在使用抗生素治疗的时候应注意:1.1对待老年患者以及有既往药品不良反应史的患者应该更加小心、谨慎,老年人基础疾病较多,多存在长期口服用药的现象,临床医务人员对老年人用药时应慎重,考虑联合用药引起的药品不良反应,坚持合理用药原则,做到个体化给药,从而降低药品不良反应的发生率。1.2临床上根据病情选择合适的给药途径,能口服给药达到治疗目的,原则上尽量不选择注射给药。2基层医疗机构应加强对药品不良反应的重视程度,应按照《药品不良反应报告和监测管理办法》主动上报药品不良反应报告。
[Abstract]:Objective: adverse drug reaction (Adverse drug reaction ADR) refers to and unrelated to the drug adverse reaction of qualified drugs in normal usage appears. Although China's adverse reaction system was established late, but at present our country's ADR monitoring system has been gradually improved in Hebei province.2012 adverse drug monitoring system basically established. This collection of reports of adverse drug reactions has made great progress, reporting coverage rate reached 100%, the number of reports to 42586 cases per million population, the average number of adverse reaction reports reached 592.7, with the recommended amount of the WHO. The data show that the number of cases of adverse drug reactions occurred more anti infection every year in adverse drug reaction reports in particular, the adverse reaction of antibiotics. This study collected Hebei drug monitoring and evaluation center of anti infective drugs application data Analysis of the province in 2012 -2014 infection the occurrence of adverse drug reactions, especially the factors of serious adverse reactions and patients, the relationship between regional factors and drug factors, puts forward the corresponding preventive measures, reduce the incidence of adverse drug reactions. Methods: to collect around the city of Hebei Province in 201220132014 medical institutions of anti infective drug adverse reaction report data, data on gender, age, severity, time distribution, hospital level, drug classification etc. were analyzed. By using Microsoft Excel software (Microsoft Excel 2010) audit, organization of data. X2 test was used to the study of the gender, age, severity level, hospital level, classification of drugs. Compare the differences in regional distribution, using conditional Logisitic regression to estimate relative risk estimates (Oddratio, OR) and its confidence interval, all based on the P value of bilateral Test, test standard was set to 0.05.. Results: the Hebei province in 2012 -2014 received anti infection of 33434 cases of adverse drug reactions (14546 males, 15332 females), including 740 cases of serious cases, accounting for 0.02% of the total number of the report, the 2012 report of 100 cases of severe, severe 2013 report of 209 cases in 2014, a report of 431 cases of serious, serious adverse drug reaction / incident report showed a rising trend year by year. In 11 cities, 6288 cases were reported in Baoding City, the number of reported significantly higher than other cities. At different levels of medical institutions, three medical institutions reported serious adverse drug reactions / incident report in 178 cases, accounting for 5.67%; the incidence of ADR of anti infective drugs mainly by antibiotics and total synthesis of anti infective drugs. And the injection route than the oral route of administration is more likely to cause adverse reactions of single factor. The analysis found that serious adverse drug reactions and the patient's age, weight, previous adverse drug reaction history, smoking history, drug classification, route of administration, hospital grade, the 8 geographical factors. Multivariate analysis showed that elderly patients, patients with adverse drug reaction history, antibiotics, injection way, three medical institutions, 6 factors in economically developed areas is a risk factor for adverse reactions. The age, elderly patients are more prone to adverse reactions (OR=2.178); adverse drug reactions prone to adverse drug reactions in patients with a history of previous classification; synthetic drugs, anti infective drugs compared to antibiotics more prone to adverse reactions the drug (OR=0.236); route of administration, injection route more susceptible to adverse drug reaction (OR=0.556); hospital grading, three medical institutions are more susceptible to adverse drug reaction (OR=0.928); regional The economically developed city, compared to the underdeveloped city are more susceptible to adverse drug reaction (OR=0.471). Conclusion: 1 medical personnel should pay attention to when using antibiotics in the treatment of the elderly patients and patients: 1.1 treated the history of previous drug adverse reactions should be more careful, cautious, more basic diseases in the elderly, there are many long term oral medication phenomenon, clinical medical personnel for the elderly medication should be carefully considered, adverse drug reactions caused by drug combination, adhere to the principles of rational drug use, do personalized medicine, so as to reduce the incidence of adverse drug reaction.1.2 clinically chosen according to the condition of the route of administration, oral administration can achieve treatment the purpose, principle, try not to choose injection to the grassroots medical institutions drug.2 should strengthen the degree of attention to adverse drug reaction, should be in accordance with the "measures for the administration of reporting and monitoring of adverse drug reactions. Report on adverse drug reactions (ADR) on the initiative.

【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R95

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