2012年-2016年张家口市药物不良反应监测概况研究

发布时间：2018-02-01 08:49

本文关键词： 药物不良反应损伤系统用药途径用药剂型一致性检验　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:了解张家口市2012年-2016年全市药品不良反应的发生情况,并对报告不良反应的单位、县级、市级报告一致性进行验证。在此基础上,评价药物不良反应发生对河北省乃至全国的合理用药状况的影响,为下一步有关部门制定更为有效的药物不良反应的上报机制提供参考。方法:通过国家药物不良反应监测系统收集河北省张家口市2012年-2016年发生不良药品反应的共19731例报告。内容主要包括:性别、年龄、既往药品不良反应记录、剂型、药物用量等。采用SPSS22统计软件进行分析,两组定量数据的比较直接采用独立样本T检验,多组定量数据差异性分析采用方差分析,如有统计学差异,则使用LSD-t检验进行组间两两比较。一致性检验采用卡方检验Kappa值。P0.05认为差别有统计学意义。结果:1一般情况:药物不良反应例数逐年增加,2016年达到了4710例。五年之间平均年有统计学差异,发生药物不良反应的平均年龄逐年增长,呈老龄化趋势。监测对象的性别组成无统计学差异。2药物不良反应的主要类型:2012年-2016年,胃肠系统损害、皮肤及其附件损害、中枢及外周神经系统损害占药物不良反应的前三位。胃肠系统损害主要表现为:恶心、呕吐、腹泻、腹痛、口干;皮肤及其附件损害:皮疹、瘙痒、荨麻疹、局部红肿、斑丘疹;中枢及外周神经系统损害主要表现为:头晕、头痛、眩晕、震颤、头晕加重。上述三种损害在药物不良反应中所占的比例从2013年开始呈逐年上升的趋势。3用药剂型和用药途径的主要类型:2012年-2016年,注射剂、片剂和胶囊三种用药剂型占比前三位。注射剂所占比例呈逐年下降的趋势,片剂在2014年增高了近9个百分点,胶囊占比呈缓慢升高的趋势。药物口服和静脉滴注两种途径是引起药物不良反应的主要途径,口服占比呈逐年上升的趋势,静脉滴注占比呈逐年下降的趋势。4不同年份的药物不良反应的严重程度有统计学差异(P0.0001);不同年份的严重的药物不良反应的构成有统计学差异(P0.0001);不同年份的药物不良反应的结局构成比有统计学差异(P0.0001);不同年份停药后的药物不良反应转归情况有统计学差异(P0.0001);不同年份的药物不良反应结束后再次用药是否再次引发不良反应的人数构成有统计学差异(P0.0001)。5一致性检验:2012年-2016年,报告人评价结果和单位评价结果一致性较高;报告人评价结果、单位评价结果和县评价结果的一致性较差;市评价结果与其他报告途径的评价结果一致性较好。结论:张家口市药物不良反应事件呈逐年增加的趋势,且由于我国人口老龄化加重,发生药物不良反应的患者平均年龄也在逐渐增长。五年药物不良反应主要侵害胃肠系统、皮肤及其附件和中枢及外周神经系统,发生率逐年增加。主要是由于注射剂和片剂的使用居高不下,通过静脉注射或口服药容易对上述三个系统造成损伤。同时导致药物不良反应的用药途径中口服方式占比呈逐年上升趋势,静脉滴注方式逐年下降。临床工作者在用药是一定要了解患者的既往病史和用药史,尽量减少药物不良反应的发生。不同级别上报结果一致性方面,上报人评价和单位评价一致性很高,由于与县市级单位沟通不畅,导致前两者评价结果与县市级食药监局评价结果一致性不高,以后在上报药物不良反应事件时应该加强沟通。
[Abstract]:Objective: to understand the occurrence of Zhangjiakou city in 2012 the city's -2016 adverse drug reactions, and the adverse events were reported in the county, municipal units, to verify the report consistency. On this basis, an impact on rational use of drugs in Hebei province and the status of the evaluation of adverse drug reactions, provides a reference for the relevant departments to develop reported adverse drug reaction mechanism is more effective. Methods: a total of 19731 cases reported by the national adverse drug reaction monitoring system collected in Zhangjiakou city of Hebei Province in 2012 adverse drug reaction in -2016. The main contents include: gender, age, previous adverse drug reaction records, dosage form, drug dosage etc. were analyzed by SPSS22 the software, compared two groups of quantitative data directly by independent samples T test, multiple groups of quantitative data difference analysis using analysis of variance, such as statistical differences, use the LSD-t test were compared between the 22 groups. Consistency test using chi square test Kappa value.P0.05 that the difference was statistically significant. Results: 1 general situation: the number of cases of adverse drug reactions increased year by year, in 2016 reached 4710 cases. There were significant differences in the average of five years, the average age of occurrence of drug adverse reactions increased year by year. A trend of aging. The main types of monitoring objects in gender composition no significant difference in the.2 adverse drug reaction: 2012 -2016, gastrointestinal system damage, damage of skin and its accessories, the central and peripheral nervous system damage for adverse drug reactions before three. Gastrointestinal system damage mainly for nausea, vomiting, diarrhea, abdominal pain, dry mouth; damage of skin and its accessories: skin rash, itching, hives, swelling, rash; the central and peripheral nervous system injury is mainly: dizziness, head pain, dizziness, tremor, dizziness aggravated. The three kinds of damage for adverse drug reactions in the proportion of a trend of.3 main types of medication dosage form and route of administration increased year by year from 2013: 2012 -2016, injections, tablets and capsules of three kinds of medicine accounted for three. The proportion of injections was gradually decreased, the tablet increased nearly 9 percentage points in 2014, accounting for a slow capsule increased. Two ways of oral and intravenous drug is the main way to cause adverse drug reaction, oral proportion rises year by year. There were significant differences in the severity of the trend of.4 in different years of drug adverse reaction of intravenous infusion of a declining proportion the (P0.0001); a serious adverse drug reactions in different years have significant difference (P0.0001); there were significant differences in the constituent ratio of adverse drug reactions in different years ending in different years (P0.0001); Adverse drug reactions after discontinuation of outcome was statistically different (P0.0001); the end of the number of adverse drug reactions in different years again after the medication is again causing adverse reactions which had significant difference (P0.0001).5 consistency test: 2012 -2016 report, the evaluation results and unit evaluation results consistent evaluation report; the poor consistency evaluation results and evaluation results of the unit; consistent evaluation, assessment results and other reports of ways. Conclusion: Zhangjiakou adverse drug events showed an increasing trend year by year, and because of China's population aging, the average age of patients with adverse drug reactions are gradually bad growth. Drug reaction mainly against the gastrointestinal system five years, skin and its accessories and the central and peripheral nervous system, the incidence rate increased year by year. Mainly due to injection and Tablet usage is high, by intravenous or oral medication to avoid the damage of the above three systems. At the same time lead to oral drug adverse drug reaction in the proportion increased year by year, intravenous decreased year by year. The clinical workers must understand the patient's medical history and medication history on medication and minimize adverse drug reaction. Different levels of reporting results consistency, evaluation and reporting unit evaluation consistency is very high, due to poor communication with the county municipal units, leading to both the evaluation results and the county municipal food and Drug Administration evaluation results consistency is not high, should strengthen communication after the reporting of adverse drug events.

【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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