2型糖尿病住院患者药品不良事件发生情况及影响因素探讨

发布时间：2018-04-05 09:54

本文选题：2型糖尿病　切入点：药品不良事件　出处：《山东大学》2014年硕士论文

【摘要】：研究背景：糖尿病是一种慢性终身性疾病,严重威胁人类健康。流行病学研究表明,近30年来我国糖尿病患病率显著增加,最近10年糖尿病流行情况更为严重。目前全球大约有近2亿糖尿病患者,其中2型糖尿病占90%-95%。 2型糖尿病(Type2diabetes mellitus, T2DM)为终生疾病,易致机体多系统的损害,导致多种并发症。为治疗2型糖尿病及其导致的慢性并发症,患者往往需要长期使用2种以上药物,多药并用导致药品不良事件(Adverse drug event, ADE)发生的几率大幅增高。ADE是致患者病情恶化的常见原因,同时也在很大程度上决定了原有疾病的死亡率。了解2型糖尿病患者住院期间ADE的产生原因、发生率、类型及特点,并针对其原因进行防范措施的研究,对于减少ADE的发生,降低药物治疗相关的危害具有重要的意义。欧、美、日等发达国家在预防ADE方面起步较早,研究历史较长,同时依赖于信息系统与计算机技术的广泛应用,在此领域取得了良好效果。我国对ADE的预防也非常重视,1998年国家建立了药品不良反应监测网,2012年建立了合理用药国际网络(International Network for Rational Use of Drugs, INRUD)中国中心组临床安全用药监测网,发现ADE后通过网络上报给相关部门,并通过这些部门将ADE信息在医疗工作者中进行共享,这样能及时地让更多的医务工作者针对ADE的发生原因、预防策略等问题进行交流,尽可能降低或避免ADE的发生。虽然国内外有关ADE的研究较多,但就国内研究而言,对ADE的研究多为回顾性,而本课题的信息采集方式为与患者面对面进行同步采集,并对采集的信息进一步分析,深入研究ADE的发生率、类型、特点和影响因素。目的：通过对2型糖尿病患者在住院期间ADE的发生率、ADE类型及影响因素等进行研究,探讨此类人群中ADE的预防策略,旨在保障患者用药安全,促进临床合理用药。方法：入选患者为某三甲医院2012年7月1日至2013年6月31日第一诊断为2型糖尿病的全部住院患者。研究者根据本课题调查研究内容,设计《2型糖尿病患者信息记录表》、《药品不良事件记录表》。在患者入院后的24小时内收集并按照《2型糖尿病患者信息记录表》要求填写患者的基本信息及疾病相关信息,在以后每日医疗查房和药学查房中观察患者用药后的反应,并填写表格中药物治疗信息部分。若患者在用药过程中出现疑似ADE,详细询问患者或家属,配合临床医生对ADE进行处理,并填写《药品不良事件记录表》,记录ADE全过程(包括症状、体征、临床检验等)及处理情况。对所收集的信息进行汇总,计算ADE发生率、探寻其影响因素,根据ADE的可预防性和严重程度进行分类分析,并基于研究结果对ADE预防策略进行探讨,制定防范ADE的措施。结果：本研究中入选病例696例,其中123名(17.67%)住院患者累计发生128例次ADE。引起ADE最常见的药品种类分别为胰岛素类降糖药(31.64%)、心血管系统用药(24.29%)、非胰岛素类降糖药(17.51%)、抗感染药物(10.73%)、神经系统用药(7.34%) 128例次ADE所累及的人体系统包括内分泌系统(35.16%),其次为皮肤及附件损害(11.72%)和全身性损害(11.72%)；对其转归的跟踪数据显示,79例次(61.72%)为好转,48例次(37.5%)为治愈,1例次(0.78%)未好转,未发现导致后遗症及死亡病例。对ADE的分类分析结果表明,71例次(55.47%)为可预防性,57例次(44.53%)为不可预防,可预防的ADE最主要的原因是给药剂量不恰当(42.25%),共发生30例次；导致可预防性ADE发生的原因中排第二位的是药物相互作用,共12例次,占可预防性ADE的16.90%,另外,还有患者依从性不良等因素；根据其严重程度分类结果表明,16例次ADE(12.5%)为严重ADE,其余112例次(87.5%)为一般的ADE。发生ADE的患者,其合并症数量、年龄、用药品种数、住院天数及入院次数,均明显高于未发生ADE的患者；此外,女性发生ADE的几率亦显著高于男性。结论：本研究证明,2型糖尿病住院患者常发生ADE, ADE的发生与患者合并症、性别、年龄、使用药品数量、住院天数及入院次数等相关。在发生的ADE中有相当一部分是可预防的,可根据ADE发生的影响因素制定有效的预防策略,降低ADE的发生率,从而保障患者用药安全,提高整体医疗服务质量。
[Abstract]:Background of Study :

Diabetes mellitus is a chronic , lifelong disease that is a serious threat to human health . Epidemiological studies have shown that the prevalence of diabetes in our country has increased significantly in recent 30 years , and the prevalence of diabetes in recent 10 years is more serious . There are approximately 200 million patients with diabetes worldwide , of whom type 2 diabetes accounts for 90 % -95 % .

In order to treat type 2 diabetes mellitus and its chronic complications , it is often necessary for patients to use more than two kinds of drugs for a long time .

The developed countries , such as Europe , the United States and Japan , have started early in the prevention of ADE , the research history is relatively long , while relying on the wide application of information system and computer technology . In 1998 , China established a network of drug reaction monitoring . In 1998 , China established a monitoring network for clinical safety of China ' s central group . After finding the ADE , the network was reported to the relevant departments , and the ADE information was shared among medical workers through the network , so that more medical workers can communicate with the cause of ADE , prevention strategy and so on , so as to reduce or avoid the occurrence of ADE as much as possible .

Although there are many researches on ADE at home and abroad , the research on ADE is much more retrospective than domestic research , and the information acquisition way of this subject is to carry out synchronous acquisition with the patient in face - to - face , and further analyze the collected information to study the incidence , type , characteristics and influencing factors of ADE .

Purpose :

Through the study of the incidence of ADE , the type of ADE and the influencing factors in patients with type 2 diabetes mellitus during hospitalization , the preventive strategies of ADE in these populations were discussed , and the aim of this study was to ensure the safety of drug use and to promote rational drug use .

Method :

The patient was enrolled in the first diagnosis of type 2 diabetes from July 1 , 2012 to June 31 , 2013 . According to the investigation and research contents of this subject , the investigator collected the information of the patient or family , and filled in the drug treatment information part in the form . If the patient had suspected ADE in the course of medication , the patient or his family was asked to complete the whole process of ADE ( including symptoms , signs , clinical tests , etc . ) and the treatment . In case the patient was suspected of ADE in the course of medication , the whole process of ADE ( including symptoms , signs , clinical tests , etc . ) was completed .

Results :

In the study , 696 patients were enrolled , of whom 123 ( 17.67 % ) had a cumulative total of 128 secondary ADEs .

The most common drug types were insulin - like hypoglycemic drugs ( 31.64 % ) , cardiovascular system ( 24.29 % ) , non - insulin - like hypoglycemic drugs ( 17.51 % ) , anti - infective drugs ( 10.73 % ) and nervous system ( 7.34 % ) .

The system included endocrine system ( 35.16 % ) , followed by skin and accessory damage ( 11.72 % ) and systemic damage ( 11.72 % ) .
The follow - up data showed that 79 ( 61.72 % ) were better , 48 ( 37.5 % ) were cured , 1 ( 0.78 % ) had not improved , and no cases of sequelae and death were found . The results showed that 71 cases ( 55.47 % ) were preventable , 57 ( 44.53 % ) were non - preventable , and the most important reason for ADE was that the dosage of the drug was inappropriate ( 42.25 % ) , and there were 30 cases .
In the second place , the causes of preventable ADEs occurred were drug interactions , 12 of which accounted for 16.90 % of the preventive ADE , and the patient ' s compliance was poor .
According to its severity classification , the results showed that 16 cases ( 12.5 % ) were serious ADE , and the remaining 112 cases ( 87.5 % ) were general ADE .

In patients with ADE , the number , age , number of drugs , the number of days of hospitalization and the number of hospitalization were significantly higher than those without ADEs .
In addition , the incidence of ADE in women was also significantly higher than that of men .

Conclusion :

This study shows that the incidence of ADE and ADE in hospitalized patients with type 2 diabetes mellitus is related to the patient ' s complication , sex , age , the number of drugs used , the number of days of hospitalization and the number of hospitalization .

【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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