本文選題：2型糖尿病　切入點：藥品不良事件　出處：《山東大學》2014年碩士論文

【摘要】：研究背景： 糖尿病是一種慢性終身性疾病,嚴重威脅人類健康。流行病學研究表明,近30年來我國糖尿病患病率顯著增加,最近10年糖尿病流行情況更為嚴重。目前全球大約有近2億糖尿病患者,其中2型糖尿病占90%-95%。 2型糖尿病(Type2diabetes mellitus, T2DM)為終生疾病,易致機體多系統(tǒng)的損害,導致多種并發(fā)癥。為治療2型糖尿病及其導致的慢性并發(fā)癥,患者往往需要長期使用2種以上藥物,多藥并用導致藥品不良事件(Adverse drug event, ADE)發(fā)生的幾率大幅增高。ADE是致患者病情惡化的常見原因,同時也在很大程度上決定了原有疾病的死亡率。了解2型糖尿病患者住院期間ADE的產生原因、發(fā)生率、類型及特點,并針對其原因進行防范措施的研究,對于減少ADE的發(fā)生,降低藥物治療相關的危害具有重要的意義。 歐、美、日等發(fā)達國家在預防ADE方面起步較早,研究歷史較長,同時依賴于信息系統(tǒng)與計算機技術的廣泛應用,在此領域取得了良好效果。我國對ADE的預防也非常重視,1998年國家建立了藥品不良反應監(jiān)測網,2012年建立了合理用藥國際網絡(International Network for Rational Use of Drugs, INRUD)中國中心組臨床安全用藥監(jiān)測網,發(fā)現(xiàn)ADE后通過網絡上報給相關部門,并通過這些部門將ADE信息在醫(yī)療工作者中進行共享,這樣能及時地讓更多的醫(yī)務工作者針對ADE的發(fā)生原因、預防策略等問題進行交流,盡可能降低或避免ADE的發(fā)生。 雖然國內外有關ADE的研究較多,但就國內研究而言,對ADE的研究多為回顧性,而本課題的信息采集方式為與患者面對面進行同步采集,并對采集的信息進一步分析,深入研究ADE的發(fā)生率、類型、特點和影響因素。 目的： 通過對2型糖尿病患者在住院期間ADE的發(fā)生率、ADE類型及影響因素等進行研究,探討此類人群中ADE的預防策略,旨在保障患者用藥安全,促進臨床合理用藥。 方法： 入選患者為某三甲醫(yī)院2012年7月1日至2013年6月31日第一診斷為2型糖尿病的全部住院患者。研究者根據(jù)本課題調查研究內容,設計《2型糖尿病患者信息記錄表》、《藥品不良事件記錄表》。在患者入院后的24小時內收集并按照《2型糖尿病患者信息記錄表》要求填寫患者的基本信息及疾病相關信息,在以后每日醫(yī)療查房和藥學查房中觀察患者用藥后的反應,并填寫表格中藥物治療信息部分。若患者在用藥過程中出現(xiàn)疑似ADE,詳細詢問患者或家屬,配合臨床醫(yī)生對ADE進行處理,并填寫《藥品不良事件記錄表》,記錄ADE全過程(包括癥狀、體征、臨床檢驗等)及處理情況。對所收集的信息進行匯總,計算ADE發(fā)生率、探尋其影響因素,根據(jù)ADE的可預防性和嚴重程度進行分類分析,并基于研究結果對ADE預防策略進行探討,制定防范ADE的措施。 結果： 本研究中入選病例696例,其中123名(17.67%)住院患者累計發(fā)生128例次ADE。 引起ADE最常見的藥品種類分別為胰島素類降糖藥(31.64%)、心血管系統(tǒng)用藥(24.29%)、非胰島素類降糖藥(17.51%)、抗感染藥物(10.73%)、神經系統(tǒng)用藥(7.34%) 128例次ADE所累及的人體系統(tǒng)包括內分泌系統(tǒng)(35.16%),其次為皮膚及附件損害(11.72%)和全身性損害(11.72%)；對其轉歸的跟蹤數(shù)據(jù)顯示,79例次(61.72%)為好轉,48例次(37.5%)為治愈,1例次(0.78%)未好轉,未發(fā)現(xiàn)導致后遺癥及死亡病例。對ADE的分類分析結果表明,71例次(55.47%)為可預防性,57例次(44.53%)為不可預防,可預防的ADE最主要的原因是給藥劑量不恰當(42.25%),共發(fā)生30例次；導致可預防性ADE發(fā)生的原因中排第二位的是藥物相互作用,共12例次,占可預防性ADE的16.90%,另外,還有患者依從性不良等因素；根據(jù)其嚴重程度分類結果表明,16例次ADE(12.5%)為嚴重ADE,其余112例次(87.5%)為一般的ADE。 發(fā)生ADE的患者,其合并癥數(shù)量、年齡、用藥品種數(shù)、住院天數(shù)及入院次數(shù),均明顯高于未發(fā)生ADE的患者；此外,女性發(fā)生ADE的幾率亦顯著高于男性。 結論： 本研究證明,2型糖尿病住院患者常發(fā)生ADE, ADE的發(fā)生與患者合并癥、性別、年齡、使用藥品數(shù)量、住院天數(shù)及入院次數(shù)等相關。在發(fā)生的ADE中有相當一部分是可預防的,可根據(jù)ADE發(fā)生的影響因素制定有效的預防策略,降低ADE的發(fā)生率,從而保障患者用藥安全,提高整體醫(yī)療服務質量。
[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 .

【學位授予單位】：山東大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R95

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