本文選題：不良反應(yīng)　切入點(diǎn)：抗感染藥品　出處：《河北醫(yī)科大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目的:藥品不良反應(yīng)(Adverse drug reaction ADR)是指合格藥品在正常用法用量下出現(xiàn)的與用藥目的無關(guān)的有害反應(yīng)。雖然我國的不良反應(yīng)體系成立較晚,但目前我國的藥品不良反應(yīng)監(jiān)測體系已經(jīng)逐步完善。2012年河北省藥品不良監(jiān)測體系基本建立,在藥品不良反應(yīng)報(bào)告收集方面取得了很大進(jìn)展,報(bào)告縣級覆蓋率達(dá)到100%,報(bào)告數(shù)達(dá)到42586例,每百萬人口平均不良反應(yīng)報(bào)告數(shù)達(dá)到592.7份,符合世界衛(wèi)生組織的推薦數(shù)量。有資料顯示,每年的藥品不良反應(yīng)報(bào)告中抗感染藥品發(fā)生的不良反應(yīng)例數(shù)較多,尤其是抗生素類的不良反應(yīng)。本研究通過收集河北省藥品監(jiān)測評價(jià)中心抗感染藥品應(yīng)用情況數(shù)據(jù)分析全省2012年-2014年抗感染藥品不良反應(yīng)發(fā)生情況,尤其是嚴(yán)重不良反應(yīng)與患者因素、地域因素以及用藥因素等之間的關(guān)系,提出相應(yīng)的預(yù)防措施,降低藥品不良反應(yīng)的發(fā)生率。方法:收集河北省各地市2012、2013、2014年醫(yī)療機(jī)構(gòu)上報(bào)的抗感染藥品不良反應(yīng)報(bào)告數(shù)據(jù),對數(shù)據(jù)中患者性別、年齡、嚴(yán)重級別、時(shí)間分布、醫(yī)院級別、藥物分類等內(nèi)容進(jìn)行描述性分析。利用Microsoft Excel軟件(Microsoft Excel 2010)對數(shù)據(jù)進(jìn)行審核、整理。用X2檢驗(yàn)對研究對象的性別、年齡、嚴(yán)重級別、醫(yī)院級別、藥物分類、地域分布等差異進(jìn)行比較,用條件Logisitic回歸分析計(jì)算相對危險(xiǎn)估計(jì)值(Oddratio,OR)及其可信區(qū)間,所有P值基于雙側(cè)檢驗(yàn),統(tǒng)計(jì)學(xué)檢驗(yàn)水準(zhǔn)а均設(shè)定為0.05。結(jié)果:河北省2012年-2014年共收到抗感染藥品不良反應(yīng)病例報(bào)告33434例(男性14546例,女性15332例),其中嚴(yán)重病例報(bào)告740例,占報(bào)告總數(shù)的0.02%,其中2012年嚴(yán)重報(bào)告100例,2013年嚴(yán)重報(bào)告209例,2014年嚴(yán)重報(bào)告431例,嚴(yán)重藥品不良反應(yīng)/事件報(bào)告呈逐年上升的趨勢。在11個(gè)地市中,保定市上報(bào)6288例病例報(bào)告,上報(bào)報(bào)告數(shù)量明顯高于其它地市。在不同級別醫(yī)療機(jī)構(gòu)中,三級醫(yī)療機(jī)構(gòu)上報(bào)嚴(yán)重藥品不良反應(yīng)/事件報(bào)告178例,占比5.67%;發(fā)生藥品不良反應(yīng)的抗感染藥物主要由抗生素類和全合成抗感染類構(gòu)成。與注射給藥途徑相比口服給藥途徑更易引起不良反應(yīng)。單因素分析發(fā)現(xiàn),嚴(yán)重藥品不良反應(yīng)的發(fā)生與患者的年齡、體重、既往藥品不良反應(yīng)史、吸煙史、藥物分類、給藥途徑、醫(yī)院分級、地域8個(gè)因素有關(guān)。多因素分析結(jié)果顯示老年患者、既往有藥品不良反應(yīng)史、抗生素類藥物、注射給藥途徑、三級醫(yī)療機(jī)構(gòu)、經(jīng)濟(jì)發(fā)達(dá)地區(qū)6個(gè)因素是不良反應(yīng)的危險(xiǎn)因素。年齡方面,老年患者更易出現(xiàn)不良反應(yīng)(OR=2.178);既往藥品不良反應(yīng)史患者易發(fā)生藥品不良反應(yīng);藥物分類方面,合成抗感染類藥品相比抗生素類更不易發(fā)生藥品不良反應(yīng)(OR=0.236);給藥途徑方面,注射給藥途徑更易發(fā)生藥品不良反應(yīng)(OR=0.556);醫(yī)院分級方面,三級醫(yī)療機(jī)構(gòu)更易發(fā)生藥品不良反應(yīng)(OR=0.928);地域方面,經(jīng)濟(jì)發(fā)達(dá)的城市相比較經(jīng)濟(jì)欠發(fā)達(dá)城市更易發(fā)生藥品不良反應(yīng)(OR=0.471)。結(jié)論:1醫(yī)務(wù)人員在使用抗生素治療的時(shí)候應(yīng)注意:1.1對待老年患者以及有既往藥品不良反應(yīng)史的患者應(yīng)該更加小心、謹(jǐn)慎,老年人基礎(chǔ)疾病較多,多存在長期口服用藥的現(xiàn)象,臨床醫(yī)務(wù)人員對老年人用藥時(shí)應(yīng)慎重,考慮聯(lián)合用藥引起的藥品不良反應(yīng),堅(jiān)持合理用藥原則,做到個(gè)體化給藥,從而降低藥品不良反應(yīng)的發(fā)生率。1.2臨床上根據(jù)病情選擇合適的給藥途徑,能口服給藥達(dá)到治療目的,原則上盡量不選擇注射給藥。2基層醫(yī)療機(jī)構(gòu)應(yīng)加強(qiáng)對藥品不良反應(yīng)的重視程度,應(yīng)按照《藥品不良反應(yīng)報(bào)告和監(jiān)測管理辦法》主動上報(bào)藥品不良反應(yīng)報(bào)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.

【學(xué)位授予單位】：河北醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R95

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本文編號：1599157