本文關(guān)鍵詞： 藥物不良反應(yīng) 損傷系統(tǒng) 用藥途徑 用藥劑型 一致性檢驗(yàn)　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:了解張家口市2012年-2016年全市藥品不良反應(yīng)的發(fā)生情況,并對(duì)報(bào)告不良反應(yīng)的單位、縣級(jí)、市級(jí)報(bào)告一致性進(jìn)行驗(yàn)證。在此基礎(chǔ)上,評(píng)價(jià)藥物不良反應(yīng)發(fā)生對(duì)河北省乃至全國(guó)的合理用藥狀況的影響,為下一步有關(guān)部門制定更為有效的藥物不良反應(yīng)的上報(bào)機(jī)制提供參考。方法:通過(guò)國(guó)家藥物不良反應(yīng)監(jiān)測(cè)系統(tǒng)收集河北省張家口市2012年-2016年發(fā)生不良藥品反應(yīng)的共19731例報(bào)告。內(nèi)容主要包括:性別、年齡、既往藥品不良反應(yīng)記錄、劑型、藥物用量等。采用SPSS22統(tǒng)計(jì)軟件進(jìn)行分析,兩組定量數(shù)據(jù)的比較直接采用獨(dú)立樣本T檢驗(yàn),多組定量數(shù)據(jù)差異性分析采用方差分析,如有統(tǒng)計(jì)學(xué)差異,則使用LSD-t檢驗(yàn)進(jìn)行組間兩兩比較。一致性檢驗(yàn)采用卡方檢驗(yàn)Kappa值。P0.05認(rèn)為差別有統(tǒng)計(jì)學(xué)意義。結(jié)果:1一般情況:藥物不良反應(yīng)例數(shù)逐年增加,2016年達(dá)到了4710例。五年之間平均年有統(tǒng)計(jì)學(xué)差異,發(fā)生藥物不良反應(yīng)的平均年齡逐年增長(zhǎng),呈老齡化趨勢(shì)。監(jiān)測(cè)對(duì)象的性別組成無(wú)統(tǒng)計(jì)學(xué)差異。2藥物不良反應(yīng)的主要類型:2012年-2016年,胃腸系統(tǒng)損害、皮膚及其附件損害、中樞及外周神經(jīng)系統(tǒng)損害占藥物不良反應(yīng)的前三位。胃腸系統(tǒng)損害主要表現(xiàn)為:惡心、嘔吐、腹瀉、腹痛、口干;皮膚及其附件損害:皮疹、瘙癢、蕁麻疹、局部紅腫、斑丘疹;中樞及外周神經(jīng)系統(tǒng)損害主要表現(xiàn)為:頭暈、頭痛、眩暈、震顫、頭暈加重。上述三種損害在藥物不良反應(yīng)中所占的比例從2013年開(kāi)始呈逐年上升的趨勢(shì)。3用藥劑型和用藥途徑的主要類型:2012年-2016年,注射劑、片劑和膠囊三種用藥劑型占比前三位。注射劑所占比例呈逐年下降的趨勢(shì),片劑在2014年增高了近9個(gè)百分點(diǎn),膠囊占比呈緩慢升高的趨勢(shì)。藥物口服和靜脈滴注兩種途徑是引起藥物不良反應(yīng)的主要途徑,口服占比呈逐年上升的趨勢(shì),靜脈滴注占比呈逐年下降的趨勢(shì)。4不同年份的藥物不良反應(yīng)的嚴(yán)重程度有統(tǒng)計(jì)學(xué)差異(P0.0001);不同年份的嚴(yán)重的藥物不良反應(yīng)的構(gòu)成有統(tǒng)計(jì)學(xué)差異(P0.0001);不同年份的藥物不良反應(yīng)的結(jié)局構(gòu)成比有統(tǒng)計(jì)學(xué)差異(P0.0001);不同年份停藥后的藥物不良反應(yīng)轉(zhuǎn)歸情況有統(tǒng)計(jì)學(xué)差異(P0.0001);不同年份的藥物不良反應(yīng)結(jié)束后再次用藥是否再次引發(fā)不良反應(yīng)的人數(shù)構(gòu)成有統(tǒng)計(jì)學(xué)差異(P0.0001)。5一致性檢驗(yàn):2012年-2016年,報(bào)告人評(píng)價(jià)結(jié)果和單位評(píng)價(jià)結(jié)果一致性較高;報(bào)告人評(píng)價(jià)結(jié)果、單位評(píng)價(jià)結(jié)果和縣評(píng)價(jià)結(jié)果的一致性較差;市評(píng)價(jià)結(jié)果與其他報(bào)告途徑的評(píng)價(jià)結(jié)果一致性較好。結(jié)論:張家口市藥物不良反應(yīng)事件呈逐年增加的趨勢(shì),且由于我國(guó)人口老齡化加重,發(fā)生藥物不良反應(yīng)的患者平均年齡也在逐漸增長(zhǎng)。五年藥物不良反應(yīng)主要侵害胃腸系統(tǒng)、皮膚及其附件和中樞及外周神經(jīng)系統(tǒng),發(fā)生率逐年增加。主要是由于注射劑和片劑的使用居高不下,通過(guò)靜脈注射或口服藥容易對(duì)上述三個(gè)系統(tǒng)造成損傷。同時(shí)導(dǎo)致藥物不良反應(yīng)的用藥途徑中口服方式占比呈逐年上升趨勢(shì),靜脈滴注方式逐年下降。臨床工作者在用藥是一定要了解患者的既往病史和用藥史,盡量減少藥物不良反應(yīng)的發(fā)生。不同級(jí)別上報(bào)結(jié)果一致性方面,上報(bào)人評(píng)價(jià)和單位評(píng)價(jià)一致性很高,由于與縣市級(jí)單位溝通不暢,導(dǎo)致前兩者評(píng)價(jià)結(jié)果與縣市級(jí)食藥監(jiān)局評(píng)價(jià)結(jié)果一致性不高,以后在上報(bào)藥物不良反應(yīng)事件時(shí)應(yīng)該加強(qiáng)溝通。
[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.

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

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本文編號(hào)：1481454