本文選題：鹽酸莫西沙星注射液　切入點(diǎn)：鹽酸莫西沙星氯化鈉注射液　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:比較分析國(guó)產(chǎn)喹諾酮類抗菌藥物品種鹽酸莫西沙星注射液與國(guó)外原研藥品鹽酸莫西沙星氯化鈉注射液在藥品不良反應(yīng)/事件的差異性。方法:1收集某院2014年4月至2017年02月鹽酸莫西沙星注射液和鹽酸莫西沙星氯化鈉注射液使用情況及藥品不良反應(yīng)上報(bào)情況,分別以觀察組和對(duì)照組進(jìn)行分類。2對(duì)上報(bào)的藥品不良反應(yīng)數(shù)據(jù)按發(fā)生率,發(fā)生人員基本情況,所患疾病和不良反應(yīng)類型進(jìn)行對(duì)比分析。結(jié)果:1觀察組共計(jì)報(bào)道發(fā)生藥品不良反應(yīng)/事件67例,涉及皮膚、血管、心臟、消化、神經(jīng)精神等多個(gè)系統(tǒng)。對(duì)照組共計(jì)報(bào)道藥品不良反應(yīng)/事件8例,涉及泌尿,神經(jīng)精神,皮膚系統(tǒng)。觀察組不良反應(yīng)/事件發(fā)生率為7.25%,對(duì)照組不良反應(yīng)/事件發(fā)生率為1.77%,有統(tǒng)計(jì)學(xué)差異(P0.01);2觀察組67例不良反應(yīng)患者平均年齡62.24±16.32歲,最大96歲,最小21歲;男性21人(31.34%),女性46人(68.66%)。對(duì)照組8例不良反應(yīng)/事件平均年齡為55.00±19.67歲,最大88歲,最小29歲;男性5人(62.50%),女性3人(37.50%);3原患疾病分析,觀察組呼吸系統(tǒng)感染有46例(68.66%),泌尿系統(tǒng)感染8例(11.94%),軟組織感染5例(7.46%),消化道膽道系統(tǒng)感染3例(4.48%),未明確感染部位5例(7.46%)。對(duì)照組呼吸系統(tǒng)感染6例(75.00%),泌尿系統(tǒng)感染1例(12.50%),未明確感染部位1例(12.50%);4觀察組不良反應(yīng)/事件上報(bào)最多的是靜脈炎24例(35.82%),其次是消化系統(tǒng)異常13例(19.40%)主要表現(xiàn)是惡心、嘔吐,第三多的不良反應(yīng)是心臟異常10例(14.93%)主要表現(xiàn)是心慌,第四是精神系統(tǒng)異常8例(11.94%)。對(duì)照組最多發(fā)生的是靜脈炎3例(37.50%),第二的是皮疹和瘙癢2例(25.00%),第三是神經(jīng)系統(tǒng)異常、頭暈、腎功能異常,各1例。結(jié)論:1觀察組不良反應(yīng)/事件發(fā)生率為7.25%,對(duì)照組不良反應(yīng)/事件發(fā)生率為1.77%,鹽酸莫西沙星注射液不良反應(yīng)發(fā)生率高于鹽酸莫西沙星氯化鈉注射液。2觀察組不良反應(yīng)發(fā)生類型以靜脈炎為主,滴注速度過快可能是產(chǎn)生靜脈炎的原因之一。其他主要的不良反應(yīng)還有有惡心,嘔吐,心慌,心臟不適,精神異常,幻覺。
[Abstract]:Objective: to compare and analyze the differences of adverse drug reactions / events between moxifloxacin hydrochloride injection and moxifloxacin hydrochloride sodium chloride injection. From April to February 2017, the use of moxifloxacin hydrochloride injection and moxifloxacin hydrochloride sodium chloride injection and adverse drug reactions were reported. The observation group and the control group were classified into 2 groups according to the incidence of adverse drug reaction data reported and the basic situation of the personnel. Results 67 cases of adverse drug reactions / events involving skin, blood vessels, heart and digestion were reported in the observation group of 1: 1. The control group reported a total of 8 cases of adverse drug reactions / events involving urology and neuropsychosis. The incidence of adverse reactions / events in the observation group was 7.25 and that in the control group was 1.77. The average age of 67 adverse reactions in the observation group was 62.24 鹵16.32 years old, the maximum was 96 years old and the youngest was 21 years old. The average age of 8 cases of adverse reactions / events in the control group was 55.00 鹵19.67 years, the oldest was 88 years old, the youngest was 29 years old, and the male 5 persons were 62.50 and the female 3 were 37.50% and 37.50% respectively, and the average age was 55.00 鹵19.67 years old, and the average age of the 8 cases was 55.00 鹵19.67 years old, and the average age of the 8 cases was 55.00 鹵19.67 years old. In the observation group, there were 46 cases of respiratory system infection, 8 cases of urinary tract infection, 5 cases of soft tissue infection, 3 cases of gastrointestinal tract system infection, 5 cases of biliary tract infection, 5 cases of undefined infection site, 6 cases of respiratory system infection and 75.00% of urinary system infection, respectively. In the observation group, 24 cases with phlebitis and 35.82 cases with phlebitis, 13 cases with abnormal digestive system and 19.40 cases with abnormal digestive system showed nausea. Vomiting, the third most common adverse reaction was cardiac abnormality in 10 cases (14. 93%) and 4th in 8 cases (11. 94%). In the control group, the most common adverse reactions were phlebitis in 3 cases and phlebitis in 3 cases, rash and pruritus in 2 cases and nervous system abnormality in 2 cases. Dizziness, abnormal renal function, Conclusion the incidence of adverse reactions / events was 7.25 in the observation group and 1.77 in the control group. The adverse reaction rate of moxifloxacin hydrochloride injection was higher than that of moxifloxacin hydrochloride sodium chloride injection. Phlebitis was the main type of adverse reactions. Too fast dripping may be one of the causes of phlebitis. Other major adverse effects include nausea, vomiting, palpitations, heart discomfort, mental disorders, hallucinations.
【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)】：R978

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