国产与原研莫西沙星注射剂不良反应对比分析

发布时间：2018-03-11 18:36

本文选题：盐酸莫西沙星注射液　切入点：盐酸莫西沙星氯化钠注射液　出处：《河北医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:比较分析国产喹诺酮类抗菌药物品种盐酸莫西沙星注射液与国外原研药品盐酸莫西沙星氯化钠注射液在药品不良反应/事件的差异性。方法:1收集某院2014年4月至2017年02月盐酸莫西沙星注射液和盐酸莫西沙星氯化钠注射液使用情况及药品不良反应上报情况,分别以观察组和对照组进行分类。2对上报的药品不良反应数据按发生率,发生人员基本情况,所患疾病和不良反应类型进行对比分析。结果:1观察组共计报道发生药品不良反应/事件67例,涉及皮肤、血管、心脏、消化、神经精神等多个系统。对照组共计报道药品不良反应/事件8例,涉及泌尿,神经精神,皮肤系统。观察组不良反应/事件发生率为7.25%,对照组不良反应/事件发生率为1.77%,有统计学差异(P0.01);2观察组67例不良反应患者平均年龄62.24±16.32岁,最大96岁,最小21岁;男性21人(31.34%),女性46人(68.66%)。对照组8例不良反应/事件平均年龄为55.00±19.67岁,最大88岁,最小29岁;男性5人(62.50%),女性3人(37.50%);3原患疾病分析,观察组呼吸系统感染有46例(68.66%),泌尿系统感染8例(11.94%),软组织感染5例(7.46%),消化道胆道系统感染3例(4.48%),未明确感染部位5例(7.46%)。对照组呼吸系统感染6例(75.00%),泌尿系统感染1例(12.50%),未明确感染部位1例(12.50%);4观察组不良反应/事件上报最多的是静脉炎24例(35.82%),其次是消化系统异常13例(19.40%)主要表现是恶心、呕吐,第三多的不良反应是心脏异常10例(14.93%)主要表现是心慌,第四是精神系统异常8例(11.94%)。对照组最多发生的是静脉炎3例(37.50%),第二的是皮疹和瘙痒2例(25.00%),第三是神经系统异常、头晕、肾功能异常,各1例。结论:1观察组不良反应/事件发生率为7.25%,对照组不良反应/事件发生率为1.77%,盐酸莫西沙星注射液不良反应发生率高于盐酸莫西沙星氯化钠注射液。2观察组不良反应发生类型以静脉炎为主,滴注速度过快可能是产生静脉炎的原因之一。其他主要的不良反应还有有恶心,呕吐,心慌,心脏不适,精神异常,幻觉。
[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 卤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 卤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 卤19.67 years old, and the average age of the 8 cases was 55.00 卤19.67 years old, and the average age of the 8 cases was 55.00 卤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.
【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R978

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