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目的:分析常熟市第一人民医院2008年药物不良反应(ADR发生的原因与特点,了解抗感染药物ADR)发生的规律及影响因素。方法:将上报国家食品药品监督管理局ADR监察中心的195份抗感染药物ADR报告,按患者的年龄、性别与药品种类、给药途径、ADR所累及的系统/器官及主要临床表现等信息进行分析和评价。结果:18岁以下的未成年患者ADR发生率8.1%,60岁以上老年患者为0.9%。喹诺酮类药物ADR发生49例,β内酰胺类ADR发生72例,按照药物使用量(频次)计算,喹诺酮类药物ADR发生率则是β内酰胺类的数倍。静脉输注引发ADR185例,占94.87%,皮肤及其附件损害的ADR147例,占70.33%。结论:不同的疾病与给药途径差异是未成年与老年患者ADR发生率差异的重要原因之一;ADR与不同抗感染药物药物使用量(频次)有一定联系,但不呈线性关系,将某药物ADR例数在总ADR例数中的构成比等同于ADR发生率是不恰当的;静脉输注引发ADR发生率较高,皮肤及其附件损害的ADR易观察,及早全面发现ADR对其他器官/系统造成损害的方法或标准方面可能还存在缺陷。
OBJECTIVE: To analyze the regularity and influential factors of adverse drug reactions (the causes and characteristics of ADR and understand the ADR of anti-infectives) of the First People’s Hospital of Changshu in 2008. Methods: 195 ADRs reported to the ADR surveillance center of the State Food and Drug Administration were collected according to the patient’s age, sex and drug category, route of administration, system / organ involved in ADR, and major clinical manifestations Analysis and evaluation. Results: The incidence of ADR in juvenile patients under 18 was 8.1% and in elderly patients over 60 years was 0.9%. Quinolones ADR occurred in 49 cases, β-lactam ADR occurred in 72 cases, according to the drug usage (frequency), the incidence of quinolones ADR incidence is several times β-lactams. There were ADR185 cases (94.87%) induced by intravenous infusion and ADR147 cases (70.33%) damaged by skin and its accessories. Conclusion: The difference of different diseases and route of administration is one of the important reasons for the difference of incidence of ADR in adolescent and elderly patients. There is a certain relationship between the ADR and the usage of different anti-infective drugs (frequency), but there is no linear relationship. ADR cases in the total number of ADR cases in the composition ratio is equivalent to the incidence of ADR is not appropriate; intravenous infusion of lead to a higher incidence of ADR, ADR damage to the skin and its accessories easy to observe early comprehensive detection of ADR on other organs / System may cause damage to the method or standard may be flawed.