徐州某医院2005～2016年药品不良反应报告回顾性分析

Retrospective Analysis of Adverse Drug Reaction Reports in Xuzhou Hospital During 2005-2016

目的:了解徐州某医院药品不良反应(ADR)报告病例的特点,为临床安全用药提供依据和参考。方法:采用回顾性调查方法,对该院2005~2016年上报的ADR病例进行分析,并按年龄、性别、药品种类等进行分类统计。结果:12年间该院共上报ADR病例1 356例,男性679例(50.1%),平均年龄(36.4±26.1)岁。每年上报的ADR数量从18例到274例不等,以一般不良反应为主(1 169例,86.2%),给药途径以静脉滴注为主(1 110例,81.9%),以单一用药引发为主(1 041例,76.8%);ADR主要累及消化系统(568例次,22.8%)和皮肤及其附件(537例次,21.6%);ADR由抗微生物药引发最多(1 006例,55.6%),其次是中成药(175例,10.0%)和抗肿瘤药(125例,7.1%);抗微生物药主要以喹诺酮类(29.9%)、β-内酰胺类(27.2%)和大环内酯类(22.5%)为主;引发ADR排名前3位的药物分别是阿奇霉素、左氧氟沙星、加替沙星等。结论:该院上报的ADR病例主要由抗微生物药、中成药和抗肿瘤药引起,应加强该类药物的管理,同时积极开展ADR监测,提高医务人员上报ADR的积极性,促进临床用药安全。

Objective：To study the characteristics of adverse drug reactions （ADR） in a hospital of Xuzhou, and to provide some reference for clinical rational drug use. Methods：ADR reports were collected from 2005 to 2016, and ret- rospective method was used to analysis their characteristics according to age, sex, drug type and so on. Results： 1 356 ADR cases were reported in past twelve years and the number of ADR reported varied from 18 cases to 274 cases per year. Among the 1 356 ADR cases, 679 cases were male （50.1%） , and mean age was （36.4 ＋26.1） years. The vast majority of ADR cases were general adverse reactions （86.2%）, and caused by intravenous infusion （81.9%） and by a single drug （76.8%）. ADR mainly involved the digestive system （22.8%） and skin and its accessories （21.6%）. ADRs were most initiated by antimicrobials （ 55.6% ）, and followed by Chinese patent drug （ 10.0% ） and antineoplastic agents （7.1% ）. Among antimicrobials, the most common drugs were quinolones （29.9%）, β-lactam （27.2 % ） and macrolides （22.5%）. Atithromycin, levoiloxacin, and gatifloxacin were the top three suspected drugs. Conclusion：In this hospital, ADRs were mainly caused by antimicrobials, Chinese patent drugs and antineoplastic agents. The management of these drugs should be strengthened and ADR monitoring should be actively carried out. It should improve the enthusiasm of medi- cal personnel to report ADR, All those would promote clinical drug safety.