410例药品不良反应报告

Reports on 410 Cases of Adverse Drug Reaction

目的:探讨惠州市中心人民医院(以下简称"我院")2016年上报广东省药品不良反应(adverse drug reaction,ADR)管理平台的ADR发生的规律和特点,为合理用药提供参考。方法:从报告级别、患者性别及年龄、引发ADR的给药途径、ADR系统累及器官和(或)系统及主要临床表现、引发ADR的药物种类、引发ADR病例数排序居前5位的药品及引发ADR的抗菌药物种类等方面对410例ADR报告进行统计分析。结果:410例ADR报告中,一般的ADR 230例(占56.10%),严重的ADR 64例(占15.61%),新的、一般的ADR 63例(占15.37%),新的、严重的ADR 53例(占12.93%);严重的ADR共117例(占28.54%)。男性患者208例(占50.73%),女性患者202例(占49.27%);>60~70岁者最多(67例,占16.34%),且新的、严重的ADR中该年龄段患者数最多(9例,占2.20%);严重的ADR多发于>70~80岁者(14例,占3.41%)。静脉滴注致ADR最为常见,其次为口服给药。ADR主要累及皮肤及其附件,其次为循环系统及全身性。410例ADR报告共涉及药物16类262种,抗微生物药所致ADR病例数最多,其次为调节电解质、酸碱平衡及营养药和抗肿瘤药;抗菌药物引发ADR 153例(占37.32%),排序居前5位的药品分别为哌拉西林钠舒巴坦钠注射液/冻干粉末、左氧氟沙星注射液、氧化钠注射液、复方氨基酸-18注射液和氯化钾注射液。结论:ADR的发生与多种因素相关,医疗机构加强对ADR的监测十分必要,同时应加强医药合作,积极发挥临床药师的作用,促进合理用药。

OBJECTIVE： To investigate the characteristics and rules of incidence of adverse drug reaction（ ADR）reported form Huizhou Municipal Central People＇s Hospital（ hereinafter referred to as ＂our hospital＂） to Guangdong Platform of ADR,so as to provide reference for the rational drug use in clinic. METHODS： There were 410 cases of ADR,statistical analysis was conducted on application data in terms of reporting level,patients＇ age and gender,ADR-inducing route of administration,ADR involved organs and（ or） systems and main clinical manifestations,ADRinducing drug categories,the top 5 specific drugs ranked by number of ADR cases and ADR-inducing antibiotics,etc.RESULTS： Of the 410 ADR reports,230 cases（ 56. 10%） were general ADR,64 cases（ 15. 61%） were severe ADR,63 cases（ 15. 37%） were new general ADR,53 cases（ 12. 93%） were new severe ADR,and 117 cases（ 28. 54%） were the total number of severe ADR. Meanwhile,208 cases（ 50. 73%） were males and 202 cases were（ 49. 27%） females; ADR occurred in all age groups,patients aged 60 ~ 70 years old took the lead（ 67 cases,16. 34%）,and the number of new severe ADR were the largest（ 9 cases,2. 20%）; severe ADR most occurred in patients aged 70 ~ 80 years old（ 14 cases,3. 41%）. The most common route of administration that induced ADR was intravenous drip,followed by oral administration. ADR involved organs and（ or） systems mainly performed as skin and appendages disorders,followed by circulatory system and systemic damage. Totally 16 categories 262 kinds of drugs were involved in ADR reports,among which the number of ADR cases induced by antimicrobial drugs took the lead,followed by Electrolyte,acid base balance and nutrition drugs and antineoplastic drugs; ADR induced by antibiotics were 153 cases（ 37. 32%）; and the top 5 specific drugs ranked by number of ADR cases were Peracillin sodium sulbutamine injection and freeze-dried powder,levofloxacin injection,sodium oxide injection,compound amino acid-18 injection and potassium chloride injection. CONCLUSIONS： The occurrence of ADR was related to various clinical factors,the medical institutions are suppose to strengthen the monitoring on ADR,improve the cooperation between clinicians and drugs and actively play the role of clinical pharmacists so as to promote the rational drug application in clinic.