422例抗肿瘤药物不良反应分析

目的:研究抗肿瘤药发生药物不良反应(adverse drug reaction,ADR)的人群分布?ADR级别?用药途径及严重ADR报告,以提示相应人群提高健康意识,注意防癌和尽可能减少严重不良反应发生?方法:从全国药品不良反应监测网数据库下载南京大学医学院附属鼓楼医院2011年ADR报告,运用Excel软件统计分析ADR年龄?性别?药品种类?用药途径?ADR级别等?结果:抗肿瘤药ADR 422例次位居第一;不良反应中50~59岁人群357例明显高于其他年龄,其中男性163例,女性194例,又以肿瘤病例151例最多,其中男90例,女61例;发生ADR级别严重?新的严重居多为349例(82.70%);用药途径以静脉滴注[385例(91.23%)]为主;严重不良反应以奥沙利铂(50例)居首?结论:2011年抗肿瘤药ADR比例大幅上升,人群以50~59岁且男性居多,所以此人群要特别注意防癌及合理用药,尽可能减少严重不良反应发生?

Analysis of 422 cases adverse drug reactions of antineoplastic drugs

Objective:To study population distribution,ADR level,route of administration and the serious ADR reports of antineoplastic adverse drug reactions,in order to help related population to increase health awareness,pay attention to the prevention of cancer and minimize serious adverse drug reactions. Methods:Downloaded ADR reports occurred and reported in Affiliated Drum Tower Hospital of Nanjing University in 2011 from National Adverse Drug Reaction Monitoring Network database. We performed Excel to statistical analyze the medical records and data by category of age,gender,types of drugs,route of administration and ADR level. Results:Antineoplastic ADR had 422 cases,ranking the first place of all types of drugs. Among 1 503 cases of ADR reported in 2011,the mean age of 357 cases of adverse reactions was 50~59 years old,significantly higher than other age,in which there were 163 male cases and 194 female cases. Of the 357 cases,there were 151 cases of antineoplastic ADR,in which there were 90 male cases and 61 female cases. Of 422 cases of antineoplastic ADR,there were 349 cases (82.70%) in the level of severe or severe new,route of administration was mostly intravenous infusion (385 cases,91.23%). Severe antineoplastic adverse reactions were firstly caused by Oxaliplatin (50 cases). Conclusion:ADR is significantly reduced after the anti-infective standardized management,but is significant increased in the proportion of antineoplastic ADR. Antineoplastic ADR mostly occurred in the 50~59 years old male population. This particular population should pay special attention to cancer prevention and rational use of drugs to minimize the serious adverse reactions.