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目的:了解安陆市药品不良反应(ADR)的发生特点和数据处理方法,为ADR监测工作提供参考。方法:提取国家药品不良反应监测系统中该市2011~2014年上报的ADR报告1 309份,统计报告来源、患者性别、药品种类、给药途径、ADR累及器官/系统等项目并作数据处理。结果:1 309份ADR报告主要来自医疗机构(93.12%),引起ADR的药物以抗感染药多见(54.24%),其中以β-内酰胺类抗菌药构成比最高(56.34%);引起ADR的给药途径以静滴多见(86.94%);ADR主要累及皮肤及附件(41.94%)和消化系统(36.13%);严重ADR 11例(0.84%),以严重过敏性休克为主(72.73%)。结论:增加ADR监测的覆盖面,加强严重ADR的监测,不断提高ADR监测水平,降低用药风险。
Objective: To understand the occurrence characteristics and data processing methods of adverse drug reaction (ADR) in Anlu, and provide a reference for ADR monitoring. Methods: A total of 1 309 ADR cases were reported from 2011 to 2014 in the national adverse drug reaction monitoring system. The sources of the reported reports, the sex of the patients, the types of drugs, the routes of administration, and the ADR involving the organs / systems were analyzed and data were processed. Results: 1 309 copies of ADR were mainly from medical institutions (93.12%). ADR-causing drugs were more common in anti-infectives (54.24%), with the highest proportion of β-lactam antibiotics (56.34% (86.94%). ADR mainly involved skin and appendix (41.94%) and digestive system (36.13%). Serious ADR occurred in 11 cases (0.84%) with severe anaphylactic shock (72.73% %). Conclusion: To increase the coverage of ADR monitoring, to strengthen the monitoring of severe ADR, continuously improve the monitoring level of ADR and reduce the risk of medication.