我院121例药品不良反应报告描述性分析1.doc

我院1例药品不良反应报告描述性分析( .3 [文献标识码] A [文章编号] Descriptive Analysis of 121 ADR Reports in Our Hospital Abstract Objective?:To investigate the characteristics of adverse drug reactions(ADRs) in our hospital, and master the status of ADR monitoring and assessment for preventing the drug risk in clinic. Methods:ADR reports in our hospital from September 1, 2008 to August 31, 2010 were downloaded from the national and municipal ADR monitoring network. The related datas were converted and analyzed statistically. Results:Of the 121 ADR cases, antimicrobial drugs ranked firstly and followed by the antitumor drugs and the circulation system drugs．The lesions of systems or organs involved in ADRs were systemic disorders, skin and its appendage damages, digestive system disorders. 90 ADR cases(74.4％)were induced by intravenous drip. 16 kinds of medicines occured in the 19 new and serious ADR reports．ConclusionIt should be paid more attention to establishing the high-level system of ADR monitoring, carrying out the analysis and tracking of high risk medicine, expanding safe research and promulgating precaution to decrease the drug risk. Key words: Adverse drug reaction; Descriptive analysis; Pharmacovigilance 近年来，随着我国药品不良反应（ADR）监督法规体系的逐步完善，省市级及国家级ADR监测网络的广泛建立，ADR报告的数量和质量呈逐年增长之势。医疗机构作为ADR的主要发生场所，势必承担ADR病例直接上报义务和相关患者的医疗救治责任，在ADR监测和评价工作中扮演着举足轻重的角色[1]。因此，本文对我院2008年9月1日～2010年8月31日期间网络呈报有效的121份ADR报告进行汇总分析，旨在进一步完善药品监测措施，加强ADR呈报比率及质量控制，保障患者用药安全，提高合理用药水平，同时为明确今后我院ADR监测工作重心提供参考。 1 资料与方法 用药情况及ADR转归：121例ADR报告中，可疑药品为化学药品116例（占95.9%），中药制剂5例（占4.1%）；其中单一用药97例（占80.2%），合并用药24例（占19.8%），用药情况及转归见表1。 表1 用药情况及ADR转归分布 Tab 1 Distribution of drugs utilization and prognosis of ADRs 用药情况 例数 转 归 治愈 好转 有后遗症 死亡 单一用药 97 12 82 1 2 合并用药 24 2 22 0 0 合计 121 14 104 1 2 可疑药品相关信息 2.3.1 药理分类：抗微生物药物所占比例最大，共涉及药物32种，ADR报告计54例（占44.6%）；其次为抗肿瘤药物（12例，占9.9%），循环系统药物（11例，占9.1%），其具体药理分类及分布见表2，可疑抗微生物药物药理分类及分布见表3，本院8种发生ADR频次较高的药品ADR报告总计32例，占26.4%，具体情况见表4。 表2 ADR涉及的可疑药品药理分类及其分布 Tab 2 Categories and distribution of d