2011～2014年孝感市药品不良反应/事件报告描述性分析

Descriptive Analysis of Adverse Drug Reaction/event Reporting in Xiaogan from 2011 to 2014

目的：了解药品不良反应的发生特点,为ADR监测工作提供参考。方法：提取国家ADR监测系统中2011~2014年孝感市上报的ADR/ADE有效报告7 732例,采用SPSS 19.0对报告来源、患者性别、药品种类、给药途径、ADR累及器官/系统等进行分析。结果：7 732例报告,主要来自医疗机构（6 959例,90.00%）和临床医师（5 061例,65.46%）;引起ADR/ADE最多的药物为抗菌药物（4 388例,54.90%）和中药注射剂（897例,11.60%）;引起ADR的给药途径以静滴多见（69.83%）;一般ADR/ADE主要累及皮肤及附件（42.96%）和消化系统（16.55%）;严重ADR/ADE 181例（2.43%）,其中严重过敏性反应80例（42.20%）,皮肤及附件损害36例（19.89%）。引起严重ADR/ADE的药品中抗感染药物79例（43.65%）,中药注射剂32例（17.68%）;前3位的药品分别为头孢哌酮/舒巴坦（14例）、参麦注射液（10例）和头孢呋辛（10例）。结论：加强ADR/ADE的监测报告力度和抗菌药物临床合理使用的监管,重视严重ADR/ADE的监测,不断提高ADR监测水平,降低用药风险。

Objective：To investigate the occurrence characteristics of adverse drug reactions and to provide a ref- erence for ADR monitoring. Methods：The reports of 7 732 cases of ADR/ADE submitted by Xiaogan city from 2011 to 2013 were extracted from the National ADR monitoring system. The data was analyzed such as the source of report, patient sex, drug species, route of administration and ADR involving organs/systems and SPSS 19.0 were used for data process- ing. Results：7 732 cases were collect from medical institutions （6 959 cases, 90.00% ） and physicians （5 061 cases, 65.46% ） mainly. ADR/ADE were caused by antibacterial （4 388 cases, 54.90% ） and traditional Chinese medicine in- jections （897 cases, 11.60% ） and intravenous administration （69.83%） mainly. General ADR/ADE major included skin and its appendages （42.96%） and digestive system （ 16.55% ）. Severe ADR/ADE 181 cases （2.43%）, included 80 cases of severe allergic reactions （42.20%） and 36 cases of skin and appendages （ 19.89% ）. Severe ADR/ADE of 79 cases （43.65%） were cause by anti-infective drugs and 32 cases （ 17.68% ） were cause by traditional Chinese medicine injections. The first three drugs were cefoperazone sulbactam （ 14 cases）, shen mai （ 10 cases） and cefuroxime （ 10 cases） ~ Conclusion： It is important to strengthen the ADR/ADE monitoring and reporting efforts and regulate rational use of anti- biotics, and emphasis on severe ADR/ADE monitoring, continuously improve the level of ADR monitoring so as to reduce the risk of medication.