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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 understand the occurrence of adverse drug reactions, provide a reference for ADR monitoring. Methods: A total of 7 732 valid ADR / ADE reports were collected from Xiaodan City from 2011 to 2014 in the national ADR monitoring system. SPSS 19.0 was used to analyze the sources of reports, patient’s gender, drug category, route of administration, ADR involved organ / system . Results: A total of 7 732 reports were mainly from medical institutions (6 959 cases, 90.00%) and clinicians (5 061 cases, 65.46%). The most common drugs causing ADR / ADE were antimicrobial drugs (4 388 cases, 54.90%) and (897 cases, 11.60%); the route of administration causing ADR was more common (69.83%); general ADR / ADE mainly involved skin and appendix (42.96%) and digestive system (16.55%); severe ADR / ADE 181 cases (2.43%), of which 80 cases of severe allergic reactions (42.20%), skin and accessories damage in 36 cases (19.89%). 79 cases (43.65%) of anti-infectives and 32 cases (17.68%) of traditional Chinese medicine injections caused serious ADR / ADE. The top three drugs were cefoperazone / sulbactam (14 cases), Shenmai injection (10 cases) and cefuroxime (10 cases). Conclusion: To strengthen the monitoring report of ADR / ADE and the clinical use of antimicrobial agents, pay attention to the monitoring of serious ADR / ADE, continuously improve the monitoring level of ADR and reduce the risk of medication.