316份中药注射剂不良反应报告分析  

Analysis of 316 Cases of ADR Induced by TCM Injection

作　　者：丁长玲[1] 宿振国[1] 张玉杰[1] 赵永德[1] 张树平[2] 高菲[1] 

机构地区：[1]滨州医学院附属医院,山东滨州256603 [2]滨州医学院药学院,山东烟台264003

出　　处：《中国药房》2013年第39期3718-3721,共4页China Pharmacy

基　　金：国家卫生行业科研专项项目(No.200902008);山东省中医药科技发展计划项目(No.2009-184)

摘　　要：目的:了解滨州医学院附属医院316个中药注射剂不良反应/事件(ADR/ADE)发生的特点和规律,减少ADR/ADE的重复发生。方法:采用回顾性研究方法,对该院2007-2012年收集的中药注射剂ADR/ADE报告表进行统计分析。结果:316份ADR/ADE报告中,涉及中西药552例次,其中中药注射剂348例次,药物品种25种,出现例次排名前三位的为痰热清注射液、醒脑静注射液、疏血通注射液;ADR/ADE涉及部位以皮肤及附属器官损害最多,其次是全身性损害和呼吸系统损害;导致出现ADR/ADE的原因主要与中药注射剂本身特点有关,亦与临床不合理使用有关。结论:应加强对中药注射剂ADR/ADE的监测和临床合理应用的相关研究,重视中药注射剂的安全性和质量再评价,采取有效防范措施。OBJECTIVE： To understand the characteristics and regular patterns of 361 cases of adverse drug reaction/event （ADR/ADE） induced by TCM injection in the Affiliated Hospital of Binzhou Medical College, and to reduce the occurrence of ADR/ADE. METHODS： By retrospective method, ADR/ADE reports of TCM injection in the hospital from 2007 to 2012 were ana- lyzed statistically. RESULTS： Among 316 cases of ADR/ADE reports, 552 cases involved Chinese and Western medicine, and TCM injections were involved in 348 cases. There were 25 kinds of drugs, and the top 3 drugs were Tanreqing injection, Xingnao- jing injection and Shuxuetong injection; main ADR/ADE were lesion of skin and its appendants, followed by systemic damages and respiratory damages; the reasons of ADR/ADE were mainly associated with the characteristics of TCM injection, also related to unreasonable use of it. CONCLUSIONS ： We should pay much attention to ADR/ADE monitoring and related research of rational use of TCM injection in the clinic, and attach importance to the security and quality evaluation and take effective measures to pre- vent the ADR/ADE.

关 键 词：中药注射剂 不良反应 事件 回顾性分析 安全性评价 合理用药 

分 类 号：R283.61[医药卫生—中药学] R969.3[医药卫生—中医学]