【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。更多还原

【Abstract】 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 analyzed 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,Xingnaojing 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 prevent the ADR/ADE.更多还原