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中文摘要：
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AD刚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。
英文摘要：
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.
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