中文摘要：

目的：分析中药注射剂引起严重不良反应/事件（ADR/ADE）的发生特点和一般规律。方法：提取2010—2014年重庆市689例中药注射剂所致的严重ADR/ADE报告,利用Excel表及人工筛查的方法进行回顾性分析。结果：在689例中药注射剂所致严重ADR/ADE报告中,＂新的＂严重ADR/ADE有290例（42.09%）;60岁以上老年人比例较高（43.54%）;涉及药品前3位分别为香丹注射液64例（9.29%）、注射用血塞通（冻干）59例（8.56%）、清开灵注射液57例（8.27%）;81.39%的患者在用药30 min内发生ADR/ADE;超适应证用药和超剂量用药导致ADE共221例（32.07%）;严重ADR/ADE主要表现为过敏性休克、过敏样反应、呼吸困难、皮疹、心悸等。结论：中药注射剂新的严重ADR/ADE较多,相关生产企业应及时完善说明书。临床需注重对老年患者的用药监测,同时加强中药注射剂药物严重不良反应的集中监测,规范超说明书用药,提高用药安全性。

英文摘要：

OBJECTIVE To analyze characteristics and patterns of serious adverse drug reactions/events（ADR/ADE）induced by traditional Chinese medicine injection.METHODS Totally 689 serious ADR/ADE induced by traditional Chinese medicine injection in Chongqing from2010 to 2014 were retrospectively analyzed by Excel and artificial screening.RESULTSAmong 689 ADR/ADE,290 were new and serious ADR/ADE（42.09%）.Proportion of old people（≥60 years）was the largest（43.54%）.ADR/ADE were mostly caused by Xiangdan injection（9.29%）,Sanqi panax notoqinseng for injection（8.56%）,Qingkailing injection（8.27%）.Of these ADR/ADE,81.39% happened within 30 min of medication,221（32.07%）were induced by off-label use and overdose.Clinical manifestations of serious ADR/ADE were anaphylactic shock,anaphylactoid reaction,dyspnea,rash and palpitation.CONCLUSION New and serious ADR/ADE of traditional Chinese medicine injection are relatively more.Pharmaceutical enterprises should improve instructions for drug use.It is essential to pay attentions to elderly people.Serious ADR/ADE should be monitored and reported centrally,and off-lable drug use should be regulated,to enhance medication security.