重庆市689例中药注射剂严重不良反应/事件报告分析

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。

Analysis of 689 serious adverse drug reactions/events of traditional Chinese medicine injection in Chongqing City

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 from 2010 to 2014 were retrospectively analyzed by Excel and artificial screening.RESULTS Among 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.