2013-2018年西安市18家“三甲”医院中药注射剂不良反应/事件分析  

Analysis of Adverse Drug Reactions/Events of TCM Injections in 18 Third Grade Class A Hospitals from Xi’an during 2013-2018

作　　者：寿晓嫒 郝宇 胡斌[1] 薛小荣[1] 翟宇瑶[1] 王静[1] 黄永亮[3] 闵慧[1] SHOU Xiaoai;HAO Yu;HU Bin;XUE Xiaorong;ZHAI Yuyao;WANG Jing;HUANG Yongliang;MIN Hui(Dept.of Pharmacy,Xi’an Forth Hospital,Xi’an 714000,China;Luochuan County Food Quality andSafety Inspection and Testing Center,Shaanxi Province,Shaanxi Yan’an 727400,China;College of Clinical Medicine,Chengdu University of TCM,Chengdu 611137,China)

机构地区：[1]西安市第四医院药剂科,西安714000 [2]陕西省洛川县食品质量安全检验检测中心,陕西延安727400 [3]成都中医药大学临床医学院,成都611137

出　　处：《中国药房》2019年第19期2696-2701,共6页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81503254);陕西省重点研发计划项目(No.2018SF-319)

摘　　要：目的:分析西安市18家"三甲"医院中药注射剂不良反应/事件(ADR/ADE)发生的特点,为临床合理用药提供参考。方法:对2013-2018年西安市18家"三甲"医院临床上报的304例中药注射剂ADR/ADE报告进行统计分析,包括患者性别与年龄,ADR/ADE发生的时间分布,引发ADR/ADE的药品分布,ADR/ADE累及器官/系统及临床表现,ADR/ADE的分级、转归及关联性评价、合并用药情况。结果:纳入研究的医院同期共上报ADR/ADE 6 683例,其中304例(4.55%)由中药注射剂引起;在304例ADR/ADE报告中,女性(162例,53.29%)例数略多于男性(142例,46.71%),患者年龄以>40岁为主(223例,73.35%),其中>60岁的有118例(38.82%);ADR/ADE发生在给药后1 min内~10 d,以给药后30 min内为主(123例,40.46%);ADR/ADE涉及36个品种,主要包括活血通络类、扶正补益类和清热解毒类,丹红注射液例数占比最高(43例,14.14%);304例患者共发生352例次ADR/ADE,以皮肤及附件损害为主(164例次,46.59%),其次是心血管系统损害(54例次、15.34%)和全身性损害(51例次,14.49%),临床表现以瘙痒为主(117例次),其次为皮疹(68例次)和心悸(34例次);在304例ADR/ADE报告中,重度ADR/ADE 26例(8.55%)、新的ADR/ADE 8例(2.63%),302例(99.34%)患者痊愈或好转,2例(0.66%)不详,但均未死亡;266例(87.50%)关联性评价为很可能;46例(15.13%)患者存在联合用药情况,其中9例联用了中药注射剂、37例联用了化学药注射剂。结论:中药注射剂因其成分的复杂性、患者个体差异及临床使用等方面的原因导致ADR/ADE发生率较高,多为30 min内的速发型、常表现为皮肤及附件损害的轻度ADR/ADE,可通过临床合理使用与用药监测降低其发生率,对于患心血管等基础疾病的老年患者,要注意辨别其原发疾病与中药注射剂导致的ADR/ADE,更要注意其个体化用药。OBJECTIVE: To analyze the characteristics of adverse drug reactions/events(ADR/ADE) caused by TCM injections in 18 third grade class A hospitals from Xi’an,and to provide reference for rational drug use in clinic. METHODS:Totally 304 ADR/ADE cases of TCM injection reported by 18 third grade class A hospitals of Xi’an were analyzed statistically during 2013-2018 in respect of gender and ages,time distribution of ADR/ADE,distribution of ADR/ADE-inducing drugs,organs/systems involved in ADR/ADE and clinical manifestations,grading of ADR/ADE,outcome and relationship evaluation,drug combination. RESULTS:Totally 6 683 cases of ADR/ADE cases were reported in same period,304 cases were caused by TCM injection(4.55%). Among 304 cases of ADR/ADE,the number of women(162 cases,53.29%)was slightly higher than that of men(142 cases,46.71%). The age of patients was mainly over 40 years old(223 cases,73.35%). Among them,118 cases (38.82%)were over 60 years old. ADR/ADE occurred within 1 min to 10 days after administration,especially within 30 min after administration(123 cases,40.46%). ADR/ADE involved 36 varieties,mainly including agent for promoting blood circulation and dredging,agent for reinforcing and tonifying and agent for clearing away heat and detoxification,and Danhong injection accounted for the highest proportion(43 cases,14.14%). A total of 352 ADR/ADE case times occurred in 304 patients,mainly lesion of skin and appendents(164 case times,46.59%),followed by cardiovascular system lesions(54 case times,15.34%) and systemic lesions(51 case times,14.49%). The main clinical manifestations were mainly pruritus(117 case times),followed by rash(68 case times) and palpitation(34 case times). Among 304 ADR/ADE reports,26 cases(8.55%) were severe,8 cases(2.63%)were new ADR/ADE,302 cases(99.34%)were cured or improved,2 cases(0.66%)were unknown,but none of them died. 266 cases(87.50%) were evaluated as likely to be related. 46 patients(15.13%) had combined use of drugs,including 9 cases of combined use of TCM injection and

关 键 词：西安市 中药注射剂 药品不良反应 药品不良事件 合理用药 

分 类 号：R969.3[医药卫生—药理学]