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邹菊英1， 陈卫红1*， 余 辉1， 易胜先2， 熊瑞云2， 黄 科3.2011～2013年长沙市中药注射剂不良反应/事件[J].湖南中医药大学学报英文版,2015,35(10):59-62.[Click to copy
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| 2011～2013年长沙市中药注射剂不良反应/事件 |
| 邹菊英1，陈卫红1*，余辉1，易胜先2，熊瑞云2，黄科3 |
| (1.湖南中医药大学第二附属医院，湖南 长沙 410005;2.湖南省长沙市药品不良反应监测中心，湖南 长沙 410005;3.湖南中医药大学药学院，湖南 长沙 410208) |
| 摘要: |
| 目的 了解中药注射剂不良反应/事件（ADR/ADE）的发生情况、特点及规律，为临床合理用药提供参考。方法 检索长沙市药品不良反应监测中心数据库，对长沙市2011~2013年各单位上报的中药注射剂不良反应/事件报告进行分类统计、分析。结果 共筛选出980例中药注射剂不良反应/事件报告，占同期报告总数的6.15%。长沙市ADR/ADE报告数呈逐年增加的趋势，2012年是报告数急剧增加的一年。2012年、2013年严重ADR/ADE比例均在10%以上。 ADR/ADE累及系统-器官主要为皮肤及其附件、全身性损害，其次为呼吸系统、胃肠系统、心血管系统等。ADR/ADE涉及84个生产厂家的55个中药注射剂品种，有5个用于心脑血管疾病的中药注射剂品种出现ADR/ADE频率居前10位。结论 中药注射剂不良反应/事件具有客观性、多样性和一定的规律性，应当充分重视中药注射剂发生的ADR/ADE，进一步加强监测，提高临床合理用药水平，保障患者用药安全。 |
| 关键词: 中药注射剂 药品不良反应 分类分析 |
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| Analyses of Reports on Adverse Drug Reactions /Events induced by TCM Injection from Changsha 2011 to 2013 |
| ZOU Juying1, CHEN Weihong1*, YU Hui1, YI Shengxian2, XIONG Ruiyun2, HUANG Ke3 |
| (1. The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha, Hunan 410005, China;2. Adverse Drug Reaction Monitoring Center, Changsha, Hunan 410005, China;3. School of Pharmacy, Hunan University of Chinese Medicine, Changsha, Hunan 410208, China) |
| Abstract: |
| Objective To study the situation，feature and regularity of adverse drug reaction/event (ADR/ADE) induced by TCM injection, and provide reference for rational clinical use of drug. Methods The reports of adverse drug reaction/event induced by TCM injection from 2011 to 2013 were classified with statistical analysis by searching Changsha adverse drug monitoring center database. Results A total of 980 reports on adverse drug reaction/event induced by TCM injection were concluded in this study, account for 6.15% of the same period reports. ADR/ADE reports for increasing trend year by year in Changsha city，the reports number has increased dramatically in 2012. Serious ADR/ADE proportions were above 10% in 2012 and 2013. The lesion of ADR/ADE involved primarily in skin and its accessories, systematic lesions, followed by respiratory system，gastrointestinal system and circulation system etc. ADR/ADE involved 55 varieties of TCM injections from 84 manufacturers. There are five kinds of TCM injections for cardiovascular and cerebrovascular diseases, with ADR/ADE frequency in the top ten. Conclusion TCM injection adverse reactions/events have the objectivity, diversity and regularity. We should pay more attention to ADR/ADE，further strengthen monitoring，improve the level of clinical rational drug use, and ensure the safety of patients with medication. |
| Key words: traditional Chinese medicine injection adverse drug reactions classification analysis |
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