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。
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.
出处
《湖南中医药大学学报》
CAS
2015年第10期59-62,共4页
Journal of Hunan University of Chinese Medicine
关键词
中药注射剂
药品不良反应
分类分析
traditional Chinese medicine injection
adverse drug reactions
classification analysis
作者简介
邹菊英，女，硕士，药师，主要从事临床药学的研究。
[通讯作者]陈卫红，女，主任药师，E-mail：418328009@qq．com。
