摘要
目的促进中药制剂说明书的不断更新与完善。方法收集医院2013至2017年上报的中药制剂"新的一般"和"新的严重"药品不良反应(ADR)报表,对涉及的中药制剂说明书进行核实和分析。结果筛选出中药制剂"新的ADR"共157例,其中丹参川芎嗪注射液9例,自占比为75. 00%,其次为参芎葡萄糖注射液5例(71. 43%)、生脉注射液18例(60. 00%)、注射用盐酸川芎嗪6例(60. 00%);"新的ADR"占总ADR比例前10位的中药制剂中有2例涉及临床研究,且说明书更新时间间隔多为5~7年。结论中药制剂ADR中"新的ADR"占比过高,与其药品说明书不完善、ADR等信息过于简单、未及时有效更新有关,应完善相关管理。
Objective To continuously update and improve the instructions of traditional Chinese medicine(TCM) preparations. Methods The ″new general″ and ″new serious″ adverse drug reactions ( ADRs ) reports of TCM preparations reported by the hospital from 2013 to 2017 were collected,and the instructions of related TCM preparations were verified and analyzed. Results A total of 157 cases of new ADRs of TCM preparations were screened out,of which 9 cases were induced by Salviae Miltiorrhizae and Ligustrazine Hydrochloride Injection,the new ADRs accounting for 75. 00% among the ADRs induced by this injection,followed by Salivae Miltiorrhizae,Liguspyragine Hydrochloride and Glucose Injection ( 5 cases,71. 43%),Shengmai Injection ( 18 cases,60. 00%) and Ligustrazine Hydrochloride for Injection ( 6 cases,60. 00%). Of the top 10 TCM preparations with the proportion of new ADR to total ADR,2 cases involved in clinical research,and the update interval of instructions was mostly 5 - 7 years. Conclusion The proportion of new ADRs in ADRs induced by TCM preparations is too high,which is related to the imperfection of drug instructions,the simplicity of ADR information and the lack of timely and effective updating,and the relevant management should be improved.
作者
周歧骥
莫巧凤
刘承统
ZHOU Qiji;MO Qiaofeng;LIU Chengtong(Affiliated Hospital of Youjiang Medical University for Nationalities,Baise,Guangxi,China 533000;College of Pharmacy,Youjiang Medical University for Nationalities,Baise,Guangxi,China 533000)
出处
《中国药业》
CAS
2019年第18期93-95,共3页
China Pharmaceuticals
基金
广西中医药民族医药自筹经费科研课题[GZZC16-57]
关键词
中药制剂
新的药品不良反应
药品说明书
药品监管
traditional Chinese medicine preparations
new adverse drug reactions
drug instructions
drug administration
