从药品不良反应信息通报探究中药注射剂问题及对策  

Study on the Issues of the Clinical Use of Traditional Chinese Medicine Injections and Countermeasures from the Adverse Drug Reactions Bulletin

作　　者：巩颖[1] 郑飞[1] 刘文亚 顾媛媛[1] 鲁雨荍 华国栋[1] 

机构地区：[1]北京中医药大学东方医院,北京100078

出　　处：《现代中药研究与实践》2017年第3期75-77,共3页Research and Practice on Chinese Medicines

摘　　要：目的从《药品不良反应信息通报》探究中药注射剂临床使用中存在的问题,分析对策减少其不良反应发生。方法对70期《药品不良反应信息通报》所涉及的中药注射剂进行回顾性分析。结果涉及中药注射剂不良反应的通报15期,通报中药注射剂20品次,其中有4种中药注射剂被通报两次。中药注射剂的免疫原性和临床不合理用药是导致中药注射剂不良反应发生的主要原因。结论为保障中药注射剂临床使用的安全性,需要提升中药注射剂品质,开展临床再评价工作,并在临床使用中严格按照规范操作。Objective Analyze the problems existed in clinical use of traditional Chinese medicine injection（TCMI） from Adverse Drug Reactions（ADR） Bulletin, and study on the countermeasures so that to reduce the occurrence of ADR. Methods Making retrospective analysis of 70 issues of ADR Bulletin that involving the TCMI. Results There were 20 times of TCMI were mentioned in 15 issues of ADR Bulletin, and 4 kinds of TCMI were mentioned twice. The immunogenicity and unreasonable use of TCMI were the main reason for the ADR of TCMI. Conclusion To secure the safety of TCMI in clinical use, it was necessary to improve quality of TCMI, carried out clinical re-evaluation, and to comply standard operating procedure in clinical use of TCMI.

关 键 词：中药注射剂 不良反应 上市后再评价 临床合理用药 

分 类 号：R288[医药卫生—中药学]