中药注射剂致变态反应特征分析  

Analysis of allergic reaction characteristics of traditional Chinese medicine injection

作　　者：吕玲[1] 昝树杰 郑文科[1] 张俊华[1] LYU Ling;ZAN Shu-jie;ZHENG Wen-ke;ZHANG Jun-hua(Tianjin University of Chinese Medicine,Tianjin 300193,China)

机构地区：[1]天津中医药大学,天津300193

出　　处：《中华中医药杂志》2018年第9期4048-4052,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金青年科学基金项目(No.81603493);天津市卫生和计划生育委员会中医中西医结合科研课题(No.2015073)~~

摘　　要：目的:探讨中药注射剂所致变态反应的临床特征。方法:电子检索中文全文期刊数据库(CNKI)、万方数据库、中国生物医学文献数据库(CBM)、维普数据库(VIP)、Pub Med数据库,检索中药注射剂致变态反应相关病例报告,检索时限均为建库至2016年10月。结果:本研究纳入文献962篇,涉及69个中药注射剂品种,其中变态反应发生率品种最多为清热剂646例。致变态反应的中药注射剂绝大多数采用静脉滴注的给药方式。瘙痒为中药注射剂致变态反应的最主要临床症状。超适应症用药、溶媒使用不当、更改用药途径比例分别为20.06%、18.80%、3.30%。结论:中药注射剂变态反应与中药注射剂组成、超说明书用药等多种因素相关,应进一步增强中药注射剂临床前安全性评价,提高预防意识,规范临床用药,降低发生率。Objective： To explore the clinical features of allergic reactions caused by traditional Chinese medicine injections. Methods： Chinese full-text journal database（CNKI）, Wanfang database, China Biomedical Literature Database（CBM）, VIP database（VIP）, Pub Med database were electronically searched, and allergic reaction related case reports of traditional Chinese medicine injections were retrieved. The retrieval time limit was up to October 2016. Results： This study included 962 articles involving 69 Chinese medicine injections, and the highest incidence of allergic reactions was heat-clearing agent（646 cases）. Most of the traditional Chinese medicine injections causing allergic reactions were administered by intravenous drip. Itching was the main clinical symptom of allergic reaction caused by traditional Chinese medicine injection. The proportions of off-label medications, improper solvents, and Changing of medicine route were 20.06%, 18.80%, and 3.30%, respectively. Conclusion： The allergic reaction of traditional Chinese medicine injection is related to the composition of traditional Chinese medicine injection and offlabel medications, etc. The pre-clinical safety evaluation of traditional Chinese medicine injection should be further enhanced, and improving the awareness of prevention and standardizing clinical medication are also needed to reduce the incidence.

关 键 词：中药注射剂 病例报告 变态反应 临床特征 

分 类 号：R288[医药卫生—中药学]