摘要
参麦注射液由红参和麦冬组成,现代药理学研究表明其具有强心、抗心律失常、增强心脏耐缺氧能力和抗菌等功效。然而作为中药注射剂的一种,参麦注射液同样存在致过敏反应等安全性问题。巢式病例对照研究(nested case-control study,NCCS)是将传统的病例对照研究和队列研究的一些要素进行组合后形成的一种研究方法,医院信息系统(hospital information system,HIS)再现了临床诊疗的真实世界,提供了参麦注射液临床应用的海量数据信息,该文基于全国20家三级甲等医院的医院信息系统,采用NCCS方法对使用参麦注射液后发生过敏反应与未发生过敏反应的患者年龄、性别、入院病情、过敏史、用药剂量、溶媒及合并用药等具体信息及真实世界临床应用特征进行比较,探讨可能使参麦注射液产生过敏反应的因素,方法学上是可行的,但致过敏因素的最终发现与确定还需要药学实验与临床前瞻性研究等进一步证实。
Parenterally administered Shenmai, made from constituents of Ginseng Rubra Radix and Ophiopogonis Radix has, confirmed by modem pharmacological studies, the function of increasing cardiac hypoxia tolerance and anti arrhythmic and antibacterial properties. However, parenterally administered Shenmai is also prone to cause allergic reactions, which is clearly a safety issue. NCCSs combine elements from case-control and cohort studies. HIS data provides real world clinical information on the use of parenter- ally administered Shenmai. To explore suspected allergic factors this article compares specific information of those who showed allergies to those who didnt in the real world clinical application based on HIS data from 20 nationwide hospitals. Data includes age, gender, severity and type of allergic response, dosage, solvents used in the medication＇s preparation and drugs used in combination with paren- terally administered Shenmai. Whilst this methodology is a possible route of exploration, ultimately pharmaceutical experiments and prospective clinical studies are required to identify and confirm factors related to allergic reactions.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2013年第18期3019-3023,共5页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2009ZX09502-030)
国家自然科学基金青年基金项目(81202776)
中国中医科学院第7批自主选题项目(Z0255)
中国中医科学院客座研究员联合创新研究项目(ZZ070817)
关键词
巢式病例对照研究
HIS真实世界
参麦注射液
可疑过敏因素
LOGISTIC回归
nested case control study
hospital information system real world
parenterally administered Shenmai
questiona- ble allergic factors
logistic regression
