基于血清免疫毒理学的中药注射剂过敏反应类型分析  

Analysis of the allergic reaction types of Chinese medicine injection based on immunotoxicty

作　　者：王志飞[1] 艾青华[1] 黎元元[1] 姜俊杰[1] 王连心[1] 杨薇[1] 谢雁鸣[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2015年第24期4762-4765,共4页China Journal of Chinese Materia Medica

基　　金：中央级公益性科研院所基本科研业务费专项(Z0406;PY1303);国家"重大新药创制"科技重大专项(2015ZX09501004-001-009);北京市中医药科技发展资金项目(JJ2015-58)

摘　　要：该研究依托前瞻性、多中心、大样本、登记注册式医院集中监测探讨了中药注射剂临床过敏反应的类型、发生比例及发生特征。监测的品种包括疏血通注射液、灯盏细辛注射液、参芪扶正注射液、参麦注射液、刺五加注射液、痰热清注射液和热毒宁注射液,共监测15余万病例;病例按巢式病例对照设计分组,采集过敏患者血样14例,匹配患者血样55例;运用酶联免疫吸附实验(ELISA)检测血清C3,C4,Ig E,Ig G,MCT-β共5项免疫毒理学指标,根据结果分析其过敏反应类型为:疏血通注射液过敏2例,1例判定为Ⅰ型变态反应,1例无法判定类型;灯盏细辛注射液过敏3例,1例判定为Ⅰ型变态反应,1例判定为Ⅰ型变态反应和类过敏反应同时发生,1例无法判定类型;参芪扶正注射液过敏4例,3例判定为Ⅰ型变态反应,1例无法判定类型;参麦注射液过敏1例,判定为类过敏反应;刺五加注射液、舒血宁注射液、痰热清注射液和热毒宁注射液过敏各1例,无法判定类型。结果提示纳入监测的上述中药注射剂过敏反应以Ⅰ型变态反应为主,类过敏反应较少;过敏反应的类型可能与中药注射剂品种关系密切,同一品种的过敏反应类型相同;灯盏细辛注射液过敏的同一患者可以同时发生Ⅰ型变态反应和类过敏反应。The purpose of the study is to find the allergic reaction types and characteristics of Chinese medicine injection （CMI）. The authors monitored patients who used Shuxuetong injection, Dengzhan Xixin injection, Shenqi Fuzheng injection, Shenmai injection, Ciwujia injection, Shuxuening injection, Tanreqing injection, Reduning injection, a total of 150 000 cases were monitored. They used a nested case-control design to group the patients and obtained the serum samples from 14 allergic patients and 55 matched patients. They used enzyme-linked immunosorbent assay （ELISA） to detect serum C3, C4, IgE, IgG, MCT/3, and judge the allergic reaction types： Shuxuetong injection hypersensitivity（1 case）, can not determine（1 case）; Dengzhan Xixin injection hypersensitivity（ 1 case）, hypersen- sitivity ＆ anaphylactoid reaction（ 1 case）, can not determine（ 1 case） ; Shenqi Fuzheng injection hypersensitivity（3 cases）, can not de- termine（ 1 case） ; Shenmai injection anaphylactoid reaction（ 1 case） ; Ciwujia injection can not determine（ 1 case）, Shuxuening injection can not determine（ 1 case）, Tanreqing injection can not determine（ 1 case）, Reduning injection can not determine（ 1 case）. The results showed that the main type of allergic reaction of CMI was hypersensitivity, the type of allergic reaction was closely related to the varieties of CMI, the hypersensitivity and anaphylactoid reaction might occur in one patient at the same time which used Dengzhan Xixin injection.

关 键 词：中药注射剂 免疫毒理学 过敏反应 超敏反应 类过敏反应 

分 类 号：R286[医药卫生—中药学]