中国中药杂志

2014, v.39(18) 3567-3570

[打印本页] [关闭]
本期目录(Current Issue) | 过刊浏览(Past Issue) | 高级检索(Advanced Search)

巢式病例对照设计在痰热清注射液过敏反应机制研究中的应用举隅
Demonstration of nested case-control study design in mechanisms research of allergic reaction of Tanreqing injection

谢鹏扬;谢雁鸣;王连心;常艳鹏;刘绍勇;
XIE Peng-yang;XIE Yan-ming;WANG Lian-xin;CHANG Yan-peng;LIU Shao-yong;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;College Information and Computer Science,Shanghai Business School;Shenyang Orthopaedic Hospital;Shanghai Kaibao Pharmaceutical Co.,Ltd;

摘要(Abstract):

该文从痰热清注射液从上市后临床应用着眼,采用前瞻性、多中心、大样本、注册登记式临床安全性监测嵌套巢式病例对照设计,检测与分析过敏反应患者相关血液指标,探讨其过敏反应可能的机制。共监测使用痰热清注射液的患者3006例,出现不良反应的患者3例,其中2例为过敏反应。每例过敏反应患者,按1:4匹配4例未发生不良反应的患者作为对照组,同时纳入5例健康志愿者组成健康组,对各组之间总IgE,IgA,IgG,C3,C4,IFN-g,IL-2,IL-4,IL-6,IL-10等过敏反应相关检测指标进行比较。基于现有的研究数据发现痰热清注射液的过敏反应可能为由IgE介导的Ⅰ型过敏反应,这也为促进临床安全合理用药起到促进作用。
The paper is focused on the clinical applications of Tanreqing injection after listing,detecting and analyzing the related blood indicators of patients with allergic reactions based on prospective,multi-center,large sample,registration-type clinical safety monitoring nested case-control study(NCCS) to explore the possible mechanisms of allergic reaction of Tanreqing injection,3 006 patients cases used with Tanreqing injection were monitored,including 3 cases of adverse reactions and 2 cases of allergic reactions.Each patient of allergic reactions,according to the ratio of 1:4 matches four cases of not adverse reactions as a control group of patients,while 5 healthy and 5 cases of volunteers into the healthy group.We examined the correlation detection of cases of allergic reactions among groups such as T-IgE,IgA,IgG,C3,C4,IFN-g,IL-2,IL-4,IL-6,IL-10.Allergic reactions of Tanreqing injection may be mediated by IgE as type Ⅰ based on existing research data.This results and conclusions will promote the justifiability and safety of clinical applications.

关键词(KeyWords): 痰热清注射液;注册登记研究;巢式病例对照;过敏反应机制;人体免疫毒理学
Tanreqing injection;registration research;nested case-control study;mechanisms of allergic reaction;immune toxicology

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2009ZX09502030);; 国家中医药管理局中医药行业科研专项(200907001-5-6)

作者(Authors): 谢鹏扬;谢雁鸣;王连心;常艳鹏;刘绍勇;
XIE Peng-yang;XIE Yan-ming;WANG Lian-xin;CHANG Yan-peng;LIU Shao-yong;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;College Information and Computer Science,Shanghai Business School;Shenyang Orthopaedic Hospital;Shanghai Kaibao Pharmaceutical Co.,Ltd;

参考文献(References):

扩展功能
本文信息
服务与反馈
本文关键词相关文章
本文作者相关文章
中国知网
分享