中国药物警戒 ›› 2021, Vol. 18 ›› Issue (10): 936-939.
DOI: 10.19803/j.1672-8629.2021.10.08

• 基础与临床研究 • 上一篇    下一篇

真实世界中使用茵栀黄颗粒疑似过敏反应的影响因素

秦雪颖1,2, 孙粼希1, 谢雁鸣1,*, 吕健1, 张成1, 谢瑀婷3, 郭朋2   

  1. 1中国中医科学院中医临床基础医学研究所,北京 100700;
    2中国中医科学院西苑医院,北京 100091;
    3中国人民大学统计学院,北京 100872
  • 收稿日期:2020-07-14 出版日期:2021-10-15 发布日期:2021-10-27
  • 通讯作者: *谢雁鸣,女,研究员·博导,中医临床评价。E-mail：datamining5288@163.com
  • 作者简介:秦雪颖,女,硕士,中医肝胆内科。
  • 基金资助:
    国家重点研发计划（2018YFC1707400）; 中国中医科学院自主选题项目（Z0605）

Influencing Factors of Suspected Allergic Reactions Caused by Yinzhihuang Granules in the Real World

QIN Xueying1,2, SUN Linxi1, XIE Yanming1*, LYU Jian1, ZHANG Cheng1, XIE Yuting3, GUO Peng2   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;
    3Renmin University of China, School of Statistics, Beijing 100872, China
  • Received:2020-07-14 Online:2021-10-15 Published:2021-10-27

PDF (PC)

86

摘要： 目的 探究真实世界中使用茵栀黄颗粒发生疑似过敏反应的影响因素。方法 本研究提取了2008年3月31日年至2011年3月31日全国21家三甲医院信息系统中使用茵栀黄颗粒的4 966例患者信息。采用处方序列分析的方法确定过敏组,利用巢氏病例对照设计,按性别、年龄等条件,1∶4配比对照组,利用条件Logistic回归分析模型,分析合并疾病、合并用药、住院天数分段、疗程分段、单次剂量分段等43个潜在影响因素与过敏反应是否存在统计学关联。结果 单因素Logistic回归显示,腹水、乙型病毒性肝炎、肝炎后肝硬化活动期等3个因素具有统计学意义（P<0.05）。将单因素分析结果纳入多因素Logistic回归模型后,以上3个因素未观察到统计学意义（P>0.05）。结论 基于现有样本,未筛选出有统计意义的疑似过敏反应影响因素,茵栀黄颗粒导致的过敏反应及其影响因素仍需进一步药理及临床研究来发现和证实。

关键词: 茵栀黄颗粒, 疑似过敏反应, 真实世界, 巢式病例对照研究, Logistic回归分析

Abstract: Objective To explore the influencing factors of suspected allergic reactions caused by Yinzhihuang granules in the real world. Methods This study collected information form 4 966 patients who had used Yinzhihuang granules in the hospital information systems of 21 tertiary hospitals across the country from March 2008 to March 2011. Prescription sequence analysis and nested case-control study were performed, prescription sequence analysis and nested case-control study were performed to select the allergic group and the control group (non-allergic patients) to find out about the potential relationship between the medication allergy to Yinzhihuang granules and forty-three influencing factors including the combination of diseases, combined medication, age, sex, length of hospital stay, course of treatment and dosage using the conditional Logistic regression analysis model. Results Single factor Logistic regression showed that three factors, including ascites, viral hepatitis B and the active stage of post-hepatitis cirrhosis, were statistically significant (P<0.05). After the univariate analysis results were incorporated into the multivariate Logistic regression model, no statistical significance was observed for the above three factors (P>0.05). Conclusion Based on the current sample size, no statistically significant factors related to allergic reactions caused by Yinzhihuang granules have been screened out. Real risk factors remain to be discovered and confirmed by pharmacological and clinical studies.

Key words: Yinzhihuang granules, suspected allergic reaction, real world, nested case-control study, Logistic regression

中图分类号: