中国药物警戒 ›› 2022, Vol. 19 ›› Issue (7): 740-743.
DOI: 10.19803/j.1672-8629.2022.07.09

• 基础与临床研究 • 上一篇    下一篇

真实世界中鹿瓜多肽注射液疑似过敏反应影响因素研究

姚羽1,2, 黎元元1,*, 魏戌3#, 谢雁鸣1, 王志飞1, 高明慧4   

  1. 1中国中医科学院中医临床基础医学研究所,北京100700;
    2中国中医科学院广安门医院,北京100053;
    3中国中医科学院望京医院,北京100102;
    4中国人民大学统计学院,北京100872
  • 收稿日期:2020-09-04 出版日期:2022-07-15 发布日期:2022-07-12
  • 通讯作者: *黎元元,女,博士,研究员,中药上市后临床安全性评价。E-mail：chibjyy@163.com;#为共同通信作者。
  • 作者简介:姚羽,女,在读硕士,中医外科学。
  • 基金资助:
    国家重点研发计划（2018YFC1707410）

Influencing factors of suspected allergic reactions related to cervus and cucumis polypeptide for injection in the real world

YAO Yu1,2, LI Yuanyuan1,*, WEI Xu3#, XIE Yanming1, WANG Zhifei1, GAO Minghui4   

  1. 1Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China;
    3Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China;
    4School of Statistics, Renmin University of China, Beijing 100872, China
  • Received:2020-09-04 Online:2022-07-15 Published:2022-07-12

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摘要： 目的 探讨真实世界鹿瓜多肽注射液发生疑似过敏反应的影响因素。方法 基于2003年7月1日至2014年12月31日全国26家三甲医院信息系统中使用过鹿瓜多肽注射液患者的信息,采用回顾性巢式病例-对照研究方法,对比发生疑似过敏反应人群组与未发生过敏反应人群组的合并疾病、合并用药、住院天数分段、用药疗程、用药剂量等信息,运用Logistic回归方法分析引发疑似过敏反应的影响因素。结果 最终纳入过敏反应分析病例5 745例,其中疑似过敏反应者（过敏组）1 149例,未发生过敏反应者（对照组）4 596例。经Logistic回归分析发现,合并疾病、住院天数、用药疗程、单次用药剂量对鹿瓜多肽注射液发生疑似过敏反应无显著影响;鹿瓜多肽注射液联合使用诺氟沙星时有统计学意义（P=0.011 3）。结论 合并使用诺氟沙星可能是鹿瓜多肽注射液发生疑似过敏反应的影响因素（P<0.05）,该研究可为临床合理用药提供参考。

关键词: 鹿瓜多肽注射液, 疑似过敏反应, 影响因素, 真实世界

Abstract: Objective To explore the influencing factors of suspected allergic reactions caused by cervus and cucumis polypeptide for injection in the real world. Methods The study was based on information about patients who had used cervus and cucumis polypeptide for injection in the hospital information system of 26 large-scale tertiary hospitals in China from July 1, 2003 to December 31, 2014. A retrospective nested case-control study was conducted to compare the group of suspected allergic patients with the group of non-allergic patients. The logistic regression method was used to analyze the influencing factors of suspected allergic reactions based on such information as complications, combined medications, length of hospital stay, courses of medication and dosage. Results A total of 5 745 cases were included in this study, including 1 149 suspected allergic reactions (the allergic group) and 4 596 patients who had not developed any allergic reactions (the control group). Logistic regression analysis found that complications, combined medications, length of hospital stay, courses of medication and single dose had no significant effect on the incidence of suspected allergic reactions caused by cervus and cucumis polypeptide for injection. However, the difference was statistically significant when cervus and cucumis polypeptide for injection was combined with norfloxacin (P=0.011 3). Conclusion The combined use with norfloxacin may be a determinant of suspected allergic reactions related to cervus and cucumis polypeptide for injection (P<0.05). Which provides a reference to the rational use of drugs in clinic.

Key words: cervus and cucumis polypeptide for injection, suspected allergic reaction, influencing factors, real world

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