中国药物警戒 ›› 2021, Vol. 18 ›› Issue (10): 956-959.
DOI: 10.19803/j.1672-8629.2021.10.13

• 安全与合理用药 • 上一篇    下一篇

处方序列分析结合巢式病例对照设计研究刺五加注射液疑似过敏反应影响因素

张柏钰1,2, 谢雁鸣1,*, 刘峘1, 孙粼希1,2, 庄鋆妮3   

  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:2020-11-30 出版日期:2021-10-15 发布日期:2021-10-27
  • 通讯作者: *谢雁鸣,女,首席研究员·博导,中医临床评价方法。E-mail：ktzu2018@163.com
  • 作者简介:张柏钰,女,硕士,中医内科学。

Influencing Factors of Suspected Allergic Reactions Caused by Ciwujia Injection Based on Prescription Sequence Analysis and Nested Case-control Design

ZHANG Baiyu1,2, XIE Yanming1*, LIU Huan1, SUN Linxi1,2, ZHUANG Yunni3   

  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;
    3School of Statistics, Renmin University, Beijing 100872, China
  • Received:2020-11-30 Online:2021-10-15 Published:2021-10-27

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摘要： 目的 研究真实世界中使用刺五加注射液后发生疑似过敏反应的相关影响因素,以指导临床安全用药。方法 通过回顾性分析,分析2006年至2014年全国24家大型三级甲等医院信息系统（hospital information system, HIS）中使用过刺五加注射液的住院患者信息,采用处方序列分析（prescription sequence analysis, PSA）,将第一次使用刺五加注射液后≤24 h即停止使用且停药24 h内又使用了氯雷他定、地氯雷他定、异丙嗪、地塞米松的患者判断为疑似过敏反应病例,共计93例,与采用巢式病例对照设计（nested case control study, NCCS）筛选的可能未发生过敏反应病例372例进行对比,采用Logistic回归分析方法探讨合并疾病、合并用药、单次用药剂量等信息与疑似过敏反应发生的相关性。结果 数据分析发现,维生素C或甘油与刺五加注射液联合使用会增加使用刺五加注射液疑似过敏反应发生的机会。刺五加注射液与单硝酸异山梨酯、化瘀通脉类中药制剂、硝苯地平及其类似药物、注射用胰岛素及其类似药物、美托洛尔、乙酰水杨酸制剂、呋塞米合用,对刺五加注射液引起疑似过敏反应的发生无显著影响。合并疾病、单次用药剂量不是疑似过敏反应的相关危险因素。结论 临床应用刺五加注射液时应注意避免与维生素C或甘油联合使用,以免增加疑似过敏反应发生风险。

关键词: 刺五加注射液, 处方序列分析, 巢式病例对照, 过敏反应, 真实世界

Abstract: Objective To explore the influencing factors of suspected allergic reactions caused by Ciwujia injection in the real world and to guide safe clinical medication. Methods Retrospective analysis was conducted of the data on inpatients who had used Ciwujia injection in the hospital information system (HIS) of 24 large tertiary hospitals in China between 2006 and 2014. Patients who discontinued Ciwujia injection within 24 hours of the first use and switched to loratadine, desloratadine, promethazine and dexamethasone within 24 hours of the first use were regarded as suspected cases of allergic reactions. A total of 93 cases were collected. Logistic regression analysis was used to explore the correlation between the information about comorbidities, combinations of drugs, single doses and the incidence of suspected allergic reactions. Results Data analysis found that the use of vitamin C or glycerin combined with Ciwujia injection could increase the chance of suspected allergic reactions. The combination of Ciwujia injection with isosorbide mononitrate, Huayu Tongmai traditional Chinese medicine preparation, nifedipine and its analogues, insulin for injection and its analogues, metoprolol, acetylsalicylic acid preparation and furosemide had no significant effect on the occurrence of suspected allergic reactions caused by Ciwujia injection. Comorbidities and single doses were not risk factors for suspected allergic reactions. Conclusion Ciwujia injection should not be combined with vitamin C or glycerin clinically to minimize the risk of suspected allergic reactions.

Key words: Ciwujia injection, prescription sequence analysis, nested case control study, allergic reactions, the real world

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