中国药物警戒 ›› 2020, Vol. 17 ›› Issue (5): 284-289.
DOI: 10.19803/j.1672-8629.2020.05.06

• 安全与合理用药 • 上一篇    下一篇

仙灵骨葆口服制剂的不良反应信号挖掘研究

高欢欢1,2, , 章轶立1, 谢雁鸣1, 郭政亿3, 王志飞1*   

  1. 1 中国中医科学院中医临床基础医学研究所,北京100700;
    2 中国中医科学院望京医院,北京 100102;
    3 中国人民大学统计学院,北京 100872
  • 收稿日期:2020-02-24 修回日期:2020-06-22 出版日期:2020-05-15 发布日期:2020-05-13
  • 通讯作者: *王志飞,博士,副研究员,中药上市后再评价。E-mail: wzhftcm@163.com
  • 作者简介:高欢欢,男,在读硕士,骨与关节疾病基础与临床研究。
  • 基金资助:
    1.国家重点研发计划（2018YFC1707410）中药上市后临床研究共性技术及方法技术体系研究; 2.中央级公益性科研院所基本业务费项目（Z0439）基于免疫组测序的舒血宁注射液过敏反应机制研究

Study on Adverse Drug Reactions Signal Early Warning of XianlingGubao Capsule and Tablet

GAO Huanhuan1,2, ZHANG Yili1, XIE Yanming1, GUO Zhengyi3, WANG Zhifei1*   

  1. 1 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Science, Beijing 100700, China;
    2 Wangjing Hospital of China Academy of Chinese Medical Science, Beijing 100102, China;
    3 School of Statistics, Renmin University of China, Beijing 100872, China
  • Received:2020-02-24 Revised:2020-06-22 Online:2020-05-15 Published:2020-05-13

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摘要： 目的 发现基于SRS数据的仙灵骨葆口服制剂的不良反应预警信号,提高其临床应用的安全性。方法 基于仙灵骨葆口服制剂2004年1月1日至2016年7月21日的自发呈报系统数据,对自发呈报系统数据以及背景数据中出现频次最多的10种不良反应表现（皮疹、瘙痒、恶心、呕吐、寒战、胃功能紊乱、头晕、发热、过敏反应、气胸）采用报告率比例法（PRR）和贝叶斯置信传播神经网络法（BCPNN）进行分析,并应用倾向评分法对混杂因素进行控制。结果 2种计算方法均出现预警信号的ADR表现是恶心、呕吐、胃功能紊乱和头晕;而头晕在倾向评分控制了混杂因素之后,预警信号消失。结论 恶心、呕吐、胃功能紊乱是仙灵骨葆口服制剂的预警信号。该结果是否与仙灵骨葆口服制剂有直接关系,由于SRS数据的局限性,还需结合多方面研究以形成综合性证据,为临床合理使用及降低风险提供更可靠有效的指导。

关键词: 仙灵骨葆口服制剂, 药物警戒, 药品不良反应, 报告率比例法, 贝叶斯置信传播神经网络法

Abstract: Objective To improve the safety of clinical application of Xianlinggubao oral dosage forms, a Chinese patent medicine commonly used for orthopedics by detecting early warning signals of adverse reactions (ADR) in clinical practice. Methods SRS data of Xianlinggubao oral dosage forms provided by Guizhou Tongjitang Pharmaceutical Co., Ltd. were used as the subjects of this study. The data was collected between January 1, 2004 and July 21, 2016. Early warning signals of adverse drug reactions related to Xianlinggubao oral dosage forms were analyzed. PRR and Bayesian confidence propagation neural network (BCPNN) were used to analyze the top ten frequent ADR manifestations (rash, itching, nausea, vomiting, chills, gastric dysfunction, dizziness, fever, allergic reaction and pneumothorax) in SRS data reports and background data, while the propensity score method (PS) was used to control the confounding factors. Results The early warning signals of ADR manifestations confirmed by both methods were nausea, vomiting, gastric dysfunction and dizziness. The warning signals disappeared after the tendency score brought the confounding factors under control. Conclusion Nausea, vomiting and gastric dysfunction are the early warning signals of ADRs caused by Xianlinggubao oral dosage forms. Due to the limitation of SRS data, whether this result is directly related to Xianlinggubao oral dosage forms needs to be confirmed by multiple studies to find comprehensive evidence and provide more reliable and effective guidance for rational clinical use and risk reduction.

Key words: Xianlinggubao oral dosage forms, pharmacovigilance, adverse drug reactions, proportion reporting ratio, Bayesian onfidence propagation neural network

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