中国药物警戒 ›› 2021, Vol. 18 ›› Issue (8): 705-709.
DOI: 10.19803/j.1672-8629.2021.08.02

• 基于真实世界的中成药联合用药方案研究专栏 • 上一篇    下一篇

真实世界的茵栀黄颗粒临床联合用药特征分析

张利丹1, 谢雁鸣1,*, 谢瑀婷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中国人民大学统计学院,北京 100872
  • 收稿日期:2021-02-18 出版日期:2021-08-15 发布日期:2021-08-17
  • 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:张利丹,女,硕士,中药上市后评价。
  • 基金资助:
    国家重点研发计划(2018YFC1707400)

Characteristics of Clinical Combination with Yinzhihuang Granules in the Real World

ZHANG Lidan1, XIE Yanming1,*, XIE Yuting2   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2School of Statistics, Renmin University of China, Beijing 100872, China
  • Received:2021-02-18 Online:2021-08-15 Published:2021-08-17

摘要: 目的 深入分析真实世界中使用注射用茵栀黄颗粒患者的用药特征,为茵栀黄颗粒在临床中的合理用药及科学研究提供参考。方法 基于真实世界电子医疗病历系统(hospital information system,HIS),提取使用茵栀黄颗粒用药患者诊疗数据,对患者基本信息、诊断信息等进行描述性分析,并通过Apriori算法关联规则的分析方法对合并用药深入挖掘,探索临床实践中茵栀黄颗粒的使用规律。结果 提取2010年6月15日至2016年6月15日全国21家三甲医院5 310例使用注射用茵栀黄颗粒用药患者数据纳入研究,男性多于女性,以45~65岁为最多,真实世界中茵栀黄颗粒的使用大多数在说明书规定范围内。使用茵栀黄注射液常见疾病分别为新生儿高胆红素血症、肺结核和乙型病毒性肝炎,常见的用药方案为茵栀黄颗粒+苦黄注射液/柴胡注射液+甘草酸、吡嗪酰胺合并使用利福平和乙胺丁醇基础上,联用康复新液。结论 本研究揭示了使用茵栀黄颗粒患者在真实世界中的临床用药现状,适应证与使用剂量基本符合相关指南,探索发现了2种临床常用治疗方案,在促进茵栀黄颗粒的临床合理用药等方面具有参考价值。

关键词: 茵栀黄颗粒, 真实世界, 临床特征, 关联规则

Abstract: Objective To analyze the way Yinzhihuang granules for injection are used in the real world in order to provide reference for rational drug use. Methods Based on the real world electronic medical record system (hospital information system, HIS), the data on diagnosis and treatment of patients treated with Yinzhihuang granules was retrieved while the basic information of patients and diagnosis was analyzed descriptively. The combined use of related drugs was mined using association rules of the Apriori algorithm to explore how Yinzhihuang granules were used in clinical practice. Results A total of 5310 patients treated with Yinzhihuang granules for injection in 21 tertiary hospitals between June 2010 and June 2016 were included in the study. Male patients outnumbered female ones. Most of them were aged 45 to 65. The common diseases treated with Yinzhihuang injection were neonatal hyperbilirubinemia, pulmonary tuberculosis and viral hepatitis B. The common drug regimens were Yinzhihuang granules plus Kuhuang injection / Chaihu injection plus glycyrrhizic acid and pyrazinamide combined with rifampicin and ethambutanol. Conclusion The indications and dosage related to Yinzhihuang granules are basically in line with the relevant guidelines. Two common clinical treatment schemes have been found, which are of referential value in promoting the rational use of Yinzhihuang granules.

Key words: Yinzhihuang granules, real world, clinical features, association rules

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