中国药物警戒 ›› 2021, Vol. 18 ›› Issue (8): 715-718.
DOI: 10.19803/j.1672-8629.2021.08.04

• 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

真实世界的注射用灯盏花素用药特征分析

王亚娇1,2, 黎元元1#, 谢雁鸣1,*, 杨晓晨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中国中医科学院广安门医院,北京 100053;
    3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,中药上市后再评价与医药大数据挖掘。E-mail：ktzu2018@163.com #为共同通信作者。
  • 作者简介:王亚娇,女,硕士,中医学。
  • 基金资助:
    国家重点研发计划(2018YFC1707400）

Analysis of the Medication Characteristics of Breviscapine Injection in the Real World

WANG Yajiao1,2, LI Yuanyuan1#, XIE Yanming1,*, YANG Xiaochen3   

  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;
    3School of Statistics, Renmin University of China, Beijing 100872, China
  • Received:2021-02-18 Online:2021-08-15 Published:2021-08-17

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摘要： 目的 基于真实世界研究,探索应用注射用灯盏花素患者的人群特征和用药规律。方法 从全国34家三级甲等医院信息系统中,提取2002年1月1日至2015年12月31日应用注射用灯盏花素患者的医疗数据,规范化后使用Apriori算法建立模型,Clementine12.0软件进行关联规则分析。结果 共收集48 710例患者,年龄多在45~64岁之间（34.66%）,男性多于女性,使用科室多为骨科（19.14%）、心血管内科（14.83%）等;西医诊断占前3位的为原发性高血压（19.33%）、冠心病（12.39%）、脑梗死（11.25%）,中医证候多为肝肾亏虚证（17.29%）、气滞血瘀证（16.60%）、痰瘀互结证（8.78%）等;给药途径多为静脉滴注,单次用药剂量多为20~50 mg（51.47%）;西药联合用药频数最多的是乙酰水杨酸（4.59%）、肝素类（3.04%）等,中药联合用药中频数最多的是复方丹参滴丸（2.12%）、四磨汤口服液（1.84%）等。结论 应用注射用灯盏花素的患者以中老年人为主,适应证基本符合说明书,但仍存在超说明书适应证用药（骨科疾病治疗）,并且临床实际使用剂量超说明书比例偏高,需加强用药剂量规范及用药监管,临床应用仍应参照说明书;联合用药与指南相契合,有一定规律可循,可提供临床用药线索。

关键词: 注射用灯盏花素, 真实世界, 联合用药

Abstract: Objective To explore the demographic characteristics and patterns of medication among patients using breviscapine injection in the real world. Methods The medical data on patients treated with breviscapine injection was retrieved from the information system of 34 tertiary hospitals from January 1, 2002 to December 31, 2015 in China. After normalization, a model was established using the Apriori algorithm, and association rule analysis was carried out with Clementine12.0 software. Results Most of the 48 710 patients were between 45 and 64 years old (34.66%), and male patients outnumbered female ones. Departments of Orthopedics (19.14%) and Cardiology(14.83%) were the biggest users of the drug. The top three diagnoses by Western medicine were essential hypertension (19.33%),coronary heart disease (12.39%),and cerebral infarction (11.25%),while the dominating syndromes diagnosed by TCM were liver and kidney Yin deficiency syndrome (17.29%),followed by qi stagnation and blood stasis syndrome (16.60%),and phlegm and blood stasis syndrome (8.78%). The route of administration was mostly intravenous drip, and the single dose was mostly 20-50mg (51.47%).The most frequent combination with western medicines involved acetylsalicylic acid (4.59%) and heparin (3.04%) , compared with compound salvia miltiorrhiza dropping pills (2.12%) and Simo decoction (1.84%) from TCM. Conclusion The results showed that the patients with breviscapine injection were mainly middle-aged and elderly patients, and the indications were basically in line with the instructions, but there were still off-label drug use (orthopedic disease treatment), and the proportion of off-label dose in actual clinical use was relatively high, it is necessary to strengthen the dosage specification and medication supervision. The clinical application should still refer to the instructions. Combined drug use is consistent with the guidelines and has certain rules to follow, which can provide clues for clinical medication.

Key words: breviscapine injection, real world, combined medication

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