基于关联规则和真实世界数据研究中药配方颗粒临床用药特征  

Clinical Medication Characteristics of Traditional Chinese Medicine Formula Granules Based on Association Rules and Real-World Data

作　　者：李韵梅 李家兆 方壬德 黄林石 全克违 邓剑雄 LI Yunmei;LI Jiazhao;FANG Rende;HUANG Linshi;QUAN Kewei;DENG Jianxiong(Dongguan Traditional Chinese Medicine Hospital,Dongguan,Guangdong,China 523127;Guangdong Pharmacological Society,Guangzhou,Guangdong,China 510080;School of Pharmacy,Guangdong Pharmaceutical University,Guangzhou,Guangdong,China 510006)

机构地区：[1]广东省东莞市中医院,广东东莞523127 [2]广东省药理学会,广东广州510080 [3]广东药科大学药学院,广东广州510006

出　　处：《中国药业》2025年第9期20-25,共6页China Pharmaceuticals

基　　金：广东省基础与应用基础研究基金省企联合基金(面上项目)[2021A1515220094]。

摘　　要：目的为临床安全、合理使用中药配方颗粒提供参考。方法通过广东省东莞市中医院医院信息系统(HIS)选取2022年1月1日至12月31日使用了中药配方颗粒患者的基本信息,包括患者的年龄、性别、民族、入院科室、主要诊断名称、主要诊断类型、用药类型、用药通用名、用药剂型等,疾病信息根据《国际疾病分类第十一次修订本》(ICD-11)和《中医病症分类与代码(GB/T 15657—2011)》对中西医诊断进行数据规范化,用药信息根据2020年版《临床用药须知》对中药品种及其毒性进行数据规范化。采用中国医院药物警戒系统(CHPS)对发生了药品不良反应(ADR)的患者进行筛选和获取,ADR术语根据《监管活动医学词典(MedDRA)》(26.0版)进行数据规范化,ADR的严重性参考《常见不良事件评价标准CTCAE)》(5.0版)。基于Apriori算法对患者用药信息进行系统聚类分析,并建立关联规则网络。结果共纳入155039例次患者,男女比例为1∶1.17,主要使用中药配方颗粒的患者年龄为18~44岁(54.30%),民族主要为汉族(96.02%);诊断频次最高的中医术语为乳癖(6364例次)和痹症(6325例次),西医术语为咳嗽(27552例次);ADR发生率为0.13%,毒性药物ADR发生率为0.10%;最常用的单味中药配方颗粒为茯苓(4.51%);使用频率最高的中药配方颗粒药方频次达到440剂次;59.44%的患者存在合并用药;茯苓、陈皮、白术、党参、炙甘草、甘草等用药关系较密切。使用中药配方颗粒药方较多的科室分别为内科、妇产科、皮肤科、骨科、外科。结论该院中药配方颗粒安全性高,单味药用药频次较高的有茯苓、甘草、陈皮、白术,用药关系密切,符合岭南地区气候,可为中药配方颗粒用药规律和相关的多中心研究提供参考。Objective To provide a reference for the safe and rational use of traditional Chinese medicine(TCM)formula granules in the clinic.Methods The basic information of patients treated with TCM formula granules from January 1,2022 to December 31,2022 were selected through the hospital information system(HIS)of the Dongguan Traditional Chinese Medicine Hospital,including patients'age,gender,ethnicity,admission department,main diagnosis name,main diagnosis type,medication type,medication generic name,medication dosage form,etc.Disease information was standardized according to the 11th Revision of the International Classification of Diseases(ICD-11)and the Classification and Codes of Diseases and ZHENG of Traditional Chinese Medicine(GB/T 15657—2011).In terms of medication information,the data on traditional Chinese medicine varieties and their toxicity were standardized according to the 2020 Version of the Clinical Medication Guidelines.The Chinese Hospital Pharmacovigilance System(CHPS)was used to screen and obtain patients who had experienced adverse drug reactions(ADRs).ADR terminology was standardized according to the MedDRA(Version 26.0),and the severity of ADRs was determined based on the Common Terminology Criteria for Adverse Events(CTCAE,Version 5.0).Systematic clustering analysis was performed on patients'medication information based on the Apriori algorithm and an association rule network was established.Results A total of 155039 patients were included,with a male-to-female ratio of 1∶1.17.The main age range of patients treated with TCM formula granules was 18-44 years old(54.30%),and the ethnic group was mainly Han(96.02%);the most frequently diagnosed TCM terminologies were mastitis(6364 cases)and rheumatism(6325 cases),while the Western medical terminology was cough(27552 cases);the incidence of ADR was 0.13%,and the incidence of ADR for toxic drugs was 0.10%;the most commonly used single TCM formula granule was Poria(4.51%);the most frequently used TCM formula granules have a frequency of 440 doses;59

关 键 词：中药配方颗粒 关联规则 真实世界研究 用药特征 

分 类 号：R932[医药卫生—生药学] R288[医药卫生—药学]