中国药业2025，Vol.34Issue(9)：20-25,6.DOI:10.3969/j.issn.1006-4931.2025.09.005
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
摘要
Abstract
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 155 039 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(6 364 cases)and rheumatism(6 325 cases),while the Western medical terminology was cough(27 552 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;59.44%of patients had combined medication;Poria,Citri Reticulatae Pericarpium,Atractylodis Macrocephalae Rhizoma,Codonopsis Radix,Glycyrrhizae Radix et Rhizoma Praeparata cum Melle,Glycyrrhizae Radix et Rhizoma and other medicinal herbs were closely related.The departments that used TCM formula granules more frequently were the department of internal medicine,department of obstetrics and gynecology,department of dermatology,department of orthopedics,and department of surgery.Conclusion The ADR of TCM formula granules in this hospital has high safety.The single medicinal herbs with high frequency include Poria,Glycyrrhizae Radix et Rhizoma,Citri Reticulatae Pericarpium,Atractylodis Macrocephalae Rhizoma,which are closely related to the use of herbs and conform to the climate of Lingnan region,and can provide a reference for the medication rules of TCM formula granules and related multi-center research.关键词
中药配方颗粒/关联规则/真实世界研究/用药特征Key words
traditional Chinese medicine formula granules/association rules/real world research/medication characteristics分类
药学引用本文复制引用
李韵梅,李家兆,方壬德,黄林石,全克违,邓剑雄..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[J].中国药业,2025,34(9):20-25,6.基金项目
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]. （面上项目）
