The selection of an appropriate control group is a critical component of pharmacoepidemiologic research.This article provides an interpretation of the control selection methods outlined in the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition).According to the 2nd edition,studies are categorized into interventional and non-interventional research.In interventional research,control group options include placebo controls,no-treatment controls,active controls,and dose-response controls.For non-interventional research,the gold standard design is the active comparator new user(ACNU)design.When the ACNU design is not feasible,alternative control group strategies should be selected based on the research objective,data sources,exposure characteristics,and potential confounding.These alternatives may include non-user comparators,prevalent user comparators,self-controlled comparators,and external controls.Finally,this article compares the applicability,strengths,and limitations of various control group types.It aims to provide methodological guidance for the scientific selection of control groups in pharmacoepidemiologic studies and to support the conduct of high-quality research.

The selection of an appropriate control group is a critical component of pharmacoepidemiologic research.This article provides an interpretation of the control selection methods outlined in the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition).According to the 2nd edition,studies are categorized into interventional and non-interventional research.In interventional research,control group options include placebo controls,no-treatment controls,active controls,and dose-response controls.For non-interventional research,the gold standard design is the active comparator new user(ACNU)design.When the ACNU design is not feasible,alternative control group strategies should be selected based on the research objective,data sources,exposure characteristics,and potential confounding.These alternatives may include non-user comparators,prevalent user comparators,self-controlled comparators,and external controls.Finally,this article compares the applicability,strengths,and limitations of various control group types.It aims to provide methodological guidance for the scientific selection of control groups in pharmacoepidemiologic studies and to support the conduct of high-quality research.

Objective To analyze the medication rules of traditional Chinese medicine in treating breast cancer based on real-world data mining.Methods Inpatients with breast cancer who received traditional Chinese medicine treatment at the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from January 2017 to December 2021 were selected.Python 3.10 software was used to mine traditional Chinese medicine prescription data;SPSS 23.0 software was applied for descriptive analysis,and systematic cluster analysis was performed on high-frequency drugs.Results A total of 3026 consultation records of inpatients with breast cancer were collected.The main traditional Chinese medicine syndrome diagnosis of"predominantly liver depression and Qi stagnation"accounted for 60.94％of the total consultations.A total of 240 kinds of traditional Chinese medicine were used,with a cumulative frequency of 35 462 times.Among them,29 kinds of traditional Chinese medicine such as Danggui,Fuling,Baizhu,Chaihu had a cumulative usage frequency exceeding 300 times.Regarding the four natures of drugs,cold-natured(43.55％),warm-natured(30.05％),and neutral-natured(23.34％)drugs were predominant;In terms of five flavors,sweet(46.12％),bitter(30.91％),and pungent(20.02％)were the main ones.The most frequently used drugs were tonifying herbs(32.77％),followed by heat-clearing herbs(15.96％)and phlegm-resolving herbs(14.71％).Systematic cluster analysis yielded 7 groups of drug combinations.Conclusion In real-world clinical practice,traditional Chinese medicine for breast cancer mainly uses tonifying herbs,reflecting the traditional Chinese medicine principle of"strengthening healthy Qi and cultivating the root"in treating tumors.The four natures and five flavors of drugs follow syndrome differentiation and the combination of cold and heat.The clustered drug combinations have extensive therapeutic effects,covering various syndromes of breast cancer at different stages,which can provide a reference for clinical medication.

Objective To analyze the medication rules of traditional Chinese medicine in treating breast cancer based on real-world data mining.Methods Inpatients with breast cancer who received traditional Chinese medicine treatment at the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from January 2017 to December 2021 were selected.Python 3.10 software was used to mine traditional Chinese medicine prescription data;SPSS 23.0 software was applied for descriptive analysis,and systematic cluster analysis was performed on high-frequency drugs.Results A total of 3026 consultation records of inpatients with breast cancer were collected.The main traditional Chinese medicine syndrome diagnosis of"predominantly liver depression and Qi stagnation"accounted for 60.94％of the total consultations.A total of 240 kinds of traditional Chinese medicine were used,with a cumulative frequency of 35 462 times.Among them,29 kinds of traditional Chinese medicine such as Danggui,Fuling,Baizhu,Chaihu had a cumulative usage frequency exceeding 300 times.Regarding the four natures of drugs,cold-natured(43.55％),warm-natured(30.05％),and neutral-natured(23.34％)drugs were predominant;In terms of five flavors,sweet(46.12％),bitter(30.91％),and pungent(20.02％)were the main ones.The most frequently used drugs were tonifying herbs(32.77％),followed by heat-clearing herbs(15.96％)and phlegm-resolving herbs(14.71％).Systematic cluster analysis yielded 7 groups of drug combinations.Conclusion In real-world clinical practice,traditional Chinese medicine for breast cancer mainly uses tonifying herbs,reflecting the traditional Chinese medicine principle of"strengthening healthy Qi and cultivating the root"in treating tumors.The four natures and five flavors of drugs follow syndrome differentiation and the combination of cold and heat.The clustered drug combinations have extensive therapeutic effects,covering various syndromes of breast cancer at different stages,which can provide a reference for clinical medication.