Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions(2022)

Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.

Exploring the compatibility theory of traditional Chinese medicine formulae:the disassembled prescriptions study

Traditional Chinese medicine(TCM)has become very popular in the treatment of complex diseases worldwide in recent decades.Despite the promising performance of TCM,how herbs work synergistically in a formula and their therapeutic targets remain ambiguous.This largely limits the correct use and modernization of TCM formulas clinically.The study of disassembled prescriptions is important for investigating the compatibility theory of Chinese medicines.By dissecting the mechanisms of TCM formulae,the compatibility principles of some well-known formulae,such as Realgar-Indigo naturalis,have been elucidated to a certain extent.In this review,several common methods of disassembled prescription studies are summarized,including those of single herb or mineral,sub-prescription,active ingredients or effective parts,large formulae,and systems pharmacology studies,as well as the methods of grouping based on the properties or efficacy of Chinese medicines,in order to provide evidence for formulae study.Moreover,some challenges to be addressed in disassembled prescriptions studies have been identified in this review.

Discussion on the Application of Ascending and Descending Property of Traditional Chinese Medicine in Compatibility of Clinical Prescriptions

Through the method of literature mining,the classics of traditional Chinese medicine,materia medica works,medical cases and documents are studied.Based on common prescriptions for the treatment of diseases such as abnormal Zang-fu viscera and qi movement,dysfunction,etc.,and combined with the theory of ascending and descending property of traditional Chinese medicine,the application of ascending and descending property of traditional Chinese medicine in clinical prescription compatibility and the factors affecting the application are summarized.The ascending and descending properties of traditional Chinese medicine have been widely used in prescription compatibility for the clinical treatment of impairment of purifying and descending function of the lung,spleen and stomach's ascending and descending disorders and heart-kidney noninteractionpatte.

Ultrasonic Nebulization Extraction Coupled with Gas Chromatography-Mass Spectrometry for Analysis of Volatile Components in Traditional Chinese Patent Medicine

The ultrasonic nebulization extraction（UNE） was developed and applied to the extraction of volatile components from traditional Chinese patent medicine Xiaoyao Pills. Several parameters of ultrasonic nebulization extraction including the sample particle size, solvent volume, extraction time and ultrasonic power were studied and selected. As a result, 2.4 g of sample with particle size of 80 mesh was extracted with 15 mL of n-hexane for 20 min at an ultrasonic power of 35 W. The volatile components were analyzed by gas chromatography-mass spectrometry （GC-MS） under the optimal conditions and 57 compounds were identified. The precision, repeatability and stability of the proposed method were also studied. Compared with ultrasonic-assisted extraction（UAE） and hydrodistillation（HD） extraction, the proposed method is more efficient, faster and easier to be operated at room temperature with smaller sample and energy consumption. It is suggested that the ultrasonic nebulization extraction can be used as a novel alternative method for the extraction of volatile components from traditional Chinese patent medicine.

The Characteristics of the Drug Composition in the Treatment of Insomnia by External Bath Prescription of Traditional Chinese Medicine

[Objectives]The research aimed to carry out a retrospective analysis on the characteristics of the drug composition in the treatment of insomnia by external bath prescription of traditional Chinese medicine,to provide ideas for the research and development of new Chinese medicine for insomnia.[Methods]The external bath prescriptions of traditional Chinese medicine related to insomnia were collected,and the appearance frequency of drug was analyzed,and statistical analysis of drug with high appearance frequency was conducted.[Results]In the external bath prescriptions of traditional Chinese medicine related to insomnia,the top ten herbs with high appearance frequency were as follows:Chaozaoren,Drgonsbones,Margaritifera,Yejiaoteng,Schisandrae Chinensis Fructus,Lilii Bulbus,Platycladi Semen,Poria,Coptidis Rhizoma,and Scutellariae Radix.According to the classification by efficacy,these herbs mostly have the effects of calming,nourishing and heat clearing.[Conclusions]Traditional Chinese medicine is most closely related to heart,kidney,liver and other viscera.Tranquilizing and sedative drugs should be chosen,which corresponds with the understanding on pathogenesis of insomnia in traditional Chinese medical science,and embodies the characteristics of external bath prescription of traditional Chinese medicine in the treatment of insomnia.

A brief overview of traditional Chinese medicine prescription powered by artificial intelligence

Traditional Chinese medicine prescription is one of the treasures of traditional Chinese medicine(TCM).There are tens of thousands TCM prescriptions accumulated in the past thousands of years,corresponding to different diseases,symptoms and therapeutic goals.The correspondences are so complicated that there is an urgent need to leverage new technologies such as artificial intelligence(AI)to analyze,understand and utilize them effectively.In this paper,we present a brief overview of this direction,where current research progress on TCM prescription powered by AI is summarized.Our summarization focuses on three aspects,TCM prescription mining that aims at understanding the TCM prescription,TCM prescription or herb knowledge base construction that aims at extracting knowledge to support the TCM prescription-related study,and TCM prescription discovery that aims at utilizing AI technologies to further energize TCM.It is encouraging to see that steady progress in this direction has been made recently.Besides,a toy experiment on image-based TCM herb recognition by using convolutional neural networks is also conducted.It basically verifies that it is promising to use AI technologies to address challenging tasks in TCM.We also point out several research topics that could be cooperatively performed by researchers from the two disciplines.

Applicability of Zipfs Law in Traditional Chinese Medicine Prescriptions

Objective Traditional Chinese medicine(TCM)prescriptions have been used to cure diseases in China for thousands of years,in which many TCM herbs have no definite common quantity.Some key TCM herbs are commonly used and thus deserve in-depth investigations based on a more acceptable classification method.This study analyzes whether TCM prescriptions follow Zipf's law and attempts to obtain the thresholds of key TCM herbs based on the application of Zipfs law;Methods A total of 84,418 TCM prescriptions were collected and standardized.We tested whether Zipf's law and Zipfs distribution fit the Chinese herb distributions.A linear fitting experiment was performed to verify the relationship between the frequency distribution and frequency of TCM herbs.Results The distribution of TCM herbs in TCM prescriptions conformed to Zipf's law.Accordingly,the thresholds were obtained for the key TCM herbs.Conclusion The distribution of TCM herbs in TCM prescriptions follows Zipfs law.

Screening of Traditional Chinese Medicine Prescription for Treating Damp-heat Diarrhea of Piglets

[Objective] The paper was to explore the therapeutic effect of traditional Chinese medicine on damp-heat diarrhea of piglets in summer.[Method] Three prescriptions were developed with a dozen of traditional Chinese medicines,and in vitro antibacterial test against swine standard Escherichia coli [O149：K91,K88 ac（C83907）] was conducted.Moreover,106 natural cases of diarrhea piglets caused by coinfection of damp-heat and E.coli through clinical and laboratory diagnosis were then treated.[Result] The oral liquids prepared by three traditional Chinese medicine prescriptions had certain antibacterial effect on standard pathogenic E.coli.Prescription 2 presented the strongest inhibitory effects on swine E.coli in vitro,with the MIC of 31.25 mg/m L.It had better therapeutic effect,and the effective rate reached 94.74%.[Conclusion] The prescription 2 mainly consisted of Coptis chinensis and Prunus mume might be effective in treatment of piglet diarrhea caused by damp heat and E.coli in clinic.

Based on the national patent database to explore the rule of traditional Chinese medicine in the treatment of hyperlipidemia

Objective:To explore the medication law of traditional Chinese medicine compound patent for hyperlipidemia,and to provide reference for the research and development of traditional Chinese medicine new drugs for clinical treatment of hyperlipidemia.Methods:All compound TCM patents related to the treatment of hyperlipidemia were searched and extracted from the national patent database(http://epub.sipo.gov.cn)from the establishment of the database to 10st,March 2021.The data was established by the TCM Inheritance Support System(V2.5)and Microsoft Excel 2010 Softwore,and used to conduct TCM syndromes,frequency statistics,four nature and five flavors of traditional Chinese medicine,meridian attribution statistics.IBM SPSS statistics 20 software was used for drug clustering analysis,IBM SPSS modeler 18.2.2 software was used for association rules and web visualization analysis.Results:Totally 284 compound TCM patents were included,involving 577 kinds of Chinese medicine,and the most common syndrome was Yin deficiency of liver and kidney syndrome(74 times,accounting for 26.06%).The most ten common Chinese materiamedica was Hawthorn,Salvia miltiorrhiza,Alismaorientalis,Cassia seed,Polygonummultiflorum,Licorice,Poriacocos,chinese rhubarb,dried tangerine peel,Radix Paeoniae Alba.The top three appeared frequently in drug categories were tonifying deficiency medicine,activating blood-circulation and dissipating blood-stasis medicine,and heat-clearing medicine,respectively.The top two of its drug properties were warm and cold;the top three drug tastes were sweet,bitterness and pungent;the top two meridians were liver and spleen meridian,respectively.Seven drug groups were obtained by cluster analysis,and 16 were obtained by association rule analysis,including 5 drug pairs and 11 three drug groups.Conclusion:Through the data mining of the patent of traditional Chinese medicine compound prescription for regulating and treating hyperlipidemia,it is concluded that the fundamental pathogenesis of the disease is deficiency of viscera function and obstruction of phlegm and blood stasis.The clinical methods are tonifying the liver and kidney,activating blood circulation and removing stasis,resolving phlegm and removing dampness.Traditional Chinese medicine is mostly used for tonifying deficiency,activating blood circulation,removing stasis,resolving phlegm and removing dampness.This paper provides a reference for the research and development of traditional Chinese medicine for hyperlipidemia.

Research based on data mining compatibility of traditional Chinese medicine with Professor WANG Dong-mei in the treatment of primary dysmenorrhea

Objective:To study the law of compatibility of traditional Chinese medicine in the treatment of primary dysmenorrhea by Professor WANG Dong-mei.Methods:This study collected the Professor WANG Dong-mei’s prescriptions for primary dysmenorrhea cases in the outpatient department,to establish a database by Excel 2015,and to use IBM SPSS statistics 24.0 and SPSS Clementine 12.0 software for clustering analysis and association rules data mining analysis.Results:A total of 106 cases were included,106 prescriptions were collected,114 kinds of drugs were used,nd the cumulative frequency of drug use was 1876 times;the top three drugs were white peony(89 times),Xiangfu(77 times),red peony(75 times);the drugs with the most drug properties and taste frequency were warm and sweet drugs,which were mainly liver meridian;four common pair-used drug groups were Xiangfu yanhusuo,angelica white peony etc.and six groups were common clustering groups.Conclusion:Professor WANG Dong-mei usually chooses the drugs of sweet,warm or spicy in the treatment of primary dysmenorrhea.In addition to the natural efficacy,Prof.Wang also considers modern pharmacological effect in the specific drug selection.The commonly used prescription combination is Shaofu Zhuyu Decoction,which embodies Professor WANG Dong-mei's academic thought of treating primary dysmenorrhea"mainly by warming and regulating qi and blood",and for patients with reproductive needs,in addition to promoting blood circulation and relieving pain,she also adds menstruation regulating and pregnancy aiding drugs,which can not only improve the symptoms of primary dysmenorrhea,but also meet their fertility desire.

Analysis of the rule of medication of compound Chinese traditional patent medicine for digestive system tumors based on data mining

Objective:Based on the data mining method,explore the medication rules of Chinese patent medicines for the treatment of digestive system tumors.Method:Based on the"Chinese Traditional Medicine Prescription Database"in https://db.yaozh.com/,collect Chinese patent medicines for the treatment of digestive system tumors,establish an Excel table,and use the ancient and modern medical case cloud platform(V2.2.1)to perform frequency statistics,association rules,and drugs on the data Clustering and complex network analysis.Results:A total of 36 Chinese patent medicines for the treatment of digestive system tumors were screened.The medicinal properties were mainly warm and cold,the taste was bitter and sweet,and the meridians were mainly liver and spleen meridians.High frequency Chinese medicine include Astragalus,Scutellaria-barbata,Ginseng,Curcuma,Triangle,Atractylodes,Hedyotis diffusa,etc.Correlation analysis obtained 17 drug combinations,High-frequency drug pairs include Scutellaria-barbata-Astragalus,Ginseng-Astragalus,Curcuma-Astragalus,Scutellaria-barbata-Curcuma,etc.Cluster analysis found 3 types of drugs.The core drug network is composed of 27 drugs,and the core compatibility network consists of 3 groups of drugs.Conclusion:The Chinese patent compound medicine for the treatment of digestive system tumors has the characteristics of combining cold and warming,replenishing and reducing treatment,and treating the liver and spleen at the same time.The medicine is mainly used to replenish qi and invigorate the spleen,promote blood circulation and remove blood stasis,and clear away heat and detoxification.Replenish qi,nourish yin,invigorate blood,and detoxify are mainly compatible with each other,reflecting the pathogenesis characteristics of"deficiency,stasis,and toxin"in digestive system tumors.Data mining can provide references for the prescription and compatibility of Chinese patent medicines.

Prediction of the mechanism of prostate prescription Ⅰ in the treatment of chronic prostatitis based on integrative pharmacology of traditional Chinese medicine

Objective:To investigate potential mechanism of Prostate prescriptionⅠin the treatment of chronic prostatitis based on integrated pharmacology.Methods:with the help of TCMIP,the effective compounds of Prostate prescriptionⅠwere screened,and the potential target database of Prostate prescriptionⅠwas established by using the target prediction function of TCMIP.Based on the Human Phenotype Ontology database and protein interaction network(PPI)database,the disease target of CP was identified and the target interaction network was constructed;Through the GO function analysis and KEGG pathway enrichment analysis of the candidate targets,combined with Chinese and foreign literature studies to predict the potential Signaling pathway of Prostate prescriptionⅠin the treatment of CP.Results:79 effective compounds of Prostate prescriptionⅠexerted its effect on 33 targets through 11 pathways.Conclusion:Clinical efficacy of Prostate prescriptionⅠon CP may be reflected in antiinflammation and anti-tumor,cell metabolism,immune regulation,neuroregulation and so on.

Analysis of prescription rules in the treatment of diabetic heart disease based on traditional Chinese medicine inheritance support system

Diabetes is a common clinical disease and has many complications,among which diabetic heart disease is the leading cause of death in diabetic patients.This article collected the prescriptions for the treatment of diabetic heart disease,and used the traditional Chinese medicine inheritance support system to explore the prescription formulation rules.Finally,we included 43 prescriptions for analysis.We found that the rules of formulas for treating diabetic heart disease are complex,but Chinese medicines in these formulas are mainly with the effects of nourishing Qi,nourishing Yin and activating blood circulation.At the same time,we obtained 3 new prescriptions and discussed the clinical rationality of the new prescriptions.The purpose of this article is to provide reference for clinical prescription in the treatment of diabetic heart disease and the development of related new drugs.

Potential Preventive and Therapeutic Effects of Traditional Chinese Medicine Compound Prescription and Traditional Chinese Medicine Products on COVID-19

This paper mainly analyzes the traditional Chinese medicine compound prescription and traditional Chinese medicine products with remarkable epidemic prevention effect since the outbreak of COVID-19,and discusses their potential prevention and treatment effects,so as to provide a basis for the further development and application of traditional Chinese medicine compound prescription and traditional Chinese medicine products against COVID-19.

Analysis on the rules of prescriptions for ischemic stroke based on the traditional Chinese medicine inheritance auxiliary system

In China,traditional Chinese medicine is widely used in the treatment of ischemic stroke,but its prescription rules needs to be further studied.This paper uses the traditional Chinese medicine inheritance auxiliary system(a software)to analyze the composition rules of a large number of prescriptions for the treatment of ischemic stroke,and discusses the clinical rationality of the new prescriptions.We found that the prescriptions for the treatment of ischemic stroke are mainly composed by herbs for promoting blood circulation and removing blood stasis,dredging collaterals and tonifying deficiency,and some of the new prescriptions are also in line with this characteristic.This paper can provide reference for clinical prescription in the treatment of ischemic stroke and the development of related new drugs.

Research Progress in the Application of Network Pharmacology in Traditional Chinese Medicine and Compound Prescriptions

Network pharmacology is a new discipline based on the theory of systems biology,mainly for network analysis of biological systems.It selects specific signal nodes for multi-target drug molecular design.This article summarizes the application of network pharmacology in traditional Chinese medicine and compound prescriptions in recent years from the research progress of network pharmacology,the current research status of single herbs,and the research and application of compound prescriptions.

Traditional Chinese medicine prescriptions and herbs for the treatment of hypothyroidism:a narrative review

The increasing prevalence of hypothyroidism,which can cause endocrine dysfunction,abnormal neurological function,and cardiovascular and cerebrovascular injuries,poses serious health problems.Thyroid hormone supplementation constitutes the current main therapeutic method for hypothyroidism,yet it has many limitations and risks and is not suitable for everyone.Therefore,it is necessary to seek alternative and complementary treatment methods.It has been proven in practice that traditional Chinese medicine(TCM)possesses multi-channel comprehensive characteristics for the treatment of hypothyroidism and has more advantages than single thyroid hormone supplementation.Through a comprehensive examination of existing literature about TCM efficacy in addressing hypothyroidism,we have meticulously consolidated the most recent research findings on prescriptions and herbal substances employed in the treatment of this condition.Furthermore,we have explicated their respective functions in the management of hypothyroidism,thereby offering valuable perspectives and recommendations for the prospective utilization of natural remedies in its treatment.

Pharmaceutical Rules of Traditional Chinese Medicine For Stroke Based on Dictionary of Prescriptions and Complex Network Analysis

Objective:Taking the Dictionary of Prescriptions as a clue,we collected effective prescriptions for treating Stroke,and systematically summarized the medication and compatibility rules of the core Chinese medicines for treating Stroke.Methods:A database of prescriptions for stroke based on complex relationship analysis system of traditional Chinese medicine was established.From the point of view of complex network,the hierarchy of drug compatibility rules of compound prescriptions(such as courtiers and envoys)was analyzed,the statistical characteristics of complex networks were analyzed,and an attempt was made to explain the characteristics of complex networks of drugs for stroke.Results:A total of 974 prescriptions were collected,including 1040 Chinese herbs.The core Chinese herbal medicines with nodal degree(>500)for Stroke were divaricate saposhnikovia root,liquorice root,Chinese angelica,tall gastrodia tuber,incised notopterygium rhizome and root.The compatibility relationship of the core Chinese medicines in the treatment of stroke is divaricate saposhnikovia root-liquorice root,ephedra-divaricate saposhnikovia root,divaricate saposhnikovia root-sichuan lovage rhizome,divaricate saposhnikovia root-Chinese angelica in order of frequency.Conclusion:Through the analysis of the common network structure of effective prescriptions for Stroke,the core prescription compatibility structure reflecting the prescription thinking and clinical characteristics was found.

A study on the medication law of oral administration of traditional Chinese medicine in treating breast carbuncle based on the Traditional Chinese Medicine Prescription Dictionary

Objective:Based on the database of Traditional Chinese Medicine Prescription Dictionary,the prescription medication rules of oral administration of traditional Chinese medicine in the treatment of breast carbuncle were explored by using the software of Traditional Chinese Medicine Inheritance Support System(V2.5).Methods:To screen and retrieve the prescriptions for treating breast carbuncle in the Traditional Chinese Medicine Prescription Dictionary,and data mining was carried out by using association rule algorithm,complex system entropy clustering and so on.Results:A total of 208 prescriptions which met the inclusion criteria were selected,involving 175 traditional Chinese medicines.Among them,23 medicines were found to be more than 21 times in the treatment of breast carbuncle.The nature of the medicine is mainly cold or warm,the flavour of the medicine is mainly bitter or sweet,most of them belong to the spleen,liver,stomach.15 commonly used drug combinations and 9 new prescriptions were obtained.Conclusion:The key pathogenesis of breast carbuncle is liver depression and Qi stagnation,stomach heat blocking collaterals,the treatment is mainly to clear heat and detoxify,regulate Qi to diffuse the knot,which provides reference for the choose of traditional Chinese medicine prescription in treating breast carbuncle.

Discussion on the Application of Real-World Study in the Inheritance and Development of Empirical Prescriptions of Traditional Chinese Medicine

Objective To study the research on real-world data and to provide new ideas and methods for the inheritance and development of empirical prescriptions of traditional Chinese medicine(TCM).Methods The disadvantages of using randomized controlled trials for empirical prescriptions of TCM and the advantages of using real-world study(RWS)were analyzed by summarizing the previous RWS and the empirical prescriptions.Meanwhile,the methods for marketing of new TCMs derived from empirical prescriptions of TCM,the data source and trial design of the RWS were discussed.Results and Conclusion RWS can provide new ideas for the listing of new TCMs.With the improvement of relevant laws and regulations,RWS will promote the development of TCM greatly.To promote the application of RWS in the inheritance and development of empirical prescriptions of TCM,the government should improve laws and regulations as soon as possible,and enterprises and research institutions should strengthen patient privacy protection and clarify the responsible parties.