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.

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.

Advances in the management of arteriosclerosis of the lower extremity:Integrating Western and Chinese medicine approaches

This editorial provides a commentary on the recent article.The paper reviews current literature and explores innovative treatment strategies for lower extremity arteriosclerosis obliterans(LEASO)through an integrative approach.It highlights the effectiveness of combination therapies that merge traditional Chinese medicine(TCM)with Western medical practices,suggesting that such integrative methods may improve patient compliance and outcomes through personalized care.This paper stresses the importance of rigorous clinical trials to evaluate the efficacy and safety of TCM interventions within LEASO treatment protocols,advocating for evidence-based validation of these combined therapies.Our recommendations emphasize accurate diagnosis,appropriate pharmacological in-terventions,the use of advanced surgical and endovascular techniques,and the inclusion of TCM to address underlying dysfunctions.Additionally,continuous monitoring,patient education,and lifestyle modifications are essential to slow disease progression and achieve optimal patient outcomes.The paper concludes by calling for further research to develop standardized treatment protocols that effectively integrate both Western and Chinese medical approaches in managing LEASO.

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.

Treatment of 140 cerebral palsied children with a combined method based on traditional Chinese medicine(TCM)and western medicine

Objective:To observe and evaluate a method that is effective and practical for treatment of cerebral palsied(CP)children in China.Method:The patient's age and disease type and individual specific conditions were considered in choosingtherapy methods accordingly:Chinese herbs,acupuncture,auricnlar seed pressure,point finger pressing,massage,orthopedichand manipulation,physiotherapy,occupational therapy,language therapy,etc.Meanwhile we created a new CP treatment modelthat combines hospitalized treatment with family therapy.Results:The majority of CP patients improved greatly in motor andsocial adaptation capacities after treatment.Wilcoxon paired rank sum test analysis showed that there were significant differencesbetween the data before and after treatment(P<0.01).Conclusion:This combined therapy method,based on traditional Chinesemedicine and western medicine plus family supplemental therapy,is an effective and practical treatment strategy for CP children inChina.

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.

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.

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.

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.

Network pharmacology and experimental validation to reveal the pharmacological mechanisms of Qizhu prescription for treating breast cancer

Objective:To investigate the mechanism underlying the effects exerted by the Qizhu prescription(QZP)in breast cancer(BC),and the respective targets.Methods: Expression data from the ArrayExpress and The Cancer Genome Atlas(TCGA)were used to identify differentially expressed genes(DEGs)in BC.Gene Ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analyses were performed on the DEGs to identify genes involved in protein–protein interactions.Molecular docking was used to explore the dynamic relationship between active molecules and targets.Cell function experiments and animal studies were conducted to evaluate the effects of hub genes and active QZP compounds on BC cell behavior.Results: Among the 25 evaluated BC-related targets of QZP,matrix metalloproteinase-1(MMP1)and epidermal growth factor receptor(EGFR)exhibited the highest degrees of dysregulation.GO and KEGG enrichment analyses revealed that the anti-BC targets of QZP primarily affected drug responses and pathways in cancer cells.Molecular docking analysis suggested potential interactions between EGFR and quercetin/luteolin,as well as between MMP1 and luteolin/kaempferol/quercetin.Quercetin significantly reduced BC cell proliferation,migration,invasion,and tumor development in vivo.Treatment of BC cells with quercetin decreased the expression or activation of several associated proteins.Conclusion: The findings of our study provide new insights into the therapeutic potential of traditional Chinese medicine against BC,with particular reference to QZP.

Therapeutic effect of traditional Chinese medicine on coagulation disorder and accompanying intractable jaundice in hepatitis B virus-related liver cirrhosis patients

AIM： TO observe the therapeutic effects of new traditional Chinese medicine （TClVl） therapy on coagulation disorder and accompanying intractable jaundice in HBV-related liver cirrhosis patients. METHODS： Using stratified random sampling according to fibrinogen （Fib） levels, 145 liver cirrhosis patients due to hepatitis B complicated by coagulation disorder were treated. Of them, 70 in research group were treated with TCM by ＂nourishing yin, cooling blood and invigorating blood circulation＂ and Western medicine, 75 in control group were treated with conventional Western medicine. The indexes of liver function, coagulation function and bleeding events were observed and compared. RESULTS： The prothrombin time （PT） was shorter and the fibrinogen （Fib） level was higher in the research group than in the control group （Fib = 1.6-2.0 g/L, 1.1-1.5 g/L, and ≤ 1.0 g/L）. The total bilirubin （TBIL） level was significantly lower in the research group than in the control group, except for the subgroup of FIB ≤ 1.0 g/L. CONCLUSION： TCM therapy can improve coagulation fuction and decrease TBIL.

Treatment of Helicobacter pylori-associated gastritis using traditional Chinese medicine

Helicobacter pylori is a pathogenic bacterium with strong pathogenicity, which can induce chronic gastritis and peptic ulcer in addition to causing gastric mucosal atrophy and intestinal metaplasia after longterm infection. It is even associated closely with the occurrence of gastric cancer and mucosa-associated lymphoid tissue lymphoma. Recently, the incidence of H. pylori-associated gastritis has increased rapidly worldwide, especially in China. The prevention and treatment of H. pylori infection has become an urgent issue to be resolved by the medical community. Traditional Chinese medicine and the combination of traditional Chinese medicine and Western medicine have recently shown unique advantages in the treatment of H. pylori–associated gastritis. The progress in this area is summarized in this review.