Quality of life and survival analyses of breast cancer cases treated with integrated traditional Chinese and Western medicine

BACKGROUND Breast cancer(BC)is the second leading cause of tumor-related mortality after lung cancer.Chemotherapy resistance remains a major challenge to progress in BC treatment,warranting further exploration of feasible and effective alternative therapies.AIM To analyzed the quality of life(QoL)and survival of patients with BC treated with integrated traditional Chinese and Western medicine(TCM-WM).METHODS This study included 226 patients with BC admitted to the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine between February 2018 and February 2023,including 100 who received conventional Western medicine treatment(control group)and 126 who received TCM-WM treatment(research group).The total effective rate,side effects(alopecia,nausea and vomiting,hepatorenal toxicity,and myelosuppression),QoL assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire(EORTC QLQ-C30),1-year overall survival(OS),recurrence and metastasis rates,and serum inflammatory factors[interleukin(IL)-6,IL-10,and tumor necrosis factor alpha]were comparatively analyzed.RESULTS The research group showed statistically better overall efficacy,EORTC QoL-C30 scores,and 1-year OS than the control group,with markedly lower side effects and 1-year recurrence and metastasis rates.Moreover,the posttreatment levels of serum inflammatory in the research group were significantly lower than the baseline and those in the control group.CONCLUSION Overall,TCM-WM demonstrated significantly improved therapeutic efficacy while ensuring drug safety in BC,which not only improved patients’QoL and prolonged survival,but also significantly inhibited the inflammatory response.

TCMLLM-PR:evaluation of large language models for prescription recommendation in traditional Chinese medicine

Objective To develop and evaluate a fine-tuned large language model(LLM)for traditional Chinese medicine(TCM)prescription recommendation named TCMLLM-PR.Methods First,we constructed an instruction-tuning dataset containing 68654 samples(ap-proximately 10 million tokens)by integrating data from eight sources,including four TCM textbooks,Pharmacopoeia of the People’s Republic of China 2020(CHP),Chinese Medicine Clinical Cases(CMCC),and hospital clinical records covering lung disease,liver disease,stroke,diabetes,and splenic-stomach disease.Then,we trained TCMLLM-PR using Chat-GLM-6B with P-Tuning v2 technology.The evaluation consisted of three aspects:(i)compari-son with traditional prescription recommendation models(PTM,TCMPR,and PresRecST);(ii)comparison with TCM-specific LLMs(ShenNong,Huatuo,and HuatuoGPT)and general-domain ChatGPT;(iii)assessment of model migration capability across different disease datasets.We employed precision,recall,and F1 score as evaluation metrics.Results The experiments showed that TCMLLM-PR significantly outperformed baseline models on TCM textbooks and CHP datasets,with F1@10 improvements of 31.80%and 59.48%,respectively.In cross-dataset validation,the model performed best when migrating from TCM textbooks to liver disease dataset,achieving an F1@10 of 0.1551.Analysis of real-world cases demonstrated that TCMLLM-PR's prescription recommendations most closely matched actual doctors’prescriptions.Conclusion This study integrated LLMs into TCM prescription recommendations,leverag-ing a tailored instruction-tuning dataset and developing TCMLLM-PR.This study will pub-licly release the best model parameters of TCMLLM-PR to promote the development of the decision-making process in TCM practices(https://github.com/2020MEAI/TCMLLM).

Construction of competency evaluation system for infection control personnel in traditional Chinese medicine hospitals

Background:This study uses a literature review and the Delphi expert consultation method to construct a competency evaluation model for infection control personnel in traditional Chinese medicine(TCM)hospitals.The aim is to strengthen infection control management in TCM hospitals,assess the competency of infection control personnel in their positions,and assist them in identifying the competencies that need improvement.Methods:Based on the literature research method and the Delphi expert consultation method,a competency model for the position was constructed through two rounds of expert consultations,analyzing the relationships between various factors and establishing a hierarchical structure model.Pairwise comparisons were made among the elements at the same level to construct a judgment matrix.Through the analytic hierarchy process,the weight coefficients of the indicators at each level in the competency model were obtained.Results:This study conducted a comprehensive assessment of various capabilities and practices related to hospital infection control.The survey results indicate that participants excelled in multiple areas,with a high overall satisfaction rate.95.28%of participants were able to develop hospital infection monitoring plans based on national infection control policies,demonstrating a good understanding and execution of these policies.94.09%of participants were familiar with high-risk populations and key departments in the hospital.91.73%of participants were able to establish monitoring scopes based on the trends of multidrug-resistant bacteria and conduct information monitoring,reflecting strong response capabilities.92.91%of participants were able to collaborate with relevant departments to conduct bacterial resistance monitoring,showing a good team spirit.94.49%of participants were able to perform targeted monitoring,including surgical site infections,indicating that they have effective monitoring strategies.91.34%of participants were able to collect and organize monitoring data and establish a systematic database,demonstrating good data management skills.90.16%of participants were able to interpret laws and regulations related to hospital infection management,indicating a high level of legal knowledge.89.37%of participants generally possessed good communication skills.92.52%of participants were able to guide medical staff on occupational safety and protective knowledge,showing an emphasis on occupational health.Participants demonstrated a strong desire to learn and innovate,with 87.01%actively participating in continuing education and research activities,reflecting a pursuit of professional development.Conclusion:Based on the results of the two rounds of expert consultations,a competency evaluation model for infection control personnel in TCM hospitals was formed.Through the analytic hierarchy process,the weight coefficients of various indicators at different levels in the model were obtained,and the research results have good scientific validity and reliability.

A Comparative Analysis of the Control Effect of Medical Expenses between General Hospitals and Traditional Chinese Medicine Hospitals from 2012 to 2021

Objective To analyze the changing trend of average medical expenses and structure in general hospitals and traditional Chinese medicine(TCM)hospitals and the effects and differences achieved by the two kinds of hospitals through controlling unreasonable growth of medical expenses,so as to provide reference for controlling the rapid rise of medical cost in public hospitals and optimizing the cost structure.Methods Based on the changes of related indicators of medical expense control from 2012 to 2021,the overall characteristics,changes of cost structure and trends of medical expenses in general hospitals and TCM hospitals were investigated.Results and Conclusion From 2012 to 2021,the increase of medical expenses in general hospitals and traditional Chinese medicine hospitals had slowed down,the proportion of drug revenue to medical income began to decline,and the medical service income increased.However,the proportion of inspection,test and sanitary materials income has increased instead of decreasing,but the management cost has decreased.The two kinds of hospitals have achieved certain cost control results,the structure of medical cost has changed greatly,and the technical service and labor value of medical personnel have been reflected to a certain extent.However,it is still necessary to explore a more scientific and reasonable cost control mechanism to promote the further optimization of medical cost structure.

Research on Empowering the Development of Traditional Chinese Medicine with New Quality Productivity

The Traditional Chinese Medicine(TCM)industry,deeply rooted in cultural heritage and complex production processes,has been advancing through technological innovations such as intelligent production systems,digital management,blockchain traceability,and personalized health services.Despite its historical and cultural significance,the integration of these modern technologies offers significant potential to enhance the industry’s modernization and internationalization.Empirical research and case studies indicate that adopting intelligent production systems,blockchain-enabled traceability,and data-driven resource management strategies can address industry challenges while promoting sustainable development.This paper examines the current state of new quality productivity in TCM,evaluates the challenges and opportunities of its application,and proposes strategic recommendations for the industry’s sustainable growth.The findings suggest that new quality productivity can improve production efficiency,ensure consistent product quality,and boost consumer confidence,particularly in global markets.These insights offer a theoretical foundation and practical strategies for applying advanced productivity models in TCM,with potential implications for other traditional healthcare industries.

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia

As an important branch of medicine, Traditional Chinese Medicine(TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia(ChP) is a drug code formulated by the Chinese government, and it includes a special volume for the monographs of TCM, which plays an important role in ensuring the quality of drugs. The use of quality control technology has always been a complex and important factor in TCM. Owing to the chemical diversity of TCM, chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP.This article provides an overview of the classical and modern chromatographic technologies applied in the ChP, and summarizes the advantages and disadvantages of each technique in the TCM monographs.In 2020, the new edition of the Ch P(the 2020 edition) has been implemented at the end of 2020. This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.

Metabonomics/metabolomics analysis technology and its application in quality control of traditional Chinese medicines

Chinese medicines are an important part of traditional Chinese medicines,but their'safe,effective,stable and controllable'issue still remains to be solved.The rise of metabonomics in 20th century,consistent with the overall adjustment concept of multi-component,multi-level,multi-target,multi-metabolic pathways of traditional Chinese medicines,is conducive to solve basic problems in their quality control.This paper systematically describes recent application and development of 1H-NMR metabonomics techniques,LC-MS metabonomics techniques and GC-MS metabonomics techniques in the quality control of traditional Chinese medicines.It provides a new reference for Chinese medicines and the identification and quality assessment of their products.

Construction and optimization of traditional Chinese medicine constitution prediction models based on deep learning

Objective To cater to the demands for personalized health services from a deep learning per-spective by investigating the characteristics of traditional Chinese medicine(TCM)constitu-tion data and constructing models to explore new prediction methods.Methods Data from students at Chengdu University of Traditional Chinese Medicine were collected and organized according to the 24 solar terms from January 21,2020,to April 6,2022.The data were used to identify nine TCM constitutions,including balanced constitution,Qi deficiency constitution,Yang deficiency constitution,Yin deficiency constitution,phlegm dampness constitution,damp heat constitution,stagnant blood constitution,Qi stagnation constitution,and specific-inherited predisposition constitution.Deep learning algorithms were employed to construct multi-layer perceptron(MLP),long short-term memory(LSTM),and deep belief network(DBN)models for the prediction of TCM constitutions based on the nine constitution types.To optimize these TCM constitution prediction models,this study in-troduced the attention mechanism(AM),grey wolf optimizer(GWO),and particle swarm op-timization(PSO).The models’performance was evaluated before and after optimization us-ing the F1-score,accuracy,precision,and recall.Results The research analyzed a total of 31655 pieces of data.(i)Before optimization,the MLP model achieved more than 90%prediction accuracy for all constitution types except the balanced and Qi deficiency constitutions.The LSTM model's prediction accuracies exceeded 60%,indicating that their potential in TCM constitutional prediction may not have been fully realized due to the absence of pronounced temporal features in the data.Regarding the DBN model,the binary classification analysis showed that,apart from slightly underperforming in predicting the Qi deficiency constitution and damp heat constitution,with accuracies of 65%and 60%,respectively.The DBN model demonstrated considerable discriminative power for other constitution types,achieving prediction accuracy rates and area under the receiver op-erating characteristic(ROC)curve(AUC)values exceeding 70%and 0.78,respectively.This indicates that while the model possesses a certain level of constitutional differentiation abili-ty,it encounters limitations in processing specific constitutional features,leaving room for further improvement in its performance.For multi-class classification problem,the DBN model’s prediction accuracy rate fell short of 50%.(ii)After optimization,the LSTM model,enhanced with the AM,typically achieved a prediction accuracy rate above 75%,with lower performance for the Qi deficiency constitution,stagnant blood constitution,and Qi stagna-tion constitution.The GWO-optimized DBN model for multi-class classification showed an increased prediction accuracy rate of 56%,while the PSO-optimized model had a decreased accuracy rate to 37%.The GWO-PSO-DBN model,optimized with both algorithms,demon-strated an improved prediction accuracy rate of 54%.Conclusion This study constructed MLP,LSTM,and DBN models for predicting TCM consti-tution and improved them based on different optimisation algorithms.The results showed that the MLP model performs well,the LSTM and DBN models were effective in prediction but with certain limitations.This study also provided a new technology reference for the es-tablishment and optimisation strategies of TCM constitution prediction models,and a novel idea for the treatment of non-disease.

Integrative analysis of bone-formation associated genes and immune cell infiltration in osteoporosis, and the prediction of active ingredients in targeted traditional Chinese medicine

Objective To explore the differential expression and mechanisms of bone formation-related genes in osteoporosis(OP)leveraging bioinformatics and machine learning methodologies;and to predict the active ingredients of targeted traditional Chinese medicine(TCM)herbs.Methods The Gene Expression Omnibus(GEO)and GeneCards databases were employed to conduct a comprehensive screening of genes and disease-associated loci pertinent to the pathogenesis of OP.The R package was utilized as the analytical tool for the identification of differentially expressed genes.Least absolute shrinkage and selection operator(LASSO)logis-tic regression analysis and support vector machine-recursive feature elimination(SVM-RFE)algorithm were employed in defining the genetic signature specific to OP.Gene Ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)pathway enrichment analyses for the selected pivotal genes were conducted.The cell-type identification by estimating rela-tive subsets of RNA transcripts(CIBERSORT)algorithm was leveraged to examine the infiltra-tion patterns of immune cells;with Spearman’s rank correlation analysis utilized to assess the relationship between the expression levels of the genes and the presence of immune cells.Coremine Medical Database was used to screen out potential TCM herbs for the treatment of OP.Comparative Toxicogenomics Database(CTD)was employed for forecasting the TCM ac-tive ingredients targeting the key genes.AutoDock Vina 1.2.2 and GROMACS 2020 softwares were employed to conclude analysis results;facilitating the exploration of binding affinity and conformational dynamics between the TCM active ingredients and their biological targets.Results Ten genes were identified by intersecting the results from the GEO and GeneCards databases.Through the application of LASSO regression and SVM-RFE algorithm;four piv-otal genes were selected:coat protein(CP);kallikrein 3(KLK3);polymeraseγ(POLG);and transient receptor potential vanilloid 4(TRPV4).GO and KEGG pathway enrichment analy-ses revealed that these trait genes were predominantly engaged in the regulation of defense response activation;maintenance of cellular metal ion balance;and the production of chemokine ligand 5.These genes were notably associated with signaling pathways such as ferroptosis;porphyrin metabolism;and base excision repair.Immune infiltration analysis showed that key genes were highly correlated with immune cells.Macrophage M0;M1;M2;and resting dendritic cell were significantly different between groups;and there were signifi-cant differences between different groups(P<0.05).The interaction counts of resveratrol;curcumin;and quercetin with KLK3 were 7;3;and 2;respectively.It shows that the interac-tions of resveratrol;curcumin;and quercetin with KLK3 were substantial.Molecular docking and molecular dynamics simulations further confirmed the robust binding affinity of these bioactive compounds to the target genes.Conclusion Pivotal genes including CP;KLK3;POLG;and TRPV4;exhibited commendable significant prognostic value;and played a crucial role in the diagnostic assessment of OP.Resveratrol;curcumin;and quercetin;natural compounds found in TCM;showed promise in their potential to effectively modulate the bone-forming gene KLK3.This study provides a sci-entific basis for the interpretation of the pathogenesis of OP and the development of clinical drugs.

The enlightenment of artificial intelligence large-scale model on the research of intelligent eye diagnosis in traditional Chinese medicine

Eye diagnosis is a method for inspecting systemic diseases and syndromes by observing the eyes.With the development of intelligent diagnosis in traditional Chinese medicine(TCM);artificial intelligence(AI)can improve the accuracy and efficiency of eye diagnosis.However;the research on intelligent eye diagnosis still faces many challenges;including the lack of standardized and precisely labeled data;multi-modal information analysis;and artificial in-telligence models for syndrome differentiation.The widespread application of AI models in medicine provides new insights and opportunities for the research of eye diagnosis intelli-gence.This study elaborates on the three key technologies of AI models in the intelligent ap-plication of TCM eye diagnosis;and explores the implications for the research of eye diagno-sis intelligence.First;a database concerning eye diagnosis was established based on self-su-pervised learning so as to solve the issues related to the lack of standardized and precisely la-beled data.Next;the cross-modal understanding and generation of deep neural network models to address the problem of lacking multi-modal information analysis.Last;the build-ing of data-driven models for eye diagnosis to tackle the issue of the absence of syndrome dif-ferentiation models.In summary;research on intelligent eye diagnosis has great potential to be applied the surge of AI model applications.

An interpretability model for syndrome differentiation of HBV-ACLF in traditional Chinese medicine using small-sample imbalanced data

Objective Clinical medical record data associated with hepatitis B-related acute-on-chronic liver failure(HBV-ACLF)generally have small sample sizes and a class imbalance.However,most machine learning models are designed based on balanced data and lack interpretability.This study aimed to propose a traditional Chinese medicine(TCM)diagnostic model for HBV-ACLF based on the TCM syndrome differentiation and treatment theory,which is clinically interpretable and highly accurate.Methods We collected medical records from 261 patients diagnosed with HBV-ACLF,including three syndromes:Yang jaundice(214 cases),Yang-Yin jaundice(41 cases),and Yin jaundice(6 cases).To avoid overfitting of the machine learning model,we excluded the cases of Yin jaundice.After data standardization and cleaning,we obtained 255 relevant medical records of Yang jaundice and Yang-Yin jaundice.To address the class imbalance issue,we employed the oversampling method and five machine learning methods,including logistic regression(LR),support vector machine(SVM),decision tree(DT),random forest(RF),and extreme gradient boosting(XGBoost)to construct the syndrome diagnosis models.This study used precision,F1 score,the area under the receiver operating characteristic(ROC)curve(AUC),and accuracy as model evaluation metrics.The model with the best classification performance was selected to extract the diagnostic rule,and its clinical significance was thoroughly analyzed.Furthermore,we proposed a novel multiple-round stable rule extraction(MRSRE)method to obtain a stable rule set of features that can exhibit the model’s clinical interpretability.Results The precision of the five machine learning models built using oversampled balanced data exceeded 0.90.Among these models,the accuracy of RF classification of syndrome types was 0.92,and the mean F1 scores of the two categories of Yang jaundice and Yang-Yin jaundice were 0.93 and 0.94,respectively.Additionally,the AUC was 0.98.The extraction rules of the RF syndrome differentiation model based on the MRSRE method revealed that the common features of Yang jaundice and Yang-Yin jaundice were wiry pulse,yellowing of the urine,skin,and eyes,normal tongue body,healthy sublingual vessel,nausea,oil loathing,and poor appetite.The main features of Yang jaundice were a red tongue body and thickened sublingual vessels,whereas those of Yang-Yin jaundice were a dark tongue body,pale white tongue body,white tongue coating,lack of strength,slippery pulse,light red tongue body,slimy tongue coating,and abdominal distension.This is aligned with the classifications made by TCM experts based on TCM syndrome differentiation and treatment theory.Conclusion Our model can be utilized for differentiating HBV-ACLF syndromes,which has the potential to be applied to generate other clinically interpretable models with high accuracy on clinical data characterized by small sample sizes and a class imbalance.

Histological efficacy of traditional Chinese medicine plus entecavir therapy for HBV-related liver fibrosis

Background/Aims:Traditional Chinese medicine(TCM)combined with antiviral therapy has been proven to be effective for liver fibrosis due to chronic hepatitis B(CHB)in clinical practice in China.However,the robust evidence is limited,and the validity of results has been controversial in the past.The current study is to evaluate the efficacy and safety of the combination therapy of TCM plus entecavir(ETV)in the management of HBV-associated liver fibrosis or cirrhosis.Methods:Seven electronic databases were searched from inception to 10 August 2021.Primary outcome of this study was the regression of liver fibrosis;the secondary outcomes were a necro-inflammatory improvement,alanine aminotransferase(ALT),HBV DNA undetectable rate,HBeAg loss and HBeAg seroconversion.All the trials included were assessed by the Cochrane risk-of-bias tool.Results:It showed that TCM plus ETV attenuated liver fibrosis or cirrhosis in chronic hepatitis B patients as compared to ETV monotherapy(OR=1.65;95%CI:1.29~2.11;P<0.000,1).There is no statistical difference between TCM plus ETV and ETV in histological activity index,HBV DNA undetectable rate,HBeAg loss,HBeAg seroconversion and adverse events(P<0.05).Conclusion:The comprehensive evaluation showed that TCM combined with ETV treatment was safe for the patients with CHB,and better promoted the regression of liver fibrosis than ETV monotherapy.However,the standardized,rigorously designed,and large-scale randomized controlled trials(RCTs)were needed for further validation.

Top 10 research achievements of traditional Chinese medicine in 2023

In order to fulfill the requirements of the 20th National Congress of the Communist Party of China and the Opinions on Promoting the Inheritance,Innovation and Development of Traditional Chinese Medicine,regularly summarize the research achievements of traditional Chinese medicine(TCM),present the academic progress of TCMdynamically,and give full play to the leadership of academic groups in research,the China Association of ChineseMedicine organized the selection of the top 10 academic achievements of TCMin 2023.The selection work adhered to the“4 orientations”;eliminated the“4 only”;highlighted the solution of clinical problems and scientific questions,the development of the industry,and the exploratory,forward-looking,innovative,and breakthrough research;and focused on new laws,new discoveries,new methods,new products,and new theories in the basic research and applied basic research of TCM.After dynamic collection,preliminary examination,review,and final judgment,the top 10 academic achievements of TCMin 2023 were determined.First,breakthroughs have been achieved in the treatment of ST-segment elevation myocardial infarction by Tongxinluo.Second,evidence has been gained regarding the efficacy of acupuncture in treating chronic spontaneous urticaria and vomiting in pregnancy.Third,evidence has been gained regarding the improvement of neurological function outcomes by Xuesaitong soft capsules in treating patients with ischemic stroke.Fourth,the mechanisms of Huashi Baidu Powder and Pien Tze Huang in clinical treatment have been revealed.Fifth,the pharmacodynamic mechanisms of astragaloside and capsaicin have been revealed for the first time.Sixth,new technologies represented by spatial metabolomics assist in elucidating the material basis of the complex systems ofTCM.Seventh,network medicine framework reveals the genericmechanism underlying the effectiveness of TCM treatment based on syndrome differentiation.Eighth,a comprehensive platform for multidimensional nucleic acid data of TCM promotes data sharing inmolecular pharmacognosy.Ninth,multiprocess transfer and information fusion provide solutions for digitalmanufacturing of big honeyed pills.Tenth,the scientific system of TCM regulatory science has been preliminarily built and applied.

Quality Markers of Traditional Chinese Medicine:Concept,Progress,and Perspective

As the most important complementary medication against a variety of diseases,traditional Chinese medicines(TCMs)have been extensively applied over thousands of years.Current quality control of herbal medicines,however,is in great dispute.Unlike chemical drugs,which have clear and validated quality standards,the content of only one(or a few)compounds of many herbs and preparations is currently assessed as an indicator of quality,even though the assessed compound(s)is neither closely associated with the efficacy nor representative of the medicine as a whole.Based on the clinical use,compatibility of multiple component prescriptions,and manufacturing process of TCM,the new concept of a TCM quality marker that was proposed in previous work is discussed further here.In addition,practical technological approaches are described for the qualitative analysis and quantification of TCMs including herbs,processed products,and preparations,which lead to the discovery and identification of specific chemicals as quality markers and new quality control patterns.The progress that has been made in TCM quality control is also addressed.This work provides useful information for the quality control of herbal medicines in the future.

Epigastric pain syndrome: What can traditional Chinese medicine do? A randomized controlled trial of Biling Weitong Granules

BACKGROUND Recent research suggests that although prokinetic agents,acid suppressors,and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia(FD),a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions.Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases.The present study was designed to verify the efficacy of Biling Weitong Granules(BLWTG),a traditional Chinese medicinal herbal compound formula,in alleviating epigastric pain syndrome(EPS)in FD patients,in an attempt to provide an effective prescription for the clinical treatment of this disease.AIM To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.METHODS In this multicenter,stratified,randomized,double-blind,placebo-controlled,parallel group clinical trial,eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk.Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.RESULTS The baseline demographic data and clinical characteristics,such as epigastric pain symptoms,pain intensity,and frequency of attacks,were matched between the two groups before randomization.After 6 wk of treatment and after the center effect was eliminated,the epigastric pain was significantly improved in 28.33%and 85.59%of the patients in the placebo and BLWTG groups,respectively(P<0.05).At 6 wk,the resolution rate of epigastric pain was 15%and 69.49%in the placebo and BLWTG groups,respectively(P<0.05).The differences of total FD clinical score between these two groups were significant(P<0.05)at 2,4,and 6 wk(P<0.05).The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated(P<0.05).There was no significant difference in the incidence of adverse events between the two groups,and no serious adverse event was noted during the observation.CONCLUSION Compared with placebo,BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.

Multimodal integrated strategy for the discovery and identification of quality markers in traditional Chinese medicine

With the modernization and internationalization of traditional Chinese medicine(TCM),the requirement for quality control has increased.The quality marker(Q-marker)is an important standard in this field and has been implemented with remarkable success in recent years.However,the establishment of Qmarkers remains fragmented and the process lacks systematicity,resulting in inconsistent quality control and insufficient correlation with clinical efficacy and safety of TCM.This review introduces four multimodal integrated approaches that contribute to the discovery of more comprehensive and accurate Qmarkers,thus aiding in the establishment of new quality control patterns based on the characteristics and principles of TCM.These include the whole-process quality control strategy,chemical-activity-based screening method,efficacy,safety,and consistent combination strategy,and TCM theory-guided approach.Furthermore,methodologies and representative examples of these strategies are described,and important future directions and questions in this field are also proposed.

An ultra-robust fingerprinting method for quality assessment of traditional Chinese medicine using multiple reaction monitoring mass spectrometry

Chromatographic fingerprinting has been perceived as an essential tool for assessing quality and chemical equivalence of traditional Chinese medicine.However,this pattern-oriented approach still has some weak points in terms of chemical coverage and robustness.In this work,we proposed a multiple reaction monitoring(MRM)-based fingerprinting method in which approximately 100 constituents were simultaneously detected for quality assessment.The derivative MRM approach was employed to rapidly design MRM transitions independent of chemical standards,based on which the large-scale fingerprinting method was efficiently established.This approach was exemplified on QiShenYiQi Pill(QSYQ),a traditional Chinese medicine-derived drug product,and its robustness was systematically evaluated by four indices:clustering analysis by principal component analysis,similarity analysis by the congruence coefficient,the number of separated peaks,and the peak area proportion of separated peaks.Compared with conventional ultraviolet-based fingerprints,the MRM fingerprints provided not only better discriminatory capacity for the tested normal/abnormal QSYQ samples,but also higher robustness under different chromatographic conditions(i.e.,flow rate,apparent pH,column temperature,and column).The result also showed for such large-scale fingerprints including a large number of peaks,the angle cosine measure after min-max normalization was more suitable for setting a decision criterion than the unnormalized algorithm.This proof-of-concept application gives evidence that combining MRM technique with proper similarity analysis metrices can provide a highly sensitive,robust and comprehensive analytical approach for quality assessment of traditional Chinese medicine.

Protection and Quality Control of Wild Chinese Herbal Medicine Resources in Nature Reserves by Taking Longyuwan Scenic Spot Within Funiu Mountain Nature Reserve as an Example

This paper discussed how to protect and control the quality of wild Chinese herbal medicine resources in nature reserves by taking Longyuwan National Forest Park within Funiu Mountain Nature Reserve as an example. Through the combination of three methods including literature review, visiting and investigational studies, and field surveys, the data of investigation, collection and collation were analyzed. According to data of surveys, collection and collation, problems related to the protection of wild Chinese herbal medicine resources faced by Longyuwan Scenic Spot within Funiu Mountain Nature Reserve were also analyzed and protection strategies and quality control of wild Chinese herbal medicine resources in this nature reserve were discussed. It was expected that the results would provide important scientific references for the sustainable development, protection and quality control of wild Chinese herbal medicine resources within nature reserves.

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.