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.

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.

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.

QUALITY CONTROL OF TRADITIONAL CHINESE MEDICINES: INVESTIGATION ON CHEMICAL MARKERS

Traditional Chinese medicines(TCMs)have played an important role in the treatment of diseases for thousands of years.With the rise of the combination therapy for multi-gene diseases,TCMs attracted more attentions gradually.However,TCMs is a complex system which could contain tens,or even hundreds of compounds.Selection of chemical markers is thus a key to the

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.

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.

Traditional Chinese medicine for acute mountain sickness prevention: A systematic review and meta-analysis of randomized controlled trials

Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence intervals(CIs) were applied to express the effect size. The risk of bias in the included studies was evaluated using the Cochrane risk assessment tool 2.0(RoB 2.0), and the evidence certainty was assessed using the Grading of Recommendations Assessment and the Development and Evaluation(GRADE) approach.Results: Twenty RCTs involving 3015 participants and 16 TCM patent drugs were included. The overall risk of bias in the majority of studies(15/20) was of some concerns. In terms of the AMS incidence,Rhodiola rosea(R. rosea, Hong Jing Tian) and Ginkgo biloba(G. biloba, Yin Xing Ye) were equivalent to the placebo/no treatment [RR(95% CI): 0.66(0.43-1.01), 0.82(0.63-1.06), respectively]. The AMS incidence in the G. biloba group was higher than that in the acetazolamide group [RR(95% CI): 2.92(1.69-5.06)]. In terms of improving the AMS symptom score on days 1 and 3 in the plateau, R. rosea and G. biloba were superior to the placebo or no treatment [MD(95% CI):-0.98(-1.71,-0.25),-2.05(-3.14,-0.95), respectively]. The other 14 Chinese patent medicines were evaluated in a single trial, and the majority of the results were negative. The subgroup analysis showed that the effect of R. rosea was related to the intervention time, way of ascending, and altitude.Conclusion: R. rosea and G. biloba were effective in improving AMS symptoms but had no effect in reducing the AMS incidence. There was insufficient evidence to support the use of other TCM patent drugs to prevent AMS. More randomized double-blind placebo-controlled trials are warranted to evaluate and screen effective Chinese patent medicines for AMS prevention.

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.

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.

Quality Control for Traditional Medicines–Chinese Patent Medicines

Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.

Quality Control for Traditional Medicines–Chinese Crude Drugs

Distinguished guests,ladies and gentlemen,I am very happy to meet many of my old friends today.I would also like to thank Chinese Pharmaceutical Association for providing me with such a good opportunity to communicate with Chinese and European friends.The topic of my report today is the quality standard of Chinese crude drugs and the development ideas.Director Ma introduced the relevant situation of the quality standards of Chinese patent medicines.

Study and Countermeasures on Safety Control of Traditional Chinese Medicines Industry Chain

I'm very grateful to Chinese Pharmaceutical Association and DIA for their elaborate organization,so that we are able to participate in the Sino-Europe Symposium.Yesterday and today,several professors have talked about various aspects.It is true that the effectiveness of traditional Chinese medicine is important,and safety is equally important.For this reason,our laboratory works on the effective test,and at the same time,since 2001,we have been focusing on the safety of traditional Chinese medicines,especially the research on exogenous pollution.Today,I would like to share with you some of the quality control of the whole industry chain of traditional Chinese medicine and some of our thoughts.

Enhancing ulcerative colitis treatment with traditional Chinese medicine

Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analysis that evaluated the efficacy of and highlighted the superior outcomes achieved by combining each of five traditional Chinese medicine(TCM)formulations with mesalazine for the adjuvant treatment of UC.Clinical outcomes included enhanced mucosal healing,improved quality of life,and reduced recurrence rates.Additionally,the combination therapy resulted in a lower incidence of adverse reactions compared with mesalazine monotherapy.Despite these promising results,limitations such as variability in study quality and TCM dosage highlight the need for further highquality,large-sample,multicenter randomized controlled trials.This editorial underscores the potential of TCM in enhancing UC management and calls for more rigorous research to substantiate these findings and refine clinical guidelines.

Analysis of the Clinical Effect of Chinese Medicine Combined with Acupuncture and Moxibustion on Insomnia

Objective:To explore and analyze the clinical efficacy of Chinese medicine combined with acupuncture and moxibustion in the treatment of insomnia.Method:80 patients with primary insomnia were selected as the study sample,with 20 cases randomly selected as the control group and the rest as the observation group.The control group was treated with ordinary western medicine,while the observation group patients were treated with traditional Chinese medicine combined with acupuncture and moxibustion based on this syndrome differentiation.The comparison items were treatment effect,sleep quality,mental health,quality of life,specific sleep indicators,cerebral blood flow and neurotransmitters.Result:The treatment effectiveness showed that the observation group had a higher treatment effectiveness rate than the control group(P<0.05);The results of sleep quality showed that after treatment,the scores of the observation group were lower than those of the control group in seven dimensions:sleep quality,sleep time,sleep onset time,sleep efficiency,sleep disorders,hypnotic drugs,and daytime dysfunc‐tion score(P<0.05);The quality of life results showed that after treatment,the observa‐tion group had higher scores than the control group in eight dimensions:physiological function,physiological function,physical pain,health status,energy,social function,emotional function,and mental health(P<0.05);The results of slow wave sleep time and fast eye movement sleep time showed that after treatment,the HAMA and HAMD scores of the physiological mechanism in the observation group were lower than those in the control group(P<0.05);The results of cerebral blood flow and neurotransmitter indica‐tors show that after treatment,glutamateγ-The peak systolic blood flow velocity of ami‐nobutyric acid,vertebral artery,and basilar artery in the observation group was higher than that in the control group(P<0.05).Conclusion:The clinical treatment of Chinese medicine combined with acupuncture and moxibustion in the treatment of insomnia patients can significantly improve the clinical treatment effect,and improve the cerebral hemorrhage and neurotransmitter status of patients,promote the improvement of their physical and mental status,can more significantly improve the quality of sleep,reduce sleep difficulties,reduce the dosage of sleeping pills,which has important clinical application value.

Clinical study on the treatment of acute pancreatitis with external application of Yi-Dan Therapy based on the method of“stagnation requiring dispersion”:study protocol for a randomized controlled trial

Background:Acute pancreatitis is an unpredictable and potentially lethal disease,causing tremendous pain in patients.The initial treatment of acute pancreatitis in modern medicine is supportive,but it is generally ineffective in relieving abdominal pain and distension.Traditional Chinese medicine has been shown to be more effective in regulating the body’s homeostasis and reducing the clinical symptoms of pancreatitis.Yi-Dan ointment,derived from Dahuang-Mudan Decoction,is an effective external ointment for treating acute pancreatitis.The aim of this trial is to investigate the clinical efficacy of Yi-Dan ointment,providing a valuable complement to existing treatment options for pancreatitis.Methods:This is a randomized controlled clinical trial with two parallel groups.Patients in the control group were given basic treatment and nursing for 7 days;in the treatment group,Yi-Dan ointment was applied externally in addition to basic treatment and nursing.The main indicator is the overall efficacy,serum amylase,acute physiology and chronic health evaluationⅡscore,symptom score,inflammatory markers,and classification of computed tomography.Conclusion:The trial results will provide high-quality evidence for Yi-Dan ointment,and provide a complement to existing treatment options for pancreatitis.

Treatment of Coronary Heart Disease from the Perspective of Liver Controlling Dispersion

The liver is in charge of distributing and regulating the movement of qi throughout the whole body,coordinating the transportation and transformation of the internal organs in the middle part of the body,promoting the biochemical circulation of qi,blood,and body fluids,and regulating emotions.Liver dysfunction can disrupt the transportation and transformation of qi,blood,and body fluids,causing phlegm turbidity,blood stasis,and other unwanted symptoms.Poor regulation of emotion further aggravates the accumulation of pathological substances,resulting in the obstruction of heart vessels,and ultimately coronary heart disease(CHD).Through regulating lipid metabolism,inflammatory reaction,vasoactive substances,platelet function,neuroendocrine,and other factors,liver controlling dispersing qi plays a comprehensive role in the prognosis of atherosclerosis,the primary cause of CHD.Therefore,it is recommended to treat CHD from the perspective of liver-controlling dispersion.

The Influence of Integrated Chinese and Western Medicine Treatment on the Quality of Life and Laboratory Indicators of Patients with Novel Coronavirus Pneumonia

Objective: To investigate the influence of integrated Chinese and Western medicine treatment on the quality of life and laboratory indicators of patients with novel coronavirus pneumonia (COVID-19). Methods: A prospective, self-controlled study was conducted to analyze the changes in corresponding laboratory indicators and quality of life in 75 confirmed COVID-19 patients treated with integrated Chinese and Western medicine in our hospital during the early stage, middle stage, recovery period, and two weeks after discharge. The effectiveness and safety of the treatment regimen were evaluated in conjunction with the time for 2019-nCoV nucleic acid conversion, disease progression, and adverse reactions. Results: The PLT levels in the initial stage were significantly lower than those in the recovery period in 75 patients. The CRP levels in the initial stage were significantly lower than those after discharge for 2 weeks. The TBIL, IBTL, and DHIL levels in the initial stage were significantly lower than those in the middle stage. The K+ levels in the initial stage were significantly lower than those in the recovery period and after discharge for 2 weeks. The LYMGH levels in the initial stage were significantly lower than those in the recovery period and after discharge for 2 weeks. The TP and ALB levels in the initial stage were higher than those in the middle stage and the recovery period. The LDH levels, scores of daily activity limitation, scores of respiratory distress symptoms, scores of psychological emotions, CT imaging scores, and positive rate of nucleic acid were significantly lower than those in the recovery period and after discharge for 2 weeks. The AG, CK, CK-MB, and α-HBDH levels in the initial stage were significantly higher than those in the recovery period. However, the AMY level in the initial stage was significantly lower than that in the recovery period and after discharge for 2 weeks (p Conclusion: Integrated Chinese and Western medicine treatment has a significant impact on laboratory indicators such as PLT, LYMGH, CRP, TBIL, IBTL, DHIL, TP, ALB, K+, AG, LDH, CK, CK-MB, α-HBDH, AMY, CT imaging, and 2019-nCoV nucleic acid in COVID-19 patients. It has good clinical efficacy and safety, and can improve the quality of life of patients.

Nursing outcomes of traditional Chinese medicine adjunctive therapy on osteofascial compartment syndrome:a review

The rate of disability due to acute osteofascial compartment syndrome(OCS)is high,and the therapeutic effect of decompressive fasciotomy is not ideal.This paper retrospectively reviews the modern treatment of OCS,including Western medicine and Traditional Chinese medicine(TCM),mainly in the context of the advantages of TCM in the treatment process of decompressive fasciotomy or conservative treatment to the patients who are suffering from OCS.It was found that TCM treatment reduced the levels of serum creatine kinase(CK),lactate dehydrogenase(LDH),and aspartate aminotransferase(AST);it is beneficial to the elimination of swelling and pain.TCM adjunctive therapy promotes patients’postoperative functional recovery and decreases the occurrence of fasciotomy in patients;TCM can relieve tissue hypoxia of compartments and prevent necrosis of muscle and nerve tissue.TCM treatment improves the quality of medical service and ensures the safety of OCS patients.This paper aims to summarize the function of TCM in the treatment of OCS,provide reference for the clinical treatment of OCS,and improve the nursing/medical outcomes of OCS.

Design of Traditional Chinese Medicine Extraction Workshop Process and Automation System

Objective: This paper takes the example of a Panax notoginseng extraction workshop and designs an automated production workshop with advanced domestic capabilities. Methods: 1) Based on the small-scale Panax notoginseng extraction process, the feasibility of the workshop production process is demonstrated. 2) The workshop process design for Panax Notoginseng saponin extraction is completed, including production organization plans and the selection of key equipment. 3) For the Panax notoginseng extraction workshop process, an automated production control system is designed. Conclusion: Through optimized design of the production process and automation system, continuous and automated production of traditional Chinese medicine extraction is achieved, leading to improvements in drug quality and production efficiency.