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.

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.

Quality Inspection and Preparation of Diarrhea Arresting and Dysentery Treating Dietary Traditional Chinese Herbal Medicine for Livestock

[Objective] This study was aimed to formulate the quality inspection of diarrhea arresting and dysentery treating dietary traditional Chinese herbal medicines for livestock.[Methods] Physiochemical identification and contrast test of UV spectrophotometer qualitative detection were adopted.[Results] The difference in the peak value of maximum adsorption peak detected by diluted water method was greater than 1 nm; the maximum adsorption peak values obtained by the 0.9％ hydrochloric acid and 60％ ethanol methods had a difference of less than 1 nm,and the secondary adsorption peak values also had a difference of less than 1 nm.[Conclusion] The 0.9％ hydrochloric acid and 60％ ethanol methods were selected as the quality inspection standards for the preparation of diarrhea arresting and dysentery treating dietary traditional Chinese herbal medicines for livestock.

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.

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.

Pharmacological intervention of traditional Chinese medicine for the quality of life in patients with colorectal cancer： a systematic review and meta-analysis

Objective： The objective of this study is to evaluate the impact of various traditional Chinese medicine （TCM）approaches on the quality of life in patients with colorectal cancer. Methods： In this study, we systematically performedthe screening of randomized controlled trials from Cochrane Library, Pubmed, Embase, Medline, and Web of Science.The data were extracted by two reviewers independently, and then risk assessment was performed. All the analyses wereconducted using Review Manager 5.3. Results： A total of 18 eligible studies containing 1312 patients were included.Experimental group were treated with TCM combined with Western medicine or TCM alone （N = 688） and controlgroup were treated with Western medicine treatment alone （N = 624）. The results showed that the recent clinicalefficiency between the two groups was not statistically significant （P = 0.06）. KPS scores of the experimental group werehigher than those in the control group [P 〈 0.001, WMD = 9.60, 95%CI = （5.62, 13.57）]. The toxicity comparisonshowed that the occurrence of toxicities, such as leucopenia, thrombocytopenia, nausea and vomiting, diarrhea, andneurotoxicity in the experimental group was lower than that in the control group [P 〈 0.001, OR = 0.31, 95%CI = （0.19,0.50）], [P = 0.003, OR = 0.49, 95%CI = （0.31, 0.78）], [P 〈 0.001, OR = 0.30, 95%CI = （0.16, 0.54）], [P 〈 0.001, OR =0.40, 95%CI = （0.27, 0.58）], and [P 〈 0.001, OR = 0.43, 95%CI = （0.30, 0.61）]. The immunological test comparisondemonstrated that the immunological parameters （CD3, CD4, and CD4/CD8） showed higher values in the experimentalgroup than those in the control group [P 〈 0.001, MD = 5.55, 95%CI = （4.83, 6.28）], [P 〈 0.0001, MD = 6.75, 95%CI =（5.25, 8.26）], and [P = 0.001, MD = 0.26, 95%CI = （0.10, 0.41）]. Conclusions： TCM did not show significant recentclinical efficiency. However, treatment with TCM showed increase in KPS scores in patients with colorectal cancer,alleviation of toxicity associated with chemotherapy, regulation of autoimmunity, and improvement in the quality of lifeof patients.

Quality 4.0 technologies to enhance traditional Chinese medicine for overcoming healthcare challenges during COVID-19

The Quality 4.0 concept is derived from the industrial fourth revolution,i.e.,Industry 4.0.Quality 4.0 is the future of quality,where new digital and disruptive technologies are used to maintain quality in organizations.It is also suitable for traditional Chinese medicine(TCM)to maintain quality.This quality revolution aims to improve industrial and service sectors’quality by incorporating emerging technologies to connect physical systems with the natural world.The proposed digital philosophy can update and enhance the entire TCM treatment methodology to become more effective and attractive in the current competitive structure of the pharmaceutical and clinical industries.Thus,in healthcare,this revolution empowers quality treatment during the COVID-19 pandemic.There is a major requirement in healthcare to maintain the quality of medical tools,equipment,and treatment processes during a pandemic.Digital technologies can widely be used to provide innovative products and services with excellent quality for TCM.In this paper,we discuss the significant role of Quality 4.0 and how it can be used to maintain healthcare quality and fulfill challenges during the pandemic.Additionally,we discuss 10 significant applications of Quality 4.0 in healthcare during the COVID-19 pandemic.These technologies will provide unique benefits to maintain the quality of TCM throughout the treatment process.With Quality 4.0,quality can be maintained using innovative and advanced digital technologies.

Quality Evaluation on Traditional Chinese Medicine Nursing Plan for Stroke in Acute and Recovery Phases

OBJECTIVE: To formulate the quality evaluation questionnaire of Traditional Chinese Medicine(TCM) nursing plan for stroke in acute and recovery phases, and to evaluate the quality of TCM nursing plan for stroke by clinical nurses. METHODS: The questionnaire was designed by referring to the Applicability Questionnaire of TCM Clinical Diagnosis and Treatment Guideline, and the expert consultation was used to assess the content validity. In addition, the results of the questionnaire were processed and analyzed with SPSS20.0 software. RESULTS: The content validity of the self-designed questionnaire was 0.94 for the S-CVI/Ave score. The results of the questionnaire demonstrated that the overall content of the plan was "better than the original routine nursing plan"(59.18%); the recognition degree of "common symptoms"(36.70%) and "syndrome classification"(36.70%) of the plan was the lowest. CONCLUSION: The plan is supposed to be further improved in the future in order to be coincident with clinical reality.

Discussion on Ideological and Political Theories Teaching in Traditional Chinese Medicine Courses Based on National Standard for Teaching Quality

This paper analyzes the necessity and existing problems of ideological and political theories teaching in traditional Chinese medicine courses,and puts forward some suggestions,such as improving the ideological and political ability of professional teachers,perfecting the evaluation mechanism,and exploring ideological and political elements based on the characteristics of courses,so as to provide the basis for ideological and political theories teaching in traditional Chinese medicine courses under the National Standard for Teaching Quality.

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.

Promise of the gut microbiota in prevention and traditional Chinese medicine treatment of diabetic peripheral neuropathy

The pathogenesis of diabetic peripheral neuropathy(DPN)has not been fully elucidated,and treatment options are limited.Currently,the main strategies for treating DPN are strict glycemic control and symptomatic pain relief.In this editorial,we comment on an article by Li et al,which suggested that modulating the gut microbiota using traditional Chinese medicine(TCM)may be a promising strategy for alleviating DPN symptoms.The regulation of the gut microbiota has received widespread attention in the study of various diseases.TCM can parti-cipate in the regulation of gut microbiota through multiple mechanisms,and this regulatory effect can alleviate the clinical symptoms of DPN.We briefly analyzed the promise of the gut microbiota in the early diagnosis,treatment,and clinical efficacy of TCM for DPN.The gut microbiota has potential value at multiple no-des in the occurrence and progression of DPN.

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.

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.

Deeper Chemical Perceptions for Better Traditional Chinese Medicine Standards

Traditional Chinese medicines (TCMs), a complex system of natural resources with many diverse components, are widely used as approved medicinal agents in China. Quality control of TCMs is a huge challenge for the government and for testing institutes and is associated with numerous scientific issues. Among these considerations include the following questions: How many components are in TCMs? How can the multiple components in TCMs be comprehensively delineated and subsequently characterized? What is the level and range of these (active) metabolites within these multiple-component TCMs, in order to recommend standards? and What are the qualities required for a marker constituent to be selected, and from a practical perspective, how can these components be assessed with low cost and in a short time? All of these factors require significant and deep thinking in order to understand the individualistic chemistry of TCM in order to develop enhanced TCM quality standards for improved and consistent patient care. In this review, the latest exploratory research in TCM chemistry analytical techniques and methods is summarized in order to begin to develop responses to these scientific issues. Advances in these methods have included multidimensional separation for liquid chromatography–high-resolution mass spectrometry (LC–HRMS), smart triggering data-dependent acquisition of LC–HRMS, target analysis with liquid chromatography–mass spectrometry (LC–MS), supercritical fluid chromatography, and data mining of large mass spectrometry (MS) datasets. In addition, two quality strategies have been introduced in order to save reference standards and the analysis time for a TCM quality standard, including the application of the single standard to determine multi-components (SSDMC) and monomethodheterotrait matrix methods. Finally, a series of future improvements for analytical methods for TCMs are proposed.

International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

Detection of consensuses and treatment principles of diabetic nephropathy in traditional Chinese medicine: A new approach

Objective:To propose and test a new approach based on community detection in the field of social computing for uncovering consensuses and treatment principles in traditional Chinese medicine(TCM).Methods:Three Chinese databases(CNKI,VIP,andWan Fang Data)were searched for published articles on TCM treatment of diabetic nephropathy(DN)from their inception until September 31,2014.Zheng classification and herbdatawereextractedfromincluded articlesand usedto construct a Zheng classification and treatment of diabetic nephropathy(DNZCT)network with nodes denoting Zhengs and herbs and edges denoting corresponding treating relationshipsamong them.Community detection was applied to the DNZCT and detected community structures were analyzed.Results:A network of 201 nodes and 743 edges were constructed and six communities were detected.Nodes clustered in the samecommunity captured the samesemantic topic;different communities had unique characteristics,and indicated different treatment principles.Large communities usually represented similar points of view or consensuses on common Zheng diagnoses and herb prescriptions;small communities might help to indicate unusual Zhengs and herbs.Conclusion:The results suggest that the community detection-based approach is useful and feasible for uncovering consensuses and treatment principles of DN treatment in TCM,and could be used to address other similar problems in TCM.

Translational Chinese Medicine: A Way for Development of Traditional Chinese Medicine

Translational Chinese medicine is one of the latest developing fields in traditional Chinese medicine. In this paper, we discuss the “3 w” namely, “what is”, “why to advance”, “how to carry out” and the significance of translational Chinese medicine. To overcome the innate drawbacks of traditional Chinese medicine (TCM), the basic theory of TCM had better be refreshed. The safety and efficacy of classic formulae and therapy experience of TCM should be evaluated based on strict quality control and reaffirmed with evidence based medicine. The significance of translational Chinese medicine is to transform Chinese medicine into a balanced, personalized medicine with sound safety, good efficacy and strict quality control.

Clinical practice guidelines for traditional Chinese medicine and integrated traditional Chinese and western medicine:a cross-sectional study of data analysis from 2010 to 2020

Objective With the increasing publication of clinical practice guidelines(CPG)for Traditional Chinese Medicine(TCM)and Integrated Traditional Chinese and Western Medicine(IM),the standardization and scientifiction of its formulation have gradually attracted many people’s attention.To offer an overview of TCM and IM CPGs published over the past decade and analyze their general characteristics and methodological quality.Methods The China National Knowledge Infrastructure(CNKI)and WANFANG databases were searched for clinical practice guidelines and expert consensus papers from January 2010 to June 2021.Two researchers independently completed the literature screening and cross-checking according to the inclusion and exclusion criteria of CPGs and extracted information on general characteristics and methodological quality of CPGs.Results According to the selection criteria,231 CPGs(EB-CPGs=119,CBCPGs=112)were selected and the number of CPGs published in the 11 years showed an overall upward trend.The vast majority of CPGs used the Western naming system for the diseases,and only 11 CPGs were named of TCM diseases or symptoms.TCM treatments were recommended in 223 CPGs.There were 156 ancient Chinese Medicine literature sources cited in 231 CPGs and opinions and experiences of 62 TCM experts cited in 37 CPGs.The methodological quality of EB-CPGs for TCM and IM were significantly better than CB-CPGs in 11 items.Only 60 EB-CPGs and 7 CB-CPGs designated clear criteria for grading quality of evidence and strength of the recommendations and 74 CPGs presented both the level of evidence and the strength of recommendations.We classified all CPGs according to whether or not they used GRADE,and the results showed that the CPGs using GRADE had higher methodological quality and more standardized reports.Conclusion This research has shown that the quantity and quality of CPGs in both TCM and IM have improved over the time span,but the methodological quality,especially evidence citation,and the use of criteria for grading quality of evidence and strength of the recommendations,still needs to further improvement in the future.