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.

Exploring the Application Effect of Flipped Classroom Combined with Problem-Based Learning Teaching Method in Clinical Skills Teaching of Standardized Training for Resident Doctors of Traditional Chinese Medicine

Objective: To explore the application effect of flipped classroom combined with problem-based learning teaching method in clinical skills teaching of standardized training for resident doctors of traditional Chinese Medicine. Methods: The study used the experimental control method. The study lasted from September to November 2022. The subjects of this study were 49 students of standardized training for resident doctors of traditional Chinese Medicine from grades 2020, 2021 and 2022 of Dazhou integrated TCM & Western Medicine Hospital. They were randomly divided into experiment group (25) and control group (24). The experiment group adopted flipped classroom combined with problem-based learning teaching method, and the control group adopted traditional teaching method. The teaching content was 4 basic clinical skill projects, including four diagnoses of traditional Chinese Medicine, cardiopulmonary resuscitation, dressing change procedure, acupuncture and massage. The evaluation method was carried out by comparing the students’ performance and a self-designed questionnaire was used to investigate the students’ evaluation of the teaching method. Results: The test scores of total scores in the experimental group (90.12 ± 5.89) were all higher than those in the control group (81.47 ± 7.96) (t = 4.53, P P Conclusions: The teaching process of the flipped classroom combined with problem-based learning teaching method is conducive to improving the efficiency of classroom teaching, cultivating students’ self-learning ability, and enhancing students’ willingness to learn.

Traditional Chinese Medicine and Standardization——Origin and development of TCM

Traditional Chinese Medicine (TCM) is the medical science based on theories and practicing experience of traditional Chinese medicine to study transferring principles of health and sickness,as well as prevention, diagnosis,treatment,rehabilitation and healthcare.TCM is marked with its long history of development,integrated theory system and abundant practicing experience.

Thoughts on the Construction of Evidence-based Nursing Standard Plan for Dominant Diseases in Traditional Chinese Medicine

The evidence-based Traditional Chinese Medicine(TCM) nursing in standard plan is to be constructed by a combination of evidence-based thinking and expert consensus.(1) The symptoms of diseases with better curative effect in TCM and the nursing techniques of TCM based on scientific evidence can be preliminarily presented through bibliometric analysis.(2) Expert consultation letters can be developed based on bibliometric results, and symptoms of dominant diseases in TCM and TCM nursing techniques can be selected through those letters.(3) Based on the selected symptoms and TCM nursing techniques, the PICO can be determined, and then evidence search, evidence extraction, evidence analysis can be conducted and synthesized, and recommendations would be chosen.(4) The recommendation grade of each recommendation can be determined by applying the Delphi method and referring to GRADE.(5) The plan will be determined through discussions of experts. The construction of TCM nursing plan would make sure that TCM nursing is scientific, and internationalize TCM nursing.

Promotion of Standardization and Internalization of Traditional Chinese Medicine:Interpretation of Chapters in the 13^(th) Five-Year Special Project for Scientific Innovation of Traditional Chinese Medicine

Traditional Chinese medicine(TCM) contains profound scientific connotation and has great potential in guiding the future development of bioscience,thus becoming the Chinese Treasure of Ancient Science and the Key to Open the Treasury of Chinese Civilization. 13^(th) Five-Year Special Project for Scientific Innovation of Traditional Chinese Medicine has proposed to promote the standardization and internalization of TCM,including implementation of TCM standardized action,establishment of TCM standard system to complete system and adapt development requirements,establishment of a standard system for TCM that can complete system and meets the requirement of development to capture the advantages in international standardization competition,so as to seize the leadership and discourse power in the establishment of TCM international standardization;to promote the implementing great scientific TCM plan to accelerate the international registration of brand-name and high-quality TCM,expedite TCM service and products entering into international main markets of medicines and heath care,propel the scientific cooperation and application of TCM in various countries along One Belt and One Road(B & R),and create Chinese standards and brands,so as to promote the TCM moving towards the whole world.

Use of Non-Verbal Representations to Define Concept of Pulse Conditions in Traditional Chinese Medicine Standards

The standardization of terms and definitions is fundamental to all activities in the domain of traditional Chinese medicine(TCM).For decades,definitions of TCM terminology relied on conventional verbal representations to differentiate between related concepts.However,the ancient Chinese is obscure and comprises a massive volume of information,making it difficult to convey the definition accurately in other languages.This article proposes a potential solution that the definition for pulse terminology can be supplemented by modern means of non-verbal representation,i.e.,using pulse waveform graphs and parameters to complete the definition of each pulse.A discussion of the challenges of obtaining reliable data is also included.

Impressions on the Book“On the Standard Nomenclature of Traditional Chinese Medicine”(by Professor XIE Zhu-fan,Foreign Languages Press Beijing, 2003)

Traditional Chinese medicine(TCM)is indubitably on the top of Chinese cultural treasures,deeplyimpressed in the mind of Chinese people.Unfortunately,TCM is facing difficulties in the route towardsinternationalization,up till now,TCM has not yet been granted a legal position for clinical practice in aconsiderable number of countries.So it is our responsibility tO make TCM internationalized and push TCMtobe accepted world—wide,even though we know that it is a long way to go.

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.

Construction of nursing standard of integrated traditional Chinese and Western medicine for patients with COVID‑19 (mild and common) in Beijing based on Delphi method

Objective:The objective of this study is to establish a nursing standard of integrated traditional Chinese and Western medicine for patients with COVID‑19(mild and common)in Beijing,to provide reference for clinical nursing of patients with COVID‑19(mild and common).Methods:Through online communication meeting with nurses who are in the frontline of anti‑epidemic,clinical investigation,literature research,and expert demonstration meeting are carried out to prepare the draft of the standard,and the Delphi method is applied to determine the standard of integrated traditional Chinese and Western medicine care for patients with COVID‑19(mild and common)in Beijing.Results:The nursing standard of integrated traditional Chinese and Western medicine for patients with COVID‑19(mild and common)was established,which included 5 first‑level indicators,14 second-level indicators and 60 third‑level indicators.After two rounds of Delphi method,the positive coefficients of experts were 96%and 83%,the authoritative coefficients of experts were 0.89 and 0.91,and the Kendall’s coefficient of concordance(W)of experts were 0.12,0.09,0.10,0.13(P<0.05)and 0.44,0.43,0.37,0.39(P<0.05).Conclusion:The standard of integrated traditional Chinese and Western medicine nursing for patients with COVID‑19(mild and common)in Beijing constructed by the Delphi method is scientific and practical,which provides a reference for clinical application of integrated traditional Chinese and Western medicine nursing to fight against COVID‑19 infection.

Visualization analysis of the international standard ISO/TC 249 for traditional Chinese medicine

Objective This study proposes to visually review the current situation and progress of standards sets by the International Organization for Standardization/Technical Committee on Traditional Chinese Medicine(ISO/TC 249). The review aims to explore the development strategies of the standards, which will exhibit the considerable impact on the economy, trade and exchanges, and cooperation in the area of traditional Chinese medicine(TCM).Methods ISO/TC 249 standards were searched on the ISO website, and their title, proposed time, current stage, scope, and classification were obtained for further summarization. Gephi was utilized to portray the co-occurrence network graph of the ISO/TC 249 standards subject.Results In ISO/TC 249, there were 116 standards, including 81 published standards and 35 developing standards by April 30, 2022. Two withdrawal standards were published after revision, which were not counted in the total standards. The number of published standards has been increasing since the first standard was published in 2014, whose title was “Sterile acupuncture needles for single use”. Among these standards, 17.24%(20/116) standards were in review, 56.03%(65/116) in publication, 3.45%(4/116) in approval, 5.17%(6/116) in enquiry,3.45%(4/116) in committee, and 14.66%(17/116) in preparation, respectively. With 116 standards, most of the research focused on the medicament, as its classification of the International Classification for Standards(ICS) showed the proportion reaching 49.54%. The network analysis data revealed that the top five most frequent words were “materials” “root” “requirements” “products” and “system”, after removing the noise data, such as prepositions,conjunctions, and pronouns. Additionally, the word “system” co-exists with the terms “computerized” “coding” “image” “tongue” and “analysis”;the word “requirement” co-exists with“manufacturing” “decoction” “process” and “materials”;whereas the word “devices” coexists with “pulse” “electric” “skin” and “measurement”.Conclusion With the increased diversification and complexity of problems, the development of standards is also oriented to multidisciplinary fields to cultivate the interdisciplinary talents, and especially the international standardization talents of compound TCM. Multi-angle analysis, formulation, and demonstration of standards, in line with industry needs in different disciplines, enhance the availability of standards and the ability to serve the industry.

Standardization of Basic Terms Translation of Traditional Chinese Medicine

Standardization of translation of traditional Chinese medicine(TCM) terms has been the focus of TCM translation for a long time; and it is the important force to enhance the steps of TCM internationalization. The standardization of translation of TCM terms is also the key to promote the theoretical research of TCM translation and the international exchange and scientific research.

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.

Traditional Chinese Medicine(TCM)Domain Ontology:Current Status and Rethinking for the Future Development

The past twenty years have seen the increasingly important role of ontology in traditional Chinese medicine(TCM).However,the development of TCM ontology faces many challenges.Since the epistemologies dramatically differ between TCM and contemporary biomedicine,it is hard to apply the existing top-level ontology mechanically.“Data silos”are widely present in the currently available terminology standards,term sets,and ontologies.The formal representation of ontology needs to be further improved in TCM.Therefore,we propose a unified basic semantic framework of TCM based on in-depth theoretical research on the existing top・level ontology and a re-study of important concepts in TCM.Under such a framework,ontologies in TCM subdomains should be built collaboratively and be represented formally in a common format.Besides,extensive cooperation should be encouraged by establishing ontology research communities to promote ontology peer review and reuse.

Research of Quality Standards for Stachydrine Hydrochloride in Chinese Medicine TJF Granule

A high-performance liquid chromatographic method was applied to the determination of stachydrine hydrochloride concentration in TJF granule (Chinese name: Tiao-Jing-Fang), using a mobile phase of methanol-acetonitrile (50:50, v/v) by the Agilent Kromasi NH2 column (250 mm × 4.6 mm, 5 μm, S/N: 22N25110). Detection wavelength was 201 nm. The result revealed good linearity of stachydrine hydrochloride and was obtained within the range of 0.20 - 1.98 μg/mL (R = 0.9995). The average recovery was 97.01%;the relative standard deviation (RSD) was 0.19%. To the best of our knowledge, this is the first report dedicated to the determination of stachydrine hydrochloride by the evaporative light scattering detector-high-performance liquid chromatographic (ELSD-HPLC) method.

Research and Analysis on the Origin of the Term“Xinche”in Traditional Chinese Medicine and Its Translation

Translating the terminology of traditional Chinese medicine(Thereafter referred to as TCM)is the core of translating TCM culture.By analyzing the connotation and denotation of the word“Xinche”(心掣)in Huangdi Neijing(Yellow Emperor’s Canon of Medicine),the earliest existing TCM classic,and by comparing different English translations of the term“Xinche,”we hope to provide certain reference for the standardization of TCM terminology and to share some ideas for the translation of TCM classics.

Preliminary Study on the Training Mode of Chinese Pharmacy Professionals Based on the National Standard of Teaching Quality

With the promulgation of the National Standard for the Teaching Quality of Undergraduate Majors in Ordinary Colleges and Universities, the state has made clear regulations on the standard for the cultivation of Chinese pharmacy talents. Based on their own actual conditions, major colleges and universities have implemented different talent training modes, including talent training modes of running talent classes, "2+1+1", "Chinese Medicine Research Practice Class", employment-oriented professional talent training mode, three-level three-type diversified talent training mode, and talent training mode oriented with adapting to the characteristics of ethnic regions. Various talent training modes have different training objectives, and corresponding training programs are formulated to meet the requirements of the National Standard for the Teaching Quality of Undergraduate Majors in Ordinary Colleges and Universities. In addition, according to the notice on Solidly Promoting Labor Education into the "National Standard for the Teaching Quality of Undergraduate Majors in Ordinary Colleges and Universities" issued by the Department of Higher Education of the Ministry of Education, the introduction of labor education to the teaching of Chinese pharmacy majors will be a trend, and Chinese pharmacy professionals are required to achieve comprehensive and coordinated development of morality, intelligence, physique, beauty, and labor. How to integrate labor education with high quality and high efficiency into the training of Chinese pharmacy professionals is a problem that major universities will think about.

International standard of Traditional Chinese Medicine techniques:the operating specification for Traditional Chinese Medicine enema(2022)

Chinese Medicine Enema is one of the external therapies in Traditional Chinese Medicine(TCM),which has been widely used clinically.The"International Standard of Traditional Chinese Medicine Techniques:The Operating Specifications for Chinese Medicine Enema is drawn up by the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University and Beijing University of Chinese Medicine Xiamen Hospital in collaboration with domestic TCM universities and hospitals.The specification includes definition,operating process,points for attention and contraindications.It is targeted to provide reference for TCM providers at home and abroad with TCM background in clinical decision-making.

顺应信息化时代探讨中医药研究生科研能力培养模式

具有较强科研能力的中医药研究生是中医药文化、中医药继承创新的有力保障。过去几年,中医药研究生教育因疫情长期开展线上教学的经历提示,利用“信息化”背景下的优秀资源,多途径培养科研能力优秀的研究生是时代的需求,更是各中医类高校需面对的挑战。文章在信息化技术支撑下,立足于理论学习,重视科研项目和科研平台的培养作用,探索当代中医药研究生科研能力培养的新模式,旨在使中医药研究生科研能力培养顺应时代发展并更具科学性,形成行之有效的培养创新能力的方法与途径。

中医住培过程考核体系构建

我国已全面启动新的住院医师规范化培训制度,并取得了一定成效,然而目前还存在培训模式偏西化、理论学习轻基础、考核模式轻过程和管理模式未分层等不足。考核是住院医师规范化培训管理的重要组成部分,其结果是衡量基地与住院医师规范化培训学员培养质量的客观指标,其中的过程考核是重中之重。浙江中医药大学附属第三医院作为首批国家中医住院医师规范化培训基地,按照上级主管部门相关文件要求建立了过程考核体系,制定了规范的考核管理制度,采取规范日常考核、严肃出科考核、增设季度考核、设置专项考核、组织年度考核、落实绩效考核等相关举措,多管齐下,保证培训质量。

心内科急症情景模拟教学在中医住院医师规培的应用

目的分析中医住院医师规范化培训中应用心内科急症情景模拟的教学效果。方法选择2021年1月—2021年12月在广西中医药大学附属瑞康医院中医住院医师规范化培训基地心内科学习的学员88人作为研究对象,随机分成两组,试验组采用情境模拟教学法,对照组采用传统教学方法。观察两组出科考核成绩、迷你临床演练评估(Mini-CEX)评分、教学满意度及试验组对每次情景模拟教学效果的评价。结果试验组出科笔试、综合实践操作考核得分及总分均高于对照组,Mini-CEX评分高于对照组(P<0.05)。试验组教学满意度为97.7%(43/44),高于对照组的79.5%(35/44)(P<0.01)。结论在中医住院医师规培临床教学中开展心内科急症情景模拟教学,获得了很好的效果,提高了学员的学习积极性,提升了规培质量和效率,值得临床教学推广使用。