1.Key questions of translational research on international standards of acupuncture-moxibustion techniques: an example from the WFAS Technical Benchmark of Acupuncture and Moxibustion: General Rules for Drafting.
Shuo CUI ; Jingjing WANG ; Zhongjie CHEN ; Jin HUO ; Jing HU ; Ziwei SONG ; Yaping LIU ; Wenqian MA ; Qi GAO ; Zhongchao WU
Chinese Acupuncture & Moxibustion 2025;45(8):1159-1165
OBJECTIVE:
To provide the experience and demonstration for the transformation of acupuncture-moxibustion techniques standards from Chinese national standards to international standards.
METHODS:
Questionnaire research, literature research, semi-structured interviews and expert consultation were used.
RESULTS:
The safety of acupuncture-moxibustion techniques was evaluated through literature research, and based on the results of the questionnaire survey, expert interviews, and expert consultation, 11 main bodies and structure of the former Chinese national standard, Technical Benchmark of Acupuncture and Moxibustion: General Rules for Drafting, were adjusted and optimized in accordance with the requirements of international standard (including the language, normative references, purpose, scope, applicable environment, target population, work team, terms and definitions, general principles and basic requirements, structural elements and text structure, and compilation process); and the first international standard, World Federation of Acupuncture-Moxibustion Societis (WFAS) Technical Benchmark of Acupuncture and Moxibustion: General Rules for Drafting was formulated to specify the general rules for drafting.
CONCLUSION
The 3 key questions, "international compatibility", "technical operability" and "safety" should be solved technically on the basis of explicit international requirements. It is the core technical issue during transforming the national standards of technical benchmark of acupuncture and moxibustion into international standards.
Moxibustion/methods*
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Acupuncture Therapy/methods*
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Humans
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Translational Research, Biomedical/standards*
;
Surveys and Questionnaires
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China
;
Benchmarking/standards*
2.Evolution, current status, and prospects of clinical research guidelines for new traditional Chinese medicine drugs in China.
China Journal of Chinese Materia Medica 2025;50(13):3574-3578
The guidelines for clinical research on new drugs provide unified standards for drug developers, researchers, and regulatory authorities, playing a crucial role in new drug development. This article systematically reviews the evolution of guidelines for clinical research on new traditional Chinese medicine(TCM) drugs in China, with a focus on analyzing the current status of these guidelines and the problems that exist. It also provides interpretations of three important guidelines. The article points out that with the continuous emergence of new clinical trial design methods, development concepts, and tools, and under the background of the "three combinations" evidence evaluation system for new TCM drugs, it is imperative to revise existing guidelines, formulate new ones, and develop new tools for clinical efficacy evaluation. It is hoped that relevant departments will adopt an open attitude and work together to build a technical system of clinical research guidelines for new TCM drugs that aligns with the characteristics of TCM.
Humans
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Biomedical Research/trends*
;
China
;
Clinical Trials as Topic
;
Drugs, Chinese Herbal/therapeutic use*
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Guidelines as Topic
;
Medicine, Chinese Traditional/standards*
3.Preliminary experience on construting research-based gastrointestinal surgery department of Nanfang Hospital.
Guoxin LI ; Jiang YU ; Yanfeng HU ; Hao CHEN
Chinese Journal of Gastrointestinal Surgery 2019;22(1):22-26
Construction of research-based surgery department includes standardizing surgical practices, collecting and analyzing clinical data, discovering problems in clinical practices, designing and conducting reliable and high-level clinical research, improving and innovating surgical technologies according to research conclusions, working out technical specifications and promoting them through clinical education, and creating new clinical research needs arised by innovative and cutting-edge technologies and theories. By integrating technology, research, standardization, promotion and evaluation, and making close connections between different parts of clinical practices, scientific research and clinical teaching, it helps achieve coordinated development of surgical practices and translational research, and will finally promote the cultivation of medical talents and the progress of medical technologies. Since 2010, the General Surgery Department of Nanfang Hospital has established the basic idea of subject construction of "research-oriented surgery with data as the core, minimally invasive surgery with laparoscopic as the characteristic, and specialized surgery with high-efficiency service as the guidance", and has taken a series of measures to build it into a well-known research-based gastrointestinal surgery in China. The achievements of this speciaty have emerged from nothing, research platforms from few to many, the talent echelon from following to leading, and the influence from regional to international. The discipline construction has achieved a leap from quantitative to qualitative changes.
Biomedical Research
;
standards
;
China
;
Digestive System Surgical Procedures
;
standards
;
Gastrointestinal Diseases
;
surgery
;
Hospitals
;
standards
;
Humans
;
Minimally Invasive Surgical Procedures
;
standards
;
Program Development
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Surgery Department, Hospital
;
standards
4.Statistical reporting requirements for medical journals: Amplifications and explanations.
Chinese Journal of Epidemiology 2019;40(1):99-105
Our study aimed to amplify and explain the items of statistical reporting requirements proposed by medical journals, and to improve the statistical reporting quality of medical articles. Statistical reporting requirements were obtained from the reporting standards published by the International Committee of Medical Journal Editors (ICMJE), the Enhancing the QUAlity and Transparency of Health Research (EQUATOR) network, and the editorial board of Chinese Medical Journal, etc. The items involved in statistical reporting requirements were summarized as issues of study design, statistical analysis, and interpretation of results. Each item was amplified based on cases of original articles. It is noticeable that the statistical reporting requirements of English medical journals generally referring to guidance documents, including "Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals" proposed by the ICMJE, or the statements for different study types published by the EQUATOR network, where the statistical reporting of medical articles had been detailed specified. The statistical reporting requirements of Chinese medical journals, however, were usually stated by the editorial boards. Although the formats and contents of statistical analysis had been regulated, the requirements of Chinese medical journals were to some extent insufficient and should be enhanced in accordance with the international standards. In conclusion, the amplification and explanation of statistical reporting requirements were expected to help investigators understand the requirements for statistical reporting in medical researches, so as to effectively improve the quality of medical articles.
Biomedical Research
;
Editorial Policies
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Humans
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Periodicals as Topic/standards*
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Publishing/standards*
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Reference Standards
;
Research Design
6.Standardization of cancer biobank in precision medicine era.
Journal of Zhejiang University. Medical sciences 2016;45(4):331-334
Tumor specimens have a great role in basic and clinical translational researches on cancer, especially in the era of precision medicine. Thus the standardization of cancer biobank is of high importance. The establishment and maintenance of cancer biobank require comprehensive quality management, so as to provide high quality service for basic and clinical researches. At present, sample-oriented collection and management, and clinical and pathological data annotation are the main focuses of biobank standardization in China.
Biological Specimen Banks
;
standards
;
Biomedical Research
;
China
;
Documentation
;
standards
;
Humans
;
Neoplasms
;
Precision Medicine
;
Specimen Handling
;
standards
7.The Main Biological Hazards in Animal Biosafety Level 2 Facilities and Strategies for Control.
Xiao Yan LI ; Kang Ning XUE ; Jin Sheng JIANG ; Xuan Cheng LU
Biomedical and Environmental Sciences 2016;29(4):300-304
Concern about the biological hazards involved in microbiological research, especially research involving laboratory animals, has increased in recent years. Working in an animal biosafety level 2 facility (ABSL-2), commonly used for research on infectious diseases, poses various biological hazards. Here, the regulations and standards related to laboratory biosafety in China are introduced, the potential biological hazards present in ABSL-2 facilities are analyzed, and a series of strategies to control the hazards are presented.
Animal Diseases
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epidemiology
;
prevention & control
;
Animals
;
Biomedical Research
;
legislation & jurisprudence
;
China
;
epidemiology
;
Containment of Biohazards
;
methods
;
standards
;
Government Regulation
;
Laboratories
;
legislation & jurisprudence
;
standards
;
Safety Management
;
legislation & jurisprudence
;
standards
9.History and development trend of minimally invasive techniques for gastric cancer in China.
Chinese Journal of Gastrointestinal Surgery 2016;19(8):846-849
Laparoscopic gastrectomy is one of the main directions of minimally invasive surgery for gastric cancer. Since 1999, the first laparoscopic gastrectomy was reported, minimally invasive laparoscopic surgery for gastric cancer in China has undergone three stages: initial exploration period, rapid development period and gradual maturation period. The hospitals which performed laparoscopic gastrectomy and the reported cases have been increasing, at the same time the clinical efficacy is satisfied. However, there is still lack of standard and insufficient evidence in the treatment of gastric cancer by laparoscopic gastrectomy. The 3D laparoscopic and robotic gastrectomies still can not be performed in the most hospitals in China. So we should strengthen the standardization training of laparoscopic gastrectomy, develop the evidence-based medical research, promote the 3D laparoscopic and robotic gastrectomies to enhance the level of minimally invasive surgery for gastric cancer.
Biomedical Research
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China
;
Gastrectomy
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Humans
;
Laparoscopy
;
Minimally Invasive Surgical Procedures
;
Physical Examination
;
Reference Standards
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Robotic Surgical Procedures
;
Robotics
;
Stomach Neoplasms
;
surgery
10.Scientific Positioning of Traditional Chinese Medicine.
Chinese Journal of Integrated Traditional and Western Medicine 2016;36(3):266-268
Whether traditional Chinese medicine (TCM) could be categorized as a kind of science or not has been a controversial issue over last century. Part of the confusion is caused by the indistinguishable usage of Chinese words "science" and "scientific" during discussion. According to western academic standards, TCM cannot be considered as pure or conventional science. However, in author's view, the foundation of a majority part of TCM practice is probably scientific, while many TCM theories remain unproved. In this article, medical theories and practices are classified based on scientific content into eight levels: medical science, scientific medicine, medical system, medical theory, medical opinion, medical belief, medical cultism, and medical fraud. Both Western medicine and TCM are positioned in this system accordingly. Currently, the scientific level of TCM is much lower than that of Western medicine, and more research is needed for its improvement.
Biomedical Research
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Humans
;
Medicine, Chinese Traditional
;
standards

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