1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
3.Construction of the Diagnosis and Treatment System of "Sinew Prescription Correspondence" under the Guidance of Systematic Dialectical Sphygmology
Feng ZHANG ; Baoqiang DONG ; Xingxing LIN ; Yapeng LIU ; Lujia XIAO ; Bodong XING ; Yiyun CAO ; Wenhui ZHANG ; Wenqian QI
Journal of Traditional Chinese Medicine 2026;67(10):1038-1043
"Sinew prescription correspondence" is the principle of selecting prescriptions for channel sinew diseases. On the basis of the theory of syndrome differentiation and treatment, the pulse manifestation corresponds to the channel sinew syndrome, which can improve the flexibility and standardization of clinical prescriptions. From the perspective of systematic dialectical sphygmology, this paper explains the dialectical relationship between channel sinew theory and pulse body elements, pulse wall elements, pulse elements and blood flow elements, and clarifies the internal relationship between pulse manifestation and prescriptions at the level of channel sinew disease. The prescription is derived from the method, while the method is established with the syndrome, and the prescription is unified by the method. According to the theory of "sinew prescription correspondence", the treatment ideas of channel sinew diseases were analyzed from the perspective of channel sinew distribution, functional characteristics and structural changes. On this basis, the diagnosis of channel sinew disease and the application of prescriptions are expanded, and the research on the internal treatment and diagnosis mode of "pulse manifestation-channel sinew-zang fu (脏腑)" is prospected, so as to expand the differentiation and treatment methods of channel sinew theory.
4.Investigation on the Role of Medical Recombinant Human-Derived Collagen Functional Dressings in Wound Healing.
Xiaoxiao GAI ; Xiaoxia SUN ; Wenqian MA ; Zhenhua LIN ; Xinyuan LI ; Chenghu LIU
Chinese Journal of Medical Instrumentation 2025;49(4):415-422
OBJECTIVE:
To investigate the biological effect of medical recombinant human-derived collagen functional dressings in wound healing.
METHODS:
MTT assay and RTCA assay were used to detect cell toxicity and proliferation. Scratch assay and Transwell cell migration assay were used to detect cell motility and migration ability. Enzyme-linked immunosorbent assay was used to detect the contents of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-endothelial cell adhesion molecule (CD31) in the supernatant of four types of cells. After animal surgery, the surgical wound was taken at 1 week, 4 weeks and 13 weeks, respectively, for hematoxylin eosin (HE) staining and immunohistochemistry to observe the inflammatory response and CD31 expression of the wound.
RESULTS:
Medical recombinant human-derived collagen functional dressing promotes cell proliferation and migration, enhances wound angiogenesis by upregulating the expression of VEGF, FGF, and CD31 in human dermal vascular endothelial cells (HDVEC) and human vascular endothelial cells (HVEC), thereby improving local blood supply to the wound, regulating the inflammatory response of the wound, and accelerating wound healing.
CONCLUSION
Recombinant type Ⅲ humanized collagen plays an important role in wound healing.
Humans
;
Wound Healing/drug effects*
;
Recombinant Proteins/pharmacology*
;
Animals
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Cell Proliferation
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Cell Movement
;
Collagen/pharmacology*
;
Vascular Endothelial Growth Factor A/metabolism*
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Bandages
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Platelet Endothelial Cell Adhesion Molecule-1/metabolism*
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Endothelial Cells
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Fibroblast Growth Factors/metabolism*
5.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.
6.The Solomon Four-Group Design:Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
Wenqian ZHANG ; Yufei LI ; Tong LIN ; Xintong WEI ; Yingjie WANG ; Jianping LIU ; Ying ZHANG
Journal of Traditional Chinese Medicine 2025;66(16):1649-1655
The Solomon four-group design, a critical method for improving internal validity in clinical research, can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results, which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design, summarized its applications in clinical research at home and abroad, explored its advantages and limitations, and discussed the potential value in traditional Chinese medicine (TCM) clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies, and reduce the bias in the evaluation of subjective indicators. Meanwhile, given the complexity of the Solomon four-group design and the particularity of TCM clinical research, it is proposed that future TCM clinical studies should focus on using psychological scales, know-ledge, attitude, and behavior measurements, and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.
7.Incidence of pulmonary tuberculosis and its influencing factors in Hubei Province based on the geographically weighted regression model
Xingxing LU ; Xun LIU ; Fan WANG ; Jianjun YE ; Yu ZHANG ; Chengfeng YANG ; Liping ZHOU ; Hongxing WANG ; Wenqian ZHOU
Journal of Public Health and Preventive Medicine 2025;36(5):28-31
Objective To study the spatial distribution of the incidence of pulmonary tuberculosis in Hubei Province and its influencing factors, so as to improve the theoretical basis for scientific development of tuberculosis prevention and control measures in the future. Methods The data of reported incidence of tuberculosis and related influencing factors in various counties and districts of Hubei Province in 2020 were collected. Global Moran's I index, hotspot analysis and geographically weighted regression (GWR) model analysis were used to calculate the spatial autocorrelation of the incidence of tuberculosis, and to analyze the influencing factors affecting the incidence rate of tuberculosis. Results There were obvious regional differences in the space distribution of the incidence rate of tuberculosis. Hot spot analysis showed positive spatial correlation and obvious clustering. The GWR model (AICc=784.251) in this study had higher AICc value compared to the ordinary least squares regression (OLS) model (AICc=804.2585). The GWR model showed that the increase in the proportion of the population aged 65 and above and the proportion of the ethnic minority population had a significant promoting effect on the increase of the incidence rate of tuberculosis, and there was significant spatial heterogeneity. The effect of PM2.5 concentration on the incidence rate of pulmonary tuberculosis varied in different regions, and the degree of effect was also different. Conclusion The proportion of people aged 65 and above and the proportion of ethnic minorities may significantly influence the incidence of pulmonary tuberculosis. The effect of PM2.5 concentration varies in different regions, so targeted measures should be formulated according to the situation in different regions.
8.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*
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Surveys and Questionnaires
;
China
;
Benchmarking/standards*
9.Advances in the Study of Varenicline Combined with Nicotine Patches for the Treatment of Tobacco Dependence
Qiuqi WEI ; Wenqian ZHAO ; Ling LIU
Journal of Kunming Medical University 2025;46(4):157-162
China has the highest number of smokers in the world with more than 1 million tobacco-related deaths each year.Smoking cessation is a feasible intervention to reduce the prevalence of smoking-related diseases and premature deaths.The smoking cessation therapies approved for use in China are ineffective for some tobacco dependent patients.In order to further improve the rate of smoking cessation,a combination of medications can be chosen,including varenicline combined with nicotine replacement therapy.However,there are conflicting evaluation conclusions on the effectiveness and safety of combination therapy.This article aims to review the mechanism of action,efficacy,and safety of varenicline combined with nicotine replacement therapy in the treatment of tobacco dependence,aiming to provide a basis for this combination therapy.
10.Construction of stress injury risk prediction model in patients with chronic pain based on machine learning
Weijun YI ; Wenqian LUO ; Zhouqi ZHANG ; Yong LIU ; Bitian FAN ; Lin ZHANG
Chongqing Medicine 2025;54(2):413-417,424
Objective To construct the predictive model of pressure injury(PI)in the patients with chronic pain based on machine learning,and to analyze its accuracy and rationality,so as to provide an evidence for the predictive evaluation of clinical PI.Methods The clinical medical records data of 396 patients with chronic pain and high risk Braden scores hospitalized in a class 3A hospital of Chongqing City from March 2023 to June 2024 were retrospectively analyzed.Based on the Python3.10 programming language,the decision tree model,random forest model,linear regression model,naive Bayes model and K-Means model were con-structed,and the model performances were compared by accuracy,sensitivity,precision,F1 score and area un-der the receiver operating characteristic(ROC)curve(AUC).Results PI occurred in 35 cases with an inci-dence rate of 8.84%.Age,NRS score,pain site and pain affected sleep were the independent influencing fac-tors for the PI occurrence in the patients with chronic pain.Among 5 kinds of PI risk predictive model,the ac-curacy(0.873),sensitivity(0.874),precision(0.848),F1 score(0.844)and ROC AUC(0.81)of the ran-dom forest model were all higher than those of other models.Conclusion The random forest model has a high predictive performance for PI in the patients with chronic pain,and could be used for the screening and man-agement of high risk groups of PI in the patients with chronic pain.


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