1.Exploring on Quality Evaluation Methods of Clinical Case Reports in Traditional Chinese Medicine Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Feng ZHANG ; Bo ZHOU ; Haimin CHEN ; Yong ZHU ; Changcheng HOU ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Guoshuang ZHU ; Shukun GONG ; Jianwen HE ; Yang YE ; Yuqiu AN ; Chunquan SUN ; Qingjie YUAN ; Buman LI ; Xingzhong FENG ; Kegang CAO ; Hongcai SHANG ; Jihua GUO ; Xiaoxiao ZHANG ; Zhining TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):271-276
As the core vehicle for preserving and transmitting traditional Chinese medicine(TCM) academic thought and clinical experience, the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine, this study conducted a comprehensive analysis of critical challenges, including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic, encompassing three dimensions of authenticity and standardization, characteristics and advantages, application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment, while aligning with modern scientific research standards, achieving a balance between individualized TCM experience and standardized evaluation. Concurrently, this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases, contributing significantly to the inheritance of TCM knowledge, evidence-based practice, and the reform of talent evaluation mechanisms.
2.Intervention Mechanism of Guizhi Fulingwan in Delaying Colitis-associated Colon Cancer via Modulating and Restoring MDSCs and Reshaping Immune Microenvironment
Yanwei HAO ; Chunrun LI ; Zhengwu QU ; Junmei TANG ; Jing GUO ; Yi ZHANG ; Fengming YOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):185-194
ObjectiveThis paper aims to investigate the efficacy and related actions of Guizhi Fulingwan in intervening in the mice with colitis-associated colon cancer (CAC) based on the immunosuppressive microenvironment associated with myeloid-derived suppressor cells (MDSCs). MethodsSixty male C57BL/6 mice were randomly assigned to a blank group, a model group, an aspirin group (0.04 g·kg-1), and low-, medium-, and high-dose Guizhi Fulingwan groups (4.87, 9.75, and 19.50 g·kg-1), with ten mice per group. The CAC mouse model was established via combined induction of azoxymethane (AOM)/dextran sulphate sodium (DSS). Drug intervention commenced in week five, with continuous intragastric administration for nine weeks. The food intake, body weight, fecal characteristics, and haematochezia were observed and recorded, and disease activity index (DAI) scores were calculated according to scoring criteria. Hematoxylin and eosin (HE) staining was used to observe the histopathological changes in the colon tissues of the mice. Immunohistochemistry was used to determine proliferating cell nuclear antigen-67 (Ki67) expression in the colon tissues, and enzyme-linked immunosorbent assay (ELISA) was used to detect the contents of interleukin-6 (IL-6), IL-1β, and tumor necrosis factor-α (TNF-α) in the serum of the mice. Flow cytometry was employed to determine the proportion levels of MDSCs, CD4+ T cells, and CD8+ T cells in the spleen tissues of the mice. The mRNA expressions of MDSC-associated effector molecules, including arginase 1 (Arg1) and inducible nitric oxide synthase (iNOS), were detected by real-time quantitative polymerase chain reaction (Real-time PCR). After that, an in vitro co-culture model of MDSCs and CD8+ T cells was established, and drug-containing serum of Guizhi Fulingwan was used for intervention. The Flow cytometry was employed to assess the effects of drug-containing serum of Guizhi Fulingwan with different concentrations on the levels of reactive oxygen species (ROS) and iNOS in MDSCs and the proliferation of CD8+ T cells. The levels of granzyme B (GZMB) and interferon-γ (IFN-γ) in cell supernatant were detected by ELISA. ResultsCompared with those in the control group, the mice in the model group exhibited significantly reduced body weight, elevated DAI scores, shortened colon length (P<0.01), increased number of tumors and Ki67 expression (P<0.01), and significantly elevated contents of IL-6, IL-1β, and TNF-α in the serum (P<0.01). Significant increases in the number of MDSCs were observed in mouse spleens, alongside marked reductions in the levels of CD4+ T and CD8+ T cells (P<0.01). Furthermore, the mRNA expressions of MDSC function-associated effector molecules Arg1 and iNOS were significantly upregulated (P<0.01). Compared with those in the model group, the mice in the middle-dose Guizhi Fulingwan group exhibited increased body weight and significantly decreased DAI scores (P<0.05, P<0.01). The mice in the middle- and high-dose Guizhi Fulingwan groups exhibited significantly improved colon shortening, significantly decreased number of tumors and Ki67 expression (P<0.05, P<0.01), and significantly decreased contents of IL-6, IL-1β, and TNF-α in the serum (P<0.05, P<0.01). Furthermore, administration of Guizhi Fulingwan markedly reduced MDSC infiltration in the spleen of the mice, with different degrees of increase in the levels of both CD4+ T and CD8+ T cells (P<0.05, P<0.01), alongside significant decreases in the mRNA expressions of Arg1 and iNOS (P<0.05, P<0.01). In vitro cell co-culture shows that administration of drug-containing serum of Guizhi Fulingwan significantly decreases the activity levels of ROS and iNOS in MDSCs and promotes the proliferation of CD8+ T cells and the secretion of GZMB and IFN-γ (P<0.05, P<0.01). ConclusionGuizhi Fulingwan can reduce pro-inflammatory cytokine secretion and inhibit tumor proliferation in the colon tissues of CAC mice. Its potential mechanism may involve reducing MDSC infiltration, enhancing effector T cells, particularly CD8+ T cell response, and improving the tumor immunosuppressive microenvironment.
3.Characteristics of hearing loss among noise-exposed workers in the lithium battery manufacturing industry
Yunqiang XU ; Chunnian YOU ; Rongguang LI ; Huandi CHEN ; Yongxiang TANG ; Jijun GUO ; Huanwen TANG
China Occupational Medicine 2026;53(2):223-226
Objective To analyze the characteristics of hearing loss at different frequencies among noise-exposed workers in a lithium battery manufacturing enterprise. Methods A total of 1 954 noise-exposed workers from a large lithium battery manufacturing enterprise were selected as the study subjects using the judgmental sampling method. Pure-tone audiometry, individual noise exposure level monitoring, and workplace noise intensity measurement were conducted. Results The overall detection rate of hearing loss among the study subjects was 39.0%. The detection rates of unilateral and bilateral hearing loss were 21.0% (410/1 954) and 18.0% (352/1 954), respectively. The detection rate of hearing loss in the right ear was higher than that in the left ear (30.1% vs 26.9%, P<0.05). The detection rates of elevated hearing thresholds at high frequencies and speech frequencies were 38.8% and 1.1%, respectively. Comparisons of the detection rates of elevated hearing thresholds across different frequencies between the left and right ears showed significant differences (all P<0.01); specifically, the detection rate at 4.0 kHz in the right ear was higher than that in the left ear (P<0.01). The detection rates of elevated hearing thresholds at 2.0, 4.0, and 6.0 kHz increased with longer duration of noise exposure (all P<0.05). Except at 1.0 kHz, the detection rates of elevated hearing thresholds at 0.5, 2.0, 3.0, 4.0, and 6.0 kHz showed increasing trends with age (all P<0.05). Conclusion Hearing loss among noise-exposed workers in the lithium battery manufacturing industry is predominant in the high-frequency type, with the highest sensitivity at 4.0 kHz and greater susceptibility in the right ear. The detection rate of high frequency hearing loss increases with longer noise exposure duration and advacing age. Health surveillance should focus on workers with longer noise exposure duration and older age. Noise control measures should be strengthened.
4.Thoughts and practices on research and development of new traditional Chinese medicine drugs under "three combined" evaluation evidence system.
Yu-Qiao LU ; Yao LU ; Geng LI ; Tang-You MAO ; Ji-Hua GUO ; Yong ZHU ; Xue WANG ; Xiao-Xiao ZHANG
China Journal of Chinese Materia Medica 2025;50(7):1994-2000
In recent years, the reform of the registration, evaluation, and approval system for traditional Chinese medicine(TCM) has been promoted at the national level, with establishment of an evaluation evidence system for TCM registration that combines TCM theory, human use experience, and clinical trials(known as the "three-combined" evaluation evidence system). This system, which aligns with the characteristics of TCM clinical practice and the laws of TCM research and development, recognizes the unique value of human use experience in medicine and returns to the essence of medicine as an applied science, thus receiving widespread recognition from both academia and industry. However, it meanwhile poses new and higher challenges. This article delves into the value and challenges faced by the "three-combined" evaluation evidence system from three perspectives: registration management, medical institutions, and the TCM industry. Furthermore, it discusses how the China Association of Chinese Medicine, leveraging its academic platform advantages and leading roles, has made exploratory and practical efforts to facilitate the research and development of new TCM drugs and the implementation of the "three-combined" evaluation evidence system.
Drugs, Chinese Herbal/standards*
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Humans
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Medicine, Chinese Traditional/standards*
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China
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Drug Development
5.Exploring the need for head simulation teaching of stomatology in the eight-year medical doctor program of clinical medicine
Pengyue YOU ; Jiayi LI ; Chunlan GUO ; Xinyuan ZHANG ; Jingyi HUO ; Kuo WAN ; Haitao DONG
Basic & Clinical Medicine 2025;45(11):1528-1531
Objective To explore the need and evaluate the effectiveness for head-simulator in the teaching of sto-matology within the eight-year program of clinical medicine.Methods Questionnaire survey was conducted among the students from 2017 cohort of the eight-year program of clinical medicine at Peking Union Medical College.The survey results were statistically analyzed and described.Results Totally 87.9%of the students believed that incor-porating head-simulator into the clinical practice course of stomatology were necessary,and 93.9%expressed will-ingness to join the training.Most students preferred to practice peri-odontal scaling and cavity preparation for caries during the simulated training sessions.The majority of students considered two or four class hours of simulated head teaching to be reasonable.The pilot head simulation training was successfully implemented;75.0%of the students acknowledged clear teaching and convincible demonstrations.All the trainees agreed that the head simulation course helped them better understand stomatology knowledge,stimulated their interest in learning and expressed a desire for increased head simulation sessions during clinical practice course of stomatology.Additionally,87.5%of the students preferred head simulation training course to be applied in classic clinical clerkships.Conclusions There is strong demand among students of eight-year program of clinical medicine for incorporating head-simulator into the education of stomatology.The pilot simulation training received positive evaluations.Further exploration is needed to optimize specific scheduling and content arrangement.
6.Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.
Shengde LI ; Anxin WANG ; Lin SHI ; Qin LIU ; Xiaoling GUO ; Kun LIU ; Xiaoli WANG ; Jie LI ; Jianming ZHU ; Qiuyi WU ; Qingcheng YANG ; Xianbo ZHUANG ; Hui YOU ; Feng FENG ; Yishan LUO ; Huiling LI ; Jun NI ; Bin PENG
Chinese Medical Journal 2025;138(5):579-588
BACKGROUND:
Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke.
METHODS:
This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days.
RESULTS:
There were 57 and 60 patients finally included in the ANP and placebo groups, respectively for modified intention-to-treat analysis. The median age was 66.0 years, and the median NIHSS score at baseline was 12.0. The changes in cerebral infarct volume at day 14 were 0.3 mL and 0.4 mL in the ANP and placebo groups, respectively (median difference: -7.1 mL; interquartile range [IQR]: -18.3 to 2.3 mL, P = 0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4 mL and 4.0 mL, respectively ( median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P = 0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups ( P = 0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P = 0.03).
CONCLUSIONS:
ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis.
TRAIL REGISTRATION
Clinicaltrials.gov , No. NCT04475328.
Aged
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Female
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Humans
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Male
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Middle Aged
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Double-Blind Method
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Drugs, Chinese Herbal/adverse effects*
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Ischemic Stroke/drug therapy*
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Pilot Projects
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Stroke/drug therapy*
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Treatment Outcome
7.Greenness evaluation metric for analytical methods and software.
Tong XIN ; Luyao YU ; Wenying ZHANG ; Yingxia GUO ; Chuya WANG ; Zhong LI ; Jiansong YOU ; Hongyu XUE ; Meiyun SHI ; Lei YIN
Journal of Pharmaceutical Analysis 2025;15(7):101202-101202
The focus of green analytical chemistry (GAC) is to minimize the negative impacts of analytical procedures on human safety, human health, and the environment. Several factors, such as the reagents used, sample collection, sample processing, instruments, energy consumed, and the quantities of hazardous materials and waste generated during analytical procedures, need to be considered in the evaluation of the greenness of analytical assays. In this study, we propose a greenness evaluation metric for analytical methods (GEMAM). The new greenness metric is simple, flexible, and comprehensive. The evaluation criteria are based on both the 12 principles of GAC (SIGNIFICANCE) and the 10 factors of sample preparation, and the results are presented on a 0-10 scale. The GEMAM calculation process is easy to perform, and its results are easy to interpret. The output of GEMAM is a pictogram that can provide both qualitative and quantitative information based on color and number.
8.Current situation of clinical trial registration in acupuncture anesthesia: A scoping review.
Yue LI ; You-Ning LIU ; Zhen GUO ; Mu-En GU ; Wen-Jia WANG ; Yi ZHU ; Xiao-Jun ZHUANG ; Li-Ming CHEN ; Jia ZHOU ; Jing LI
Journal of Integrative Medicine 2025;23(3):256-263
BACKGROUND:
Modern acupuncture anesthesia is a combination of Chinese and Western medicine that integrates the theories of acupuncture with anesthesia. However, some clinical studies of acupuncture anesthesia lack specific descriptions of randomization, allocation concealment, and blinding processes, with subsequent systematic reviews indicating a risk of bias.
OBJECTIVE:
Clinical trial registration is essential for the enhancement of the quality of clinical trials. This study aims to summarize the status of clinical trial registrations for acupuncture anesthesia listed on the World Health Organization International Clinical Trials Registry Platform (ICTRP).
SEARCH STRATEGY:
We searched the ICTRP for clinical trials related to acupuncture anesthesia registered between January 1, 2001 and May 31, 2023. Additionally, related publications were retrieved from PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Data. Registrations and publications were analyzed for consistency in trial design characteristics.
INCLUSION CRITERIA:
Clinical trials that utilized one of several acupuncture-related therapies in combination with pharmacological anesthesia during the perioperative period were eligible for this review.
DATA EXTRACTION AND ANALYSIS:
Data extracted from articles included type of surgical procedure, perioperative symptoms, study methodology, type of intervention, trial recruitment information, and publication information related to clinical enrollment.
RESULTS:
A total of 166 trials related to acupuncture anesthesia from 21 countries were included in the analysis. The commonly reported symptoms in the included studies were postoperative nausea and vomiting (19.9%) and postoperative pain (13.3%). The concordance between the publications and the trial protocols in the clinical registry records was poor, with only 31.7% of the studies being fully compatible. Inconsistency rates were high for sample size (39.0%, 16/41), blinding (36.6%, 15/41), and secondary outcome indicators (24.4%, 10/41).
CONCLUSION
The volume of acupuncture anesthesia clinical trials registered in international trial registries over the last 20 years is low, with insufficient disclosure of results. Postoperative nausea and vomiting as well as postoperative pain, are the most investigated for acupuncture intervention. Please cite this article as: Li Y, Liu YN, Guo Z, Gu ME, Wang WJ, Zhu Y, Zhuang XJ, Chen LM, Zhou J, Li J. Current situation of clinical trial registration in acupuncture anesthesia: A scoping review. J Integr Med. 2025; 23(3): 256-263.
Humans
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Acupuncture Analgesia
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Acupuncture Therapy
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Anesthesia
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Clinical Trials as Topic
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Registries
9.Chemical constituents of Stelmatocrypton khasianum and their biological activity
Jing YU ; Guo-xu MA ; Cui-yun YIN ; Zhao-you DENG ; Yi-hang LI ; Er LI
Chinese Traditional Patent Medicine 2025;47(11):3645-3650
AIM To study the chemical constituents from Stelmatocrypton khasianum.(Benth.)Baill.and their in vitro anti-inflammatory activity and cytotoxic activity.METHODS Separation and purification were performed using thin layer chromatography,silica gel,semi-preparative HPLC and Sephadex LH-20,then the structures of obtained compounds were identified by physicochemical properties and spectral data.The in vitro anti-inflammatory activity was evaluated by RAW264.7 model,and the cytotoxic activity was determined by CCK-8 method.RESULTS Fifteen compounds were isolated and identified as 2α,3β,19α,23-tetrahydroxy-urs-12-en-28-oic acid-3-O-β-D-glucopyranosyl-28-O-β-D-glucopyranosyl ester(1),dalzienoside(2),benzyl-(6-O-α-L-rhanmopyranosyl)O-β-D-glucopyranoside(3),corchorusoside C(4),cyclo(Ala-Tyr)(5),thymidine(6),(4S,5S)-5-hydroxy-4-hexanolide(7),2-methylpyridin-3-ol(8),butyl isobutyl phthalate(9),bis-(2-ethylhexyl)terephthalate(10),p-hydroxybenzaldehyde(11),vanilic acid(12),salicylic acid(13),isovanilic acid(14),3-hydroxy-p-anisaldehyde(15).The IC50 values of compounds 1,2 and 4 for NO were(27.69±5.51),(25.82±3.58)and(23.35±7.09)μmol/L,respectively.The IC50 value of compound 1 on MCF-7 cells was(18.15±6.45)μmol/L.The IC50 values of compound 4 on MCF-7 and HCCC-9810 cells were(19.43±2.66)and(21.76±5.81)μmol/L,respectively.CONCLUSION Compounds 2-11 are isolated from S.khasianum for the first time.Compounds 1,2 and 4 exhibit good in vitro anti-inflammatory activity,and 1,4 have cytotoxic activity.
10.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.

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