1.Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases
Fang LU ; Ping WANG ; Liqun BIAN ; Lin LYU ; Mengli XIAO ; Tai ZHANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(5):498-503
Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless, given the unique characteristics of traditional Chinese medicine (TCM) and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM, the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design, evaluation, and platform construction, compares domestic and international research landscapes, and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established, and further innovation is needed in TCM research design and methodologies, leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover, standardized and shared platforms for TCM clinical data should be accelerated, so as to provide references for the design, implementation, and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.
2.LC-MS Analysis on Material Basis of Famous Classical Formula Xuefu Zhuyutang
Shujing ZHONG ; Zhaoyue LIU ; Mengge WANG ; Lan MIAO ; Changying REN ; Mingqian SUN ; Li LIN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):188-196
ObjectiveTo systematically identify the chemical constituents of Xuefu Zhuyutang(XFZY) and quantitatively determine its main components, aiming to elucidate its pharmacodynamic material basis and provide a scientific foundation for improving its quality control standards. MethodsUltra-performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS/MS) was employed for qualitative analysis of XFZY, and the identification of compounds was accomplished by comparing their retention times, secondary MS fragment ion information, 52 reference standards and relevant databases, followed by attribution of their herbal sources. A total of 22 representative compounds were screened out, and UPLC-quadrupole-linear ion trap mass spectrometry(UPLC-Q-TRAP-MS/MS) was applied for quantitative analysis of the compounds in the formula. ResultsA total of 77 compounds were identified in XFZY, including 31 flavonoids mainly derived from Aurantii Fructus, Glycyrrhizae Radix et Rhizoma, Persicae Semen, Carthami Flos, Bupleuri Radix, Paeoniae Radix Rubra and Achyranthis Bidentatae Radix, 24 terpenoids mainly derived from Platycodonis Radix, Glycyrrhizae Radix et Rhizoma, Paeoniae Radix Rubra and Rehmanniae Radix, 9 phenylpropanoids and their derivatives mainly derived from Chuanxiong Rhizoma, Angelicae Sinensis Radix and Rehmanniae Radix, 4 phenolic acids mainly derived from Chuanxiong Rhizoma, Angelicae Sinensis Radix and Paeoniae Radix Rubra, 3 saccharides mainly derived from Rehmanniae Radix and Achyranthis Bidentatae Radix, and 6 other compounds mainly derived from Persicae Semen, Rehmanniae Radix and Angelicae Sinensis Radix. The results of quantitative analysis showed that the contents of protocatechuic acid, hydroxypaeoniflorin, amygdalin, vanillic acid, paeoniflorin, liquiritin apioside, liquiritin, isoquercitrin, naringin, cosmosiin, hesperidin, neohesperidin, isoliquiritin, liquiritigenin, naringenin, benzoylpaeoniflorin, hesperetin, isoliquiritigenin, formononetin, glycyrrhizic acid, nobiletin and ligustilide in XFZY were determined to be 0.12, 1.57, 54.53, 0.29, 36.17, 4.29, 4.84, 0.09, 46.67, 0.04, 3.44, 31.95, 0.82, 0.10, 0.11, 0.43, 0.07, 0.03, 0.01, 8.24, 0.13, 1.81 mg·g-1. ConclusionThe qualitative method established in this study enables rapid and sensitive analysis of the chemical constituents in XFZY. Among the identified compounds, 52 are confirmed by reference standards, ensuring the accuracy of identification. The quantitative analysis of 22 key components provides a reliable experimental basis for the pharmacodynamic material basis research and quality control standard improvement of XFZY.
3.Current Status and Prospects of Research on Traditional Chinese Medicine Prevention and Treatment for Gastric Precancerous Lesions
Haiyan BAI ; Tai ZHANG ; Ping WANG ; Lin LIU ; Weichao XU ; Yaxin TIAN ; Lanshuo HU ; Qian YANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(4):410-415
Traditional Chinese medicine (TCM), through its multi-target and systematic regulatory effects, has demonstrated unique advantages in the treatment of gastric precancerous lesions (GPL). At present, TCM theoretical research on GPL is mainly reflected in three aspects, the integration of macroscopic syndrome differentiation, the inflammation-carcinoma transformation mechanism, as well as the systematization and scientization of theoretical inheritance from famous TCM practitioners. High-quality evidence-based research findings serve as the foundation for clinical practice guidelines on GPL, and TCM has gained international academic recognition in the field of GPL prevention and treatment. Research on TCM mechanisms has yielded a series of important outcomes in the aspects of signaling pathways, gene expression regulation, cellular epigenetics, histone modification, and intestinal microecology. It is proposed that future research on GPL should focus on four key directions, establishing multi-omics data, exploring targeted intervention strategies on key regulatory nodes, advancing the standardization process of integrated traditional Chinese and western medicine prevention and treatment technologies, and constructing stratified screening and intervention platforms. The in-depth integration of TCM microcosmic mechanism of action with its macroscopic syndrome differentiation and treatment system, coupled with interdisciplinary research, will provide valuable references for the clinical treatment and scientific research of GPL.
4.Modern Expanded Application of Ancient Classic Formulae from the Perspective of Syndrome‑Formula Ontology Reconstruction
Guibin WANG ; Sijie LIN ; Zihan LIU ; Bo PANG
Journal of Traditional Chinese Medicine 2026;67(12):1251-1257
As the core carrier of the inheritance and innovation of traditional Chinese medicine (TCM), the modern expanded application of classic formulae is an inevitable trend for TCM to adapt to the changes in disease spectrum and achieve academic development. However, several challenges remain, including the vague definition of syndrome-formula ontology between ancient and modern times, the insufficient adaptability of the evidence grading system, and the disconnection between theory and clinical practice, having severely restricted the precise application and standardized development of classic formulae. Based on the current status of the modern expanded application of classic formulae, and grounded in the core theory of formula-syndrome correspondence in TCM, this paper constructs a theoretical framework of "syndrome-formula ontology reconstruction". The framework systematically expounds its core connotations, theoretical foundations and practical logic, and further clarifies the reconstruction direction of the TCM-specific evidence grading system by taking correspondence between formula and syndrome as the core, constructing a multi-dimensional and integrated evaluation framework, and adhering to the orientation of clinical application. The ultimate goal is to form a theoretical paradigm characterized by "syndrome-formula ontology reconstruction-evidence grading reconstruction-precise clinical application", thereby providing theoretical support for the digital inheritance, evidence-based development, and modern application of classical prescriptions.
5.Mental health literacy and its relationship with symptoms of depression,anxiety,and insomnia in young adults
Yuqing YANG ; Jing HUANG ; Zixin LIN ; Tong YU ; Xiyuan CHEN ; Ning YANG ; Shaoling ZHONG ; Liang ZHOU
Chinese Mental Health Journal 2025;39(4):344-349
Objective:To explore the level of mental health literacy and its relationship with symptoms of de-pression,anxiety,and insomnia in young adults.Methods:A total of 10 273 young adults aged 18-23 in Guang-zhou were selected and assessed with the National Mental Health Literacy Questionnaire,Patient Health Question-naire-9(PHQ-9),General Anxiety Disorder 7-Item Scale(GAD-7)and Insomnia Severity Index(ISI).Results:Totally 1 137(11.1%)participants met the criteria for adequate mental health literacy,2 758(26.8%)participants were with symptoms of depression,1 355(13.2%)with symptoms of anxiety and 4 936(48.0%)experiencing symptoms of insomnia.Logistic regression analyses showed that after adjusting for other factors,substandard mental health literacy was an independent risk factor for symptoms of depression,anxiety and insomnia(OR=2.08,1.93,1.49;95%CI:1.74-2.48,1.52-2.46,1.31-1.70).Conclusion:The level of mental health literacy in young a-dults is insufficient,and the lack of mental health literacy is significantly associated with the symptoms of depres-sion,anxiety and insomnia.
6.Mental health literacy and its relationship with symptoms of depression,anxiety,and insomnia in young adults
Yuqing YANG ; Jing HUANG ; Zixin LIN ; Tong YU ; Xiyuan CHEN ; Ning YANG ; Shaoling ZHONG ; Liang ZHOU
Chinese Mental Health Journal 2025;39(4):344-349
Objective:To explore the level of mental health literacy and its relationship with symptoms of de-pression,anxiety,and insomnia in young adults.Methods:A total of 10 273 young adults aged 18-23 in Guang-zhou were selected and assessed with the National Mental Health Literacy Questionnaire,Patient Health Question-naire-9(PHQ-9),General Anxiety Disorder 7-Item Scale(GAD-7)and Insomnia Severity Index(ISI).Results:Totally 1 137(11.1%)participants met the criteria for adequate mental health literacy,2 758(26.8%)participants were with symptoms of depression,1 355(13.2%)with symptoms of anxiety and 4 936(48.0%)experiencing symptoms of insomnia.Logistic regression analyses showed that after adjusting for other factors,substandard mental health literacy was an independent risk factor for symptoms of depression,anxiety and insomnia(OR=2.08,1.93,1.49;95%CI:1.74-2.48,1.52-2.46,1.31-1.70).Conclusion:The level of mental health literacy in young a-dults is insufficient,and the lack of mental health literacy is significantly associated with the symptoms of depres-sion,anxiety and insomnia.
7.Analysis of Animal Model Construction Methods of Different Subtypes of Gastroesophageal Reflux Disease Based on Literature
Mi LYU ; Kaiyue HUANG ; Xiaokang WANG ; Yuqian WANG ; Xiyun QIAO ; Lin LYU ; Hui CHE ; Shan LIU ; Fengyun WANG
Journal of Traditional Chinese Medicine 2025;66(13):1386-1394
ObjectiveTo collate and compare the characteristics and differences in the methods for constructing animal models of different subtypes of gastroesophageal reflux disease (GERD) based on literature, providing a reference for researchers in this field regarding animal model construction. MethodsExperimental studies related to GERD including reflux esophagitis (RE), nonerosive reflux disease (NERD) and Barrett's esophagus (BE) model construction from January 1, 2014 to January 27, 2024, were retrieved from databases such as CNKI, Wanfang, VIP, Web of Science, and Pubmed. Information on animal strains, genders, modeling methods including disease-syndrome combination models, modeling cycles were extracted; for studies with model evaluation, the methods of model evaluation were also extracted; then analyzing all those information. ResultsA total of 182 articles were included. SD rats were most frequently selected when inducing animal models of RE (88/148, 59.46%) and NERD (9/14, 64.29%). For BE, C57BL/6 mice were most commonly used (11/20, 55.00%). Male animals (RE: 111/135, 82.22%; NERD: 11/14, 78.57%; BE: 10/12, 83.33%) were the most common gender among the three subtypes. The key to constructing RE animal models lies in structural damage to the esophageal mucosal layer, gastric content reflux, or mixed reflux, among which forestomach ligation + incomplete pylorus ligation (42/158, 26.58%) was the most common modeling method; the key to constructing NERD animal models lies in micro-inflammation of the esophageal mucosa, visceral hypersensitivity, and emotional problems, and intraperitoneal injection of a mixed suspension of ovalbumin and aluminum hydroxide combined with acid perfusion in the lower esophagus (8/14, 57.14%) was the most common modeling method; the key to constructing BE animal models lies in long-term inflammatory stimulation of the esophageal mucosa and bile acid reflux, and constructing interleukin 2-interleukin 1β transgenic mice (7/25, 28.00%) was the most common modeling method. Adverse psychological stress was the most common method for inducing liver depression. ConclusionsThe construction key principles and methodologies for RE, NERD, and BE animal models exhibit significant differences. Researchers should select appropriate models based on subtype characteristics (e.g., RE focusing on structural damage, NERD emphasizing visceral hypersensitivity). Current studies show insufficient exploration of traditional Chinese medicine disease-syndrome combination models. Future research needs to optimize syndrome modeling approaches (e.g., composite etiology simulation) and establish integrated Chinese-Western medicine evaluation systems to better support mechanistic investigations of traditional Chinese medicine.
8.Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis
Jian LIU ; Hongchun ZHANG ; Chengxiang WANG ; Hongsheng CUI ; Xia CUI ; Shunan ZHANG ; Daowen YANG ; Cuiling FENG ; Yubo GUO ; Zengtao SUN ; Huiyong ZHANG ; Guangxi LI ; Qing MIAO ; Sumei WANG ; Liqing SHI ; Hongjun YANG ; Ting LIU ; Fangbo ZHANG ; Sheng CHEN ; Wei CHEN ; Hai WANG ; Lin LIN ; Nini QU ; Lei WU ; Dengshan WU ; Yafeng LIU ; Wenyan ZHANG ; Yueying ZHANG ; Yongfen FAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):182-188
The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis (GS/CACM 337-2023) was released by the China Association of Chinese Medicine on December 13th, 2023. This expert consensus was developed by experts in methodology, pharmacy, and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine (CACM) and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine (pulmonary diseases) and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung, acute bronchitis, and acute attack of chronic bronchitis from the aspects of applicable populations, efficacy evaluation, usage, dosage, drug combination, and safety. It is expected to guide the rational drug use in medical and health institutions, give full play to the unique value of Qinbaohong Zhike oral liquid, and vigorously promote the inheritance and innovation of Chinese patent medicines.
9.Hypertension Chronic Disease Management Platform-Assisted Traditional Chinese Medicine Comprehensive Antihypertensive Regimen for the Treatment of Primary Hypertension: A Prospective Cohort Study
Lin ZHAO ; Shuchen DING ; Mei XUE ; Hao XU
Journal of Traditional Chinese Medicine 2025;66(16):1687-1694
ObjectiveTo observe the effect of the hypertension chronic disease management platform-assisted traditional Chinese medicine (TCM) comprehensive antihypertensive regimen on blood pressure control in the real world, and evaluate patients' satisfaction with this regimen. MethodsA total of 160 patients with primary hypertension were recruited, and the patients were asked to use the hypertension chronic disease management platform for self-management and to decide whether to apply TCM comprehensive antihypertensive regimen (including Baduanjin for lowering blood pressure, acupoint massage, and Chinese medicinal tea). One month later, the changes in patients' blood pressure and the application rate of each treatment regimen were investigated. Logistic regression analysis was used to analyze the correlation between each regimen and blood pressure changes. Sensitivity analysis was performed by excluding some patients with comorbidities that might affect the use of the regimens to verify the reliability of the research results. Interaction analysis was conducted to explore whether there was a synergistic effect between the regimens, and patient satisfaction was also surveyed. ResultsA total of 149 patients were finally included. Compared with patients who did not use TCM comprehensive antihypertensive regimen regularly, those who used it regularly had a more significant decrease in diastolic blood pressure (P<0.05). The results of Logistic regression analysis showed that the decrease in systolic blood pressure was associated with the use of TCM decoctions, and the decrease in diastolic blood pressure was associated with the use of TCM decoctions and regular use of TCM comprehensive antihypertensive regimen (P<0.05). Sensitivity analysis suggested that the above research results were stable. The results of interaction analysis showed that there was no interactive effect between antihypertensive Baduanjin and acupoint massage, antihypertensive Baduanjin and Chinese medicinal tea, or acupoint massage and Chinese medicinal tea on systolic and diastolic blood pressure (P>0.05). One hundred and thirty patients (130/149, 87.25%) thought the hypertension chronic disease management platform was helpful or very helpful, and 111 patients (111/149, 74.50%) thought TCM comprehensive antihypertensive regimen was helpful or very helpful. ConclusionRegular use of TCM comprehensive antihypertensive regimen helps reduce the diastolic blood pressure level in patients with primary hypertension, and patients have a high degree of satisfaction with the use of the hypertension chronic disease management platform and TCM comprehensive antihypertensive regimen.
10.Mechanism of Danshenol A in Alleviating Myocardial Ischemia-reperfusion Injury-induced Ferroptosis of Cardiomyocytes
Lei ZHANG ; Jiangang LIU ; Peili WANG ; Tao GENG ; Die LIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):135-144
ObjectiveTo investigate the mechanism of danshenol A (DA) pretreatment in alleviating myocardial ischemia-reperfusion injury (MIRI) by regulating cardiomyocyte ferroptosis by in vivo and in vitro experiments. MethodsA MIRI model was established in SD rats, and an in vitro oxygen-glucose deprivation/reoxygenation (OGD/R) model was constructed with H9C2 cells. Both models were treated with DA. H9C2 cells were allocated into blank, model (OGD/R), DA, ferroptosis inducer (erastin), and ferroptosis inhibitor (Fer-1) groups. Cell viability was assessed by the methyl thiazolyl tetrazolium (MTT) assay. Biochemical assays were performed to measure the superoxide dismutase (SOD), malondialdehyde (MDA), glutathione (GSH), and ferrous ion (Fe2+) levels. Dihydroethidium (DHE) fluorescence assay was adopted to quantify the reactive oxygen species (ROS) level. Real-time PCR and Western blot were employed to quantify the mRNA and protein levels, respectively, of prostaglandin-endoperoxide synthase 2 (PTGS2), glutathione peroxidase 4 (GPX4), ferritin heavy chain 1 (FTH1), and acyl-coA synthetase long-chain family 4 (ACSL4). Sixty SPF-grade healthy male SD rats were randomly assigned to control, model (MIRI), DA, erastin, and Fer-1 groups. Enzyme-linked immunosorbent assay (ELISA) was adopted to measure the serum levels of cardiac troponin I (cTnI), lactate dehydrogenase (LDH), and creatine kinase (CK). Histopathological changes in the myocardial tissue were observed by hematoxylin-eosin (HE) staining. Cardiomyocyte apoptosis was detected by terminal deoxynucleotidyl transferase-mediated nick end labeling (TUNEL). The effect of DA on cardiomyocyte ferroptosis were observed and analyzed by in vivo and in vitro experiments. ResultsIn vitro experiment: compared with the blank group, the OGD/R model group showed reduced cell viability, elevated levels of ROS, MDA, and Fe2+, up-regulated mRNA and protein levels of ACSL4, lowered levels of SOD and GSH, and down-regulated mRNA and protein levels of PTGS2, GPX4, and FTH1 (P<0.05,P<0.01). The DA and Fer-1 groups exhibited consistent trends: cell viability, SOD and GSH levels, and the mRNA and protein levels of PTGS2, GPX4, and FTH1 were significantly restored, while the ROS, MDA, and Fe2+ levels, and the mRNA and protein levels of ACSL4 were reduced (P<0.05,P<0.01). In vivo experiment: Compared with the control group, the MIRI model group showed elevated serum levels of cTnI, LDH, and CK, increased cardiomyocyte apoptosis rate, risen levels of ROS, MDA, and Fe2+, and up-regulated mRNA and protein levels of ACSL4. However, both DA and Fer-1 groups exhibited reductions in the indicators above (P<0.05). Compared with the control group, the MIRI model group demonstrated reduced levels of SOD and GSH and down-regulated mRNA and protein levels of PTGS2, GPX4, and FTH1 (P<0.05). In contrast, both DA and Fer-1 upregulated these indicators (P<0.05), effectively reversing the trends in the model group. In addition, the MIRI model group showed swelling of cardiomyocytes, disarrangement of cardiac muscle fibers, and massive inflammatory cell infiltration, which were alleviated in the DA and Fer-1 groups. ConclusionDA alleviates MIRI by inhibiting ferroptosis and inflammation, demonstrating therapeutic potential in acute myocardial infarction.

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