1.Current Status of Traditional Chinese Medicine Diagnosis and Treatment of Inflammatory Bowel Disease and the Research on Mechanism
Junxiang LI ; Hong SHEN ; Tangyou MAO ; Lei ZHU ; Jiaqi ZHANG ; Zhibin WANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(1):103-110
In recent years, traditional Chinese medicine (TCM) has achieved significant progress in the treatment of inflammatory bowel disease (IBD). A comprehensive literature search was conducted covering the period from January 1, 2010, to December 30, 2024, across Chinese databases including China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP China Science and Technology Journal Database, and the Chinese Biomedical Literature Service System, as well as international databases such as PubMed, Web of Science, and Embase. The clinical applications and mechanistic studies of TCM in IBD were systematically reviewed. The current status of TCM research on the etiology and pathogenesis of IBD, innovative clinical practices, and multimodal therapeutic approaches, including Chinese herbal formulas, single herbs or active compounds, acupuncture, herbal retention enema, and acupoint application, were summarized, together with their synergistic effects when combined with western medical treatments. The development and application of Chinese patent medicines for IBD are undergoing a profound transition from efficacy validation to mechanistic exploration. Mechanistic studies on the effects of TCM in IBD mainly focus on regulating gut microbiota homeostasis, repairing the intestinal mucosal barrier, and modulating intestinal immune balance. Furthermore, future research directions for TCM-based IBD management are proposed, including the establishment of TCM diagnostic and treatment models, expanding integrated applications of external and internal TCM therapies, innovating personalized treatment strategies, and advancing drug development. These efforts aim to provide insights for the standardized and precision-oriented development of TCM in the diagnosis and treatment of IBD.
2.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.
3.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
4.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
5.Survey on the perception and current status of drug risk management in medical institutions
Xuelin SUN ; Mingqing XING ; Zixuan ZHANG ; Wenjing ZHAO ; Dongfang QIAN ; Yan LIANG ; Li XU ; Pengfei JIN ; Yatong ZHANG
China Pharmacy 2025;36(1):7-12
OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions, providing insights and recommendations for enhancing the drug risk management system in medical institutions. METHODS A questionnaire survey was conducted across 28 provinces, cities, and autonomous regions; stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population, the current status of drug risk management implementation in medical institutions, the cognition, definition and process of drug risk management related concepts, and the content and mode of drug risk management work in medical institutions. Finally, suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data. RESULTS A total of 446 questionnaires were collected in this survey, including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%,and the effective rate was 94.17%. 51.19% of the respondents No.2020YFC2009001)。 based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring, while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management, with the highest proportion (72.17%) was in third-grade class A medical institutions. 66.43% reported implementing risk management across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents, clarifying concepts, establishing information-sharing mechanisms. CONCLUSIONS The overall awareness of drug risk management in China’s medical institutions is high, with practices in place across various stages in multiple forms. However, there remains a need to strengthen institutional documents, management regulations, system development, and information-sharing mechanisms to improve collaborative governance, improve drug management levels, and ensure patient safety.
6.Exploration of the Intervention Mechanism of Qingshi Anti-itch Ointment (青石止痒软膏) on Psoriasis Model Mice Based on Caspase-1/GSDMD Protein Pathway
Yatong LI ; Yuanwen LI ; Yutong DENG ; Xuewen REN ; Xuewan WANG ; Xinhui YU ; Tangyunni LIU
Journal of Traditional Chinese Medicine 2025;66(2):170-177
ObjectiveTo explore the possible action mechanism of Qingshi Anti-itch Ointment (青石止痒软膏, QAO) in the treatment of psoriasis. MethodsForty mice were randomly divided into four groups, blank group, model group, calcipotriol group and QAO group, with 10 mice in each group. Except for the blank group, psoriasis was induced by applying imiquimod cream to the dorsal skin. After modeling for 6 hours daily, the calcipotriol group and QAO group were treated with 0.5 g of calcipotriol ointment or 0.5 g of QAO, respectively, applied to the treated dorsal skin. The blank group and the model group received no treatment. The skin lesions were observed, and the psoriasis area and severity index (PASI) score was assessed every other day. After 7 days, Hematoxylin and Eosin (HE) staining was performed on dorsal skin tissue to observe pathological changes. The levels of interleukin 1β (IL-1β) and interleukin 18 (IL-18) were determined by enzym-linked immunosorbent assay (ELISA). The protein levels of Caspase-1,Pro-Caspase-1, gasdermin D (GSDMD) and gasdermin-D-N (GSDMD-N) were detected by Western Blot (WB). The protein levels of GSDMD were observed by immunohistochemistry. ResultsCompared with the blank group, the model group mice showed redness, erythema, and white scales on their skin, with histological observations indicating epidermal thickening, elongated spines, and infiltration of inflammatory cells. The PASI scores of the skin tissue on days 1, 3, 5, and 7 were elevated; the IOD and AOD values of GSDMD protein increased; the protein levels of Caspase-1, Pro-Caspase-1,GSDMD, GSDMD-N, and IL-1β and IL-18 were significantly elevated (P<0.05 or P<0.01). Compared with the model group, the QAO group and calcipotriol group showed lighter skin lesions; the PASI scores on day 5 and day 7 in the QAO group, and on day 3, 5, and 7 in the calcipotriol group, were reduced; the IOD and AOD values of GSDMD protein, and the protein level of Caspase-1, GSDMD, and GSDMD-N, as well as level of IL-18 and IL-1β decreased in both groups; in the calcipotriol group, Pro-Caspase-1 protein level also decreased (P<0.05 or P<0.01). Compared with the calcipotriol group, the QAO group showed slightly redder skin, more obvious thickening of the stratum corneum, and less capillary dilation; the PASI scores on day 3 and day 7 increased, while the score on day 5 was reduced; the protein level of Pro-Caspase-1, GSDMD, GSDMD-N, and the level of IL-18 and IL-1β were increased in the QAO group (P<0.05). ConclusionQAO can effectively relieve psoriasis dermatitis in mice. Its potential mechanism may be related to the regulation of the Caspase-1/GSDMD protein pathway, down-regulation of IL-18 and IL-1β levels, and alleviation of pyroptosis.
7.Clinical Observation of Modified Zhigancao Tang in Treating Patients with Liver and Kidney Deficiency of Parkinson's Disease and Its Effect on Neuronal Signal-related Proteins
Yifo WEI ; Furong LYU ; Jia YAO ; Guonian LI ; Xianyi LUO ; Meng LUO ; Zhengzheng WEN ; Qiuqi LI ; Yihan LIU ; Linlin YANG ; Rui ZUO ; Wenxin DANG ; Fang MI ; Xiaoyan WANG ; Zhigang CHEN ; Fan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):166-173
ObjectiveMicrotube associated protein-2 (MAP-2), alpha-tubulin (α-tubulin), and synaptophysin (SYP) are important proteins in neuronal signal communication. This paper observed the effects of modified Zhigancao Tang on the expression of serum α-Synuclein (α-Syn) and its oligomers, MAP-2, α-tubulin, and SYP of patients with liver and kidney deficiency of Parkinson's disease (PD), analyzed their correlation, and evaluated the therapeutic effect of modified Zhigancao Tang in patients with liver and kidney deficiency of PD based on α-Syn transmission pathway mediated by neuronal communication in vivo. MethodsA total of 60 patients with PD who met the inclusion criteria were randomly divided into a treatment group (30 cases) and a control group (30 cases). Both groups were treated on the basis of PD medicine, and the treatment group was treated with modified Zhigancao Tang. Both groups were treated for 12 weeks. The changes in UPDRS score, TCM syndrome score, and expression of serum α-Syn and its oligomers, MAP-2, α-tubulin, and SYP were observed before and after 12 weeks of treatment in each group. The correlation between the above-mentioned serum biological indexes and the levels of serum α-Syn and its oligomers was analyzed. ResultsAfter treatment, the TCM syndrome score, UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ score of the treatment group were significantly decreased (P<0.05, P<0.01). The UPDRS score, UPDRS-Ⅱ score, and UPDRS-Ⅲ scores in the treatment group were significantly decreased compared with those in the control group after treatment (P<0.05). After treatment, the total effective rate of the control group was 63.3% (19/30), and that of the treatment group was 86.7% (26/30). The clinical effect of the observation group was better than the control group (Z=-2.03, P<0.05). The total effective rate of the observation group was better than that of the control group, and the difference was statistically significant (χ2=5.136, P<0.05). After treatment, the oligomer level of serum α-Syn and MAP-2 level in the treatment group were significantly decreased (P<0.05, P<0.01). The levels of serum α-Syn and its oligomers, as well as α-tubulin in the treatment group, were significantly decreased compared with those in the control group after treatment (P<0.05, P<0.01). Serum α-Syn was correlated with serum MAP-2 and α-Syn oligomer in patients with PD (P<0.05, P<0.01) but not correlated with serum SYP . Serum α-Syn oligomers of patients with PD were correlated with serum MAP-2 and α-tubulin (P<0.05, P<0.01) but not correlated with serum SYP level. Serum SYP of patients with PD was correlated with serum MAP-2 (P<0.05). ConclusionModified Zhigancao Tang has a therapeutic effect on patients with liver and kidney deficiency of PD by inhibiting the production of α-Syn oligomers and intervening α-Syn microtubule transport pathway in vivo.
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.The Influence of Time Rhythm and Immune System on the Pathogenesis of Ulcerative Colitis from "Theory of Wei Qi "
Xiaosi ZHANG ; Anqi YANG ; Lei SHI ; Junxiang LI
Journal of Traditional Chinese Medicine 2025;66(3):238-243
The movement of wei qi (defensive qi) follows the circadian rhythm of "circulating on the yang during the day, and on the yin at night" and serves a defensive function to "protect the body". Guided by the theory of wei qi, it is believed that time rhythms and the immune system play significant roles in the pathogenesis of ulcerative colitis (UC). Dysfunction in wei qi circulation, particularly when "yang fails to enter yin," can lead to the onset of UC; the cyclical nature of wei qi's movement results in disease patterns characterized by "morning relief, daytime stability, evening aggravation, and nighttime worsening", which align with the rhythmic characteristics of immune responses. The defensive function of wei qi is crucial in maintaining intestinal immunity of patients with UC, and the spleen and stomach, which are the sources of wei qi, are key to sustaining intestinal mucosal immune homeostasis; additionally, obstruction in the ascending and descending movements of wei qi, internal disruption, and latent pathogen in the intestines lead to the development of UC. Based on the theory of wei qi, treatment approaches for UC are proposed, including time-based dietary adjustments and chronotherapy to harmonize human activities with natural rhythms; these approaches emphasize protecting the spleen and stomach while also considering the lungs and kidneys, balancing sanjiao, and harmonizing ying qi and wei qi, so as to improve the clinical effectiveness of UC treatment.
10.Professor LIU Jinmin's Clinical Experience in Treating Epilepsy Based on the Method of Closing Yangming and Regaining Vital Activity
Lin ZOU ; Tianye SUN ; Mingyuan YAN ; Mi ZHAGN ; Shuai ZHAO ; Kaiyue WANG ; Lili LI ;
Journal of Traditional Chinese Medicine 2025;66(4):344-348
To summarize the clinical experience of Professor LIU Jinmin in treatment for epilepsy. It is believed that main pathogenesis of epilepsy is yangming failure to close and vital activity loss control, so a therapeutic approach focused on restoring the closure of yangming and regaining vital activity was proposed for the treatment of epilepsy. For excess syndrome, the treatment focuses on draining excess and descending qi, promoting purgation and restoring spirit. When yangming dryness-heat predominates, the approach involves unblock the bowels and regulating the spirit, descending qi and reducing fire, with modified Chengqi Decoction (承气汤) as prescription; when yangming phlegm-fire predominates, the treatment focuses on clearing heat and resolving phlegm, calming mind and suppressing fright, with modified Qingxin Wendan Decoction (清心温胆汤) as prescription; when yangming blood stasis predominates, the approach involves breaking up blood stasis and promoting purgation, eliminating stasis and awakening the mind, with Taoren Chengqi Decoction (桃核承气汤) as prescription. For deficiency syndrome, the treatment emphasizes tonifying deficiency and raising qi, strengthening the stomach and nourishing the spirit. When center qi deficiency and sinking of clear qi of the nutrients from food, the approach involves replenishing and uplifting qi while nourishing vital activity, with modified Liujunzi Decoction (六君子汤) as prescription; when yin deficiency and fluid consumption, the treatment focuses on nourishing stomach and tonifying yin, promoting fluid production and calming the spirit, with modified Maimendong Decoction (麦门冬汤) combined with Yiwei Decoction (益胃汤) as prescriptions. In clinical situations of deficiency-excess complex, it is essential to distinguish the primary condition from the secondary, applying both supplementing and draining methods flexibly to achieve optimal treatment.

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