1.Therapeutic efficacy of extracorporeal shock wave therapy in the upper trapezius muscle area combined with exercise control training in patients with chronic non-specific neck pain
Haojing LI ; Xin WANG ; Chenglin SONG ; Shengnan ZHANG ; Yunxin CHEN
Chinese Journal of Tissue Engineering Research 2026;30(5):1162-1170
BACKGROUND:The incidence rate of chronic non-specific neck pain is high and the etiology is unknown.Myofascial pain and deep cervical flexor atrophy are the key factors.Extracorporeal shockwave therapy can improve microcirculation,relieve local pain,and delay the degenerative development of the cervical spine,while motion control training can significantly improve neck muscle strength and endurance and reduce neck pain.However,both methods have limited effectiveness when applied individually.OBJECTIVE:To explore the therapeutic efficacy of extracorporeal shock wave intervention combined with motion control training at the upper trapezius muscle on chronic non-specific neck pain.METHODS:Forty-two patients with chronic non-specific neck pain recruited from Shenyang Sport University were randomly divided into three groups:a shock wave group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle was given for 10-15 minutes,once a week for 4 weeks;a training group(n=14),in which motion control training was given for 40-50 minutes,three times a week for 4 weeks;and a combination group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle combined with motion control training was performed for 4 weeks.Patients were assessed for pain intensity,cervical spine function,upper trapezius muscle thickness,hemodynamic parameters,and serum interleukin 6 and tumor necrosis factor α levels before intervention,1 week and 4 weeks after intervention.RESULTS AND CONCLUSION:(1)Compared with the pre-intervention period,the visual analogue scale scores and neck disability index in the three groups were lower after 1 and 4 weeks of intervention(P<0.05),and the visual analogue scale scores and neck disability index in the combination group were lower than those of the shock wave group and the training group(P<0.05).(2)Compared with the pre-intervention period,the upper trapezius thickness increased in the training group and the combination group after 4 weeks of intervention(P<0.05);the upper trapezius thickness was greater in the combination group than in the shock wave group and the training group after 4 weeks of intervention(P<0.05).(3)The shock wave group and the combination group had an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P<0.05)and a decrease in the resistance index(P<0.05)after 1 and 4 weeks of intervention,while the training group showed an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P<0.05)and a decrease in the resistance index(P<0.05)after 4 weeks of intervention.The peak systolic velocity of the ascending segment of the transverse carotid artery in the combination group was higher(P<0.05)and the resistance index was lower(P<0.05)than those in the shockwave group and the training group after 1 and 4 weeks of intervention.(4)Compared with the pre-intervention period,the levels of interleukin 6 and tumor necrosis factor α were reduced in the shock wave and combination groups after 1 and 4 weeks of intervention(P<0.05),and in the training group after 4 weeks of intervention(P<0.05).After 1 and 4 weeks of intervention,the levels of interleukin 6 and tumor necrosis factor α were lower in the combination group than in the shock wave group and the training group(P<0.05).To conclude,extracorporeal shock wave combined with motion control training for chronic non-specific neck pain significantly reduces pain and improves neck function,and the mechanism of action may be to promote the blood flow velocity at the trigger point,reduce blood flow resistance,reduce the serum levels of interleukin 6 and tumor necrosis factor α,and increase the thickness of the upper trapezius muscle.
2.Efficacy of audiovisual training on ameliorating core symptoms in children with autism spectrum disorder
QU Zhiyi, LIU Zhao, LI Yi, HE Yingli, CHE Hong, ZHANG Xin
Chinese Journal of School Health 2026;47(5):646-651
Objective:
To explore the effect of a computer assisted audiovisual combined intervention model on the core symptoms of children with autism spectrum disorder (ASD), in order to provide references for enriching intervention and treatment methods for ASD children.
Methods:
From December 2023 to March 2024, 36 ASD children aged 4-8 years were recruited from Tianjin Disabled Persons Rehabilitation Center and Xinxinyu Children s Rehabilitation Center, and were divided into a training group (22 cases) and a control group (14 cases). The training group completed a 12 week audiovisual training course (visual sessions:twice a week, for 50-60 minutes each session; auditory sessions:three times a week, for 15 minutes each time), while the control group received only conventional treatment interventions. Before and after the intervention, the core symptoms of ASD children were assessed using the Short Sensory Profile (SSP), Social Responsiveness Scale (SRS), and Repetitive Behavior Questionnaire-2 ( RBQ- 2). Eye tracking experiments were used to test preferences for social attention.
Results:
Before the intervention, there were no statistically significant differences in the total scores and factor scores of the SSP and RBQ-2 scales between the two groups ( t =-1.63, 0.38, both P >0.05). The SRS total score, social communication, and restricted interests and repetitive behavior factor scores of the training group (90.68±25.83, 33.36±11.80, 15.64±7.00) were significantly higher than those of the control group (72.29±19.84, 24.93±7.85, 10.21±5.67) ( t =2.27, 2.36, 2.43, all P <0.05). Children in the training group with higher social communication factor scores before the intervention scored lower than the control group at the post intervention test (simple slope=-14.17, t =-2.48, P = 0.02), while there was no statistically significant difference in post intervention scores between children with lower social communication factor scores before the intervention and the control group (simple slope=2.31, t =0.57, P >0.05). Eye tracking experiments showed that the total fixation time on geometric images decreased significantly more in the training group [ -4.56 (-11.42, 1.21)] compared to the control group [6.55 (-0.32, 16.53)] after the intervention ( Z=2.48, P <0.05).
Conclusions
The computer assisted audiovisual intervention model can effectively improve the core symptoms of ASD children with poorer social communication levels. The promotion of the intervention model needs to consider individual differences in ASD.
3.Clinical Efficacy of Janus Kinase Inhibitors in Combination with Chinese Herbal Medicine for Rheumatoid Arthritis:A Retrospective Study and A Meta-analysis
Chenguang ZHAN ; Shengqin YANG ; Xin LI ; Yu WEN ; Peng ZHANG ; Xingrui YAN ; Haifang DU ; Maojie WANG ; Xiaodong WU ; Liyan MEI ; Xiumin CHEN ; Yanlin LI ; Runyue HUANG
Journal of Traditional Chinese Medicine 2026;67(5):534-543
ObjectiveTo evaluate the efficacy and safety of Janus kinase (JAK) inhibitors combined with Chinese herbal medicine (CHM) in treating rheumatoid arthritis (RA). MethodsClinical data from 169 RA patients were retrospectively collected. Among them, 71 cases received JAK inhibitors as the control group, while 98 cases received JAK inhibitors plus CHM as the observation group, both treated for 24 weeks. The rheumatoid factor (RF), cyclic citic peptide antibody (anti-CCP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and white blood cell count (WBC) were recorded before and after treatment. Databases including CNKI, Wanfang, VIP, PubMed and Web of Science were searched from inception till August 31st, 2025 for randomized controlled trials (RCTs) on the combined use of JAK inhibitors and CHM for RA. The methodological quality of the included studies was evaluated using the risk of bias assessment tool. Meta-analyses were performed for RF, anti-CCP, ESR, CRP, 28-joint disease activity score (DAS28), overall clinical effective rate, and incidence of adverse events. Sensitivity analysis were also performed. ResultsThe retrospective study demonstrated that after treatment, ESR, CRP, and anti-CCP levels decreased in the observation group, while ESR and CRP levels decreased in the control group (P<0.05). Moreover, ESR and RF levels in the observation group were lower than those in the control group (P<0.05). A total of 9 RCTs involving 770 patients were included in the meta-analysis. The results indicated that the JAK inhibitors plus CHM group was superior to the JAK inhibitors group in reducing RF (MD=-8.97, 95%CI -15.01 to -2.94, P=0.004), CRP (MD=-3.34, 95%CI -3.82 to -2.86, P<0.001), ESR (MD=-5.33, 95%CI -7.98 to -2.69, P<0.001), and DAS28 score (MD=-0.54, 95%CI -0.74 to -0.34, P<0.001), as well as in improving the overall clinical effective rate (OR=4.53, 95%CI 2.55 to 8.03, P<0.001). No statistically significant differences were observed between groups in anti-CCP levels (SMD=-2.08, 95%CI -4.41 to 0.24, P=0.080) or incidence of adverse events (OR=0.93, 95%CI 0.55 to 1.57, P=0.790). ConclusionThe combination of JAK inhibitors and CHM demonstrates remarkable efficacy in treating RA, contributing to improved disease activity and reduced inflammatory markers with a favorable safety profile.
4.The study of m6A methylation-related proteins in the prefrontal cortex of PTSD mice
Jiaying LU ; Luodong YANG ; Keke LU ; Wenlong XIN ; Bin LI ; Qulong LI ; Guiqing ZHANG
Acta Universitatis Medicinalis Anhui 2026;61(3):495-500
ObjectiveTo investigate the expression of prefrontal cortical neurons, methyltransferase-like 3 (METTL3), fat mass and obesity-associated gene (FTO), and AlkB homolog 5 (ALKBH5) proteins in a mouse model of post-traumatic stress disorder (PTSD). MethodsA PTSD mouse model was established using a single prolonged stress and foot shock stimulation (SPSS) method. The despair, anxiety, and learning and memory functions of PTSD mice were assessed through the open field test, Y-maze test, and forced swimming test. Neuronal damage was detected via HE and Nissl staining. The expression levels of METTL3, FTO, ALKBH5, and neuronal nuclear protein (NEUN) were assessed by Western blot and immunofluorescence staining. ResultsCompared to control group, PTSD mice subjected to SPSS exhibited signs of despair, anxiety, and impaired learning and memory. HE and Nissl staining results showed neuronal damage in the prefrontal cortex of PTSD mice. Western blot and immunofluorescence staining results showed that the expression of the m6A-related proteins METTL3 and FTO decreased, while the expression of ALKBH5 increased in the prefrontal cortex. Additionally, NEUN protein levels showed a declining trend. ConclusionThe pathogenesis of PTSD may be associated with neuronal damage in the prefrontal cortex and alterations in m6A methylation proteins.
5.Research progress on the role of macrophages in atherosclerosis
Wenxiu MA ; Li BAI ; Wen MA ; Tingting QI ; Haonan ZHANG ; Xuan WANG ; Xin ZHANG
Acta Universitatis Medicinalis Anhui 2026;61(4):770-775
Atherosclerosis (AS) is a chronic and inflammatory vascular disease. Macrophages are common immune cells and play an important role in the development of AS. In recent years, research has found that the formation of AS plaques is closely related to pathological and physiological processes such as macrophage polarization, energy metabolism, and lipid phagocytosis. This review aims to summarize the mechanism of macrophages in the development of AS, and to explore potential therapeutic methods for delaying AS by regulating macrophages, providing new ideas for the treatment and research of AS.
6.DIA Proteomic Profiling on Staged Regulatory Effect of Tonifying Deficiency and Dredging Collaterals Method on Liver Fibrosis in Rats Based on Theory of "Zhu Ke Jiao"
Xin WANG ; Pengyu ZHU ; Li WEN ; Jibin LIU ; Aochun YUE ; Ziyi CHEN ; Jing ZHANG ; Li ZHU ; Quansheng FENG ; Cen JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(14):119-132
ObjectiveThis paper aims to investigate the differential mechanisms underlying the staged therapeutic effects of Qijia Rougan formula on liver fibrosis using proteomic technology. MethodsThe staged rat model of liver fibrosis was established by subcutaneous injection of carbon tetrachloride (CCl4) and olive oil. One hundred and four SD rats were randomized into thirteen groups:a normal group,a two-week model group,a four-week model group,a six-week model group,an eight-week model group,a two-week Qijia Rougan formula group,a four-week Qijia Rougan formula group,a six-week Qijia Rougan formula group,an eight-week Qijia Rougan formula group,a two-week compound Biejia Ruangan tablet group,a four-week Compound Biejia Ruangan Tablet group,a six-week Compound Biejia Ruangan Tablet group,and an eight-week compound Biejia Ruangan tablet group. After two weeks of drug intervention,liver tissue and abdominal aortic blood samples were collected from the rats for testing. Hematoxylin-eosin (HE) staining,Masson staining,and Picro Sirius red staining were used to observe pathological damage and collagen fiber deposition in liver tissues. Immunohistochemistry (IHC) was employed to detect the contents of fibrosis markers in liver tissues. The contents of liver function indicators in the serum were measured using a fully automated biochemical analyzer,and the levels of liver fibrosis indicators in the serum were assessed by enzyme-linked immunosorbent assay (ELISA). Liver tissues from the normal group,each model group,and each Qijia Rougan formula group were subjected to label-free quantitative proteomic analysis to identify differential proteins among the groups,with key proteins validated by Western blot. Finally,bioinformatics analysis was performed on the differential proteins. Results(1) The staged rat model of liver fibrosis constructed with CCl4 and olive oil showed pathological results at the 2nd,4th,6th,and 8th weeks of modeling that were consistent with the Metavir standards for the F1,F2,F3,and F4 stages. Compared with those in the normal control group,the protein expressions of α-smooth muscle actin (α-SMA) and Collagen Ⅰ were significantly increased in each stage (P<0.05). The levels of liver function indicators in the serum,including alanine aminotransferase (ALT),aspartate aminotransferase (AST),alkaline phosphatase (ALP),direct bilirubin (DBIL),and total bilirubin (TBil) in each model group,were significantly elevated in each stage (P<0.01). The levels of liver fibrosis indicators in the serum,including procollagen Ⅲ peptide (PⅢP),type Ⅳ collagen(Ⅳ-C),hyaluronic acid (HA),and laminin (LN) in each model group,were significantly increased in each stage (P<0.05,P<0.01). This study successfully established a staged rat model of liver fibrosis. (2) Compared with the model groups at each stage,the administration groups showed a reduction in hepatocyte ballooning degeneration,a more orderly arrangement of hepatocytes,and a decrease of inflammatory cell infiltration. The blue-stained collagen fibers became significantly thinner and finer,with reduced and narrowed fibrous septa. The areas of collagen fibers and Picro Sirius red staining were reduced (P<0.05). The positive areas of α-SMA and Collagen Ⅰ expression were significantly decreased (P<0.05). The levels of ALT,AST,ALP,DBIL,and TBil in the rats of the model groups at each stage were significantly reduced (P<0.05,P<0.01). The levels of PⅢP,Ⅳ-C,HA,and LN in the rats of the model groups at each stage were significantly decreased (P<0.05). Among these,the improvements in all indicators were most significant in the F3 stage (P<0.01).(3) The proteomic results show that a total of 165 differential proteins exhibit a callback trend when comparing the model groups at four stages with the normal group,and when comparing the Qijia Rougan formula group with the model group. Western blot analysis reveals that the levels of NAD(P)H:quinone oxidoreductase 1 (NQO1),mitogen-activated protein kinase 1 (MAPK1),arginase 1 (Arg1),and glutathione S-transferase α1 (GSTA1) were consistent with the proteomic results. Bioinformatics results reveal that 165 differentially expressed proteins are enriched in multiple signaling pathways. Notably,signaling pathways such as drug metabolism-cytochrome P450,arginine biosynthesis,and the peroxisome proliferator-activated receptor (PPAR) signaling pathway were found to be closely associated with liver fibrosis,suggesting that the Qijia Rougan formula may exert its staged regulatory effects on liver fibrosis by regulating these pathways. ConclusionThe Qijia Rougan formula may achieve staged regulation of liver fibrosis by regulating drug metabolism-cytochrome P450,arginine biosynthesis,and the PPAR signaling pathway.
7.Therapeutic efficacy of extracorporeal shock wave therapy in the upper trapezius muscle area combined with exercise control training in patients with chronic non-specific neck pain
Haojing LI ; Xin WANG ; Chenglin SONG ; Shengnan ZHANG ; Yunxin CHEN
Chinese Journal of Tissue Engineering Research 2026;30(5):1162-1170
BACKGROUND:The incidence rate of chronic non-specific neck pain is high and the etiology is unknown.Myofascial pain and deep cervical flexor atrophy are the key factors.Extracorporeal shockwave therapy can improve microcirculation,relieve local pain,and delay the degenerative development of the cervical spine,while motion control training can significantly improve neck muscle strength and endurance and reduce neck pain.However,both methods have limited effectiveness when applied individually.OBJECTIVE:To explore the therapeutic efficacy of extracorporeal shock wave intervention combined with motion control training at the upper trapezius muscle on chronic non-specific neck pain.METHODS:Forty-two patients with chronic non-specific neck pain recruited from Shenyang Sport University were randomly divided into three groups:a shock wave group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle was given for 10-15 minutes,once a week for 4 weeks;a training group(n=14),in which motion control training was given for 40-50 minutes,three times a week for 4 weeks;and a combination group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle combined with motion control training was performed for 4 weeks.Patients were assessed for pain intensity,cervical spine function,upper trapezius muscle thickness,hemodynamic parameters,and serum interleukin 6 and tumor necrosis factor α levels before intervention,1 week and 4 weeks after intervention.RESULTS AND CONCLUSION:(1)Compared with the pre-intervention period,the visual analogue scale scores and neck disability index in the three groups were lower after 1 and 4 weeks of intervention(P<0.05),and the visual analogue scale scores and neck disability index in the combination group were lower than those of the shock wave group and the training group(P<0.05).(2)Compared with the pre-intervention period,the upper trapezius thickness increased in the training group and the combination group after 4 weeks of intervention(P<0.05);the upper trapezius thickness was greater in the combination group than in the shock wave group and the training group after 4 weeks of intervention(P<0.05).(3)The shock wave group and the combination group had an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P<0.05)and a decrease in the resistance index(P<0.05)after 1 and 4 weeks of intervention,while the training group showed an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P<0.05)and a decrease in the resistance index(P<0.05)after 4 weeks of intervention.The peak systolic velocity of the ascending segment of the transverse carotid artery in the combination group was higher(P<0.05)and the resistance index was lower(P<0.05)than those in the shockwave group and the training group after 1 and 4 weeks of intervention.(4)Compared with the pre-intervention period,the levels of interleukin 6 and tumor necrosis factor α were reduced in the shock wave and combination groups after 1 and 4 weeks of intervention(P<0.05),and in the training group after 4 weeks of intervention(P<0.05).After 1 and 4 weeks of intervention,the levels of interleukin 6 and tumor necrosis factor α were lower in the combination group than in the shock wave group and the training group(P<0.05).To conclude,extracorporeal shock wave combined with motion control training for chronic non-specific neck pain significantly reduces pain and improves neck function,and the mechanism of action may be to promote the blood flow velocity at the trigger point,reduce blood flow resistance,reduce the serum levels of interleukin 6 and tumor necrosis factor α,and increase the thickness of the upper trapezius muscle.
8.Tracing Development of LIU Wansu's Theory of ''Fire-heat Inducing Stroke''
Xin LAN ; Changxiang LI ; Haojia ZHANG ; Jialin CHENG ; Zijin SUN ; Liyang DONG ; Zilin REN ; Xueqian WANG ; Fafeng CHENG ; Qingguo WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):32-41
LIU Wansu, as the foremost of the four great masters of the Jin-Yuan period, established the "theory of fire-heat'' and extended the fire-heat pathogenesis framework to the field of stroke, thereby forming the theory of ''fire-heat inducing stroke''. This achieved a paradigmatic shift in stroke etiology from ''exogenous wind inducing stroke'' to ''fire-heat inducing stroke''. This paper systematically reviews the developmental trajectory of LIU Wansu's ''fire-heat inducing stroke'' theory and explores the social background, academic origins, and core connotations of its theoretical construction. The study found that, based on the ''Nineteen Pathomechanisms'' in the Huangdi's Internal Classic (Huang Di Nei Jing) and combined with clinical practice, LIU Wansu proposed that fire-heat is the fundamental cause of stroke, and that the Six Climatic Factors and the Five Zhi-Emotions can all transform into fire. He further constructed a stratified syndrome differentiation and therapeutic system centered on clearing heat and purging fire, emphasizing differentiated treatment of exterior and interior syndromes, Six Meridians syndrome differentiation, and seasonally adjusted medication. This theory not only resolved the diagnostic and therapeutic dilemmas of febrile epidemic diseases during the Jin-Yuan period, but also exerted a profound influence on later physicians such as ZHANG Zihe and ZHU Danxi, thereby promoting the pluralistic development of stroke theory in traditional Chinese medicine (TCM). Modern pharmacological research provides solid scientific evidence, confirming that the ''fire-heat'' pathological state is highly associated with key mechanisms such as excessive inflammatory responses, oxidative stress, and excitatory amino acid toxicity following cerebral ischemia. Heat-clearing and fire-purging prescriptions and agents, such as Huanglian Jiedu Tang and baicalin, can exert multi-target neuroprotective effects by regulating inflammatory signaling, enhancing antioxidant enzyme activity, and balancing neurotransmitters. This not only verifies the scientific basis of the ''fire-heat inducing stroke'' theory from a modern biological perspective but also provides conclusive evidence for the clinical application of heat-clearing and fire-purging therapy. LIU Wansu's ''fire-heat inducing stroke'' theory represents a major milestone in the historical understanding of stroke pathogenesis, and its academically transitional insights continue to hold core guiding value for the pattern identification and treatment of ischemic stroke today.
9.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
10.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.


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