In recent years， with the extensive application of traditional Chinese medicine （TCM） both domestically and internationally， safety concerns associated with TCM have been frequently reported. Notably， some TCM substances traditionally regarded as ''non-toxic'' have exhibited significant adverse reactions during clinical use， drawing substantial attention to TCM safety. This study first analyzed the risk factors contributing to the potential toxicity of TCM from perspectives such as drug properties， individual constitution， and clinical medication practices. Subsequently， it proposed research strategies and methodologies for investigating potential TCM toxicity： ① conduct studies under the guidance of TCM theory， adhering to the principle of diversity and unity. ② adopt an integrated research paradigm of ''originating from clinical practice-syndrome-based foundation-returning to clinical practice-serving supervision''. ③ implement a three-tier technical system of ''Mathematical modeling-high-throughput screening via liquid chromatography-mass spectrometry （LC-MS）-systems biology'' to systematically elucidate the causes， material basis， and mechanisms of toxicity. Finally， scientific regulatory recommendations for potential TCM toxicity are proposed： ① establish a multidimensional prevention and control system addressing drug properties， physical constitution factors， and clinical medication practices. ② address the impact of modern processing techniques on the safety of new TCM drugs. ③ strengthen the revision of standards for Chinese medicinal materials to ensure their safety. ④ account for disease-syndrome combination animal models and interspecies differences in safety assessment outcomes. This study aims to overcome critical challenges in TCM regulation by advancing evaluation through research and driving research through evaluation. By establishing a high-level scientific regulatory framework， it seeks to not only safeguard clinical medication safety but also propel the high-quality development of the TCM industry， thereby providing scientific support for the inheritance and innovative evolution of TCM.

In recent years， with the extensive application of traditional Chinese medicine （TCM） both domestically and internationally， safety concerns associated with TCM have been frequently reported. Notably， some TCM substances traditionally regarded as ''non-toxic'' have exhibited significant adverse reactions during clinical use， drawing substantial attention to TCM safety. This study first analyzed the risk factors contributing to the potential toxicity of TCM from perspectives such as drug properties， individual constitution， and clinical medication practices. Subsequently， it proposed research strategies and methodologies for investigating potential TCM toxicity： ① conduct studies under the guidance of TCM theory， adhering to the principle of diversity and unity. ② adopt an integrated research paradigm of ''originating from clinical practice-syndrome-based foundation-returning to clinical practice-serving supervision''. ③ implement a three-tier technical system of ''Mathematical modeling-high-throughput screening via liquid chromatography-mass spectrometry （LC-MS）-systems biology'' to systematically elucidate the causes， material basis， and mechanisms of toxicity. Finally， scientific regulatory recommendations for potential TCM toxicity are proposed： ① establish a multidimensional prevention and control system addressing drug properties， physical constitution factors， and clinical medication practices. ② address the impact of modern processing techniques on the safety of new TCM drugs. ③ strengthen the revision of standards for Chinese medicinal materials to ensure their safety. ④ account for disease-syndrome combination animal models and interspecies differences in safety assessment outcomes. This study aims to overcome critical challenges in TCM regulation by advancing evaluation through research and driving research through evaluation. By establishing a high-level scientific regulatory framework， it seeks to not only safeguard clinical medication safety but also propel the high-quality development of the TCM industry， thereby providing scientific support for the inheritance and innovative evolution of TCM.

Rheumatoid arthritis belongs to arthralgia syndrome in the theory of traditional Chinese medicine， and cold-dampness obstruction syndrome and dampness-heat obstruction syndrome are core syndromes and main syndrome differentiation types of this disease. Fine therapeutic effects have been obtained in the long-term clinical practice of many famous traditional Chinese medicine practitioners following the syndrome differentiation and treatment based on the guiding principles of cold and heat. To adapt to the clinical diagnosis practice of combining disease differentiation and syndrome differentiation， and to better carry out basic research on integrated Chinese and Western medicine and preclinical study on new traditional Chinese medicines， Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-Dampness Obstruction Syndrome and Dampness-Heat Obstruction Syndrome （hereinafter referred to as the Guidelines） were compiled by our research group， in cooperation with the renowned experts in research fields including traditional Chinese medicine， clinical medicine， zoology and evidence-based medicine， which provide a meaningful reference for scientific research， teaching and clinical applications. The compilation process of the Guidelines was guided by the theory of disease and syndrome integration and the principles of "evidence takes the main place， consensus plays an auxiliary role， and experience serves as the reference". Based on the comprehensive evaluation of pathogenesis homology， behavioral phenotypic consistency， and drug treatment predictability compared between animal models and human diseases， by the nominal group method， "recommendations" were formed for recommendations supported by evidence， and "consensus recommendations" were formed for recommendations not supported by evidence. Guidelines were formed involving content such as animal types， arthritis modeling methods， external stimulation conditions， and modeling assessment indicators during the establishment of the animal models of rheumatoid arthritis with cold-dampness obstruction syndrome and dampness-heat obstruction syndrome. The Guidelines are applicable for the disease and syndrome research on rheumatoid arthritis， investigation of therapeutic mechanisms， and development of new traditional Chinese medicine. The Guidelines also provide a reference for the establishment of guidelines on other types of diseases and syndromes combined with animal models to further promote the modernization of traditional Chinese medicine research and its integration with international academic development.

The Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome （hereinafter referred to as the Guidelines） （No. T/CACM1567-2024） was published by Chinese Association of Chinese Medicine on January 11， 2024. To assist researchers and medical workers in understanding and applying the Guidelines more accurately， and also to provide reference and assistance for the establishment of guidelines on other types of diseases and syndromes combined with animal models， this paper made a declaration of the workflow， technological links， development references， promotion of its application and after-effect evaluation of the Guidelines that has been made according to the requirements of "Draft Group Standard of the Standardization Office of the Chinese Association of Traditional Chinese Medicine".

Objective: To investigate the mechanism of action of Prim-O-glucosylcimifugin (POG) to improve cholesterol metabolism in osteoarthritic (OA) chondrocytes based on the long noncoding RNA nuclear-enriched transcript 1 (lncRNA NEAT1)/microRNA-128-3p (miR-128-3p) pathway. Methods: For in vivo experiments, 60 mice were divided into the normal, sham operation, model, and POG groups using the random number table method, with 15 mice per group. The osteoarthritis mouse model was constructed using the modified Hulth method in the model and POG groups. Mice in the POG group were administered 30 mg/(kg·d)POG by gavage. The other groups were administered an equal amount of normal saline for 8 weeks. The cartilage tissue structure of mice in each group was observed using hematoxylin and eosin staining. Real-time PCR was used to detect changes in the lncRNA NEAT1 and miR-128-3p mRNA expression levels in the cartilage tissues of mice. Western blotting was used to detect the protein expressions of ATP-binding cassette transporter A1 (ABCA1), liver X receptor β (LXRβ), matrix metalloprotein-3 (MMP-3), and B-lymphoblastoma-2-associated X protein (Bax) in articular cartilage of mice. An enzyme-linked immunosorbent assay was used to measure the tumor necrosis factor-α (TNF-α) content in the synovial fluid of mice. A biochemical microplate assay was used to measure the total cholesterol level in the synovial fluid of mice. The in vitro experiments were divided into the negative control, interleukin-1β(IL-1β), IL-1β+ POG, IL-1β+ oe-lncRNA NEAT1, IL-1β+ oe-lncRNA NEAT1 + POG, IL-1β + miR-128-3p inhibition, and IL-1β+ miR-128-3p inhibition+ POG groups. An OA model was established by inducing chondrocytes with IL-1β for 24 h, and 90 mg/L of POG and miR-128-3p inhibitor(50 nmol/L) were administered for 48 h as an intervention. lncRNA NEAT1 expression in chondrocytes was detected using fluorescence in situ hybridization. A dual luciferase assay was used to detect the targeting relationship between lncRNA NEAT1 and miR-128-3p. Lentiviral plasmids overexpressing lncRNA NEAT1 were used to transfect mouse chondrocytes. Real-time PCR was used to detect the effect of lncRNA NEAT1 overexpression on the mRNA level of miR-128-3p in chondrocytes. Western blotting was used to detect ABCA1, LXRβ, MMP-3, and Bax protein expression in chondrocytes after lncRNA NEAT1 overexpression and miR-128-3p inhibition. Results: POG significantly reduced OA cartilage tissue damage. Compared with the model group, the lncRNA NEAT1 mRNA level decreased, whereas the miR-128-3p mRNA level increased in the cartilage tissue of the POG group (P<0.05). Compared with the model group, ABCA1 and LXRβ protein expression increased in the POG group, whereas MMP-3 and Bax protein expression decreased (P<0.05). The TNF-α levels decreased in the POG group compared to the model group (P<0.05). Compared with the model group, the total cholesterol level in the synovial fluid of the joint of mice in the POG group decreased (P<0.05). The mean fluorescence intensity of lncRNA NEAT1 in the IL-1β+ POG group decreased compared with the IL-1β group (P<0.05). The relative luciferase activity in the miR-128-3p mimics group bound to the lncRNA NEAT1-WT plasmid decreased compared with the miR-128-3p negative control group (P<0.05). The lncRNA NEAT1 mRNA levels decreased, whereas the miR-128-3p mRNA levels increased in the IL-1β+ oe-lncRNA NEAT1 + POG group compared with the IL-1β+ oe-lncRNA NEAT1 group (P<0.05). Compared with the IL-1β+ POG group, ABCA1 and LXRβ protein expression decreased, whereas MMP-3 and Bax protein expression increased (P<0.05). Conclusion POG mediates lncRNA NEAT1/miR-128-3p to improve cholesterol metabolism in OA chondrocytes.

OBJECTIVE To investigate the current status of quality management of cold chain medicines in direct-to-patient （DTP） pharmacies and propose measures for pre-emptive risk management， providing references for the quality risk management of cold chain medicines. METHODS Based on the requirements of national regulations， a survey was conducted on the quality management of cold chain medicines in DTP pharmacies of J Province from November 2023 to February 2024， focusing on the receipt， storage， distribution， and delivery processes， using questionnaires， telephone interviews， and on-site visits. Common quality management issues in the operation of cold chain medicines were identified， and the causes of these issues were analyzed to propose feasible pre-emptive risk management measures. RESULTS & CONCLUSIONS A total of 122 DTP pharmacies participated in the questionnaire survey， and personnel from 30 DTP pharmacies participated in on-site and telephone interviews. Typical problems were identified in some DTP pharmacies， including insufficient personnel allocation or training， incomplete or inadequate implementation of quality system documentation， inadequate provision or management of cold chain facilities and equipment， and non-compliant storage and distribution of cold chain medicines. These issues posed certain risks to the quality management of cold chain medicines. It is recommended that DTP pharmacies strengthen personnel allocation and training， improve quality system documentation， enhance the provision and management of facilities and equipment， standardize storage and transportation operations， and strengthen supervision and assessment as pre-emptive measures. In addition， all sectors of society should also collaborate in governance from the perspective of ensuring the safety of cold chain drug storage and transportation， in order to mitigate the risk of quality and safety issues during the distribution of cold chain drugs and guarantee the safe and effective use of medications for patients.

Polycystic ovary syndrome （PCOS）， a common reproductive endocrine disorder in women， is one of the leading causes of ovulatory infertility in women of reproductive age. Due to its heterogeneous etiology， complex symptoms， and challenging treatment， PCOS has become a focal point of research in gynecological and reproductive medicine globally. The pathogenesis of PCOS is complex and may involve regulatory mechanisms such as inflammatory responses， oxidative stress， and cellular autophagy. Crown-like structures （CLSs） refer to pro-inflammatory microenvironments formed by macrophages engulfing adipocytes. The inflammatory disorders induced by CLSs are one of the key factors contributing to the development of PCOS and its complications. Current studies have indicated that the obese status in PCOS accelerates the formation of CLSs， and the density of CLSs can predict the progression of metabolic disorders and influence the outcomes of various metabolic diseases. Traditional Chinese Medicine （TCM） offers the unique advantages of a holistic view， four diagnostic methods， and syndrome differentiation and treatment to ameliorate the symptoms and signs of PCOS through multiple levels， pathways， and targets. Although studies on the mechanisms of metabolic diseases and CLS formation have been reported in China and abroad， there is still a lack of literature on the correlation between CLSs and PCOS， as well as reviews on TCM interventions targeting CLSs for treating this disease. Therefore， this paper summarized the correlation between obese PCOS and CLSs and reviewed recent studies on TCM interventions based on CLS formation （adipose tissue-macrophage inflammatory crosstalk） in the treatment of obese PCOS， aiming to provide new research perspectives for the prevention and treatment of PCOS using TCM.

Polycystic ovary syndrome （PCOS）， a common reproductive endocrine disorder in women， is one of the leading causes of ovulatory infertility in women of reproductive age. Due to its heterogeneous etiology， complex symptoms， and challenging treatment， PCOS has become a focal point of research in gynecological and reproductive medicine globally. The pathogenesis of PCOS is complex and may involve regulatory mechanisms such as inflammatory responses， oxidative stress， and cellular autophagy. Crown-like structures （CLSs） refer to pro-inflammatory microenvironments formed by macrophages engulfing adipocytes. The inflammatory disorders induced by CLSs are one of the key factors contributing to the development of PCOS and its complications. Current studies have indicated that the obese status in PCOS accelerates the formation of CLSs， and the density of CLSs can predict the progression of metabolic disorders and influence the outcomes of various metabolic diseases. Traditional Chinese Medicine （TCM） offers the unique advantages of a holistic view， four diagnostic methods， and syndrome differentiation and treatment to ameliorate the symptoms and signs of PCOS through multiple levels， pathways， and targets. Although studies on the mechanisms of metabolic diseases and CLS formation have been reported in China and abroad， there is still a lack of literature on the correlation between CLSs and PCOS， as well as reviews on TCM interventions targeting CLSs for treating this disease. Therefore， this paper summarized the correlation between obese PCOS and CLSs and reviewed recent studies on TCM interventions based on CLS formation （adipose tissue-macrophage inflammatory crosstalk） in the treatment of obese PCOS， aiming to provide new research perspectives for the prevention and treatment of PCOS using TCM.

Objective To explore the feasibility and safety of using indocyanine green combined with autologous blood and methylene blue for localization of small lung nodules during thoracoscopic wedge resection. Methods Patients who underwent CT-guided percutaneous lung puncture injection of localization agents to locate lung nodules at the First Affiliated Hospital of Fujian Medical University from November 2023 to January 2024 were selected. Under thoracoscopy, lung nodules were located by white light mode, fluorescence mode, or near-infrared mode and wedge resection was performed. The feasibility of using indocyanine green combined with autologous blood and methylene blue for localization of small lung nodules was preliminarily verified by evaluating whether the localization agent concentrated around the nodules, and the safety of this method was verified by analyzing the incidence of adverse reactions during patient puncture and surgery. Results A total of 30 patients with lung nodules were included, including 10 males and 20 females, with an average age of (55.5±11.2) years. In 26 patients, the amount of localization agent used was moderate, the localization agent concentrated around the nodules, and successful precise localization of small lung nodules was achieved. In 4 patients, due to excessive use of localization agent, the marker was diffuse with pleural staining. The overall localization success rate was 86.7%, and when the injection volume of localization agent was 0.2-0.5 mL, the localization success rate was 100.0%. All patients successfully completed thoracoscopic wedge resection and found nodule lesions, with negative margins and a distance from the margin to the lesion that met the requirements. There were no complications. Conclusion Thoracoscopic surgery using indocyanine green combined with autologous blood and methylene blue for localization of small lung nodules is safe and feasible.

Objective To investigate the prognosis and satisfaction of the R2 intervention procedure and develop related predictive models. Methods The clinical data of 64 patients with primary craniofacial hyperhidrosis who underwent R2 intervention surgery at the First Affiliated Hospital of Fujian Medical University from November 2018 to October 2022 were retrospectively analyzed. By statistically analyzing the risk factors for compensatory hyperhidrosis (CH) and satisfaction, and conducting feature screening, a relevant prediction model was established. Results Finally, 51 patients were collected, including 43 (84.3%) males and 8 (15.7%) females, with an average age of (30.27±7.22) years. Overall postoperative satisfaction was high, with only 5.9% of patients expressing regret about the surgery. However, 92.2% of patients experienced CH. The onset of postoperative CH was most prominent within the first 3 months postoperatively, with the incidence rate stabilizing thereafter. Preoperative heart rate and R2 sympathetic nerve clipping were identified as independent risk factors for severe CH. The preoperative body mass index, the degree of sweating in the chest and abdomen, are significantly correlated with postoperative satisfaction. Conclusion The R2 intervention surgery effectively alleviates the symptoms of primary craniofacial hyperhidrosis, and patient satisfaction is high.