Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans ; China ; Drugs, Chinese Herbal/standards* ; History, 20th Century ; History, 21st Century ; Medicine, Chinese Traditional/trends*

The genome tagging project (GTP) plays a pivotal role in addressing a critical gap in the understanding of protein functions. Within this framework, we successfully generated a human influenza hemagglutinin-tagged sperm-specific protein 411 (HA-tagged Ssp411) mouse model. This model is instrumental in probing the expression and function of Ssp411. Our research revealed that Ssp411 is expressed in the round spermatids, elongating spermatids, elongated spermatids, and epididymal spermatozoa. The comprehensive examination of the distribution of Ssp411 in these germ cells offers new perspectives on its involvement in spermiogenesis. Nevertheless, rigorous further inquiry is imperative to elucidate the precise mechanistic underpinnings of these functions. Ssp411 is not detectable in metaphase II (MII) oocytes, zygotes, or 2-cell stage embryos, highlighting its intricate role in early embryonic development. These findings not only advance our understanding of the role of Ssp411 in reproductive physiology but also significantly contribute to the overarching goals of the GTP, fostering groundbreaking advancements in the fields of spermiogenesis and reproductive biology.
Animals ; Female ; Humans ; Male ; Mice ; Spermatids/metabolism* ; Spermatogenesis/physiology* ; Spermatozoa/metabolism* ; Thioredoxins/genetics*

OBJECTIVES: To investigate the role and mechanism of fibroblast growth factor (FGF) 19 in inflammation-induced injury of vascular endothelial cells caused by high glucose (HG). METHODS: Human umbilical vein endothelial cells (HUVECs) were randomly divided into four groups: control, HG, FGF19, and HG+FGF19 (n=3 each). The effect of different concentrations of glucose and/or FGF19 on HUVEC viability was assessed using the CCK8 assay. Flow cytometry was utilized to examine the impact of FGF19 on HUVEC apoptosis. Levels of interleukin-6 (IL-6), inducible nitric oxide synthase (iNOS), total superoxide dismutase (T-SOD), and malondialdehyde (MDA) were measured by ELISA. Real-time quantitative PCR and Western blotting were used to determine the mRNA and protein expression levels of vascular endothelial growth factor (VEGF), nuclear factor erythroid 2 related factor 2 (Nrf2), and heme oxygenase-1 (HO-1). Cells were further divided into control, siRNA-Nrf2 (siNrf2), HG, HG+FGF19, HG+FGF19+negative control, and HG+FGF19+siNrf2 groups (n=3 each) to observe the effect of FGF19 on oxidative stress injury in HUVECs induced by high glucose after silencing the Nrf2 gene. RESULTS: Compared to the control group, the HG group exhibited increased apoptosis rate, increased IL-6, iNOS and MDA levels, and increased VEGF mRNA and protein expression, along with decreased T-SOD activity and decreased mRNA and protein expression of Nrf2 and HO-1 (P<0.05). Compared to the HG group, the HG+FGF19 group showed reduced apoptosis rate, decreased IL-6, iNOS and MDA levels, and decreased VEGF mRNA and protein expression, with increased T-SOD activity and increased Nrf2 and HO-1 mRNA and protein expression (P<0.05). Compared to the HG+FGF19+negative control group, the HG+FGF19+siNrf2 group had decreased T-SOD activity and increased MDA levels (P<0.05). CONCLUSIONS FGF19 can alleviate inflammation-induced injury in vascular endothelial cells caused by HG, potentially through the Nrf2/HO-1 signaling pathway.
Humans ; NF-E2-Related Factor 2/genetics* ; Signal Transduction ; Human Umbilical Vein Endothelial Cells/drug effects* ; Fibroblast Growth Factors/pharmacology* ; Heme Oxygenase-1/physiology* ; Apoptosis/drug effects* ; Glucose ; Inflammation ; Interleukin-6/analysis* ; Vascular Endothelial Growth Factor A/genetics* ; Nitric Oxide Synthase Type II/analysis* ; Cells, Cultured

With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.

With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.

Objective:To explore the influencing factors of left ventricular thrombus (LVT) in patients with non-ischemic heart failure (NIHF) and to construct a nomogram prediction model for NIHF patients with LVT.Methods:This study was a case-control study. A total of 2 592 patients with NIHF hospitalized in Beijing Anzhen Hospital affiliated to Capital Medical University from January 2018 to July 2022 were selected. Fifty-one patients with LVT identified by echocardiography and cardiac magnetic resonance were classified into LVT group. One hundred and sixty patients were selected as the non-LVT group using a 1∶3 propensity score matching based on age and gender. Multivariate logistic regression analysis was used to explore the influencing factors of LVT in patients with NIHF. A nomogram prediction model was constructed, and the area under (AUC) the receiver operating characteristic (ROC) curve was calculated to evaluate the predictive effect of the model.Results:A total of 211 patients were enrolled, with a median age of 40 years old and 160 males (76%). Compared with non-LVT group, LVT group had lower systolic blood pressure ((112±20) mmHg vs. (120±19) mmHg; 1 mmHg=0.133 kPa), lower left ventricular ejection fraction (LVEF; (27±12)% vs. (39±14)% ), lower proportion of patients with history of hypertension (28% (14/51) vs. 44% (70/160)) and atrial fibrillation (8% (4/51)vs.39% (62/160)), higher proportion of patients with New York Heart Association functional class Ⅲ to Ⅳ (class Ⅲ: 59% (30/51) vs. 41% (66/160); class Ⅳ: 28% (14/51) vs. 19% (31/160)), and larger left ventricular end-systolic diameter (LVESD; (56±14) mm vs. (50±15) mm). The levels of hemoglobin ((152±23) g/L vs. (142±30) g/L), D-dimer (508 (300, 1 105) μg/L vs. 158 (68, 379) μg/L), and N-terminal pro-brain natriuretic peptide (3 429 (2 462, 4 734) ng/L vs. 1 288 (422, 2 544) ng/L) were higher in LVT group than in non-LVT group ( P all<0.05). LVT group had a higher proportion of patients using beta-blockers (92% (47/51) vs. 78% (124/160)), angiotensin-converting enzyme inhibitors or angiotensin receptor blockers or angiotensin receptor neprilysin inhibitors (88% (45/51) vs. 72% (115/160)), and anticoagulant drugs (98% (50/51) vs. 32% (51/160)) than non-LVT group (all P <0.05). Multivariate logistic regression showed that reduced LVEF ( OR=1.08, 95% CI 1.02-1.15, P=0.008), decreased LVESD ( OR=1.07, 95% CI 1.01-1.12, P=0.013), and increased D-dimer levels ( OR=5.40, 95% CI 1.98-14.74, P=0.001) were independent influencing factors for LVT in patients with NIHF. The ROC curve showed that the AUC of the nomogram for predicting LVT in patients with NIHF was 0.793 (95% CI 0.710-0.876, P<0.001). Conclusion:Reduced LVEF, decreased LVESD, and elevated D-dimer are associated with LVT in NIHF patients. The predictive model developed based on the above indicators has certain value in predicting LVT in NIHF patients.

Objective To explore the safety and efficacy of radiofrequency catheter ablation(RCFA)in patients with persistent atrial fibrillation(AF)/atrial flutter(AFL)and heart failure(HF)with left ventricular ejection fraction≤35％.Methods This study is a retrospective study.Patients with persistent AF/AFL and HF with left ventricular ejection fraction≤ 35％admitted to Beijing Anzhen Hospital from January 2018 to March 2024 were enrolled.The perioperative characteristics and complications changes in echocardiographic parameters,and follow-up outcomes were analyzed.Results A total of 45 patients were enrolled with a mean age of(56±13)years and a mean LVEF of(28±4)％.The ablation strategy was circumferential pulmonary vein isolation and empirical linear ablation.The operation time and fluoroscopy time were 120(120,163)min and 5(4,10)min respectively.The patients mainly underwent linear ablation including circumferential pulmonary vein isolation(38,84.4％),cavotricuspid isthmus(37,82.2％),roofline(34,75.6％),mitral isthmus(34,75.6％).21(46.7％)patients underwent ehtanol infusion into the vein of Marshall.24(53.3％)patients underwent electrocardioversion.All patients restored sinus rhythm immediately after RFCA and had no perioperative complications.After a median follow-up of 22.9(7.8,31.0)months,2 patients died of cardiovascular disease,1 patient underwent heart transplantation,14(33.3％)patients were readmitted for cardiovascular disease,and 10 patients(23.8％)had recurrence of AF.The mean LVEF of the 28 patients who obtained LVEF at the last follow-up increased from(28±4)％to(51±14)％,and the average improvement of LVEF was(23±13)％(P＜0.0001).15 of these patients had complete recovery of left ventricular systolic function(LVEF≥ 50％).Conclusions RFCA is safe and effective for patients with persistent AF/AFL and HF with LVEF ≤ 35％,and can improve patient's cardiac function and significantly increase LVEF.

Traditional open head and neck surgery often leaves permanent scars,significantly affecting appearance.The emergence of surgical robots has introduced a new era for minimally invasive surgery.However,the complex anatomy of the head and neck region,particularly the oral and maxillofacial areas,combined with the high costs associated with established systems such as the da Vinci,has limited the widespread adoption of surgical robots in this field.Recently,surgical robotic platform in China has developed rapidly,exemplified by the promise shown by the KangDuo Surgical Robot(KD-SR).Although the KD-SR has achieved some results comparable to the da Vinci surgical robot in urology and colorectal surgery,its performance in complex head and neck regions remains untested.This study evaluated the feasibility,effectiveness,and safety of the newly developed KD-SR-01,comparing it with standard endoscopic systems in head and neck procedures on porcine models.We performed parotidectomy,submandibular gland resection,and neck dissection,collected baseline characteristics,perioperative data,and specifically assessed cognitive workload using the NASA-TLX.None of the robotic procedures were converted to endoscopic or open surgery.The results showed no significant difference in operation time between the two groups(P=0.126),better intraoperative bleeding control(P=0.001),and a significant reduction in cognitive workload(P<0.001)in the robotic group.In conclusion,the KD-SR-01 is feasible,effective,and safe for head and neck surgery.Further investigation through well-designed clinical trials with long-term follow-up is necessary to establish the full potential of this emerging robotic platform.

Objective To explore the safety and efficacy of radiofrequency catheter ablation(RCFA)in patients with persistent atrial fibrillation(AF)/atrial flutter(AFL)and heart failure(HF)with left ventricular ejection fraction≤35％.Methods This study is a retrospective study.Patients with persistent AF/AFL and HF with left ventricular ejection fraction≤ 35％admitted to Beijing Anzhen Hospital from January 2018 to March 2024 were enrolled.The perioperative characteristics and complications changes in echocardiographic parameters,and follow-up outcomes were analyzed.Results A total of 45 patients were enrolled with a mean age of(56±13)years and a mean LVEF of(28±4)％.The ablation strategy was circumferential pulmonary vein isolation and empirical linear ablation.The operation time and fluoroscopy time were 120(120,163)min and 5(4,10)min respectively.The patients mainly underwent linear ablation including circumferential pulmonary vein isolation(38,84.4％),cavotricuspid isthmus(37,82.2％),roofline(34,75.6％),mitral isthmus(34,75.6％).21(46.7％)patients underwent ehtanol infusion into the vein of Marshall.24(53.3％)patients underwent electrocardioversion.All patients restored sinus rhythm immediately after RFCA and had no perioperative complications.After a median follow-up of 22.9(7.8,31.0)months,2 patients died of cardiovascular disease,1 patient underwent heart transplantation,14(33.3％)patients were readmitted for cardiovascular disease,and 10 patients(23.8％)had recurrence of AF.The mean LVEF of the 28 patients who obtained LVEF at the last follow-up increased from(28±4)％to(51±14)％,and the average improvement of LVEF was(23±13)％(P＜0.0001).15 of these patients had complete recovery of left ventricular systolic function(LVEF≥ 50％).Conclusions RFCA is safe and effective for patients with persistent AF/AFL and HF with LVEF ≤ 35％,and can improve patient's cardiac function and significantly increase LVEF.

Traditional open head and neck surgery often leaves permanent scars,significantly affecting appearance.The emergence of surgical robots has introduced a new era for minimally invasive surgery.However,the complex anatomy of the head and neck region,particularly the oral and maxillofacial areas,combined with the high costs associated with established systems such as the da Vinci,has limited the widespread adoption of surgical robots in this field.Recently,surgical robotic platform in China has developed rapidly,exemplified by the promise shown by the KangDuo Surgical Robot(KD-SR).Although the KD-SR has achieved some results comparable to the da Vinci surgical robot in urology and colorectal surgery,its performance in complex head and neck regions remains untested.This study evaluated the feasibility,effectiveness,and safety of the newly developed KD-SR-01,comparing it with standard endoscopic systems in head and neck procedures on porcine models.We performed parotidectomy,submandibular gland resection,and neck dissection,collected baseline characteristics,perioperative data,and specifically assessed cognitive workload using the NASA-TLX.None of the robotic procedures were converted to endoscopic or open surgery.The results showed no significant difference in operation time between the two groups(P=0.126),better intraoperative bleeding control(P=0.001),and a significant reduction in cognitive workload(P<0.001)in the robotic group.In conclusion,the KD-SR-01 is feasible,effective,and safe for head and neck surgery.Further investigation through well-designed clinical trials with long-term follow-up is necessary to establish the full potential of this emerging robotic platform.