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*

OBJECTIVE: To evaluate the dynamic changes of glucocorticoid (GC) dose and the feasibility of GC discontinuation in rheumatoid arthritis (RA) patients under the background of Chinese medicine (CM). METHODS: This multicenter retrospective cohort study included 1,196 RA patients enrolled in the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) from September 1, 2019 to December 4, 2023, who initiated GC therapy. Participants were divided into the Western medicine (WM) and integrative medicine (IM, combination of CM and WM) groups based on medication regimen. Follow-up was performed at least every 3 months to assess dynamic changes in GC dose. Changes in GC dose were analyzed by generalized estimator equation, the probability of GC discontinuation was assessed using Kaplan-Meier curve, and predictors of GC discontinuation were analyzed by Cox regression. Patients with <12 months of follow-up were excluded for the sensitivity analysis. RESULTS: Among 1,196 patients (85.4% female; median age 56.4 years), 880 (73.6%) received IM. Over a median 12-month follow-up, 34.3% (410 cases) discontinued GC, with significantly higher rates in the IM group (40.8% vs. 16.1% in WM; P<0.05). GC dose declined progressively, with IM patients demonstrating faster reductions (median 3.75 mg vs. 5.00 mg in WM at 12 months; P<0.05). Multivariate Cox analysis identified age <60 years [P<0.001, hazard ratios (HR)=2.142, 95% confidence interval (CI): 1.523-3.012], IM therapy (P=0.001, HR=2.175, 95% CI: 1.369-3.456), baseline GC dose ⩽7.5 mg (P=0.003, HR=1.637, 95% CI: 1.177-2.275), and absence of non-steroidal anti-inflammatory drugs use (P=0.001, HR=2.546, 95% CI: 1.432-4.527) as significant predictors of GC discontinuation. Sensitivity analysis (545 cases) confirmed these findings. CONCLUSIONS RA patients receiving CM face difficulties in following guideline-recommended GC discontinuation protocols. IM can promote GC discontinuation and is a promising strategy to reduce GC dependency in RA management. (Trial registration: ClinicalTrials.gov, No. NCT05219214).
Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Arthritis, Rheumatoid/drug therapy* ; Glucocorticoids/therapeutic use* ; Medicine, Chinese Traditional ; Retrospective Studies

Objective To analyze the application value of 3D Slicer software in endoscopic transsphenoidal surgery for pituitary adenoma resection.Methods A retrospective analysis was made on the clinical data of 36 patients with pituitary adenomas treated with 3D Slicer-assisted endoscopic transsphenoidal surgery(3D Slicer group)in the Department of Neurosurgery,The Second Affiliated Hospital of Xi'an Jiaotong University,from January 2024 to December 2024.Preoperatively,multimodal images were fused and reconstructed using 3D Slicer software to systematically evaluate bony anatomical structures such as sphenoid sinus ostia,intrasphenoidal septa,and sellar floor structures,design the size of pedicled nasoseptal flaps,and clarify the positional relationships between pituitary adenomas and surrounding vital structures including the internal carotid artery,pituitary gland,and optic chiasm,so as to provide real-time guidance for intraoperative procedures.Meanwhile,45 patients with pituitary adenomas treated with neuronavigation-assisted endoscopic transsphenoidal surgery from January 2023 to December 2023 were included as the control group(neuronavigation group).The surgical outcomes and postoperative complications were compared between the two groups.Results Compared with the neuronavigation group,the 3D Slicer group demonstrated higher identification rates of the optic nerve groove and carotid artery impression(94.4％vs.77.8％),shorter operative time[(2.9±0.6)h vs.(3.5±0.9)h],less intraoperative bleeding[(159.7±70.5)mL vs.(237.8±96.0)mL],and a lower incidence of postoperative olfactory dysfunction(8.3％vs.26.7％),with statistically significant differences(P＜0.05).However,there were no statistically significant differences between the two groups in the identification rate of the sphenoid sinus ostium(100.0％vs.97.8％),gross total resection rate(75.0％vs.64.4％),and the incidence of other postoperative complications,including cerebrospinal fluid leakage(0.0％vs.6.7％),intracranial infection(2.8％vs.11.1％),transient diabetes insipidus(30.6％vs.22.2％),and hypopituitarism(38.9％vs.37.8％,P＞0.05).Conclusion 3D Slicer software helps improve the mastery of anatomical basics in endoscopic transsphenoidal approach among junior and primary physicians,enhancing the clinical efficacy and safety of pituitary adenoma resection,and thus is worthy of clinical promotion.

The pathological mechanisms and related physiological indicators of acute mountain sickness(AMS)were introduced,and the present situation of wearable devices applied in AMS auxiliary detection and diagnosis were reviewed.The challenges and future development directions of wearable devices applied in auxiliary detection and diagnosis were pointed out.[Chinese Medical Equipment Journal,2025,46(9):100-107]

Objective To analyze the MRI artifact of the inner ear structure in patients with peripheral vertigo acquired by using 3D fast imaging employing steady state acquisition(3D FIESTA-C)and 3D fast spin echo(3D-Cube T2).Methods Data of 63 patients with peripheral vertigo treated in the Department of Otolaryngology,The First Affiliated Hospital of Xi'an Jiaotong University,from October 2023 to June 2024 were filtered for analysis.The patients consisted of 16 males and 47 females,aged 18 to 60 years old.Two senior radiologists independently evaluated the quality of the acquired images through the two MRI sequences.Kappa test was used to evaluate the consistency of the two radiologists' subjective judgments,and Wilcoxon signed-rank test was used to compare the image quality between each sequence.The accuracy of 3D FIESTA-C,3D-Cube T2 and combination of the two sequences was calculated in the presentation of inner ear structure.Results The overall image quality of 3D-Cube T2 was better than that of 3D FIESTA-C(Z=-11.670,P＜0.001),and the accuracy of 3D FIESTA-C combined with 3D-Cube T2 was superior to that of each sequence in demonstrating the semicircular canals.The demonstration accuracy of horizontal semicircular canal among three scan protocols was statistically different(P＜0.001).Conclusion 3D FIESTA-C has the advantage in detecting horizontal semicircular canal,and 3D-Cube T2 always provides high quality images of upper semicircular canal.Compared with each scanning sequence,3D FIESTA-C combined with 3D-Cube T2 can effectively avoid misdiagnosis or missed diagnosis of semicircular canal structures in the patients with peripheral vertigo.

Objective:To evaluate the safety, and feasibility of transoral robot-assisted retropharyngeal lymph node (RPLN) dissection.Methods:Clinical data of head and neck cancer patients who underwent transoral robot-assisted RPLN dissection at the Department of Otorhinolaryngology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, and Sun Yat-sen University Cancer Centre from December 2017 to March 2024 were retrospectively analyzed. A total of 35 patients(22 males, 13 females, aged 47.4±13.4 years old) with RPLN metastases from head and neck cancer, including 20 cases of nasopharyngeal cancer, 9 cases of thyroid cancer, 2 cases of salivary adenocarcinoma, 2 cases of tonsil cancer, and 2 cases of hypopharyngeal cancer. Operation time, intraoperative bleeding and complications, postoperative nasogastric tube retention time, hospital stay and complications were evaluated. Statistical analysis was performed using SPSS 22.0 software.Results:All patients successfully received transoral robot-assisted RPLN dissection without intermediate open surgery, with removals of 2 (1, 3) RPLNs. The total operation time was 130 (102, 210) minutes. The intraoperative bleeding was 50 (20, 100) ml, and there was no major bleeding or organ damage during the operation. Prophylactic tracheotomy was performed in 8 cases, and postoperatively nasogastric tubes were left in 22 patients, with retention time of 10.5 (7.5, 14.0) days. Postoperative hospital stay was 5 (4, 9) days. Postoperative complications included incision dehiscence in 4 cases and dysphagia in 4 cases. The median postoperative follow-up was 23.4 months, with progression or recurrence in 5 patients, including regional recurrence in 3 patients, lung metastasis in 1 patient, and bone metastasis in 1 patient. The 2-year regional failure-free survival and disease-free survival rates were 91.43% and 85.71%, respectively.Conclusion:Transoral robot-assisted RPLN dissection is a safe and feasible surgical method with less trauma, fewer complications, and higher safety. Patients need to be carefully selected at the initial stage of application.

Objective:To explore the clinical application value of transoral robotic surgery (TORS) in the treatment of tonsil squamous cell carcinoma (TSCC).Methods:A retrospective analysis was conducted. The clinical data of 157 TSCC patients were collected who received TORS at five medical centers, namely, the Sun Yat-sen University Cancer Center, Sun Yat-sen Memorial Hospital, Eye Ear Nose and Throat Hospital of Fudan University, the First Affiliated Hospital of China Medical University, and Tongji Hospital of Tongji Medical College, from January 1 2017 to July 31 2022. There were 130 males and 27 females, aged 24-85 years. All patients were followed-up at least for 2 years (2-year group), among them, 99 patients had a follow-up of 3 years (3-year group). The overall survival (OS), progression-free survival (PFS), clinical stage, human papillomavirus (HPV) infection status were analyzed. SPSS 25.0 and SAS 9.4 were used for statistical analysis.Results:The OS and PFS of the 2-year group were 91.7% and 87.9%, respectively. The OS and PFS of the 3-year group were 85.9% and 82.8%, respectively. The prognosis of patients with locally early-stage was better than that of locally advanced patients, with the OS of 94.4% for T1-2 vs. 78.0% for T3 ( P=0.005) and the PFS of 91.2% for T1-2 vs. 75.0% for T3 ( P=0.011) in the 2-year group; the OS of 91.1% for T1-2 vs. 65.0% for T3 ( P=0.004) and the PFS of 88.6% for T1-2 vs. 60.0% for T3 ( P=0.002) in the 3-year group; and also, the OS of 90.0% for stage Ⅰ-Ⅱ vs. 79.5% for stage Ⅲ-Ⅳ ( P=0.204) and the PFS of 86.7% for stage Ⅰ-Ⅱ vs. 76.9% for stage Ⅲ-Ⅳ ( P=0.188) in the 3-year group. The prognosis of HPV-positive TSCC patients was better than that of HPV-negative patients in the 3-year group, with the OS of 90.9% for HPV-positive vs. 80.5% for HPV-negative ( P=0.045) and the PFS of 90.9% for HPV-positive vs. 75.6% for HPV-negative ( P=0.047). The average time of postoperative tracheal cannula indwelling was 25.1 days. The indwelling rate and average indwelling time of the postoperative nasogastric tube were 94.3% (148/157) and 8.5 days, respectively. Conclusion:TORS has outstanding survival benefits for TSCC patients. HPV-positive TSCC patients have a better prognosis than HPV-negative patients. TORS treatment of TSCC patients has advantages in postoperative recovery and quality of life.

Biochemistry,as a fundamental course for science and engineering majors related to biology and chemistry,holds a significant position in the curriculum.The course team at Dalian Minzu University is committed to teaching innovation,adopting the outcome-based education(OBE)concept for teaching de-sign and incorporating ideological and political elements,in order to achieve the dual goals of knowledge transmission and value guidance.The team has established a three-dimensional teaching goal of"knowl-edge,morality,and ability",covering"consolidating core knowledge,cultivating moral sentiment,and enhancing innovation ability".Through a multi-dimensional integrated teaching method of"three integra-tions and five combinations",multiple rounds of teaching practice have been carried out in the applied chemistry major using"classification and specificity of enzyme"as an example.The output of teaching re-sults and survey questionnaires show that students highly recognize the teaching design and its"process-based learning"evaluation method,fully reflecting the student-centered teaching idea.Research has shown that OBE design combined with ideological and political elements can effectively promote students' knowl-edge acquisition,moral growth,and innovation ability improvement in the course of Biochemistry.This teaching design not only helps students construct correct worldviews,outlooks on life,and values,but also significantly enhances their innovative thinking and practical abilities.This teaching design can not only ef-fectively improve the teaching quality of the course,but also provide new perspectives and ideas for the teaching design of Biochemistry,realizing the organic integration of professional knowledge imparting and i-deological and political education,and has certain innovation and practical significance.

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.

INTRODUCTION: Radiofrequency ablation (RFA) avoids the complications of general anaesthesia, reduces length of hospitalisation and reduces morbidity from surgery. As such, it is a strong alternative treatment for patients with comorbidities who are not surgical candidates. However, to our knowledge, there have only been 1 systematic review and 3 combined systematic review and meta-analyses on this topic to date. This systematic review and meta-analysis seeks to evaluate the efficacy and safety of RFA in the treatment of papillary thyroid carcinoma (PTC) with longer follow-up durations. METHOD: PubMed, Embase and Cochrane databases were searched for relevant studies published from 1990 to 2021; 13 studies with a total of 1366 patients were included. The Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and Sandelowski et al.'s approach1 to "negotiated consensual validation" were used to achieve consensus on the final list of articles to be included. All authors then assessed each study using a rating scheme modified from the Oxford Centre for Evidence-Based Medicine. RESULTS: Pooled volume reduction rates (VRRs) from 1 to 48 months after RFA, complete disappearance rates (CDR) and complications were assessed. Pooled mean VRRs were 96.59 (95% confidence interval [CI] 91.05-102.13, I2=0%) at 12 months2-6 and 99.31 (95% CI 93.74-104.88, I2=not applicable) at 48 months.2,5 Five studies showed an eventual CDR of 100%.2,4,7-9 No life-threatening complications were recorded. The most common complications included pain, transient voice hoarseness, fever and less commonly, first-degree burn. CONCLUSION RFA may be an effective and safe alternative to treating PTC. Larger clinical trials with longer follow-up are needed to further evaluate the effectiveness of RFA in treating PTC.
Humans ; Radiofrequency Ablation/methods* ; Thyroid Cancer, Papillary/surgery* ; Thyroid Neoplasms/surgery* ; Treatment Outcome ; Postoperative Complications/etiology*