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 investigate the accuracy and safety of pedicle screw placement using 3D-printed auxiliary guides in scoliosis correction surgery for adolescents. METHODS: A retrospective analysis was conducted on the clinical data of 51 patients who underwent posterior scoliosis correction surgery from January 2020 to March 2023. Among them, there were 35 cases of adolescent idiopathic scoliosis and 16 cases of congenital scoliosis. The patients were divided into two groups based on the auxiliary tool used:the 3D-printed auxiliary guide screw placement group (3D printing group) and the free-hand screw placement group (free-hand group, without auxiliary tools). The 3D printing group included 32 patients (12 males and 20 females) with an average age of (12.59±2.60) years;the free-hand group included 19 patients (7 males and 12 females) with an average age of (14.58±3.53) years. The two groups were compared in terms of screw placement accuracy and safety, spinal correction rate, intraoperative blood loss, number of intraoperative fluoroscopies, operation time, hospital stay, and preoperative and last follow-up scores of the Scoliosis Research Society-22 (SRS-22) questionnaire. RESULTS: A total of 707 pedicle screws were placed in the two groups, with 441 screws in the 3D printing group and 266 screws in the free-hand group. All patients in both groups successfully completed the surgery. There was a statistically significant difference in operation time between the two groups (P<0.05). The screw placement accuracy rate of the 3D printing group was 95.46% (421/441), among which the Grade A placement rate was 89.34% (394/441);the screw placement accuracy rate of the free-hand group was 86.47% (230/266), with a Grade A placement rate of 73.31% (195/266). There were statistically significant differences in the accuracy of Grade A, B, and C screw placements between the two groups (P<0.05), while no statistically significant differences were observed in intraoperative blood loss, number of fluoroscopies, correction rate, or hospital stay (P>0.05). In the SRS-22 questionnaire scores, the scores of functional status and activity ability, self-image, mental status, and pain of patients in each group at the last follow-up were significantly improved compared with those before surgery (P<0.05), but there were no statistically significant differences in all scores between the two groups (P>0.05). CONCLUSION In scoliosis correction surgery, compared with traditional free-hand screw placement, the use of 3D-printed auxiliary guides for screw placement significantly improves the accuracy and safety of screw placement and shortens the operation time.
Humans ; Male ; Scoliosis/surgery* ; Female ; Adolescent ; Printing, Three-Dimensional ; Retrospective Studies ; Pedicle Screws ; Child

The Masquelet technique, also known as the induced membrane technique, is a surgical technique for repairing large bone defects based on the use of a membrane generated by a foreign body reaction for bone grafting. This technique is not only simple to perform, with few complications and quick recovery, but also has excellent clinical results. To better understand the mechanisms by which this technique promotes bone defect repair and the factors that require special attention in practice, we examined and summarized the relevant research advances in this technique by searching, reading, and analysing the literature. Literature show that the Masquelet technique may promote the repair of bone defects through the physical septum and molecular barrier, vascular network, enrichment of mesenchymal stem cells, and high expression of bone-related growth factors, and the repair process is affected by the properties of spacers, the timing of bone graft, mechanical environment, intramembrane filling materials, artificial membrane, and pharmaceutical/biological agents/physical stimulation.
Humans ; Bone Transplantation/methods* ; Membranes, Artificial ; Bone Regeneration ; Animals

OBJECTIVES: To evaluate the causal association between circulating levels of zinc, magnesium, and other minerals and autism spectrum disorder (ASD). METHODS: A two-sample Mendelian randomization (MR) analysis was performed using summary statistics from large-scale genome-wide association studies of European populations, including 18 382 ASD cases and 27 969 controls. Genetic data for iron, calcium, and magnesium were obtained from the UK Biobank, and data for zinc and selenium were sourced from an Australian-British cohort. A total of 351 genetic instrumental variables were selected. Causal inference was performed using inverse-variance weighting as the primary analysis method. Sensitivity analyses were performed by Cochran's Q test and MR-PRESSO global test to assess the robustness of the findings. RESULTS: No statistically significant causal effect was observed for circulating zinc, magnesium, calcium, selenium, or iron levels on ASD risk (all P>0.05). The odds ratios and 95% confidence intervals from the inverse-variance weighting analysis were 0.934 (0.869-1.003) for zinc, 1.315 (0.971-1.850) for magnesium, 1.055 (0.960-1.159) for calcium, 1.015 (0.953-1.080) for selenium, and 0.946 (0.687-1.303) for iron. Sensitivity analysis revealed significant heterogeneity in the causal association between circulating calcium and ASD (P=0.006), while the effect estimate remained stable after MR-PRESSO correction (P=0.487). The causal effect estimates for the remaining minerals demonstrated good robustness. CONCLUSIONS This study did not find significant evidence supporting a causal association between circulating zinc, magnesium, calcium, selenium, or iron levels and ASD risk, providing important clues for the etiology of ASD and precision nutritional interventions.
Humans ; Mendelian Randomization Analysis ; Autism Spectrum Disorder/genetics* ; Magnesium/blood* ; Zinc/blood* ; Minerals/blood* ; Genome-Wide Association Study ; Selenium/blood*

Objectives To identify key clinical factors influencing recurrence in osteosarcoma patients,to construct and validate a Nomogram-based recurrence risk prediction model,thereby providing a quantitative tool for clinical decision-making and recurrence prevention/control.Methods Clinical data of 469 osteosarcoma patients admitted to Yunnan Cancer Hospital between 2013～2022 were retrospectively collected.Statistical analysis was performed using R software(version 4.3.2).Potential influencing factors were initially screened via univariate analysis and LASSO regression analysis.Independent predictors of osteosarcoma recurrence were then identified using multivariate logistic regression analysis.Based on the identified independent factors,a Nomogram prediction model for recurrence risk was constructed.The area under the receiver operating characteristic curve(AUC)was used to evaluate the model's discriminative ability.Results Among the entire cohort,68 patients experienced recurrence,yielding a recurrence rate of 14.50%.Multivariate analysis identified the following as independent predictors of recurrence:Primary Tumor Location:Tibial lesions(P=0.009)were associated with a significantly lower recurrence risk compared to femoral lesions(OR=0.297),while lesions in"Other Bones"(P=0.008)carried a significantly higher risk(OR=3.294).Biopsy Method:Needle biopsy(P=0.033)was associated with a significantly lower recurrence risk compared to open biopsy(OR=0.461).Lung Metastasis Status:Patients with lung metastasis(P<0.001)had a significantly higher recurrence risk than those without(OR=11.873).Lymphocyte Count:A higher lymphocyte count(P=0.001)was a protective factor,associated with a lower recurrence risk(OR=0.450).The constructed Nomogram prediction model demonstrated excellent performance:Validation results showed an AUC=0.842(95%CI:0.806～0.875),indicating outstanding discriminative ability.Conclusions This study successfully constructed and validated a Nomogram prediction model for osteosarcoma recurrence risk integrating key clinical factors.The model demonstrates superior discriminative ability and can accurately and quantitatively assess the recurrence risk for individual patients.This tool thus provides critical reference for guiding clinical treatment decisions.

Objective:To analyze the values of platelet transforming growth factor-β (TGF-β) and SMAD family member 2 (Smad2) in patients′ peripheral platelets for CRC diagnosis and staging.Methods:Retrospective case-control study. Tumor tissues, paratumor tissues and peripheral blood samples were collected from 248 CRC patients (147 males, 101 females; age 21-93 years) diagnosed in the First Hospital of Jilin University from October 10th, 2020, to March 10th, 2025. Peripheral blood samples were also collected from 40 colorectal adenomatous polyp patients (21 males, 19 females; age 22-74 years) and 75 healthy individuals (43 males, 32 females; age 18-81 years) during the same period. Tissue homogenates and platelets were isolated using tissue disruption and gradient centrifugation, respectively. Total RNA was respectively extracted from tissues and platelets, and the expression levels of TGF-β and Smad2 were quantified by real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) expressed as relative quantity 2 -ΔΔCt. Differences of TGF-β and Smad2 expression were compared between CRC tissues and adjacent tissues, as well as among CRC patients, polyp patients, and healthy controls. The relationship of platelet TGF-β and Smad2 expression with pathological features includingtumor stage, pathological type, and metastasis were analyzed. The efficiency of platelet TGF-β, Smad2, and their combination in diagnosing CRC was evaluated using receiver operating characteristic (ROC) curves. Results:The expression levels of TGF-β and Smad2 in CRC tumor tissues[1.09 (0.45, 2.00), 2.93 (0.78, 6.73)] were significantly higher than those in adjacent tissues[0.81 (0.27, 1.50), 1.29 (0.40, 2.63)] ( Z TGF-β=4.54, Z Smad2=6.67, both P<0.001). The expression levels of TGF-β and Smad2 in platelets of CRC patients[2.73(1.53, 4.38), 3.16 (1.58, 4.38)] were significantly higher than those in the colorectal polyp group[1.23(0.70, 2.54), 1.16(0.78, 2.27)] and the healthy control group[0.96(0.51, 1.88), 0.92 (0.55, 1.88)] ( H TGF-β=59.71, H Smad2=78.74, both P<0.001). Platelet TGF-β expression increased progressively with tumor stage (stage 1-4) ( P<0.05), while platelet Smad2 levels were higher in metastatic CRC compared with non-metastatic cases ( P<0.05). ROC curve analysis showed that the area under the curve (AUC) for diagnosing CRC when combining platelet TGF-β and Smad2 was 0.81[95%Confidence interval( CI) 0.77—0.86], which was 0.90 (95% CI 0.86—0.93) if adding serum carcinoembryonic antigen (CEA). Conclusion:Platelet TGF-β and Smad2 expression correlates with the diagnosis and staging of CRC, demonstrating potential as liquid biopsy biomarkers for colorectal malignancies.

Objective:To explore the influence of oligospermia(OS)on the detection of sperm DNA fragmentation index(DFI)by fluorescence method based on artificial intelligence(AI)recognition and flow cytometry-based sperm chromatin structure as-say(SCSA).Methods:We collected semen samples from 201 males,including 50 azoospermia(AS)patients as negative controls,90 OS patients(sperm concentration＞0 × 106/ml and＜15 × 106/ml),and 61 normal men(sperm concentration ≥15 ×106/ml).Then we subdivided the OS patients into a mild OS(sperm concentration ≥10 × 106/ml and＜15 × 106/ml),a moderate OS(sperm concentration ≥5 × 106/ml and＜10 × 106/ml)and a severe/extremely severe OS group(sperm concentration＞0 × 106/ml and＜5 × 106/ml),with 30 cases in each group,and compared the results of DFI detection between the AI fluorescence method and tradi-tional flow cytometry.Results:The DFI value detected by AI fluorescence method showed statistically significant difference from that detected by flow cytometry in the AS,moderate OS and severe/extremely severe OS groups(P＜0.01),the former even lower than the latter,but not in the normal control and the mild OS groups(P＞0.05).In the AS group,a dramatically lower rate of non-0 results was achieved by AI fluorescence method than by flow cytometry(8％vs 100％,P＜0.01).The DFI values detected by AI fluores-cence method exhibited a good linear correlation to those obtained by flow cytometry in the normal control and mild OS groups(β2=0.7470;R2=0.7180),but a poor linear correlation in the OS full-sample,moderate OS and severe/extremely severe OS groups(R2=0.3092;R2=0.3558;R2=0.2147).Conclusion:The AI fluorescence method has a higher specificity and is more suitable than flow cytometry for detection of sperm DFI in OS patients.The DFI values obtained by the two methods are consistent with sperm concen-tration ≥10 × 106/ml,but the accuracy of the results of detection may be affected with sperm concentration＞0 × 106/ml and＜10 × 106/ml.

Objective To analyze the factors influencing hypercoagulable state in patients with benign prostatic hyperplasia(BPH)after surgery,so as to provide reference for preventing postoperative thrombosis in BPH.Methods A retrospective analysis was conducted on the clinical data of 307 BPH patients who underwent surgery in the Department of Urology at the First Affiliated Hospital of Xi'an Jiaotong University during Apr.2022 and Sep.2023.Patients were divided into the hypercoagulable state group and non-hypercoagulable state group based on the presence of abnormal postoperative coagulation parameters.Single factor and binary logistic regression analysis were used to screen risk factors affecting postoperative blood hypercoagulability in BPH patients.Results Among the 307 BPH patients,45(14.66％)developed a hypercoagulable state postoperatively.Univariate analysis revealed statistically significant differences between the hypercoagulable and non-hypercoagulable groups regarding patients'age,length of hospital stay,body mass index(BMI),history of hypertension,history of diabetes,and blood type(P＜0.05).Binary logistic regression analysis identified BMI(OR=1.135,95％CI:1.006-1.281,P=0.039),history of hypertension(OR=2.342,95％CI:1.103-4.927,P=0.027),and blood type(OR=2.270,95％CI:1.066-4.836,P=0.034)as independent risk factors for postoperative hypercoagulable state.Conclusion Non-O blood type,high BMI,and history of hypertension are independent risk factors for the occurrence of hypercoagulable state following surgery for BPH.

Objective To analyze the factors influencing hypercoagulable state in patients with benign prostatic hyperplasia(BPH)after surgery,so as to provide reference for preventing postoperative thrombosis in BPH.Methods A retrospective analysis was conducted on the clinical data of 307 BPH patients who underwent surgery in the Department of Urology at the First Affiliated Hospital of Xi'an Jiaotong University during Apr.2022 and Sep.2023.Patients were divided into the hypercoagulable state group and non-hypercoagulable state group based on the presence of abnormal postoperative coagulation parameters.Single factor and binary logistic regression analysis were used to screen risk factors affecting postoperative blood hypercoagulability in BPH patients.Results Among the 307 BPH patients,45(14.66％)developed a hypercoagulable state postoperatively.Univariate analysis revealed statistically significant differences between the hypercoagulable and non-hypercoagulable groups regarding patients'age,length of hospital stay,body mass index(BMI),history of hypertension,history of diabetes,and blood type(P＜0.05).Binary logistic regression analysis identified BMI(OR=1.135,95％CI:1.006-1.281,P=0.039),history of hypertension(OR=2.342,95％CI:1.103-4.927,P=0.027),and blood type(OR=2.270,95％CI:1.066-4.836,P=0.034)as independent risk factors for postoperative hypercoagulable state.Conclusion Non-O blood type,high BMI,and history of hypertension are independent risk factors for the occurrence of hypercoagulable state following surgery for BPH.

Objective:To analyze the values of platelet transforming growth factor-β (TGF-β) and SMAD family member 2 (Smad2) in patients′ peripheral platelets for CRC diagnosis and staging.Methods:Retrospective case-control study. Tumor tissues, paratumor tissues and peripheral blood samples were collected from 248 CRC patients (147 males, 101 females; age 21-93 years) diagnosed in the First Hospital of Jilin University from October 10th, 2020, to March 10th, 2025. Peripheral blood samples were also collected from 40 colorectal adenomatous polyp patients (21 males, 19 females; age 22-74 years) and 75 healthy individuals (43 males, 32 females; age 18-81 years) during the same period. Tissue homogenates and platelets were isolated using tissue disruption and gradient centrifugation, respectively. Total RNA was respectively extracted from tissues and platelets, and the expression levels of TGF-β and Smad2 were quantified by real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) expressed as relative quantity 2 -ΔΔCt. Differences of TGF-β and Smad2 expression were compared between CRC tissues and adjacent tissues, as well as among CRC patients, polyp patients, and healthy controls. The relationship of platelet TGF-β and Smad2 expression with pathological features includingtumor stage, pathological type, and metastasis were analyzed. The efficiency of platelet TGF-β, Smad2, and their combination in diagnosing CRC was evaluated using receiver operating characteristic (ROC) curves. Results:The expression levels of TGF-β and Smad2 in CRC tumor tissues[1.09 (0.45, 2.00), 2.93 (0.78, 6.73)] were significantly higher than those in adjacent tissues[0.81 (0.27, 1.50), 1.29 (0.40, 2.63)] ( Z TGF-β=4.54, Z Smad2=6.67, both P<0.001). The expression levels of TGF-β and Smad2 in platelets of CRC patients[2.73(1.53, 4.38), 3.16 (1.58, 4.38)] were significantly higher than those in the colorectal polyp group[1.23(0.70, 2.54), 1.16(0.78, 2.27)] and the healthy control group[0.96(0.51, 1.88), 0.92 (0.55, 1.88)] ( H TGF-β=59.71, H Smad2=78.74, both P<0.001). Platelet TGF-β expression increased progressively with tumor stage (stage 1-4) ( P<0.05), while platelet Smad2 levels were higher in metastatic CRC compared with non-metastatic cases ( P<0.05). ROC curve analysis showed that the area under the curve (AUC) for diagnosing CRC when combining platelet TGF-β and Smad2 was 0.81[95%Confidence interval( CI) 0.77—0.86], which was 0.90 (95% CI 0.86—0.93) if adding serum carcinoembryonic antigen (CEA). Conclusion:Platelet TGF-β and Smad2 expression correlates with the diagnosis and staging of CRC, demonstrating potential as liquid biopsy biomarkers for colorectal malignancies.