To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,ref-erence standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the norma-tive and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regu-latory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and stead-ily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environ-mental-friendly;replace and/orreduce the use of toxic and hazardousreagents,strengthen the requirementsofdrug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

Objective To analyze the symptomatic improvement effects of vitamin D in children with autism spectrum disorder(ASD)based on the microbiota-gut-brain axis.Methods Seventy-two children with ASD were randomly divided into an observation group and a control group,with 36 cases in each group.Three cases dropped out in the control group.The observation group received 1200 IU/day of vitamin D supplementation in addition to conventional rehabilitation training,while the control group received only conventional rehabilitation training.The intervention lasted for 12 weeks.Assessments were conducted before and after the intervention using the childhood autism rating scale(CARS),autism behavior checklist(ABC),and repetitive behavior scale-revised(RBS-R).Resting-state functional connectivity of the brain was measured using near-infrared functional imaging,and serum levels of 25(OH)D3,inflammatory cytokines,and gut microbiota were analyzed.The differences in these indicators before and after the intervention were compared between the two groups to evaluate clinical efficacy.Results The between-group differences in pre-and post-intervention changes showed that the observation group had significantly greater improvements than the control group in the following measures:CARS scores(-5.92±1.40 vs.-2.55±1.43),RBS-R scores(-5.99±1.01 vs.-3.10±1.47),resting-state brain functional connectivity(0.19±0.15 vs.0.10±0.18),serum 25(OH)D3 levels[(34.89±8.18)ng/mL vs.(0.68±6.73)ng/mL],serum interleukin-6(IL-6)levels[(-6.60±6.07)pg/mL vs.(-0.74±9.45)pg/mL],IL-1β levels[(-2.56±1.33)pg/mL vs.(-0.04±2.13)pg/mL],and tumor necrosis factor-α(TNF-α)levels[(-4.09±3.85)pg/mL vs.(0.21±4.05)pg/mL](P<0.05).Post-intervention,significant differences in gut microbial β-diversity were observed between the two groups(R2=0.030,P=0.040,Adonis).LEfSe analysis revealed that the observation group exhibited enrichment in Clostridia(LDA=4.747,P=0.003),Clostridiales(LDA=4.747,P=0.003),Clostridiaceae(LDA=3.476,P=0.001),Lachnospiraceae(LDA=4.709,P=0.004),Odoribacteraceae(LDA=3.458,P=0.027),Odoribacter(LDA=3.458,P=0.027),Burkholderiales(LDA=3.339,P=0.038),Firmicutes(LDA=4.764,P=0.003),and Betaproteobacteria(LDA=3.338,P=0.037).Conclusion Vitamin D supplementation can modulate gut microbial diversity in children with ASD,significantly influence the abundance of specific gut microbiota,reduce systemic inflammatory cytokines,enhance brain functional connectivity,and alleviate clinical symptoms of ASD.

Objective To provide a reference for the clinical individualized medication of hypertension,the antihypertensive efficacy of Gouteng Xuanshen prescription in the treatment of hypertension was verified,and its improvement on the discomfort symptoms of patients was explored.Methods This study adopted a retrospective cohort study design.The data were derived from the electronic medical records of 6770 hypertensive patients in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 1,2013 to January 1,2023.The exposure factor was the treatment of Uncaria rhynchophylla,Scrophularia ningpoensis,and Radish Seed.After the propensity score was used to deal with the confounding factors,the changes in blood pressure of the patients after treatment were observed.At the same time,in order to analyze the improvement of patients'symptoms,the Apriori algorithm to mine the core symptoms of patients was explored,and the patient symptom network was constructed.The BGLL algorithm was used to divide the symptoms into communities to form a symptom map.Finally,survival analysis and Cox regression were used to find the sensitive symptom community of Gouteng Xuanshen prescription,and the related factors were analyzed.Results 468 people were included in the exposure group and the control group.After treatment,more patients in the exposure group reached the target blood pressure(P<0.01),and the effect was better in lowering systolic blood pressure(P<0.05),and no obvious abnormalities in safety indicators were found.In terms of symptom improvement,the 134 symptoms recorded in the medical records were divided into 6 groups.As the medication time increased,the patient's head discomfort was easier to relieve.The effect was best at 8 weeks of treatment,and it was more sensitive to patients with extremely high cardiovascular risk or grade 3 hypertension.Conclusion This study verified the clinical efficacy of the Gouteng Xuanshen prescription in the treatment of hypertension through electronic medical record data,which preliminarily revealed the potential role and law of the Gouteng Xuanshen prescription in the treatment of hypertension.

Objective:To investigate the effects of repetitive transcranial magnetic stimulation(rTMS) on the core symptoms, brain functional connectivity and activation in children with attention deficit hyperactivity disorder (ADHD) using functional near-infrared spectroscopy (fNIRS).Methods:From September 2022 to March 2024, a total of 35 children with ADHD were selected as research subjects and they were randomly divided into observation group ( n=17) and control group ( n=18). The control group received conventional rehabilitation therapy, while the observation group received rTMS therapy in addition to the conventional therapy. Both groups were treated every other day, with each course of treatment lasting four weeks, and a total of three courses of treatment were administered consecutively. The clinical symptoms of the children with ADHD were assessed using Swanson, Nolan, and Pelham-Ⅳ(SNAP-Ⅳ) before and after treatment. fNIRS was used to detect the relative concentration changes of oxyhemoglobin (HbO 2) and deoxyhemoglobin (HbR) in the prefrontal cortex under resting-state and Go/Nogo task conditions before and after treatment. Statistical analysis was performed using SPSS 26.0 software. Paired sample t-test were used for within-group comparisons, and independent sample t-test were used for between-group comparisons. Results:(1) After treatment, the scores for inattention, hyperactivity/impulsivity and oppositional defiant behavior in the two groups were significantly lower than before treatment ( t=3.51-18.86, all P<0.05). The scores for inattention, hyperactivity/impulsivity and oppositional defiant behavior in the observation group were significantly lower than those in the control group ( t=2.21, 2.03, 2.39, all P<0.05). (2) After treatment, the functional connectivity strength between all regions of interest in both groups was significantly higher than before treatment ( t=3.53-37.90, all P<0.05). The functional connectivity strength of the left dorsolateral prefrontal cortex (0.25±0.03, 0.21±0.03), right dorsolateral prefrontal cortex (0.12±0.02, 0.09±0.02), left medial prefrontal cortex (0.13±0.02, 0.10±0.01) and right medial prefrontal cortex (0.31±0.04, 0.24±0.06) in the observation group was significantly higher than those in the control group (all P<0.05). (3) In the Go/Nogo task, after treatment, the average HbO 2 concentrations in the left dorsolateral prefrontal cortex, right dorsolateral prefrontal cortex, left medial prefrontal cortex, right medial prefrontal cortex, left temporal lobe, and right temporal lobe in both groups were all higher than before treatment (all P<0.05). After treatment, the average HbO 2 concentrations in the left dorsolateral prefrontal cortex, right dorsolateral prefrontal cortex, left medial prefrontal cortex and right medial prefrontal cortex of the observation group were significantly higher than those of the control group (all P<0.05). Conclusion:rTMS therapy can improve the core symptoms of children with ADHD, which may be related to the strength of brain functional connectivity and activation of ADHD brain function by rTMS.

Objective:To investigate the role of the Smad3 signaling pathway in the process of silica-induced epithelial-mesenchymal transition (EMT) .Methods:In September 2022, lung epithelial cells (BEAS-2B) were exposed to different concentrations of silica suspension (0, 50, 100, and 150 μg/ml) for 6 and 12 hours. Additionally, SIS3, a specific inhibitor of phosphorylated Smad3 (p-Smad3) , was utilized to establish the p-Smad3 inhibition model. The cells were divided into four groups: blank control gruop, silica group, SIS3 intervention group, and SIS3 +silica group. Cell morphology was observed using an inverted fluorescence microscope, while cell viability was assessed using a Cell Counting Kit-8 (CCK-8) . The mRNA and protein expression levels of E-cadherin (E-Cad) , N-cadherin (N-Cad) , Vimentin, Smad3, and p-Smad3 were analyzed by Quantitative real-time polymerase chain reaction (qRT-PCR) and Western blotting, respectively. Differences between two groups were compared using Student's t-test, and multiple group comparisons were analyzed using a one-way analysis of variance with the Student-Newman-Keuls test.Results:Compared with the blank control group, the morphology of BEAS-2B cells shifted from epithelial to mesenchymal cell-like following silica exposure, and the cell viability of BEAS-2B cells declined after exposure to 150 μg/ml silica for 6 and 12 hours. Furthermore, silica exposure led to significant reductions in mRNA and protein expression levels of the epithelial cellular marker (E-Cad) in BEAS-2B cells, accompanied by increased expressions of interstitial cellular markers (N-Cad and Vimentin) . Importantly, the level of p-Smad3/Smad3 expression levels was also elevated in silica-treated cells ( P<0.05) . Compared to the blank control group, the level of p-Smad3/Smad3 expression levels was significantty reduced. Moreover, compared to the silica group, the protein expression levels of N-Cad and Vimentin in the cell of the SIS3+silica group were significantly reduced, while the E-Cad expression was increased ( P<0.05) . Conclusion:Silica exposure can prmote the epithelial mesenchymaol transformotion process by activating smod3 signa ling pathuay, and in hibiting smad3 signa ling pathuay can effctively alleviate the occurrence of epithelial mesenchymal transformation process.

Vertebral refracture following percutaneous vertebral augmentation (PVA) is commonly seen in elderly patients with osteoporotic thoracolumbar compression fractures (OTLCF). It can lead to recurrent pain, loss of vertebral height, progression of kyphosis, and even neurological dysfunction, significantly impairing patients′ quality of life. Current diagnosis and treatment face multiple challenges, including high misdiagnosis rate, difficulty in choosing between surgical and non-surgical treatment options, lack of standardized surgical protocols, interference from intralesional bone cement during procedures, inadequate stability of internal fixation in osteoporotic bone, and suboptimal compliance of anti-osteoporotic therapy. Establishing a standardized diagnostic and therapeutic framework is urgently needed. To standardize the management process and improve outcomes for vertebral refractures after PVA in elderly OTLCF patients, Spinal Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field to develop Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures ( version 2025), based on current literature and clinical experience, and adhering to principles of scientific rigor and clinical applicability. A total of 11 recommendations were proposed, encompassing diagnosis, treatment, and rehabilitation of vertebral refracture after PVA in elderly patients with OTLCF, aiming to provide a foundation for a standardized management.

Thoracolumbar spine fracture often leads to severe pain, functional impairments, and neurological deficits, for which open reduction and internal fixation can effectively restore the spinal structural stability. Open decompression and reduction with internal fixation can help relieve spinal cord compression and improve spinal function in cases of concomitant cord injury. Although spinal stability can be restored through surgery, patients often face chronic pain and functional impairments postoperatively. A postoperative rehabilitation program is critical in optimizing therapeutic outcomes, reducing complications, and minimizing the risk of secondary injuries. However, current rehabilitation methods, such as physical therapy, functional training, and pain management, are confronted with problems in clinical practice, including significant variation in efficacy, poor patient adherence, and prolonged rehabilitation period. There is an urgent need for a unified rehabilitation strategy to address these problems. To this end, the Spinal Trauma Group of the Orthopedic Physicians Branch of the Chinese Medical Association and the Spine Health Professional Committee of the Chinese Human Health Technology Promotion Association organized experts from relevant fields to formulate Evidence-based guidelines for rehabilitation treatment after internal fixation of thoracolumbar spine fracture in adults ( version 2025) by integrating evidences from clinical researches and advanced rehabilitation concepts at home and abroad. A total number of 14 recommendations concerning the rehabilitation treatment with multimodal analgesia, psychological intervention, deep vein thrombosis prevention, core muscle and extremity exercise, appropriate use of braces, early weight-bearing, device-aided rehabilitation exercise, neuroregulatory therapy, rehabilitation team were put forward, aiming to standardize the post-operative rehabilitation process following internal fixation, promote the functional recovery, and enhance patients′ quality of life.

Acute symptomatic osteoporotic thoracolumbar compression fracture (ASOTLF) can lead to chronic low back pain, kyphosis deformity, pulmonary dysfunction, loss of mobility, and even life-threatening complications. Vertebral augmentation is currently the mainstream treatment method for this condition. In 2019, the Editorial Board of Chinese Journal of Trauma and the Spinal Trauma Group of Orthopedic Surgeons Branch of Chinese Medical Doctor Association collaboratively led the development of Clinical guideline for vertebral augmentation for acute symptomatic osteoporotic thoracolumbar compression fractures. Six years later, with advances in clinical diagnosis and treatment techniques as well as accumulating evidence in related fields, the 2019 guideline requires updating. To this end, the Spinal Trauma Group of Orthopedic Surgeons Branch of Chinese Medical Doctor Association, the Spinal Health Professional Committee of China Human Health Science and Technology Promotion Association, and the Minimally Invasive Orthopedics Professional Committee of Shaanxi Medical Doctor Association have organized experts in the field to develop the Clinical guideline for vertebral augmentation of acute symptomatic osteoporotic thoracolumbar compression fractures ( version 2025) , based on the latest evidence-based medical researches. This guideline incorporates 3 recommendations retained from the 2019 version with updated strength of evidence, along with 12 new recommendations. It provides recommendations from six aspects of diagnosis, pain management, treatment option selection, prevention of postoperative complications, anti-osteoporosis therapy, and postoperative rehabilitation, aiming to provide a reference for standard treatment of vertebral augmentation for ASOTLF in hospitals at all levels.

Objective:To investigate the correlation between membranous urethral length (MUL) and early urinary continence recovery after robot-assisted radical prostatectomy (RARP).Methods:A retrospective analysis was conducted on 71 prostate cancer patients who underwent RARP by a single surgeon at the PLA General Hospital between January 2020 and December 2023. Patient characteristics included: age of (65.32±6.04) years, BMI (25.21 ± 2.59) kg/m 2, prostate volume 32.41 (24.75, 44.40) ml, PSA 11.67 (8.22, 22.66) ng/ml. Gleason score [6/7/8/9-10: 15 (21.2%)/29 (40.8%)/16 (22.5%)/11 (15.5%)], Clinical stage [cT 1/cT 2/cT 3: 4 (5.6%)/61 (85.9%)/6 (8.5%)]. Measured MUL using multiparametric prostate MRI, median MUL was 13.25 (10.41-14.99) mm. Neurovascular bundle (NVB) preservation in 13 (18.3%) cases. Patients were grouped based on continence recovery at 1 and 3 months post-catheter removal. Age, BMI, prostate volume, PSA, Gleason score, clinical stage, NVB preservation, pathological stage, catheter indwelling time, and MUL were compared between groups. Multivariate analysis identified independent predictors of continence recovery. Results:All 71 surgeries were successful, pathological stage [pT 2/pT 3-4: 47 (66.2%)/24 (33.8%)], and catheter indwelling time 2.7 (2.0, 3.0) weeks. Follow-up data at 2 months were available for 71 patients, at 1 month, 42 patients achieved continence (continence group) and 29 had incontinence (incontinence group).No significant differences were observed between continence and incontinence groups in age [(64.93±6.48)years vs. (65.79±5.89) years], BMI [(26.26±2.52)kg/m 2 vs. (24.52±2.42) kg/m 2], prostate volume [32.00 (24.12, 41.11)ml vs. 33.00 (25.27, 47.97) ml], PSA [12.55 (8.31, 24.00) ng/ml vs. 11.30 (7.92, 20.65) ng/ml], Gleason score [6/7/8/9-10: 6 (14.2%)/18 (42.9%)/12 (28.6%)/6 (14.3%) vs. 9 (31.0%)/11 (37.9%)/4 (13.8%)/5 (17.3%)], clinical stage [cT 1/cT 2/cT 3: 2 (4.8%)/35 (83.3%)/5 (11.9%) vs. 2 (6.9%)/26 (89.7%)/1 (3.4%)], NVB preservation [7 (16.7%) vs. 6 (20.7%)], pathological stage [pT 2/pT 3-4: 27 (64.3%)/15 (35.7%) vs. 20 (69.0%)/9 (31.0%)], or catheter indwelling time [2.6(2.0, 3.0) weeks vs. 2.9 (2.0, 3.4) weeks]. However, MUL was significantly longer in the continence group [13.77 (11.70, 15.32) mm vs. 10.32 (9.65, 13.57) mm, P<0.01]. Follow-up data at 3 months were available for 69 patients, At 3 months, 61 patients achieved continence (continence group) and 8 remained incontinent (incontinence group). No significant differences were observed in age [(64.89±6.25)years vs. (68.13±4.09) years], BMI [(25.34±2.64)kg/m 2 vs. (24.36±2.49) kg/m 2], prostate volume [32.41 (24.44, 44.16)ml vs. 36.13 (27.48, 48.26) ml], PSA [12.50 (8.28, 22.76)ng/ml vs. 13.34 (5.88, 23.39) ng/ml], Gleason score [6/7/8/9-10: 12 (19.7%)/25 (41.0%)/14 (23.0%)/10 (16.3%) vs. 3 (37.5%)/3 (37.5%)/2 (25.0%)/0], clinical stage [cT 1/cT 2/cT 3: 3 (4.9%)/52 (85.2%)/6 (9.8%) vs. 1 (12.5%)/7 (87.5%)/0], NVB preservation [9 (14.8%) vs. 3 (37.5%)], pathological stage [pT 2/pT 3-4: 41 (67.2%)/20 (32.8%) vs. 5 (62.5%)/9 (31.0%)], or catheter indwelling time [2.7(2.0, 3.0)weeks vs. 3.0 (2.3, 3.7) weeks]. MUL remained significantly longer in the continence group [13.57 (10.57, 15.10)mm vs. 10.12 (9.36, 10.42) mm, P=0.002]. Multivariate logistic regression incorporating age, BMI, prostate volume, MUL, NVB preservation, and catheter indwelling time identified MUL as an independent protective factor for continence recovery at both 1 month [ OR=0.62, 95 CI 0.49-0.79, P<0.01] and 3 months [ OR=0.61, 95 CI 0.41-0.92, P=0.017]. Conclusions:MUL is independently associated with early urinary continence recovery after RARP, serving as a protective predictor at both 1 and 3 months after catheter removal.

Objective:To assess the predictive value of the percentage of Gleason pattern 4 (G4%) in prostate biopsy for adverse pathology and biochemical recurrence.Methods:We retrospectively analyzed consecutive patients who underwent radical prostatectomy in our institution between January 2019 and December 2023, and included those who were diagnosed with ISUP 2-3 cancer at biopsy. A total of 109 patients were included in this study. The average age of patients was (67.40±6.11) years, and the average BMI of patients was (25.36±2.97) kg/m 2. 49 Cases (45.0%) had a PI-RADS score of 5, and the median prostate volume was 32.60 (24.57, 45.63) ml. The median of most recent tPSA before biopsy was 9.76 (6.89, 12.95) ng/ml, the median PSAD was 0.28 (0.17, 0.44) ng/ml 2, and the median f/tPSA was 0.11 (0.08, 0.16). Clinical T 2b or higher stage was found in 84 cases (77.1%). The total biopsy core length was (22.91±5.18) cm, with a median of 24 (20, 24) biopsy cores and a median of 6 (4, 9) positive cores. Gleason score 3+ 4 was found in 52 cases (47.7%), and Gleason score 4+ 3 in 57 cases (52.3%). Cribriform was present in 30 cases (27.5%). G4% was calculated based on the proportion of Gleason grade 4 tumor relative to total tumor, tumor proportion relative to total tissue, and tissue length. Patients were divided into high-G4% (≥2.45%) and low-G4% (<2.45%) groups based on the median G4% value, with 55 and 54 cases, respectively. No significant differences were observed in baseline characteristics between the two groups ( P>0.05). The main risk factor of adverse pathology was analyzed by logistic regression, and receiver operating characteristic (ROC) curve and area under curve (AUC) were performed. Patients were further stratified by the G4% cutoff value from ROC, and Kaplan-Meier survival curves were plotted to compare biochemical recurrence free survival (BCRFS) between groups. The main risk factor affecting BCRFS was analyzed by Cox regression. Adverse pathology was defined as postoperative Gleason score ≥4+ 3 or pathological stage ≥T 3a. Results:Adverse pathology occurred in 44 (80.0%) high-G4% and 16 (29.6%) low-G4% patients ( P<0.01). Multivariate analysis identified G4% as an independent risk factor for adverse pathology ( OR=1.23, 95% CI 1.02-1.50, P=0.033). The highest ROC AUC value was seen for G4% (0.799), significantly outperforming Gleason score (0.799 vs. 0.641, P=0.003), tPSA (0.799 vs. 0.615, P=0.003), PSAD (0.799 vs. 0.679, P=0.038), positive cores (0.799 vs. 0.677, P=0.009), clinical T stage (0.799 vs. 0.607, P=0.001) and cribriform (0.799 vs. 0.639, P=0.001). The G4% cutoff value for predicting biochemical recurrence was 10.97%. The median BCRFS was significantly higher in the low G4% (<10.97%) group than that in the high G4% (≥10.97%) group (55 vs. 28 months, P=0.002). Cumulative recurrence free survival rates at 1 and 3 years were 94.6% vs. 74.1% and 78.0% vs. 47.6%, respectively. Multivariate Cox regression analysis indicates that G4% was an independent risk factor affecting BCRFS ( HR=1.11, 95% CI 1.00-1.23, P=0.041). Conclusions:For patients with ISUP 2-3 nmPCa, a higher G4% in biopsy specimens demonstrates strong predictive ability for adverse pathology and biochemical recurrence, outperforming traditional clinical indicators such as Gleason score and PSA.