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, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily 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 environmental-friendly； replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug 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 explore the effect of external attentional focus strategy on walking function after stroke.Methods From July to December 2024,40 stroke patients admitted in Beijing Bo'ai Hospital were randomly divided into control group(n=20)and experimental group(n=20).Both groups underwent conventional rehabilitation.On this basis,the control group received conventional walking training,while the experimental group received walk-ing training based on external attentional focus strategy,for three weeks.Before and after training,they were as-sessed with Gait Watch 3D gait analysis,Timed Up and Go Test(TUGT),Berg Balance Scale(BBS)and Fugl-Meyer Assessment-Lower Extremities(FMA-LE).Results After training,the step speed,step frequency,walking cycle,time of TUGT,and the scores of BBS and FMA-LE improved in both groups(|t|>3.098,P<0.01),and the step speed,step frequency,walking cycle and the score of FMA-LE improved more in the experimental group than in the control group(|t|>2.572,P<0.05).Conclusion External attentional focus strategy can improve the walking function of patients with stroke.

Objective:To investigate the clinical characteristics, imaging features, risk factors, and prognosis of childhood-onset Takayasu arteritis (TAK) with pulmonary artery involvement.Methods:A retrospective cohort study was conducted in 107 pediatric patients who were initially diagnosed with childhood-onset TAK at Department of Rheumatology and Immunology, Capital Center for Children′s Health, Capital Medical Universiy, from January 2010 to December 2024. Clinical data, including demographic information, imaging features, treatment regimens, and prognosis were collected. Patients were divided into with and without pulmonary artery involvement groups. Intergroup comparisons were performed. Multivariate logistic regression was used to identify risk factors for pulmonary artery involvement. Kaplan-Meier analysis with Log-Rank testing was used for survival analyze.Results:Among 107 children with TAK, 26 were male, 81 were female, with a diagnosis age of 88 (5, 137) months. Sixteen cases were in the pulmonary artery involvement group and 91 cases in the non-pulmonary artery involvement group. The pulmonary artery involvement group was predominantly female (14 cases), with a diagnosis age of 39 (4, 104) months. The pulmonary artery involvement group had higher incidence rates of fatigue,pulmonary hypertension, right heart failure,superior mesenteric artery involvement,as well as higher neutrophil counts, C-reactive protein (CRP) levels (all P<0.05). Hemoglobin was lower in the pulmonary artery involvement group ( P<0.05). Imaging findings revealed that all 16 children in the pulmonary artery involvement group showed signs of pulmonary arterial wall thickening. Other manifestations included dilation in 2 cases, stenosis in 2 cases, and occlusion in 1 case. Unilateral involvement (12 cases) was more common, and the right pulmonary artery (10 cases) was more frequently affected. Independent risk factors for pulmonary artery involvement in childhood-onset TAK patients included superior mesenteric artery involvement ( OR=5.58, 95% CI 1.41-22.10, P=0.014) and elevated CRP levels ( OR=1.02, 95% CI 1.00-1.03, P=0.027). During a follow-up of 3.9 (1.4,8.1) years, 2 patients with pulmonary artery involvement (all with pulmonary hypertension), among the survivors in the pulmonary artery involvement group, 2 cases still exhibited persistent pulmonary artery dilation, and one case had pulmonary artery occlusion; and 6 patients (6.6%) without pulmonary artery involvement died. Patients with pulmonary artery involvement had significantly lower survival rates compared to those without involvement ( P=0.024). Conclusions:Childhood-onset TAK with pulmonary artery involvement has an insidious clinical presentation, and can progress to pulmonary hypertension, pulmonary artery occlusion, and a significantly reduced survival rate. Patients with mesenteric artery involvement or elevated CRP have higher risks of pulmonary artery involvement, requiring close pulmonary vascular monitoring and early intervention to improve prognosis.

Objective:To investigate the clinical characteristics and independent risk factors of severe disease in patients with anti-nuclear matrix protein (NXP) 2 antibody-positive juvenile dermatomyositis (JDM).Methods:A retrospective cohort study was conducted, including 219 anti-NXP2 antibody-positive JDM patients admitted to 23 children′s hospitals across China from July 2011 to July 2023. Patients were classified into severe and non-severe groups based on classification criteria for severe dermatomyositis. Demographic characteristics, clinical manifestations, and laboratory parameters were compared between the 2 groups using independent sample t-test, Mann-Whitney U test, or χ2 test. Univariate and multivariate Logistic regression analyses were performed to identify risk factors for severe disease. The receiver operating characteristic curve was employed to calculate optimal cut-off values. Results:Among the 219 patients, 108 were male and 111 were female, with an age at onset of 6.3 (3.5, 9.4) years. The severe group comprised 69 patients, and the non-severe group 150 patients. The severe group had significantly higher rates of fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, as well as elevated levels of ferritin-to-albumin ratio (FAR), creatine kinase (CK), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH) (all P<0.05). Multivariate analysis identified anti-Ro52 antibody positivity ( OR=13.26, 95% CI 1.37-128.29) and elevated FAR ( OR=1.90, 95% CI 1.09-2.31) as independent risk factors for severe anti-NXP2 antibody-positive JDM (both P<0.05). Receiver operating characteristic curve analysis revealed that a FAR cutoff value of 6.82 predicted severe disease with an area under the curve of 0.87 (95% CI 0.81-0.94, P<0.001), sensitivity of 0.85, and specificity of 0.70. All patients received glucocorticoid therapy, and the severe group received higher proportions of steroid pulse therapy, cyclophosphamide, mycophenolate mofetil, intravenous immunoglobulin, biologics, and adjuvant treatments compared to the non-severe group (all P<0.05). In terms of outcomes, 2 patients (2.9%) in the severe group died (due to neurological involvement and intestinal perforation, respectively), while the remaining patients achieved complete clinical response or remission. All patients in the non-severe group achieved remission. Conclusions:The primary clinical features of anti-NXP2 antibody-positive JDM included fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, and elevated levels of CK, AST, LDH, and FAR. Furthermore, anti-Ro52 antibody positivity and a FAR>6.82 were identified as independent risk factors.

Objective To explore the effect of external attentional focus strategy on walking function after stroke.Methods From July to December 2024,40 stroke patients admitted in Beijing Bo'ai Hospital were randomly divided into control group(n=20)and experimental group(n=20).Both groups underwent conventional rehabilitation.On this basis,the control group received conventional walking training,while the experimental group received walk-ing training based on external attentional focus strategy,for three weeks.Before and after training,they were as-sessed with Gait Watch 3D gait analysis,Timed Up and Go Test(TUGT),Berg Balance Scale(BBS)and Fugl-Meyer Assessment-Lower Extremities(FMA-LE).Results After training,the step speed,step frequency,walking cycle,time of TUGT,and the scores of BBS and FMA-LE improved in both groups(|t|>3.098,P<0.01),and the step speed,step frequency,walking cycle and the score of FMA-LE improved more in the experimental group than in the control group(|t|>2.572,P<0.05).Conclusion External attentional focus strategy can improve the walking function of patients with stroke.

Objective:To examine the effect of antidepressant treatment on the longitudinal depressive burden in patients with bipolar depression.Methods:Subjects were recruited from a national multicenter, naturalistic observational project: Comprehensive Assessment and Follow-up Descriptive Study on Bipolar Disorder study (CAFE-BD). A total of 110 patients with bipolar depression (51 males, 59 females; aged 18-64 years, mean age 34.4±11.1 years) were consecutively enrolled between January 2012 and December 2013 from outpatients and inpatients of nine medical institutions, including six psychiatric hospitals and three general hospitals. Based on the use of antidepressants as defined in this study, patients were classified into a medicated group (Ads, n=74) and a non-medicated group (nAds, n=36). Diagnosis of bipolar depression was confirmed using the MINI (Chinese version), and baseline and follow-up assessments were conducted using the Assessment of Mood Disorders Evaluation (ADE) and the Clinical Monitoring Form (CMF). Depression burden indicators, including aggregate depression scores (SUM-D), number of depressive symptoms (NUM-D), and total depression burden, were compared between the Ads group and nAds group at mid-term (the 6 th month) and endpoint (the 12 nd month). Longitudinal changes in these indicators were also analyzed. Results:The proportion of bipolar depressive patients on antidepressants was 67% (74/110). Among them, 85% (63/74) were taking antidepressants at baseline; this dropped to 76% (56/74) at mid-term, and 64% (47/74) at the endpoint. SUM-D were higher in the Ads group than in the nAds group at baseline (9 (6.5, 11) vs 7.38 (5.5, 9.0); W=1 712.00, P=0.015), and there was no statistically significant difference in NUM-D and total depressive burden between two groups at any time points ( P>0.05). Compared to baseline, the Ads group had significantly lower SUM-D (0.5 (0, 1), 1.33 (0.5, 2.5) vs. 9 (6.5, 11); W=2 770.00, 2 743.00), NUM-D (0 (0, 0), 0 (0, 1) vs. 7 (5, 8); W=2 621.00, 2 601.50) and total depressive burden (c 2=64.36, 59.00) at both mid-term and endpoint (all P<0.001); While SUM-D (0.59 (0.4, 0.7), 1 (0.8, 2.5) vs. 7.38 (5.5, 9.0); W=664.50, W=666.00), NUM-D (0 (0, 0), 0 (0, 1) vs. 6 (4, 7); W=527.00, 528.00) and total depression burden ( χ 2=31.00, 31.00) in the nAds group were also significantly decreased at both mid-term and endpoint (all P<0.001). There were no statistically significant differences in the changes in depression burden indicators between the two groups from baseline to mid-follow-up or endpoint, nor from mid-follow-up to endpoint ( P>0.05). Conclusion:In a 12-month real-world naturalistic follow-up study, both medicated and non-medicated bipolar depression groups experienced significant and similar reductions in depression burden.

AIM To study the chemical constituents from Radix Puerariae Lobatae from Anhui province and their in vitro lipid-lowering activity.METHODS D101 macroporous resin,silica gel,MCI,and semi-preparative HPLC were used for isolation and purification,then the structures of obtained compounds were identified by physicochemical properties and spectral data.The lipid accumulation model was established by palmitic acid-induced hepatocyte AML12,and the in vitro lipid-lowering activity was evaluated.RESULTS Twenty-one compounds were isolated and identified as carboxymethyl isoferulate(1),methyl(E)feruloylglycolate(2),ariscucurbin-A(3),trans-p-coumaroygly colic acid(4),indole-3-carboxaldehyde(5),β-sitosterol(6),puerol A(7),pueroside C(8),cumoestrol(9),dihydrofurocoumarin(10),decuroside V(11),psoralen dimer(12),bergapten dimer(13),isoliquiritigenin(14),neoliquiritin(15),calycosin(16),daidzein(17),3,4,7-trihydroxyisoflavone(18),ononin(19),genistein(20),genistin(21).Compounds 1-4、7-10、13 and 17-19 significantly inhibited lipid accumulation in AML12 cells,and compound 9 inhibited PPAR-γ expression.CONCLUSION Compounds 1-6,10-13 are isolated from Pueraria genus for the first time.Compounds 1-4,7-10,13 and 17-19 have good lipid-lowering activity.

Cervical spinal cord injury without fracture-dislocation (CSCIWFD) is referred to as a special type of cervical spinal cord injury characterized by traumatic spinal cord dysfunction and no significant bony structural abnormalities on imagines. Duo to the high risk of missed diagnosis during the initial consultation, CSCIWFD may lead to progressive neurological deterioration or even complete paralysis, severely impacting patients′ prognosis. Currently, there are no established consensuses over the diagnosis and treatment of CSCIWFD, such as the lack of evidence-based standards for indications of non-surgical treatment and risk of secondary neurological injury, as well as debates over the optimal timing for surgical intervention and indications for different surgical approaches. To address these issues, the Spine Trauma Group of the Orthopedic Branch of the Chinese Medical Doctor Association organized experts in the relevant fields to formulate Diagnosis and treatment guideline for acute cervical spinal cord injury without fracture- dislocation in adults ( version 2025) . Based on evidence-based medicine and the principles of scientific rigor and clinical applicability, the guidelines proposed 11 recommendations covering terminology, diagnosis, evaluation treatment, and rehabilitation, etc., aiming to standardize the management of CSCIWFD.

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.