OBJECTIVE To provide suggestions for improving the path and system construction of patient engagement in drug regulation in China. METHODS By reviewing initiatives and experiences from the United States （U. S.）， European Union （EU）， and Japan in promoting patient engagement， this study summarizes the roles and contributions of patients in the entire drug regulatory process internationally. Combining China’s current progress and challenges in patient engagement， specific proposals are formulated to refine regulatory pathways and institutional systems. RESULTS & CONCLUSIONS With growing global emphasis on patient engagement as a regulatory strategy， countries or regions such as the U.S.， EU， and Japan have established clear policies， designated oversight agencies， and developed diversified pathways for patient engagement. Patients contribute to regulatory processes through advisory meetings， direct decision-making roles， and leveraging lived experiences and expertise to optimize drug evaluation and monitoring. In contrast， China’s patient engagement remains primarily limited to clinical value- oriented drug development， lacking formal policy guidance. It is recommended that China， based on its existing policy system， further strengthen the construction of a safeguard system for patient engagement， improve the capacity building and pathway models for patient participation in pharmaceutical regulation， and promote the continuous development of patient engagement in pharmaceutical regulation in our country.

OBJECTIVE To analyze the current status and challenges in importing rare disease drugs in China， providing references for optimizing the import process and improving relevant policies. METHODS Questionnaires and interviews were conducted with stakeholders involved in rare disease drug importation， including government departments， multinational pharmaceutical enterprises， healthcare institutions， and patient organizations. This explored the current situation and challenges encountered by each party. Expert opinions were synthesized to propose improvement suggestions. RESULTS A questionnaire survey of representatives from 25 multinational pharmaceutical companies in the rare disease field revealed that these companies had a strong willingness to import rare disease drugs， with 58.33% of them practicing diverse import models. However， significant challenges hindered this process， including unclear regulations （54.17%）， complex approval procedures （45.83%）， and excessively long approval cycles （41.67%）， negatively impacting their motivation. Meanwhile， interviews with 13 experts from government departments， healthcare institutions， pharmaceutical enterprises， and patient organizations identified deficiencies in policy design， approval processes， sampling inspection costs， and communication efficiency with regulators. Additionally， the drug import model in special medical zones also required improvement. CONCLUSIONS The importation of rare disease drugs in China faces challenges such as incomplete policies， inflexible regulatory mechanisms， and insufficient communication channels. It is recommended to enhance the rare disease definition criteria， optimize import incentive policies， and refine regulatory models， so as to further optimize the import process of rare disease drugs and improve relevant policies.

Childhood household dysfunction(CHD)is a common adverse childhood experience,which brings the heavy physical and mental afflictions to children and adolescents.Trauma-focused cognitive behavioral therapy(TF-CBT)is an evidence-based psychotherapy that helps children and adolescents who have experienced childhood trauma with traumatic memories.It aims to enhance the coping abilities of CHD children and adolescents,thereby improving the negative effects caused by trauma and effectively reducing psychological burden.TF-CBT can effectively improve post-traumatic stress disorder,emotional and behavioral problems,and family function in children and adolescents with CHD.It is recommended to conduct high-quality original research in the future,develop targeted TF-CBT intervention plans based on potential predictive factors,adopt a combination of online and offline methods,and construct TF-CBT interventions suitable for the Chinese CHD population to meet the mental health service needs of CHD children and adolescents.

Objective: To evaluate the effect of Tai Chi and Qigong on patients with lumbar disc herniation (LDH). Methods: Relevant data were retrieved from nine English and Chinese databases, including Cochrane Library, PubMed, and Wanfang Data, etc. from inception to June 2024. All published randomized controlled trials assessing the effect of Tai Chi and Qigong on visual analog scale (VAS), Japanese Orthopedic Association (JOA) score, and other health indicators in participants with LDH compared to usual medical care or other treatments were included. Grey literature, trials involving the pushing of hands (Tui Shou) or Tai Chi with weapons, and trials with co-interventions (Tai Chi/Qigong plus another treatment) were excluded. Methodological quality was analyzed using the Cochrane risk of bias tool, and evidence quality was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) tool. Results: Fourteen trials (954 patients) were included in this study. Tai Chi and Qigong were associated with lower VAS pain scores (standardized mean difference −0.55, 95% confidence interval [CI] −0.95 to −0.15, P = .01), higher JOA scores (mean difference [MD] 4.40, 95% CI 2.62 to 6.18, P < .001) and straight leg raise test results (MD 9.40°, 95% CI 7.64 to 11.15, P < .001) in patients with LDH. Furthermore, compared with usual care, Tai Chi and Qigong showed enhanced effects on pain and JOA scores. When compared to other exercises or massage, the effect on pain scores was similar but that on JOA scores was significant. Conclusions Tai Chi and Qigong may have favorable effects on VAS pain and JOA scores compared with usual care, and on JOA scores compared with other exercises or massage in patients with LDH. Given the overall poor quality of the evidence, the results of current study should be interpreted cautiously.

Tumor immune microenvironment is a local external tumor environment composed of tumor immune cells and the cytokines secreted by these cells， and it plays a regulatory role in the development and progression of tumors. In the treatment of hepatocellular carcinoma， amino acid metabolism and its reprogramming of proliferating cell metabolism have attracted more and more attention， showing potential in regulating the tumor immune microenvironment. Although amino acid metabolic reprogramming is regarded as a novel approach for tumor therapy， its specific mechanism remains unclear in the regulation of tumor immunity in hepatocellular carcinoma. This article discusses the mechanism of action of amino acid metabolism in the tumor immune microenvironment of hepatocellular carcinoma and its application prospect in clinical practice， in order to provide new ideas for immunotherapy for liver cancer.

Objective:To analyze the nutritional status of progeria, and to provide reference for scientific nutritional management of progeria.Methods:This cross-sectional study included 15 children with progeria who were treated at Children′s Hospital, Zhejiang University School of Medicine, between April 2022 and May 2023. Data of medical history, physical examination, laboratory tests, dietary survey and body composition were collected and analyzed.Results:Among 15 patients there were 7 males and 8 females, aged 7.8 (2.3, 10.8) years. Twelve of the 15 patients exhibited signs of malnutrition. A 24-hour dietary survey was carried out in 14 of them. The daily energy intake of 11 cases was below recommended levels. Carbohydrate intake was insufficient in 10 cases, protein intake was insufficient in 7 cases, and fat intake was insufficient in 12 cases. Deficiencies in calcium, magnesium, iron and zinc were noted in 13, 13, 9 and 10 cases, respectively. Body composition was determined by dual-energy X-ray absorptiometry in 8 cases, and the bone mineral density was below average in 5 of them.Conclusions:Malnutrition, characterized by reduced energy intake, micronutrient deficiencies, and alteration in body composition, is prevalent in children with progeria. Regular routine nutritional assessment and proper interventions may benefit their long-term health status.

Objective:To construct a nomogram model for differentiating gastric schwannoma (GS) from gastric stromal tumor (GST) (diameters 2 to 5 cm) based on CT imaging features before surgery.Methods:The clinical and imaging data of 49 patients with GS and 240 patients with GST in the Affiliated Hospital of Jining Medical University from July 2009 to April 2023 and Guangdong Provincial People′s Hospital from June 2017 to September 2022 were analyzed retrospectively. The independent factors for differentiating GS from GST were obtained by multivariate Logistic regression analysis. The nomogram model was constructed by R4.3.1 software. The efficacy of the nomogram model for differentiating GS from GST was evaluated by the receiver operating characteristics (ROC) curve, and calibration curve and decision curve analysis were used to evaluate the predictive efficacy and clinical application value of the nomogram model.Results:There were no statistical differences in the clinical symptom rate, calcification rate, ulcer rate, tumor vessel rate, ratio of long diameter to short diameter and CT value difference during the arterial and nonenhanced phases (CTV A-N) between GS patients and GST patients ( P>0.05). The proportion of female, incidence of lesions located in central or lower part of stomach, extraluminal or mixed growth rate, tumor-associated lymph node rate, strong enhancement rate, CT value difference during the portal and nonenhanced phases (CTV P-N), CT value difference during the delayed and nonenhanced phases (CTV D-N), CT value difference during the portal and arterial phases (CTV P-A) and CT value difference during the delayed and portal phases (CTV D-P) in GS patients were significantly higher than those in GST patients: 75.51% (37/49) vs. 58.33% (140/240), 85.71% (42/49) vs. 54.17% (130/240), 75.51% (37/49) vs. 45.00% (108/240), 44.90% (22/49) vs. 5.42% (13/240), 51.02% (25/49) vs. 27.08% (65/240), 32.0 (26.0, 43.5) HU vs. 29.0 (22.0, 37.7) HU, (44.59 ± 13.46) HU vs. (32.94 ± 12.47) HU, 20.0 (11.5, 25.0) HU vs. 10.0 (5.0, 17.0) HU and 9.0 (6.0, 12.0) HU vs. 4.0 (-2.7, 7.0) HU, the age, irregular shape rate, cystic degeneration rate and heterogeneous enhancement rate were significantly lower than those in GST patients: (58.12 ± 12.59) years old vs. (62.05 ± 11.22) years old, 16.33% (8/49) vs. 38.33% (92/240), 18.37% (9/49) vs. 51.25% (123/240) and 34.69% (17/49) vs. 56.25% (135/240), and there were statistical differences ( P<0.05 or<0.01). Multivariate Logistic regression analysis result showed that location, cystic degeneration, tumor-associated lymph node, CTV P-A and CTV D-P were the independent factors for differentiating GS from GST ( OR= 3.599, 0.201, 19.031, 1.124 and 1.160; 95% CI 1.184 to 10.938, 0.070 to 0.578, 6.159 to 58.809, 1.066 to 1.185 and 1.094 to 1.231; P<0.05 or<0.01). The nomogram model for differentiating GS from GST was constructed based on location, cystic degeneration, tumor-associated lymph node, CTV P-A and CTV D-P. The area under curve of the nomogram model for differentiating GS from GST was 0.924 (95% CI 0.887 to 0.951). The calibration curve analysis result showed that there was a good agreement between the predicted GS curve and the actual GS curve (the mean absolute error was 0.033). The result of the Hosmer-Lemeshow goodness-of-fit test indicated that the calibration of the nomogram model was appropriate ( χ2 = 2.52, P = 0.961). The clinical decision curve analysis result showed that when the threshold for the nomogram model for differentiating the two tumors was>0.03, the nomogram yielded more net benefits than the "all patients treated as GS" or "all patients treated as GST" scenarios. Conclusions:The nomogram model based on CT imaging features can be used to differentiate GS from GST before surgery.

Objective:To construct a rapid admission evaluation model for medical consumables of same category,and to achieve a balance between scientificity,efficiency and practicality in the management of medical consumables.Methods:Based on the mini health technology assessment(Mini-HTA)model,combined with expert heuristics,a rapid qualitative analysis of the intended use and technical characteristics of the same category of medical consumables were conducted.Expert opinions were solicited through the Delphi method,and a rapid admission evaluation model of same category of medical consumables was constructed.A total of 80 high-value medical consumables of 10 categories in clinical use in Sichuan Provincial People's Hospital from June 2023 to March 2024 were selected,and the traditional admission process method and expert heuristics optimization method were used to make admission decisions for medical consumables,with 40 high-value medical consumables for each method.The differences in the decision-making process and approval time between the two different admission methods were compared and analyzed.Results:The admission decision-making system indicators of the rapid admission evaluation model of medical consumables of same category included 6 primary indicators of clinical efficacy,reliability,economics,values and aspirations,hospital management and corporate services,and 25 secondary indicators.The approval process for medical consumables admission decision-making using the rapid admission evaluation model of medical consumables of same category had been reduced from 10 in the traditional admission process to 2,and the approval time had been shortened from an average of 7.03 days to 2.43 days.Conclusion:The rapid admission evaluation model for the approval of medical consumables of same category based on expert heuristics can significantly optimize the admission approval process of medical consumables,improve the comprehensiveness and transparency of medical consumables admission decisions,and improve the management efficiency of medical consumables.

To summarize the nursing experience of postoperative arrhythmia after transcatheter aortic valve replacement in an elderly patient with severe aortic stenosis.The key points of nursing include:implementing nurse led triple pre-rehabilitation,goal oriented hemodynamic monitoring and volume management,prevention and management of postoperative complications,psychological adaptation adjustment under the guidance of dual heart medicine,early and gradual rehabilitation training,and follow-up specialist guidance for extended care in the hospital.The patient was discharged from hospital with both stable physical and psychological condition after careful treatment and nursing care by the team in 12 days after operation.

Objective:To assess the effects of low temperature environment on skeletal and serum metabolites, and explore underlying mechanism.Methods:C57BL/6J mice were divided into normal temperature control group(control group) and intermittent low temperature exposure group(low temperature group). After 12 weeks of intervention, Micro-computed tomography(CT) was used to detect the bone microstructure. The mouse femur was stained by hematoxylin-eosin(HE) staining, tartrate-resistant acid phosphase(TRAP) staining, and type Ⅰ collagen staining. The serum metabolites were detected by liquid chromatography-mass spectrometry(LC-MS), comprehensive principal component analysis and random forest were used to identify potential biomarkers influencing bone metabolism in serum samples, and the metabolic pathways affecting bone metabolism were enriched through metabolic database analysis.Results:Micro-CT results showed that compared to the control group, the bone mineral density, bone volume/tissue volume, trabecular thickness, and trabecular number decreased(all P<0.05) in low temperature group of mice, while trabecular separation and bone surface/bone volume ratio increased(both P<0.05). The staining results of HE indicated that, compared with the control group, low temperature group exhibited disordered bone trabecular space structure, widened gaps, reduced unit area, and the presence of numerous adipose vacuoles. TRAP staining suggested that compared to the control group, low temperature group had an increased number of osteoclasts. The results of type Ⅰ collagen staining showed that the number of type Ⅰ collagen in the low temperature group was lower than that in the control group, and the structure was disordered. On the other hand, metabolomics identified 40 metabolites in serum, including deoxycholic acid, methionine, bilirubin, and salicylic acid, which are involved in lipid metabolism and amino acid metabolism. Conclusion:Low temperature leads to decreased bone mass, which may be related to the regulation of lipid metabolism and amino acid metabolism.