Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless， given the unique characteristics of traditional Chinese medicine （TCM） and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM， the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design， evaluation， and platform construction， compares domestic and international research landscapes， and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established， and further innovation is needed in TCM research design and methodologies， leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover， standardized and shared platforms for TCM clinical data should be accelerated， so as to provide references for the design， implementation， and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.

Background: Malignant vasovagal syncope (VVS) is characterized by cardiac arrest lasting more than 3 seconds during a syncope episode or head-up tilt test (HUTT). We aim to conduct a risk assessment for potential malignant VVS before the HUTT by using economic, simple and convenient demographic data, in order to prevent adverse outcomes for pediatric VVS.Purpose: To explore the correlation between demographic factors and pediatric malignant VVS, and verify the value of these factors in early risk assessment for malignant VVS before HUTT, so as to optimize test safety and reduce adverse events. Methods: We conducted a retrospective analysis of the clinical data of 3,734 children who were initially diagnosed with VVS due to unexplained syncope and presyncope. Finally, 122 children who met the diagnostic criteria for malignant VVS were included in the malignant VVS group, and 661 children who did not meet the criteria during the same period were matched as the control group. By analyzing demographic data and other factors, we attempted to clarify the association between these factors and malignant VVS. Results: Linear relationship: age and body mass index (BMI) have independent protective effects on malignant VVS. For every 1-year increase in age and every 1 kg/m2 increase in BMI, the risk of malignant VVS decreases by 12% and 9%, respectively. Nonlinear relationship: When the age is <12.9 years old, for every additional year of age, the risk of malignant VVS decreases by 20%. For ages 12.9 years and above, the efficacy is not significant. There is no significant nonlinear relationship between BMI and malignant VVS. Conclusion Age and BMI are independent protective factors for pediatric malignant VVS. Before the age of 12.9 years, the incidence of malignant VVS gradually decreases with the increase in age, and thereafter there is no significant impact.

Objective:To evaluate the clinical status of long-term oral anticoagulant management in patients with atrial fibrillation, and to analyze the obstacles and promoting factors in the implementation of evidence, so as to provide evidence for clinical transformation.Methods:This study was a cross-sectional study. Through the evidence-based nursing method, guided by the Ottawa Model, the review indicators and review methods were developed based on the best evidence. The clinical status review of 100 patients who met the inclusion criteria in the Department of Cardiology, Affiliated Hospital of Jiangsu University was conducted from August to November 2022 using a convenience sampling method, and based on the results of the review, an analysis of obstacles and promoting factors was carried out to develop a clinical response.Results:This study included 100 patients with atrial fibrillation, 60 males and 40 females, aged (70.14 ± 10.39) years. Totally 26 best items were included, and 24 review indicators were developed, among which only 4 indicators had a compliance rate of 100% , 2 indicators had a compliance rate of >60% , 5 indicators had a compliance rate of <60% , and 13 indicators had a compliance rate of 0. According to the results of the review, a comprehensive and systematic analysis was conducted from the three dimensions of system, practitioners, patients and family members. For each dimension, obstacles and promoting factors were analyzed in depth from evidence-based change, potential adopters and practical environment.Conclusions:There is a gap between the best evidence and clinical status of long-term oral anticoagulant management in patients with atrial fibrillation. In-depth analysis of obstacle factors, formulate countermeasures, and promote the efficient implementation of evidence in clinical practice.

Objective:Based on the best evidence, formulate the review indicators to promote the initiation and establishment of maternal lactation and carry out clinical review, analyze the barriers and promoting factors of the clinical application of evidence, and formulate countermeasures.Methods:Evidence-based nursing research was used to identify clinical problems, build evidence-based group, systematically search, evaluate and synthesize evidence. On September 1,2023 to December 31 in Affiliated Hospital of Jiangsu University document and delivery of maternal investigation, in Ottawa research application mode as a guide, based on the evidence to review indicators and review method, clear clinical status and evidence gap, combined with the stakeholders interview, using content analysis to analyze barriers and promoting factors, to formulate action countermeasures.Results:In this study, 140 pregnant women were finally included for clinical review, aged from 22 to 42 (30.13 ± 3.69) years. A total of 23 pieces of best evidence were incorporated, leading to the establishment of 29 review indicators. Among these, 20 review indicators showed compliance rates below 60%. The main obstacles based on the results of review and interviews with stakeholders: the evidence content covered perinatal stages but lacked specificity and practical applicability; nurses had insufficient knowledge and faced increased workloads; pregnant/postpartum women lacked essential knowledge and skills, with delayed resolution of lactation issues; the practice environment lacked evidence-based implementation protocols, specialized assessment tools, and professional lactation consultant teams, etc. Promoting factors: the project team had rich experience in evidence transformation; the reform aligned with national policies, high engagement from departmental leaders, and standardized management systems for evidence-based projects in the nursing department; strong motivation among pregnant/postpartum women; the hospital was an infant-friendly hospital with talents needed for evidence transformation.Conclusions:There is a big gap between the clinical status and the evidence of promoting the initiation and establishment of lactation, so nursing staff should make full use of the promoting factors and formulate countermeasures according to the obstacle factors, so as to provide reference for promoting the initiation of lactation and the establishment of relevant evidence to clinical transformation.

Objective To observe the efficacy and safety of Buyi Pishen Prescription combined with alisartan ester tablets in patients with primary chronic kidney disease stage 3(CKD3)with spleen-kidney qi deficiency syndrome.Methods Totally 80 patients were divided into treatment group and control group using a random number table method,with 40 cases in each group.Both groups received basic treatment and alisartan ester tablets(1 tablet/day,once daily,orally).The treatment group additionally received the Buyi Pishen Prescription(1 dosage/day,twice daily,orally).Both groups were treated for 24 weeks.TCM syndrome efficacy and clinical efficacy were evaluated.At 8,16 and 24 weeks,24-hour urinary protein(24 hUpro),serum creatinine(SCr),blood urea nitrogen(BUN),estimated glomerular filtration rate(eGFR)and TCM syndrome scores were measured.Serum oxidative stress markers(SOD,GSH-Px,MDA)were assessed before and after treatment.Blood potassium and liver function were monitored throughout.Results The total effective rate for TCM syndrome efficacy was 82.50%(33/40)in the treatment group and 60.00%(24/40)in the control group(P<0.05),and the treatment group was better than the control group.The total clinical efficacy rate was 77.50%(31/40)in the treatment group and 50.00%(20/40)in the control group,and the treatment group was better than the control group(P<0.05).Compared with before treatment,the treatment group showed a significant decrease in 24 hUpro and SCr at weeks 8,16 and 24,a significant decrease in BUN at weeks 16 and 24,and a significant increase in eGFR at weeks 8,16 and 24(P<0.01);the control group showed a decrease in 24 hUpro at weeks 8,16 and 24 of treatment(P<0.05),a decrease in SCr at weeks 16 and 24 of treatment(P<0.05),and an increase in eGFR at weeks 16 and 24 of treatment(P<0.05).In addition,the treatment group had lower 24 hUpro and SCr at weeks 16 and 24 of treatment than the control group(P<0.05,P<0.01),and higher eGFR than the control group(P<0.05,P<0.01).Compared with before treatment,the total scores of both the treatment group and control group significantly decreased at 16 and 24 weeks of treatment(P<0.01).The total scores of the treatment group were significantly lower than those of the control group at 8,16 and 24 weeks of treatment(P<0.01).Compared with before treatment,both groups showed a significant increase in serum SOD levels(P<0.05,P<0.01)and a significant decrease in MDA levels after treatment(P<0.05,P<0.01).The improvement in the treatment group was more significant than that in the control group(P<0.05).Both groups showed no abnormalities in blood potassium and liver function.Conclusion Buyi Pishen Prescription combined with alisartan ester tablets can reduce the levels of 24 hUpro,BUN and SCr,improve eGFR,alleviate TCM symptoms,and delay CKD progression in CKD3 patients with spleen-kidney qi deficiency syndrome,which can effectively reduce the serum MDA level and increase the antioxidant enzyme SOD level in patients,and its mechanism may be related to improving oxidative stress levels.

Objective:To investigate the epidemiological dynamics and spatiotemporal diffusion trend of brucellosis in China from 2010 to 2024.Methods:Data on reported human brucellosis cases in mainland China from January 1, 2010, to December 31, 2024, were collected via the"China Information System for Disease Control and Prevention", including detailed information on the date of onset, gender, age, occupation, and residential address of the cases. The Joinpoint regression and spatial interpolation techniques were used to investigate the spatiotemporal dynamics and population distribution characteristics of human brucellosis in pastoral/semi-pastoral areas and other regions, as well as urban and rural areas, and explore the epidemic trends of the disease.Results:From 2010 to 2024, pastoral/semi-pastoral regions reported 252 094 brucellosis cases, with a mean annual incidence rate of 36.57±7.28 per 100 000. In contrast, other regions cumulatively recorded 519 748 cases during the same period, demonstrating a significantly lower mean annual incidence rate of 2.54±0.74 per 100 000. The incidence rate of human brucellosis in pastoral/semi-pastoral regions exhibited a declining-rebounding-declining trend. Specifically, the incidence rate decreased significantly from 2010 to 2017 (APC=-7.20; P<0.001) and increased notably from 2017 to 2021 (APC=18.00; P=0.015) with a decline again from 2021 to 2024 (APC=-7.53; P=0.027). In other regions, the incidence rate showed a fluctuating upward trend. Specifically, the incidence rate increased significantly from 2010 to 2015 (APC=20.37; P<0.001) and decreased notably from 2015 to 2018 (APC=-21.78; P<0.001), followed by an increase again from 2018 to 2024, a significant upward trend in incidence rate from 2018 to 2021 (APC=26.73; P<0.001) and a non-significant decline from 2021 to 2024 (APC=-0.99; P=0.735), resulting in the maintenance of a relatively high incidence level. Rural areas demonstrated significantly higher brucellosis incidence rates than urban settings (all P<0.001). Brucellosis exhibited a diffusion trend from the northern epidemic areas of China to neighboring regions, along with sporadic diffusion in southern regions between 2010 and 2024. The age structure of patients in pastoral/semi-pastoral areas differed significantly from that in other regions. Specifically, in pastoral/semi-pastoral areas, the incidence rate was higher among the 35-49 age groups, while in other regions, the incidence rate was higher among those aged 55-64. Conclusion:There are notable disparities in the incidence of human brucellosis between pastoral/semi-pastoral areas and other regions in China. Human brucellosis exhibits a diffusion trend from the northern epidemic areas of China to neighboring regions, along with sporadic diffusion in southern regions.

Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0％.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.

Objective:To investigate effects of macrophage polarization on PI3K/Akt/mTOR signaling pathway and inflammatory response of vascular smooth muscle cells.Methods:THP-1 cells were induced to become macrophages by phaboate,then treated with LPS and IFN-γ,IL-4 and IL-13 for 48 h,and cultured with fresh medium without serum for 24 h.Supernatant was used as conditioned medium.Vascular smooth muscle cells were divided into control group,M0 medium group,M1 medium group and M2 medium group.CCK-8 was used to detect cell proliferation,flow cytometry was used to detect cell apoptosis,ELISA was used to detect expressions of inflammatory cytokines IL-1α,IL-6 and TGF-β in supernatant of cells,and mRNA and phosphorylated protein expressions of PI3K,Akt and mTOR in vascular smooth muscle cells were detected by RT-qPCR and Western blot.Results:Compared with control group,cell proliferation ability and TGF-β level in supernatant of M0 medium group were significantly decreased(P<0.01),apoptosis rate,IL-1α and IL-6 levels in cell supernatant,mRNA and protein phosphorylation levels of PI3K,Akt and mTOR in cells were significantly increased(P<0.01).Compared with M0 medium group,cell proliferation ability and TGF-β level in supernatant of M1 medium group were significantly decreased(P<0.05),apoptosis rate,IL-1α and IL-6 levels in cell supernatant,mRNA and protein phosphorylation levels of PI3K,Akt and mTOR in cells were significantly increased(P<0.01),the trend was opposite in M2 medium group(P<0.05).Conclusion:Macrophage polarization can regulate expressions of inflammatory cytokines by regulating PI3K/Akt/mTOR signaling pathway,and participate in inflammatory response in atherosclerosis.

Objective:To investigate the epidemiological dynamics and spatiotemporal diffusion trend of brucellosis in China from 2010 to 2024.Methods:Data on reported human brucellosis cases in mainland China from January 1, 2010, to December 31, 2024, were collected via the"China Information System for Disease Control and Prevention", including detailed information on the date of onset, gender, age, occupation, and residential address of the cases. The Joinpoint regression and spatial interpolation techniques were used to investigate the spatiotemporal dynamics and population distribution characteristics of human brucellosis in pastoral/semi-pastoral areas and other regions, as well as urban and rural areas, and explore the epidemic trends of the disease.Results:From 2010 to 2024, pastoral/semi-pastoral regions reported 252 094 brucellosis cases, with a mean annual incidence rate of 36.57±7.28 per 100 000. In contrast, other regions cumulatively recorded 519 748 cases during the same period, demonstrating a significantly lower mean annual incidence rate of 2.54±0.74 per 100 000. The incidence rate of human brucellosis in pastoral/semi-pastoral regions exhibited a declining-rebounding-declining trend. Specifically, the incidence rate decreased significantly from 2010 to 2017 (APC=-7.20; P<0.001) and increased notably from 2017 to 2021 (APC=18.00; P=0.015) with a decline again from 2021 to 2024 (APC=-7.53; P=0.027). In other regions, the incidence rate showed a fluctuating upward trend. Specifically, the incidence rate increased significantly from 2010 to 2015 (APC=20.37; P<0.001) and decreased notably from 2015 to 2018 (APC=-21.78; P<0.001), followed by an increase again from 2018 to 2024, a significant upward trend in incidence rate from 2018 to 2021 (APC=26.73; P<0.001) and a non-significant decline from 2021 to 2024 (APC=-0.99; P=0.735), resulting in the maintenance of a relatively high incidence level. Rural areas demonstrated significantly higher brucellosis incidence rates than urban settings (all P<0.001). Brucellosis exhibited a diffusion trend from the northern epidemic areas of China to neighboring regions, along with sporadic diffusion in southern regions between 2010 and 2024. The age structure of patients in pastoral/semi-pastoral areas differed significantly from that in other regions. Specifically, in pastoral/semi-pastoral areas, the incidence rate was higher among the 35-49 age groups, while in other regions, the incidence rate was higher among those aged 55-64. Conclusion:There are notable disparities in the incidence of human brucellosis between pastoral/semi-pastoral areas and other regions in China. Human brucellosis exhibits a diffusion trend from the northern epidemic areas of China to neighboring regions, along with sporadic diffusion in southern regions.

Objective To observe the efficacy and safety of Buyi Pishen Prescription combined with alisartan ester tablets in patients with primary chronic kidney disease stage 3(CKD3)with spleen-kidney qi deficiency syndrome.Methods Totally 80 patients were divided into treatment group and control group using a random number table method,with 40 cases in each group.Both groups received basic treatment and alisartan ester tablets(1 tablet/day,once daily,orally).The treatment group additionally received the Buyi Pishen Prescription(1 dosage/day,twice daily,orally).Both groups were treated for 24 weeks.TCM syndrome efficacy and clinical efficacy were evaluated.At 8,16 and 24 weeks,24-hour urinary protein(24 hUpro),serum creatinine(SCr),blood urea nitrogen(BUN),estimated glomerular filtration rate(eGFR)and TCM syndrome scores were measured.Serum oxidative stress markers(SOD,GSH-Px,MDA)were assessed before and after treatment.Blood potassium and liver function were monitored throughout.Results The total effective rate for TCM syndrome efficacy was 82.50%(33/40)in the treatment group and 60.00%(24/40)in the control group(P<0.05),and the treatment group was better than the control group.The total clinical efficacy rate was 77.50%(31/40)in the treatment group and 50.00%(20/40)in the control group,and the treatment group was better than the control group(P<0.05).Compared with before treatment,the treatment group showed a significant decrease in 24 hUpro and SCr at weeks 8,16 and 24,a significant decrease in BUN at weeks 16 and 24,and a significant increase in eGFR at weeks 8,16 and 24(P<0.01);the control group showed a decrease in 24 hUpro at weeks 8,16 and 24 of treatment(P<0.05),a decrease in SCr at weeks 16 and 24 of treatment(P<0.05),and an increase in eGFR at weeks 16 and 24 of treatment(P<0.05).In addition,the treatment group had lower 24 hUpro and SCr at weeks 16 and 24 of treatment than the control group(P<0.05,P<0.01),and higher eGFR than the control group(P<0.05,P<0.01).Compared with before treatment,the total scores of both the treatment group and control group significantly decreased at 16 and 24 weeks of treatment(P<0.01).The total scores of the treatment group were significantly lower than those of the control group at 8,16 and 24 weeks of treatment(P<0.01).Compared with before treatment,both groups showed a significant increase in serum SOD levels(P<0.05,P<0.01)and a significant decrease in MDA levels after treatment(P<0.05,P<0.01).The improvement in the treatment group was more significant than that in the control group(P<0.05).Both groups showed no abnormalities in blood potassium and liver function.Conclusion Buyi Pishen Prescription combined with alisartan ester tablets can reduce the levels of 24 hUpro,BUN and SCr,improve eGFR,alleviate TCM symptoms,and delay CKD progression in CKD3 patients with spleen-kidney qi deficiency syndrome,which can effectively reduce the serum MDA level and increase the antioxidant enzyme SOD level in patients,and its mechanism may be related to improving oxidative stress levels.