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.

Objective To analyze the factors affecting the prognosis of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) undergoing immunotherapy and construct an individualized prognostic nomogram prediction model. Methods A retrospective analysis was conducted on the clinical data of 385 patients with driver gene-negative, locally advanced or metastatic NSCLC who received first-line immune checkpoint inhibitors. Univariate and multivariate Cox regression analyses were used to identify prognostic risk factors, and a prognostic nomogram model was established. The predictive performance of the model was evaluated using the concordance index (C-index), time-dependent receiver operating characteristic (ROC) curves and area under the curve (AUC), and calibration curves. The cutoff value of the nomogram was calculated to stratify patients by risk. Survival curves were calculated by Kaplan-Meier analysis. Results Age (HR=1.775, 95%CI: 1.265-2.490), degree of differentiation (HR=0.365, 95%CI: 0.257-0.519), low PD-L1 expression (HR=0.661, 95%CI: 0.455-0.960), high PD-L1 expression (HR=0.423, 95%CI: 0.297-0.603), SCC-Ag (HR=1.549, 95%CI: 1.109-2.163), and CONUT score (HR=2.527, 95%CI: 1.797-3.554) were independent risk factors affecting overall survival (OS) of patients with NSCLC undergoing immunotherapy. The nomogram prediction model constructed on the basis of these factors had a C-index of 0.767. Time-dependent ROC curves for survival showed that the AUCs for 1-, 2-, and 3-year OS were 0.830, 0.853, and 0.886, respectively. Calibration curves indicated that the nomogram-predicted survival rates were in good agreement with the actual outcomes. The cutoff value for the study’s nomogram prediction model was 136.60 points, and survival curves showed statistically significant differences between different risk groups (P<0.05). Conclusion The nomogram model established in this study can effectively predict the prognosis of patients with driver gene-negative locally advanced or metastatic NSCLC treated with first-line immunosuppressive therapy. It provides a new tool for assessing prognosis and aids clinicians in formulating individualized treatment plans.

BACKGROUND:Traditional Chinese medicine has rich experience and unique advantages in the empirical treatment of phlegm-heat and Fu-organs excess syndrome of ischemic stroke.In order to further explore the therapeutic targets and mechanisms of traditional Chinese medicine for this disease,it is crucial to establish a stable and reliable animal model of phlegm-heat and Fu-organs excess syndrome combined with empirical symptoms of ischemic stroke. OBJECTIVE:To explore the establishment method and evaluation system of the rat model of ischemic stroke with phlegm-heat and Fu-organ excess syndrome. METHODS:Sixty male Sprague-Dawley rats were randomly divided into four groups:blank control group(n=12),ischemic stroke group(n=18),disease+syndrome group(n=18),phlegm-heat and Fu-organ excess syndrome group(n=12),all of which were given high-fat diet for 25 days.On the 26th day,the rats in the blank control group and ischemic stroke group were intragastrically given normal saline and high fat diet,while those in the other two groups were intragastrically given autologous feces suspension and high fat diet for 3 continuous days.After gavage,ischemic stroke models were established using the suture method in the ischemic stroke group and disease+syndrome group.The changes in diet,water intake,body mass,body temperature,fecal traits,nasal secretions,sputum in the throat,and tongue image were recorded.Neurological deficits,tongue image,blood lipid levels,morphological changes of brain tissue and carotid artery,and the serum levels of motilin and somatostatin were detected. RESULTS AND CONCLUSION:Compared with the control group,the rats in the disease+syndrome group had shortness of breath,listlessness,irritability,bradykinesia,a large number of secretions around the nose,audible and heavy sputum in the throat,decreased diet and water intake,increased body mass,body temperature,and slingual vein score,decreased fecal pellet count,Bristol score and fecal moisture content,increased serum total cholesterol,triglyceride,low-density lipoprotein and somatostatin levels,decreased motilin level,increased neurological deficit score,significant pathological changes of the carotid artery,and significant morphological changes of the brain tissue.The ischemic stroke group only showed pathological changes of ischemic brain tissue,without the characteristics of phlegm-heat and Fu-organ excess syndrome.The phlegm-heat and Fu-organ excess syndrome group could present with the typical characteristics of traditional Chinese medicine syndromes,without the pathological changes of brain tissue with ischemic stroke.To conclude,the compound modeling method of high-fat induction combined with suture method and autologous feces gavage can establish an animal model of ischemic stroke with phlegm-heat and Fu-organ excess syndrome.

ObjectiveTo understand the surveillance of influenza-like illness (ILI) and influenza vaccination status in Jing’an District, Shanghai, and to provide a basis for optimizing influenza prevention and control strategies. MethodsThe sentinel surveillance data for ILI and virological surveillance data of influenza viruses in Jing’an District were collected from the Chinese influenza surveillance information system, and data for influenza vaccination were collected from Shanghai immunization information system from September 2017 to August 2023. Epidemiological characteristics of ILI, influenza etiology, and the temporal and population distributions of influenza vaccination were analyzed using descriptive epidemiological methods. ResultsILI as a percentage of total visit surveillance units (ILI%) reported by sentinel hospital was increased in Jing’an District of Shanghai from September 2017 to August 2023 (F=18.841, P=0.012). The peak of the influenza cases mainly appeared in winter-spring, but there were two peaks in winter-spring and summer from September 2019 to August 2020, from September 2020 to August 2021, and from September 2021 to August 2022. In particular, there were two peaks in winter-spring from September 2022 to August 2023, with a rebound during the descending process. The average positive rate of ILI was 21.64% (2 421/11 189) during the 6 years. There was a peak in winter-spring during every year with the exception of the period from September 2020 to August 2021. The dominant strains were B/Yamagata and A/H1N1 in winter-spring from September 2017 to August 2018. The dominant strain was A/H1N1 in winter-spring from September 2018 to August 2019 and from September 2022 to August 2023. The dominant strain was B/Victoria in winter-spring from September 2019 to August 2020 and from September 2021 to August 2022. Different subtype strains occurred alternately, and the dominant strains were A/H1N1 and A/H3N2 in recent years. The influenza vaccination coverage was 2.94% from September 2017 to August 2023, and the vaccination coverage was highest in young children. The vaccination coverage for females was higher than that for males (χ²=546.963, P<0.001), and the vaccination coverage for registered residents was higher compared to that for migrants (χ²=123.141, P<0.001). ConclusionILI% exhibits an upward trend in Jing’an District of Shanghai, and the dominant strain is A subtype. The influenza vaccination coverage is still low, which is insufficient to have an impact on the spread of influenza. It is recommended that the surveillance of ILI and variations of influenza virus strains should be improved continuously, and effective steps should be taken to promote influenza vaccination.

Aim To establish and evaluate an alternative meth-od for detecting skin sensitization of cosmetics based on local lymph node assay using bromodeoxyuridine(BrdU)with flow cytometry(FCM).Methods(1)25％hexyl cinnamic alde-hyde(HCA)was chosen as a positive control with an acetone:olive oil(4∶1,V/V,AOO)mixture as a vehicle control for the experiment.The dorsal sides of both ears of mice were treated with test solutions on day 1,day 2,and day 3.Brdu solution was injected inter-peritoneally on day 5.On day 6,the bilateral ears and mandibular lymph nodes were excised,and the number of Brdu positive cells was measured by flow cytometry.The stim-ulation index(SI)was calculated to identify whether it was ≥3,in order to establish the method of LLNA:Brdu-FCM.(2)BrdU-FCM test was conducted using a blind method with the fif-teen reference substances listed in OECD TG429 whose skin sensitization potentials were known.The test substances were dissolved in AOO,N,N-dimethylformamide(DMF)or dimeth-yl sulfoxide(DMSO)at three different concentrations.Tests were performed the same as above.SI and EC2.7 were calculat-ed to evaluate whether the test substance was categorized as a skin sensitizer.The reliability and accuracy of the method were validated by comparing the classification of test substances with that in OECD TG429.Results The SI for 25％HCA was 3.9,showing positive in the skin sensitization test.It demonstrated that the LLNA:Brdu-FCM test method was properly implemen-ted.Nine test substances(2,4-dinitrochlorobenzene,4-pheny-lenediamine,cobalt chloride,2-mercaptobenzothiazole,hexyl-cinnamaldehyde,eugenol,phenyl benzoate,cinnamic alcohol,imidazolidinyl urea)were positive,and six test substances(methyl methacrylate,chlorobenzene,isopropanol,lactic acid,methyl salicylate,salicylic acid)were negative.The method was evaluated with sensitivity of 90％,specificity of 100％,positive prediction rate of 100％,negative prediction rate of 83％,false positive rate of 0％,false negative rate of 17％and accuracy of 93％.The LLNA:BrdU-FCM assay could correctly categorize the test substances that were skin sensitizers or non-sensitizers.Conclusion The LLNA:BrdU-FCM assay appears to be a relia-ble predictor of skin sensitization protential of chemicals,and it is expected to an alternative method for identifying skin sensitization as a supplementary in safety evaluation of cosmetic ingredient.

Objective:To describe the prevalence of anxiety disorders and its distribution in Inner Mongolia Autonomous Region,and to explore the relevant factors of anxiety disorders.Methods:From June 2019 to Decem-ber 2019,representative multi-stage disproportionate stratified sampling procedure was used to sample in residents aged 18 and over in the Inner Mongolia Autonomous Region.All respondents were face-to-face interviewed by trained interviewers.Composite International Diagnostic Interview-3.0(CIDI-3.0)was used to diagnose anxiety disorders according to the criteria and definition of the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition(DSM-Ⅳ).Chi-square test and multivariate logistic regression analysis were used for statistical anal-ysis.Results:Totally 12 315 people were interviewed in the survey.The weighted 12-mouth prevalence rate of any anxiety disorder was 4.64％,and the lifetime prevalence rate was 6.25％.The weighted 12-month prevalence rate of anxiety disorders was higher in female than that in male(5.38％vs.3.92％).The rate was higher in rural resi-dents than that in urban residents(5.67％vs.3.95％).The rate was higher in people with chronic diseases than that in people without chronic diseases(6.81％vs.2.29％).Logistic regression analysis showed that unmarried(OR=2.32,95％CI:1.31-4.10),separated/divorced(OR=2.49,95％CI:1.33-4.67),in debt(OR=1.55,95％CI:1.04-2.32),chronic disease(OR=2.22,95％CI:1.39-3.53),family history of anxiety disorders(OR=12.05,95％CI:8.78-16.53),poor sleep(OR=2.64,95％CI:1.97-3.54)were risk factors of occurrence of anxiety disorders,while junior high school(OR=0.65,95％CI:0.44-0.96)was protective factor of anxiety disor-ders.Conclusion:Adults with chronic diseases,poor sleep,unmarried or separated/divorced,family history of anxi-ety disorders,and financial debt are at higher risk groups of anxiety disorder in Inner Mongolia Autonomous Re-gion.

Objective:To describe the prevalence and distributions of mood disorder in Inner Mongolia Au-tonomous Region,and analyze the related risk factors.Methods:The multistage stratified sampling method with un-equal probability was used to select permanent residents aged 18 years and over in Inner Mongolia Autonomous Re-gion.The Composite International Diagnostic Interview 3.0 was used as a diagnostic tool.Mood disorders were di-agnosed according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition(DSM-Ⅳ).Single and multivariate analyses were used to investigate the related factors of mood disorders.Results:Totally,12 315 community residents were interviewed in the survey.The weighted 12-month prevalence and lifetime prevalence of mood disorder were 5.4％and 8.7％,respectively.Weighted 12-month prevalence of depressive disorder was 4.9％,and that of bipolar disorder was 0.3％.Among all subtypes of mood disorder,the 12-month prevalence rate of major depressive disorder(3.1％)was the highest.Multivariate logistic regression analysis showed that female,unmarried,separated or divorced,unemployment,family history,other mental disorders,sleep disorders and chronic diseases(OR=1.56,2.80,2.07,1.42,13.46,7.97,3.23,2.13)were risk factors of mood disorder,while aged 65 years and over(OR=0.44)was protective factor of mood disorders.The lifetime consultation rate in patients with mood disorders was 15.5％,the rate of psychiatric consultation was 3.7％,the rate of medication was 1.8％.Con-clusion:It indicates that female residents and people who are unmarried,separated and divorced,unemployed,with family history,suffering from other mental disorders,suffering from sleep disorders,and suffering from chronic dis-eases may be high risk groups of mood disorders,and the utilization rate of health services is rather low in Inner Mongolia Autonomous Region.

BACKGROUND:Currently,traditional Chinese medicine has accumulated extensive experience in the treatment and management of ischemic stroke.The application of latent structure combined with association rule analysis to deeply explore and summarize the"medicine-prescription-syndrome"rules is conducive to promoting the optimization of ischemic stroke prevention and treatment strategies.OBJECTIVE:To explore the rules of Chinese medicine in the treatment of ischemic stroke,and provide a reference for the clinical treatment of ischemic stroke based on syndrome differentiationMETHODS:A systematic search was conducted for clinical research literature on traditional Chinese medicine treatment of ischemic stroke from China National Knowledge Infrastructure(CNKI),WanFang,VIP,and SinoMed databases,covering the period from January 1,1990,to August 15,2024.The relevant studies were selected and the data were extracted into an Excel 2019 database for analysis.The frequency of use of Chinese herbs,their properties,meridional tropism,therapeutic effects and associated syndromes were analyzed.High-frequency herbs(＞4％)were subjected to latent structure modeling,comprehensive clustering,and association rule analysis using Lantern 5.0 and RStudio software,followed by summary of medication patterns and potential traditional Chinese medicine syndromes for ischemic stroke.RESULTS AND CONCLUSION:(1)A total of 231 articles were included,involving 203 kinds of traditional Chinese medicine,and the frequency of use was 2 524 times.(2)The high-frequency Chinese herbs were Chuanxiong,Earthworm,Angelica,Astragalus,Salviorrhiza,red peony root,safflower,leech,peach kernel,and pinellia.These herbs had predominantly warm,cold,or neutral properties,with bitter,sweet,and pungent flavors.Primary meridional tropism targets the liver,spleen and heart.Drug for invigorating blood circulation and eliminating stasis,deficiency tonifying drug,calming liver wind drug,expectorant cough suppressant and anti-asthmatic drug were used more frequently.(3)The latent structure model analysis identified 7 latent variables,14 latent classes,6 comprehensive clustering models,and 19 core prescriptions.It is hypothesized that the main traditional Chinese medicine syndromes for ischemic stroke are qi deficiency and blood stasis syndrome,wind-phlegm obstructing the channels syndrome,phlegm and blood stasis obstructing the channels syndrome,and phlegm-heat obstructing the viscera syndrome.(4)The association rule analysis revealed 29 strongly associative rules,including 2 two-item rules and 27 three-item rules.The highest degree of support was Angelica-Chuanxiong,and the highest degree of confidence was Angelica+licorice-Chuanxiong.The results show that ischemic stroke is a syndrome with qi and blood deficiency,liver and kidney Yin deficiency as the root causes,and wind,phlegm,blood stasis,and fire as the manifestations.The treatment is mainly to benefit qi and strengthen health,promote blood circulation and remove blood stasis,combined with pathological factors such as"phlegm and heat,""qi stagnation,""Yin deficiency,"and"liver fire,"supplemented by clearing heat and phlegm,promoting qi stagnation,nourishing liver and kidney,clearing liver and reducing fire.

OBJECTIVE To investigate the therapeutic mechanisms of electroacupuncture at"Tianshu"(ST25)and"Sanyinjiao"(SP6)acupoints combined with metformin in the treatment of type 2 diabetes mellitus(T2DM)using serum non-targeted metabolomics.METHODS Male SD rats were randomly divided into blank group,model group,metformin group,electroacupunc-ture group,and acupuncture-medicine combination(electroacupuncture combined with metformin)group.A type 2 diabetes model was established by high-fat diet combined with intraperitoneal injection of streptozotocin.The metformin group was treated with 250 mg·kg-1 metformin by gavage,the electroacupuncture group was treated with bilateral Tianshu and Sanyinjiao,the acupuncture-medicine combination group was treated with metformin by gavage combined with electroacupuncture,and the blank group and model group were treated with normal saline by gavage.All rats were treated 6 times a week for 7 weeks.After the intervention,the blood glucose level in the tail vein of the rats was measured using a blood glucose meter in the fasting state.The blood glucose levels of the rats were measured at 30,60,120,and 240 min after intraperitoneal injection of 50%glucose solution(4 mL·kg-1)to evaluate glu-cose tolerance.The serum insulin level of the rats was detected by ELISA and the insulin resistance index was calculated.The blood biochemical parameters were measured by an automatic blood biochemical analyzer.HE staining was used to evaluate the pathological conditions of the liver and pancreatic tissues of the rats.Ultra-performance liquid chromatography-mass spectrometry(UPLC-MS)technology was used for mass spectrometry detection to identify differential metabolites,and MetaboAnalyst 5.0 was used for pathway enrichment analysis.RESULTS Compared with the blank group,the fasting blood glucose,area under the glucose tolerance curve,and insulin resistance index of the model group rats were significantly increased(P<0.001),blood TP and GLB were significantly de-creased(P<0.01),AST,ALT,and ALP were significantly increased(P<0.05,P<0.01,P<0.001),and obvious inflammatory cell infiltration and pathological damage were observed in the liver and pancreas tissues;compared with the model group,the fasting blood glucose,area under the glucose tolerance curve,and insulin resistance index of the acupuncture-medicine combination group were sig-nificantly decreased(P<0.05,P<0.01,P<0.001),blood ALP was significantly decreased(P<0.01),TP and GLB were significant-ly increased(P<0.05),and the pathological damage of the liver and pancreas was significantly improved.Serum metabolomics showed that the metabolic profiles of the groups were well distinguished.Compared with the blank group,the differential metabolites in the model group were enriched in histidine metabolism,thiamine metabolism,taurine and hypotaurine metabolism,ascorbic acid and alde-hyde ester metabolism,valine,leucine and isoleucine biosynthesis pathways;compared with the model group,237 metabolites such as 3-aminoadipic acid,3-oxocyclobutanecarboxylic acid and phosphorylcholine in the acupuncture-medicine combination group were sig-nificantly reduced,and the pathways were enriched in histidine metabolism,linoleic acid metabolism,thiamine metabolism,taurine and hypotaurine metabolism,valine,leucine and isoleucine biosynthesis pathways.CONCLUSION Electroacupuncture combined with metformin can effectively improve the glucose and lipid metabolism of T2DM rats,and its potential mechanism may be related to the regulation of amino acid metabolism.

Managing look-alike/sound-alike medications is important to medical institutions'pharmaceutical manage-ment and pharmacy services.Based on national policies and regulations,this standard focuses on the whole life cycle of look-alike/sound-alike medications in medical institutions.It is developed based on the principles of scientific validity,universality,guidance,and applicability,formed by sorting out problems,soliciting opinions,expert argumentation,and deliberation.It is the first group standard to standardize the management of look-alike/sound-alike medications.This paper introduced and analyzed the team com-position,problem sorting and compilation process,and various elements of the standard in the process of formulating the standard,to provide a reference for medical institutions to use this standard.