ObjectiveTo evaluate the safety and clinical utilization of traditional Chinese medicine （TCM） formula granules based on real-world data， and to provide evidence for their rational clinical use. MethodsA multicenter， prospective， open-label， observational centralized monitoring study was conducted. Participants who received TCM formula granules in 293 medical institutions throughout China from February 5th， 2020 to May 20th， 2025 were consecutively enrolled. The year of data collection was used as the stratification factor. Demographic characteristics （including sex， age， and concomitant medication use）， information on TCM formula granule use （including mean prescribed dosage and inappropriate use）， and adverse event（AE）/adverse drug reaction（ADR） occurrence and related factors were collected and statistically analyzed. ResultsA total of 42 011 participants were included in the safety set （SS）， with a mean age of （38.34±22.30） years， including 18 693 males and 23 318 females. Among them， 3519 participants （8.38%） had a history of or concomitant diseases. The three most common comorbidities were hypertension （1189 cases， 33.79%）， diabetes mellitus （850 cases， 24.15%）， and coronary heart disease （471 cases， 13.38%）. The top three diagnostic categories were respiratory， thoracic， and mediastinal diseases （7008 cases， 16.68%）， infectious and parasitic diseases （6591 cases， 15.69%）， and gastrointestinal diseases （4580 cases， 10.90%）.Among 41 961 participants with available concomitant medication data， 3332（7.94%） received concomitant medications， and western medicines were the most commonly used concomitant medications （2819 cases， 6.72%）. The mean prescribed dosage of TCM formula granules （expressed as the equivalent dosage of crude herbal pieces） was （158.23±104.86） g in 2020， （131.70±65.84） g in 2021， （130.62±59.96） g in 2022， （86.74±50.61） g in 2023， （118.59±52.01） g in 2024， and （134.38±49.43） g in 2025. The five most frequently prescribed toxic herbs were Kuxingren （Semen Armeniacae Amarum， 2746 cases， 6.54%）， Xixin （Radix et Rhizoma Asari， 2193 cases， 5.22%）， processed Kuxingren （862 cases， 2.05%）， Baiqucai （Herba Chelidonii， 747 cases， 1.78%）， and Wuzhuyu （Fructus Evodiae， 645 cases， 1.54%）. Prescriptions involving incompatible combinations of the "eighteen antagonisms" and the "nineteen mutual inhibitions" were most frequently observed in 2020 （54 cases， 0.503%）， and then decreased markedly， remaining at zero or an extremely low level thereafter. The overall incidence of adverse drug reactions （ADRs） associated with TCM formula granules was 0.057% （24 cases）， indicating a rare occurrence. The annual incidence was 0.028% （3 cases） in 2020， 0 in both 2021 and 2022， 0.065% （5 cases） in 2023， 0.158% （15 cases） in 2024， and 0.226% （1 case） in 2025. Among the 24 patients who experienced ADRs， 15 had inappropriate medication use.Five of the 24 patients used toxic herbs， and all five had inappropriate medication. Multivariate logistic regression analysis showed that no history of drug-related adverse reactions ［OR=0.053， 95%CI（0.006， 0.465）］ and no concomitant medication ［OR=0.315， 95%CI（0.109， 0.911）］ were associated with a lower risk of ADRs. ConclusionTCM formula granules are widely used in clinical practice and exhibit a favorable overall safety. Greater attention should be paid to people with a history of drug-related adverse reactions and those receiving concomitant medications to further improve medication safety.

Objective:To investigate the effects of CO2 intracavitary laser combined with pelvic floor magnetic stimulation on surface electromyography(sEMG)values and pelvic floor three-dimensional ultrasound parameters in female patients with stress urinary incontinence(SUI).Methods:A prospective study was conducted on 92 female SUI patients treated at the outpatient department of Meizhou People's Hospital from October 2021 to July 2023.The patients were randomly divided into an observation group and a control group(n=46 each)using a random number table.Both groups received home-based pelvic floor muscle training.The control group additionally received pelvic floor magnetic stimulation,while the observation group was treated with CO2 intracavitary laser combined with pelvic floor magnetic stimulation.The urinary leakage status,treatment efficacy,pelvic floor muscle sEMG,pelvic floor three-dimensional ultrasound parameters,quality of life,and sexual quality of life were compared between the two groups.Assessments included the International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF),the Incontinence Impact Questionnaire-Short Form(IIQ-7),and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire(PISQ-12).Results:1-hour leakage volume:0 g(observation group)vs.3 g(control group),24-hour leakage episodes:0 times(observation group)vs.0 times(control group),the observed differences were statistically significant(Z=-2.866,-2.355,P<0.05).Total effective rate:95.65%(observation)vs.58.70%(control),the observed differences were statistically significant(x2=4.083,P<0.05).Pelvic floor muscle sEMG(after treatment):Maximal fast contraction:(40.78±3.28)μV(observation)vs.(35.17±5.10)μV(control),Mean tonic contraction:(31.56±4.20)μV(observation)vs.(25.87±3.82)μV(control),Mean endurance contraction:(29.34±2.58)μV(observation)vs.(25.37±2.67)μV(control),all differences between the two groups were statistically significant(t=2.736,19.919,3.025,15.426,P<0.05).After treatment,both groups showed reductions in bladder neck descent(BND)during Valsalva maneuver,bladder-symphysis distance(BSD),urethral rotation angle(URA),and posterior vesicourethral angle(RVA).However,the observation group demonstrated significantly greater reductions compared to the control group(post-treatment data:observation group(24.30±3.21)mm,(2.34±0.23)mm,(56.40±5.87)°,(89.54±9.21)°;control group(26.21±3.48)mm,(3.57±0.35)mm,(60.29±6.45)°,(126.71±13.50)°.These differences were statistically significant(t=2.736,19.919,3.025,15.426,P<0.05).Similarly,both groups exhibited decreased scores on the ICIQ-SF and IIQ-7 scales,along with increased scores on the PISQ-12.Again,the observation group showed superior improvement,with statistically significant differences(t=11.478,13.168,6.631,P<0.05).Conclusion:On the basis of pelvic floor muscle training,CO2 intracavitary laser therapy combined with pelvic floor magnetic stimulation can effectively alleviate urinary incontinence symptoms in patients with female stress urinary incontinence(FSUI),enhance therapeutic efficacy,improve pelvic floor muscle strength and the stability of pelvic support structures,and promote quality of life and sexual function.

Objective:To investigate immunological non-responders (INRs) and immunological responders (IRs) during long-term antiretroviral therapy (ART), and study the dynamics of HIV reservoir and α4β7 cells in INRs and IRs and their correlation.Methods:Twenty-six patients with chronic HIV infection who received ART for 5 years were included. They were divided into INRs (CD4 + T cell counts≤350 cells/μl, n=9) and IRs (CD4 + T cell counts≥500 cells/μl, n=17) based on immune reconstitution outcomes. The percentages and numbers of α4β7 cells in both groups at baseline, ART 1, 3, and 5 years were detected by flow cytometry, and the levels of HIV DNA and cell-associated HIV RNA were quantified by real-time fluorescent quantitative PCR during the same periods. HIV viral decay, α4β7 cells dynamics, and their correlations with T cells were compared at baseline, ART 1, 3 and 5 years between the two groups. Results:Over 5 years of ART, INRs exhibited higher HIV reservoir levels compared to IRs, but the decline trend was not slow. The counts of α4β7 cell were lower and the growth trend was slow in INRs ( P<0.05). α4β7 cell counts were strongly positively correlated with CD4 + T cell counts at all timepoints (Year 1: r=0.887; Year 3: r=0.878; Year 5: r=0.887; P all <0.001), while showing significantly negative correlations with activated CD38 + HLA-DR + CD4 + T cells (Year 1: r=-0.619, P=0.001), CD38 + HLA-DR + CD8 + T cells (Year 1: r=-0.517; Year 5: r=-0.532; P all <0.01), and PD-1 + CD4 + T cells (Year 1: r=-0.476, Year 5: r=-0.390, P all <0.05). Conclusions:During long-term ART, INRs maintained higher HIV reservoir and lower α4β7 cell counts compared with IRs, and decreased α4β7 cells may be associated with disease progression.

Objective:To investigate the value of midtreatment 18F-FDG PET/CT metabolic parameters for predicting the pathological response in patients with locally advanced gastric cancer (LAGC) after neoadjuvant immunochemotherapy (NICT). Methods:Twenty-five LAGC patients (19 males, 6 females, age: (64.8±8.6) years) who underwent 18F-FDG PET/CT after NICT in Henan Cancer Hospital from August 2019 to June 2024 were retrospectively analyzed. The lesion′s ROI was delineated, then the SUV max and metabolic tumor volume (MTV) were measured, and the SUV max was divided by SUV mean of the descending aorta to obtain the tumor-to-background ratio (TBR). Patients underwent surgery after PET/CT imaging. Based on the tumor regression grade (TRG) system by the American Joint Committee on Cancer (AJCC) criteria on surgical specimen, patients were divided into responders (TRG0+ 1) and non-responders (TRG2+ 3). Independent-sample t test, Mann-Whitney U test, one-way analysis of variance, and Kruskal-Wallis rank-sum test were used to compare the differences of data. The predictive efficacy of PET/CT metabolic parameters was assessed by the ROC curve analysis. Results:Postsurgical pathology showed that 9 patients were responders and 16 were non-responders. The SUV max (3.10±1.95) and TBR (2.44±1.54) of primary lesions in responders were lower than those in non-responders (7.40±4.68, 5.85±3.74; t values: -2.61, -2.59, both P<0.05), while the MTV of primary tumors and short diameter and metabolic parameters of positive lymph nodes were not significantly different between those 2 groups ( t=-1.50, Z values: -1.09 to -0.75, all P>0.05). No significant relation was found between PET/CT parameters and pathological differentiation or Lauren classification, or other pathological features ( t values: -1.55 to 1.38, Z values: -1.84 to 0, F values: 0.12-2.43, H values: 0.13-0.98, all P>0.05). ROC curve showed that the cut-off value of SUV max for predicting postoperative TRG was 5.40, and the AUC reached 0.77 (95% CI: 0.56-0.91), with the sensitivity and specificity of 9/16, 9/9, respectively. With TBR=3.54 as the cut-off value, its AUC reached 0.77 (95% CI: 0.56-0.91), and the sensitivity and specificity were 11/16, 8/9, respectively. The sensitivity and specificity of PET/CT for predicting lymph node positivity of patients were 8/12 and 13/13, respectively. Conclusion:Interim 18F-FDG PET/CT metabolic parameters can accurately predict the pathological response of LAGC patients after NICT.

Chronic atrophic gastritis(CAG)is a precancerous lesion of gastric cancer,and its pathogenesis is complicated,with recurrent and prolonged symptoms.Starting from the view of stomach collaterals and sweat pores,the paper analyzed the pathogenesis of CAG,i.e.,stagnation and obstruction of sweat pores,and blood stasis obstructing stomach collaterals.Furthermore,this paper explored the efficacy of wind medicines in treating CAG by opening sweat pores and unblocking stomach collaterals.It is believed that wind medicines are pungent with warm nature,and have the actions of relieving exterior syndrome,regulating qi,elevating yang,unblocking collaterals and dissipating masses,which enable their efficacy on opening sweat pores and unblocking stomach collaterals.In the treatment of CAG,wind medicines are able to open the sweat pores,and the opening of sweat pores promotes the recovery of spleen-stomach function in lifting lucid yang and lowering turbid yin;wind medicines have the actions of directing herbs to the affected meridian or site,and assisting the other Chinese medicines to achieve satisfactory efficacies;wind medicines can also be used for drying dampness,and enhance the efficacy of removing dampness with the help of their actions of opening sweat pores.During the treatment of CAG,the combination of wind medicines can enhance the therapeutic effect of Chinese herbal medicine,and the exploration in this paper will provide reference for traditional Chinese medicine treatment of CAG in clinic.

Objective:This study investigated the awareness and consumption of Trogia venenata among populations in regions affected by Yunnan unexplained sudden death (YUSD). The findings aim to support etiological research on YUSD and contribute to the formulation of preventive measures against Trogia venenata poisoning. Methods:This study was a case-control study. From 2018 to 2021, surveys were conducted in 90 villages across 25 counties within YUSD-affected areas in Yunnan Province. Households with YUSD cases were designated as case households, whereas households without YUSD cases served as controls, ande were selected through convenience sampling at a 3:1 ratio. An enhanced questionnaire was designed to collect information on the consumption of Trogia venenata, and symptoms following consumption. Frequency data were presented as percentages, and group comparisons were conducted using χ 2 tests or Fisher’s exact tests. Results:A total of 711 questionnaires were collected (response rate: 100%), comprising 175 case households and 536 control households. Trogia venenata was present in 80.82% of the villages surveyed. Among the 711 households, 15.89% reported consuming Trogia venenata, primarily through stir-frying (53.10%), followed by boiling (29.20%), boiling and stir-frying (15.93%), and steaming (1.77%). Most households (94.69%) consumed fresh fruiting bodies, with 69.02% consuming them fewer than three times annually. The consumption rates were higher among the case households than among the control households. Of the 113 households with a history of Trogia venenata consumption, 35.40% reported symptoms such as nausea, vomiting, and limb soreness. The proportions of affected families in each group were compared according to their source, cooking method, fruiting body status and consumption frequency. The proportion of affected families with high consumption frequency (≥3 times/year) was higher than that with low consumption frequency (<3 times/year). Among 421 YUSD cases, 63 cases (14.96%) had a history of Trogia venenata consumption before death, with 43 cases showing symptoms within the longest known latency period (14 d) for poisoning by this mushroom. Conclusions:Trogia venenata is prevalent in 80.82% of YUSD-affected regions, with 16.67% of the population reporting its consumption, predominantly as fresh fruiting bodies prepared by stir-frying or boiling. Confirmed Trogia venenata consumption was identified in 14.96% of YUSD cases, suggesting that mushroom poisoning is a significant risk factor for YUSD. Ongoing health education and interventions are critical for mitigating the risk of Trogia venenata poisoning.

Objective:To analyze the efficacy and safety of splenic artery occlusion combined with microwave ablation (MWA) in the treatment of hepatocellular carcinoma (HCC) complicated with liver cirrhosis and hypersplenism.Methods:Clinical data of 24 patients with HCC complicated with cirrhosis and secondary hypersplenism admitted to Airport Hospital of Tianjin Cancer Hospital from August 2023 to May 2024 were retrospectively analyzed, including 13 males and 11 females, aged (57.4±7.8) years. All patients were treated with splenic artery occlusion combined with MWA of spleen. Spleen volume measured by MRI before and after MWA, blood routine changes and postoperative complications (fever, bleeding, pain, renal failure and thrombosis) were analyzed.Results:The splenic volume of 24 patients measured by MRI before MWA was 692.4 (504.7, 1023.7) cm 3, and decreased to 225.0 (186.4, 285.6) cm 3 after treatment for 60 days ( Z=-3.23, P=0.001). The red blood cell counts were comparable before and after microwave ablation. The white blood cell count before MWA was 4.3 (3.2, 5.3)×10 9/L, which increased to 11.0 (8.6, 15.8)×10 9/L three days after treatment, and to 5.0 (3.3, 6.1)×10 9/L 90 days after treatment ( Z=-4.70, -0.34, P<0.001, P=0.732). The platelet count of the patients was 47.0 (39.0, 67.0)×10 9/L before MWA, which increased to 155.0 (120.3, 214.3)×10 9/L seven days after Treatment, and to 77.0 (63.0, 125.0)×10 9/L 90 days after treatment ( Z=-5.29, -2.51, P<0.001, P=0.012). None of the patients had obvious bleeding and no death occured. One patient (4.2%) developed renal failure, one patient (4.2%) had splenic venous thrombosis, 4 patients (16.7%) had pain of different degrees, and 5 patients (20.8%) had low fever. Conclusion:Splenic artery occlusion combined with MWA in the treatment of HCC complicated with liver cirrhosis and hypersplenism can significantly reduce spleen volume and increase platelet level with acceptable complications.

Objective To investigate the effects of periodontitis induced by Prevotella nigrescens(Pn)combined with ligation on cognitive functions in mice.Methods Twenty-four C57BL/6J mice were randomly divided into control group,ligation group,and ligation+Pn treatment(P+Pn)group.Experimental periodontitis was induced by silk ligation of the first molars followed by topical application of Pn for 6 weeks.After modeling,alveolar bone resorption was assessed using micro-CT and histological analysis.Learning and memory abilities of the mice were evaluated using open field test(OFT),novel object recognition test(NORT),and Morris water maze test(MWM).Seven weeks after the start of modeling,the mice were sacrificed for examining histopathological changes in the hippocampus using HE and Nissl staining.Results After 6 weeks of molar ligation,micro-CT revealed horizontal alveolar bone resorption and furcation exposure in the mice,and histological analysis showed apical migration of the junctional epithelium,epithelial ridge hyperplasia,and lymphocyte infiltration,and these changes were obviously worsened in P+Pn group.Alveolar bone height decreased significantly in both ligation groups compared to the control group.Cognitive tests showed that the mice in both of the ligation groups traveled shorter distances in OFT,showed reduced novel object preference in NORT,and exhibited longer escape latencies in MWM,and the mice in P+Pn group had significantly poorer performances in the tests.Histologically,obvious neuronal cytoplasmic degeneration,necrosis,nuclear pyknosis,vacuolation,and reduced Nissl bodies and viable neurons were observed in the hippocampal regions of the mice in the two ligation groups.Conclusion Pn infection aggravates alveolar bone destruction,accelerates necrosis and causes morphological abnormalities of neuronal cells in the hippocampus to reduce cognitive functions of mice with periodontitis.

Objective:To investigate the value of coronary CTA (CCTA)-based traditional features and radiomics of plaque in the identification of culprit lesions that caused acute myocardial infarction (AMI).Methods:This was a retrospective multicenter study. From July 2016 to November 2023, a total of 344 patients from the Affiliated Hospital of Qingdao University (training cohort, n=184), Shandong Provincial Hospital Affiliated to Shandong First Medical University (validation cohort, n=88) and Qilu Hospital of Shandong University (test cohort, n=72) who received percutaneous coronary intervention (PCI) due to AMI and underwent CCTA within 48 hours of AMI were enrolled. The culprit plaques and non-culprit plaques were identified using a combination of electrocardiogram, CCTA, and angiographic findings. The vessel, plaque location, plaque type, Coronary Artery Disease-Reporting and Data System (CAD-RADS) score, high-risk plaque characteristics, plaque length, plaque volume, and burden were analyzed, and 1 904 radiomics features were extracted for each plaque. The traditional imaging model, the radiomics model, and the combined model were established by using multivariate Logistic regression analysis. The area under the receiver operating characteristic curve (AUC) was used to evaluate the performance of each model in identifying culprit lesions. The DeLong test was used for the comparison of AUC between every two models. The net reclassification index (NRI) was used to evaluate the incremental value of the combined model to the traditional imaging model and the radiomics model. The decision curve analysis (DCA) was used to assess the clinical net benefit of these models. A correlation heatmap was used to evaluate the correlation between the radiomics score and traditional CCTA factors. The interpretable analysis of the decision process of the combined model was performed by the Shapley Additive exPlanations (SHAP). Results:In the validation cohort and the test cohort, the AUC of the traditional imaging model developed by the vessel, plaque type, positive remodeling and CAD-RADS score was 0.898 (95% CI 0.869-0.922) and 0.881 (95% CI 0.848-0.910), respectively. The radiomics model developed by six radiomics features was 0.863 (95% CI 0.831-0.891) and 0.863 (95% CI 0.827-0.864), respectively. The AUC of the combined model was 0.930 (95% CI 0.905-0.950)and 0.919 (95% CI 0.889-0.942), respectively. In the validation cohort and the test cohort, the AUC of the combined model was higher than that of the traditional imaging model ( Z=4.013, 4.272, P<0.001) and that of the radiomics model ( Z=4.819, 3.784, P<0.001), respectively. In the validation cohort, the combined model yielded an NRI of 20.43% (95% CI 10.43%-30.44%, P<0.001) and 20.21% (95% CI 9.62%-30.80%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. In the test cohort, the combined model yielded an NRI of 28.05% (95% CI 16.72%-39.38%, P<0.001) and 23.57% (95% CI 13.58%-33.56%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. DCA showed the combined model had the highest clinical net benefit. The correlation heatmap showed the radiomics score was not correlated or only weakly correlated with traditional CCTA factors. SHAP indicated the radiomics and CAD-RADS score contributed significantly to the model. Conclusion:The CCTA-based traditional features and radiomics of plaque have favorable performance for the identification of culprit plaques in patients with AMI.