2.A Large-Scale Observational Centralized Monitoring Study on the Clinical Use and Safety of Traditional Chinese Medicine Formula Granules
Chengfeng WU ; Yaqin TANG ; Dan LI ; Jiabao LIAO ; Kaiwei HUANG ; Yanmei WU ; Zhongqi YANG
Journal of Traditional Chinese Medicine 2026;67(20):2187-2194
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.
3.Effects of CO2 intracavitary laser combined with pelvic floor magnetic stimulation on surface electromyography of pelvic floor muscle and three-dimensional ultrasound parameters of pelvic floor in patients with female stress urinary incontinence
Tao HOU ; Li CHEN ; Shan HE ; Ping ZHOU ; Qijun ZHONG ; Xiaohu LI ; Hua ZHAO ; Yang CHEN ; Yanmei GUO
China Medical Equipment 2025;22(5):87-92
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.
4.Development and verification of a risk prediction model for social dysfunction in middle-aged and elderly patients with ischemic stroke
Meiqi MAO ; Yao LIU ; Yang HAO ; Yaning ZHAO ; Yanmei QIN ; Ying HAN
Chinese Journal of Nursing 2025;60(17):2095-2101
Objective To develop and validate a risk prediction model for social dysfunction in middle-aged and elderly patients with ischemic stroke.Methods A non-matched case-control study was conducted among ischemic stroke patients admitted to the neurology department of a tertiary hospital in Tangshan between August 2022 and March 2023.Patients who developed social dysfunction within 3 months after discharge were assigned to a case group,while those without it were assigned to a control group.Multivariate logistic regression was used to identify significant predictors and construct a nomogram-based prediction model.The model's discrimination and calibration were assessed using the area under the receiver operating characteristic curve(AUC)and the Hosmer-Lemeshow test.Internal validation was performed via bootstrap resampling,and clinical utility was evaluated using decision curve analysis.Results Logistic regression identified the following as significant risk factors for social dysfunction(P<0.05):male gender,age≥60 years,primary education or below,rural residence,income<3 000,cognitive impairment,low disability acceptance,poor self-management ability,suboptimal utilization of chronic disease resources,low future-oriented coping,and high cumulative ecological risk.The nomogram achieved an AUC of 0.874,with a sensitivity of 79.4%and specificity of 80.7%.The Hosmer-Lemeshow test indicated good calibration(x2=3.631,P=0.88).Conclusion The developed nomogram provides an effective tool for predicting the risk of social dysfunction in middle-aged and elderly ischemic stroke patients,facilitating early identification of high-risk individuals.
5.The value of coronary CT angiography-based traditional features and radiomics in identification of culprit plaques to cause acute myocardial infarction
Pei NIE ; Shuo ZHANG ; Yan DENG ; Shifeng YANG ; Xinxin YU ; Kaiyue ZHI ; He ZHU ; Peng LI ; Jingjing CUI ; Wenjing CHEN ; Yanmei WANG ; Yuchao XU ; Dapeng HAO ; Ximing WANG
Chinese Journal of Radiology 2025;59(9):1017-1028
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.
6.Trend of thyroid cancer incidence in China,1992-2021:a Joinpoint regression and age-period-cohort analysis
Dan XIONG ; Xiaojun SU ; Yanmei FANG ; Ying YANG
Journal of Army Medical University 2025;47(14):1652-1659
Objective To analyze the temporal trend of thyroid cancer incidence in China from 1992 to 2021 and evaluate the impact of age,period and cohort on the incidence.Methods Based on the Global Burden of Disease 2021,the trend changes of age-standardized incidence rate(ASIR)of thyroid cancer in China from the period were analyzed,and the obtained data were further analyzed with Joinpoint regression and age-period-cohort analysis.Auto regressive integrated moving average(ARIMA)model was applied to predict the incidence of thyroid cancer in China in the next 20 years.Results The ASIR of thyroid cancer among males was increased from 0.70/100 000 to 2.11/100 000 between 1992 and 2021,with an average annual percent change(AAPC)of 3.93%(95%CI:3.86%~4.00%,P<0.001);For the females,the ASIR was elevated from 1.91/100 000 to 2.87/100 000 in the time,with an AAPC of 1.43%(95%CI:1.36%~1.50%,P<0.001).On the age effect,the overall variation in ASIR among the females was minor,and that in the males reached its peak in the≥85-years-old group,with a rate of 230.51/100 000.Regarding the period effect,the risk of thyroid cancer incidence in the males and females changed with the period and exhibited a temporal increase,and the incidence risk was consistently higher in the males than the females across different periods.Taking the incidence risk during 1992 and 1996 as a reference(RR=1),the males(RR=2.94,95%CI:2.78~3.11)and the females(RR=1.37,95%CI:1.32~1.42)had the highest risk of thyroid cancer in the period from 2017 to 2021.On the cohort effect,the risk of thyroid cancer in both sexes showed an increasing trend with cohort change.When taking the cohort during 1992 and 1996 as a reference(RR=1),the females in the pre-1986 cohort exhibited a higher risk of incidence than the males,but in the post-1996 cohort,the males demonstrated a greater risk of incidence than the females.The males in the 2012-2016 cohort had the highest risk of thyroid cancer when compared to the reference group(RR=2.54,95%CI:1.80~3.57),and the females in the cohort from 1992 to 2016 had higher risk of thyroid cancer than the reference group,though no statistical differences were observed.The ARIMA model prediction analysis found that the ASIR of thyroid cancer in males and females in China would continue to increase from 2022 to 2041,and the ASIR of thyroid cancer in males would reach 2.79/100 000(95%CI:1.96~3.61),and the ASIR of thyroid cancer in females would reach 3.54/100 000(95%CI:3.02~4.06)by 2041.Conclusion Between 1992 and 2021,the ASIR of thyroid cancer in China has exhibited a consistent upward trend,with the females having a higher ASIR than the males.However,the risk of developing thyroid cancer is higher in men who are older and those who were born more recently.In the next 20 years,the incidence of thyroid cancer among both men and women in China is projected to continue to rise,and the situation for prevention and control will be challenging.
7.Prevotella nigrescens exacerbates periodontal inflammation and impairs cognitive function in mice.
Qi CHEN ; Tiantian XIA ; Yongqiang ZHOU ; Mingyang CHANG ; Nan HU ; Yanmei YANG ; Zhong LI ; Yue GAO ; Bin GU
Journal of Southern Medical University 2025;45(3):453-460
OBJECTIVES:
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.
CONCLUSIONS
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.
Animals
;
Periodontitis/microbiology*
;
Mice
;
Mice, Inbred C57BL
;
Cognition
;
Alveolar Bone Loss
;
Hippocampus/pathology*
;
Male
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Inflammation
;
Maze Learning
8.Investigation of incidence of gathering and eating Trogia venenata among populations in communities affected by the Yunnan unexplained sudden death
Yanmei XI ; Xue TANG ; Lin MA ; Mengyao SUN ; Yongpeng YANG ; Yi DONG ; Mingfang QIN ; Yuebing WANG
Chinese Journal of Emergency Medicine 2025;34(1):90-95
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.
9.Prevotella nigrescens exacerbates periodontal inflammation and impairs cognitive function in mice
Qi CHEN ; Tiantian XIA ; Yongqiang ZHOU ; Mingyang CHANG ; Nan HU ; Yanmei YANG ; Zhong LI ; Yue GAO ; Bin GU
Journal of Southern Medical University 2025;45(3):453-460
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.
10.Discussion on the Pathogenesis of Chronic Atrophic Gastritis and the Application of Wind Medicines in Opening Sweat Pores from the View of Stomach Collaterals and Sweat Pores
Yanmei ZOU ; Chenhua YANG ; Danyan LI
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(2):493-498
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.

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