1.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.
2.Analysis the influencing factors and risk warning of the therapeutic efficacy of multi plane low temperature plasma radiofrequency ablation for OSAHS.
Xing LIU ; Kaiwei DONG ; Meng LIU ; Huachao LI ; Bo NING
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(9):871-876
Objective:To analyze the efficacy, influencing factors, and risk warning of multi-plane low-temperature plasma radiofrequency ablation(MLT-RFA) in the treatment of obstructive sleep apnea hypopnea syndrome(OSAHS). Methods:A total of 118 OSAHS patients admitted from October 2022 to June 2024 were selected as the research subjects. They were divided into mild group(n=46), moderate group(n=52), and severe group(n=20) according to the severity of their condition. MLT-RFA treatment was used for all patients. After surgery, the results of polysomnography(PSG) and the changes in the Calier Sleep Apnea Quality of Life Index(SAQLI) were observed before and after treatment. The incidence of complications after treatment was recorded, and the clinical efficacy of the patients was evaluated. At the same time, they were divided into a treatment effective group(n=106) and an ineffective group(n=12) according to their effects. The general clinical data of the two groups were compared, and binary logistics regression analysis was conducted to identify independent factors that affect treatment efficacy and construct a model. ROC curve analysis was used to evaluate the diagnostic efficacy of the model. Results:The treatment effectiveness rate of the mild group was 93.48%, the moderate group was 90.38%, and the severe group was 80.00%. There was no statistically significant difference in the treatment effectiveness rate among the three groups(P>0.05). The AHI of the mild group, moderate group, and severe group increased sequentially, while the LSaO2and SAQLI scores decreased sequentially. After treatment, the AHI of all three groups decreased compared to before treatment, while the LSaO2and SAQLI scores increased compared to before treatment, and the differences were statistically significant(P<0.05). The pre-treatment AHI of the effective group was lower than that of the ineffective group, and the pre-treatment LSaO2and SAQLI were higher than those of the ineffective group, with statistically significant differences(P<0.05). Pre-treatment LSaO2and pre-treatment SAQLI are independent factors affecting the efficacy of MLT-RFA(P<0.05). The AUC of pre-treatment LSaO2, pre-treatment SAQLI, and combined prediction were 0.907, 0.763, and 0.947, respectively, with sensitivities of 0.896, 0.840, and 0.917, and specificities of 0.833, 0.667, and 0.887, respectively. Conclusion:MLT-RFA has a significant effect on the treatment of OSAHS, and the AHI, LSaO2, and SAQLI of patients before treatment can predict the treatment effect, with LSaO2 and SAQLI being independent influencing factors. The combinerd prediction model exhibits high diagnostic efficiency, sensitivity, and specificity.
Radiofrequency Ablation/methods*
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Plasma Gases
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Sleep Apnea, Obstructive/surgery*
;
Polysomnography
;
Postoperative Complications/epidemiology*
;
Quality of Life
;
Severity of Illness Index
;
Treatment Outcome
;
Humans
3.Ventral Hippocampal CA1 GADD45B Regulates Susceptibility to Social Stress by Influencing NMDA Receptor-Mediated Synaptic Plasticity.
Mengbing HUANG ; Jian BAO ; Xiaoqing TAO ; Yifan NIU ; Kaiwei LI ; Ji WANG ; Xiaokang GONG ; Rong YANG ; Yuran GUI ; Hongyan ZHOU ; Yiyuan XIA ; Youhua YANG ; Binlian SUN ; Wei LIU ; Xiji SHU
Neuroscience Bulletin 2025;41(3):406-420
Growth arrest DNA damage-inducible protein 45 β (GADD45B) has been reported to be a regulatory factor for active DNA demethylation and is implicated in the modulation of synaptic plasticity and chronic stress-related psychopathological processes. However, its precise role and mechanism of action in stress susceptibility remain elusive. In this study, we found a significant reduction in GADD45B expression specifically in the ventral, but not the dorsal hippocampal CA1 (dCA1) of stress-susceptible mice. Furthermore, we demonstrated that GADD45B negatively regulates susceptibility to social stress and NMDA receptor-dependent long-term potentiation (LTP) in the ventral hippocampal CA1 (vCA1). Importantly, through pharmacological inhibition using the NMDA receptor antagonist MK801, we provided further evidence supporting the hypothesis that GADD45B potentially modulates susceptibility to social stress by influencing NMDA receptor-mediated LTP. Collectively, these results suggested that modulation of NMDA receptor-mediated synaptic plasticity is a pivotal mechanism underlying the regulation of susceptibility to social stress by GADD45B.
Animals
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Receptors, N-Methyl-D-Aspartate/antagonists & inhibitors*
;
CA1 Region, Hippocampal/drug effects*
;
Male
;
Stress, Psychological/physiopathology*
;
Mice
;
Neuronal Plasticity/drug effects*
;
Long-Term Potentiation/drug effects*
;
Mice, Inbred C57BL
;
Antigens, Differentiation/metabolism*
;
Dizocilpine Maleate/pharmacology*
;
Excitatory Amino Acid Antagonists/pharmacology*
;
GADD45 Proteins
4.Study on quality standard of wine-processed Coptidis Rhizoma standard decoction
Huilin YANG ; Kaiwei HUANG ; Yanghua LI ; Suqin CAI ; Shuping XU ; Jiabao WEI ; Hui ZHANG ; Weizhi ZHAO ; Pei TAN
International Journal of Traditional Chinese Medicine 2025;47(9):1285-1292
Objective:To establish the quality standard of the standard decoction of wine-processed Coptidis Rhizoma by studying the extraction rate, fingerprint and component quantitative analysis.Methods:ccording to the Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules, 15 batches of the standard decoction of wine-processed Coptidis Rhizoma were prepared, and the paste rate was determined; HPLC fingerprints of 15 batches of standard decoction of wine-processed Coptidis Rhizoma were established, and evaluated by combining similarity evaluation, clustering analysis, principal component analysis and orthogonal partial least squares discriminant analysis; the contents of berberine, epiberberine, pamadine, and safranine in the samples of the 15 batches were determined and analyzed their transfer rates.Results:A total of 15 batches of standard decoction samples were calibrated with 11 common peaks, referring to the recognition of 8 components. The similarity between the samples and the control product was greater than 0.900; the clustering analysis could cluster the 15 batches of samples into 2 classes; the results of the principal component analysis showed that the cumulative variance contribution rate of the 3 principal component factors was 89.388%; the OPLS-DA screened out the 3 components of the quality difference; the 15 batches of samples out of the paste rate was 15.7% -20.8%, and the mass fractions of berberine, epiberberine, safranine, and palmatine were 18.47%-24.38%, 2.82%-3.49%, 5.08%-6.69%, and 4.84%-6.68%, respectively, with transfer rates of 41.7%-61.7%, 46.9%-68.7%, 39.8%-61.5%, and 43.8%-65.2%.Conclusion:The fingerprint and content determination method established in this study is accurate, stable, simple, and can be used for the quality control and evaluation of the standard decoction of wine-processed Coptidis Rhizoma.
5.Early Predictors for Hypertriglyceridemic Acute Pancreatitis
Wenting PENG ; Kaiwei LI ; Yuhao SONG ; Ye ZHU
Journal of Sichuan University (Medical Sciences) 2025;56(2):591-595
The incidence of hypertriglyceridemic acute pancreatitis(HTG-AP)has been gradually rising in recent years.According to published findings,high triglyceride levels are strongly associated with the severity of acute pancreatitis,and may lead to a higher incidence of complications and worse prognosis.However,the risk factors associated with HTG-AP have not been systematically explored.Early identification and effective management of high triglyceride levels and other potential causes thereof are crucial for reducing the recurrence of acute pancreatitis in clinical practice.Herein,we reviewed the predictive factors of HTG-AP from the perspectives of etiology,pathogenesis,and the relevant biomarkers,such as C-reactive protein,Ca2+,PT,and D-dimer.We aim to provide important early warning signals for clinicians,thereby helping develop personalized treatment protocols and building a more accurate risk prediction model.
6.Clinical observation of contralateral needling combined with Maitland joint mobilization for chronic ankle sprain
Yu LI ; Zhenying WU ; Peng FAN ; Kaiwei ZHANG
Journal of Acupuncture and Tuina Science 2025;23(1):89-94
Objective:To observe the effect of contralateral needling to regulate tendons and circulate Qi combined with Maitland joint mobilization on ankle joint function and the peri-ankle muscle groups in patients with chronic ankle sprain.Methods:A total of 77 patients with chronic ankle sprain,meeting the inclusion criteria,were randomly divided into a control group(38 cases)and an observation group(39 cases).The control group received conventional acupuncture treatment,while the observation group received contralateral needling to regulate tendons and circulate Qi combined with joint mobilization.Both groups were treated once daily for two consecutive courses.The American Orthopaedic Foot&Ankle Society(AOFAS)ankle-hindfoot scale was used to assess ankle joint function in the two groups,and the biomechanical model of skeletal muscles of lower limbs(Gait2392_simbody)was used to evaluate the muscle strength of the peri-ankle muscle groups.Results:The total effective rate in the observation group was 94.9%,significantly higher than the 79.0%in the control group(P<0.05).After treatment,the AOFAS ankle-hindfoot scores in both groups increased compared to their respective pre-treatment scores(P<0.05),and the scores in the observation group were higher than those in the control group(P<0.05).After treatment,the maximum muscle strength values of the medial and lateral heads of the gastrocnemius,tibialis posterior,and flexor hallucis longus in both groups increased compared to their respective pre-treatment values(P<0.05),and the values in the observation group were higher than those in the control group(P<0.05).The maximum muscle strength values of the soleus and flexor digitorum longus in both groups decreased compared to their respective pre-treatment values(P<0.05),and the values in the observation group were lower than those in the control group(P<0.05).The maximum muscle strength values of the extensor hallucis longus and tibialis anterior in both groups increased compared to their respective pre-treatment values(P<0.05),and the values in the observation group were higher than those in the control group(P<0.05).The visual analog scale(VAS)score in both groups decreased compared to their respective pre-treatment score(P<0.05),and the score in the observation group was lower than that in the control group(P<0.05).Conclusion:Either the combined therapy(contralateral needling to regulate tendons and circulate Qi combined with joint mobilization)or the conventional acupuncture alone can alleviate pain,improve ankle joint function,and enhance the muscle strength of the peri-ankle muscle groups in patients with chronic ankle sprain,but the combined therapy shows superior efficacy.
7.Correlation analysis of urinary sodium excretion and early renal functional impairment in patients with primary hypertension
Jiaqi BAI ; Nana YIN ; Lijun LI ; Chi WANG ; Xiangyu WANG ; Siyu YAO ; Kaiwei ZHANG ; Qian XIN ; Hao XUE
Chinese Journal of General Practitioners 2025;24(6):679-685
Objective:To analyze the correlation between 24-hour urinary sodium excretion and early renal function impairment in patients with primary hypertension.Methods:This cross-sectional study included patients with primary hypertension who were admitted to the Department of Cardiology of the Chinese People′s Liberation Army General Hospital between January 2021 and October 2024. Patients were divided into low-sodium, medium-sodium, and high-sodium groups based on their 24-hour urinary sodium excretion. General clinical data were collected using the electronic medical record system. Urinary sodium, protein, and microalbumin excretion were analyzed from 24-hour urine samples. Spearman correlation analysis was used to explore the relationship between 24-hour urinary sodium excretion and urinary microalbumin excretion. A multiple linear regression model was used to further assess the independent association between these variables. Subgroup analyses were conducted based on age were performed to determine whether age influenced the relationship between urinary sodium excretion and renal function impairment.Results:A total of 1 065 patients with primary hypertension were included, with a mean age of (55.26±14.06) years, including 568(53.33%) males. The low-sodium, medium-sodium, and high-sodium groups included 223, 579, and 263 patients, respectively. The 24-hour urinary microalbumin excretion in the high-sodium group was significantly higher than in the medium-sodium and low-sodium groups, and this trend remained consistent across different age groups (all P<0.05). Spearman correlation analysis showed a positive correlation between 24-hour urinary sodium excretion and urinary microalbumin excretion ( r=0.220, P<0.001), and this relationship was observed in all age groups (all P<0.05). Multiple linear regression analysis confirmed an independent association between 24-hour urinary sodium excretion and urinary microalbumin excretion (all P<0.001), which persisted across different age groups (all P<0.05). Conclusion:In patients with primary hypertension, 24-hour urinary sodium excretion is closely associated with microalbumin excretion, suggesting a potential link to early renal function impairment.
8.Clinical observation of contralateral needling combined with Maitland joint mobilization for chronic ankle sprain
Yu LI ; Zhenying WU ; Peng FAN ; Kaiwei ZHANG
Journal of Acupuncture and Tuina Science 2025;23(1):89-94
Objective:To observe the effect of contralateral needling to regulate tendons and circulate Qi combined with Maitland joint mobilization on ankle joint function and the peri-ankle muscle groups in patients with chronic ankle sprain.Methods:A total of 77 patients with chronic ankle sprain,meeting the inclusion criteria,were randomly divided into a control group(38 cases)and an observation group(39 cases).The control group received conventional acupuncture treatment,while the observation group received contralateral needling to regulate tendons and circulate Qi combined with joint mobilization.Both groups were treated once daily for two consecutive courses.The American Orthopaedic Foot&Ankle Society(AOFAS)ankle-hindfoot scale was used to assess ankle joint function in the two groups,and the biomechanical model of skeletal muscles of lower limbs(Gait2392_simbody)was used to evaluate the muscle strength of the peri-ankle muscle groups.Results:The total effective rate in the observation group was 94.9%,significantly higher than the 79.0%in the control group(P<0.05).After treatment,the AOFAS ankle-hindfoot scores in both groups increased compared to their respective pre-treatment scores(P<0.05),and the scores in the observation group were higher than those in the control group(P<0.05).After treatment,the maximum muscle strength values of the medial and lateral heads of the gastrocnemius,tibialis posterior,and flexor hallucis longus in both groups increased compared to their respective pre-treatment values(P<0.05),and the values in the observation group were higher than those in the control group(P<0.05).The maximum muscle strength values of the soleus and flexor digitorum longus in both groups decreased compared to their respective pre-treatment values(P<0.05),and the values in the observation group were lower than those in the control group(P<0.05).The maximum muscle strength values of the extensor hallucis longus and tibialis anterior in both groups increased compared to their respective pre-treatment values(P<0.05),and the values in the observation group were higher than those in the control group(P<0.05).The visual analog scale(VAS)score in both groups decreased compared to their respective pre-treatment score(P<0.05),and the score in the observation group was lower than that in the control group(P<0.05).Conclusion:Either the combined therapy(contralateral needling to regulate tendons and circulate Qi combined with joint mobilization)or the conventional acupuncture alone can alleviate pain,improve ankle joint function,and enhance the muscle strength of the peri-ankle muscle groups in patients with chronic ankle sprain,but the combined therapy shows superior efficacy.
9.Correlation analysis of urinary sodium excretion and early renal functional impairment in patients with primary hypertension
Jiaqi BAI ; Nana YIN ; Lijun LI ; Chi WANG ; Xiangyu WANG ; Siyu YAO ; Kaiwei ZHANG ; Qian XIN ; Hao XUE
Chinese Journal of General Practitioners 2025;24(6):679-685
Objective:To analyze the correlation between 24-hour urinary sodium excretion and early renal function impairment in patients with primary hypertension.Methods:This cross-sectional study included patients with primary hypertension who were admitted to the Department of Cardiology of the Chinese People′s Liberation Army General Hospital between January 2021 and October 2024. Patients were divided into low-sodium, medium-sodium, and high-sodium groups based on their 24-hour urinary sodium excretion. General clinical data were collected using the electronic medical record system. Urinary sodium, protein, and microalbumin excretion were analyzed from 24-hour urine samples. Spearman correlation analysis was used to explore the relationship between 24-hour urinary sodium excretion and urinary microalbumin excretion. A multiple linear regression model was used to further assess the independent association between these variables. Subgroup analyses were conducted based on age were performed to determine whether age influenced the relationship between urinary sodium excretion and renal function impairment.Results:A total of 1 065 patients with primary hypertension were included, with a mean age of (55.26±14.06) years, including 568(53.33%) males. The low-sodium, medium-sodium, and high-sodium groups included 223, 579, and 263 patients, respectively. The 24-hour urinary microalbumin excretion in the high-sodium group was significantly higher than in the medium-sodium and low-sodium groups, and this trend remained consistent across different age groups (all P<0.05). Spearman correlation analysis showed a positive correlation between 24-hour urinary sodium excretion and urinary microalbumin excretion ( r=0.220, P<0.001), and this relationship was observed in all age groups (all P<0.05). Multiple linear regression analysis confirmed an independent association between 24-hour urinary sodium excretion and urinary microalbumin excretion (all P<0.001), which persisted across different age groups (all P<0.05). Conclusion:In patients with primary hypertension, 24-hour urinary sodium excretion is closely associated with microalbumin excretion, suggesting a potential link to early renal function impairment.
10.Predictive model for extubation delay undergoing non-emergency major surgery based on random forest algorithm
Peng LI ; Jingwen ZHU ; Kaiwei XU ; Yu ZHANG ; Haifeng FU ; Wenwen DU
The Journal of Clinical Anesthesiology 2024;40(1):7-12
Objective To construct and validate a clinical prediction model for delayed extubation undergoing non-emergency major surgery based on the random forest algorithm.Methods Clinical data of 7 528 patients undergoing non-emergency major surgery under general anesthesia from January 2018 to De-cember 2022 were retrospectively collected.The patients were divided into two groups according to whether extubation was performed within 2 hours after surgery:non-delayed extubation group(≤2 hours)and de-layed extubation group(>2 hours).All the patients were randomly divided into a training set and a valida-tion set in a ratio of 7 ∶ 3.The predictive factors for delayed extubation after surgery were screened through LASSO regression and Logistic regression.The random forest model was established and verified by random forest algorithm.Results There were 123 patients(1.6%)experienced delayed extubation after surgery.ASA physical status,department,intraoperative use of flurbiprofen ester,dexmedetomidine,glucocorticoid,hypocalcemia,severe anemia,intraoperative blood transfusion,and airway spasm were identified as inde-pendent predictive factors for delayed extubation.The area under curve(AUC)value of the random forest prediction model in the validation set was0.751(95%CI0.742-0.778),and the sensitivity was98.1%,and the specificity was 41.9%.Conclusion The predictive model of delayed extubation undergoing non-e-mergency major surgery based on random forest algorithm has a good predictive value,which may be helpful to prevent delayed extubation undergoing non-emergency major surgery.

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