1.Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool
Yaxiong LI ; Fusang WANG ; Mei ZHANG ; Jiawei LIN ; Wenge CHEN ; Min HUANG ; Junyan WU
China Pharmacy 2025;36(5):606-611
OBJECTIVE To provide technical support for improving recognition rate of adverse drug events (ADEs) related to traditional Chinese medicine (TCM) formula granules and decoction pieces among inpatient patients. METHODS By referencing the global trigger tool (GTT) whitepaper, literature on adverse reactions to TCM, and expert review opinions, ADE trigger items for TCM formula granules and decoction pieces used in the inpatients were established. GTT was applied to analyze ADEs in inpatients who had used TCM formula granules and decoction pieces in our hospital from August 2013 to August 2023, utilizing the Chinese Hospital Pharmacovigilance System. The effectiveness of GTT and the characteristics of these ADEs were analyzed. RESULTS A total of forty-eight triggers were established, including thirty-two laboratory test indexes, thirteen clinical symptoms, and three antidotes. Among the 1 682 patients included, GTT identified 652 potential ADEs, 284 true positive ADEs,with a trigger rate of 38.76% and a positive predictive value of 43.56%. After review by the auditor, 278 cases of ADEs were finally confirmed, with an incidence rate of 16.53%, significantly higher than the number of spontaneously reported ADEs during the same period (0). The 278 cases of ADEs were mostly grade 1 (223 cases), mainly involving hepatobiliary system, gastrointestinal system, blood- lymphatic system, etc;a total of 219 types of TCMs are involved,and the top five suspected TCMs used at a frequency higher than 1% were Poria cocos, Codonopsis pilosula, Atractylodes macrocephala, fried Glycyrrhiza uralensis, and Scutellaria baicalensis. CONCLUSIONS The established GTT can improve the recognition rate of ADEs for hospitalized patients using traditional Chinese medicine formula granules and decoction pieces.
2.Association of Estimated Glucose Disposal Rate With the Stenosis Severity of Coronary Artery Disease: A Cross-sectional Study
Yubin WU ; Zhiteng CHEN ; Maoxiong WU ; Wenhao LIU ; Qian CHEN ; Shiyi ZHOU ; Yan-xin CHEN ; Min XIA
Journal of Sun Yat-sen University(Medical Sciences) 2024;45(1):136-145
ObjectiveTo investigate the association between estimated glucose disposal rate (eGDR) and the severity of coronary heart disease. MethodsWe conducted a hospital-based cross-sectional study that included 1258 patients (mean age: 62(53-68) years) who underwent coronary angiography for suspected coronary artery disease (53.9% were male). Insulin resistance level (IR) was calculated according to eGDR formula: eGDR = 21.158 - (0.09 × WC) - (3.407 × hypertension) - (0.551 × HbA1c) [hypertension (yes = 1 / no = 0), HbA1c = HbA1c (%)]. Subjects were grouped according to the eGDR quantile. CAD severity was determined by the number of narrowed vessels: no-obstructive CAD group (all coronary stenosis were<50%, n=704), Single-vessel CAD group (only one involved major coronary artery stenosis≥50%, n=205), Multi-vessel CAD group (two or more involved major coronary arteries stenosis≥50%, n=349); Multivariate logistic regression model was used to analyze the association between eGDR and CAD severity. The linear relationship between eGDR and CAD in the whole range of eGDR was analyzed using restricted cubic spline. Subgroup analyses were used to assess the association between eGDR and CAD severity in different diabetic states. Receiver operating characteristic (ROC) curve analysis were used to evaluate the value of eGDR in improving CAD recognition. ResultsA decrease in the eGDR index was significantly associated with an increased risk of CAD severity (OR: 2.79; 95%CI: 1.72~4.55; P<0.001). In multivariate logistic regression models, individuals with the lowest quantile of eGDR (T1) were 2.79 times more likely to develop multi-vessel CAD than those with the highest quantile of eGDR (T3) (OR: 2.79; 95%CI: 1.72~4.55; P<0.001). Multivariate restricted cubic spline analysis showed that eGDR was negatively associated with CAD and multi-vessel CAD (P-nonlinear>0.05). In non-diabetic patients, compared with the reference group (T3), the T1 group had a significantly increased risk of CAD (OR: 1.42; 95% CI: 1.00~2.01; P<0.05) and multi-vessel CAD (OR: 1.86; 95%CI: 1.21~2.86; P<0.05). No statistical association was found between eGDR and CAD in diabetic patients. In ROC curve analysis, when eGDR was added to traditional model for CAD, significant improvements were observed in the model's recognition of CAD and multi-vessel CAD. ConclusionOur study shows eGDR levels are inversely associated with CAD and CAD severity. eGDR, as a non-insulin measure to assess IR, could be a valuable indicator of CAD severity for population.
3.Ischemia-free liver transplantation improves the prognosis of recipients using functionally marginal liver grafts
Shuai WANG ; Xiaohong LIN ; Yunhua TANG ; Yichen LIANG ; Min ZHANG ; Zhonghao XIE ; Yiwen GUO ; Yuqi DONG ; Qiang ZHAO ; Zhiyong GUO ; Dongping WANG ; Xiaoshun HE ; Weiqiang JU ; Maogen CHEN
Clinical and Molecular Hepatology 2024;30(3):421-435
Background/Aims:
The shortage of donor liver hinders the development of liver transplantation. This study aimed to clarify the poor outcomes of functionally marginal liver grafts (FMLs) and provide evidence for the improvement of ischemia-free liver transplantation (IFLT) after FML transplantation.
Methods:
Propensity score matching was used to control for confounding factors. The outcomes of the control group and FML group were compared to demonstrate the negative impact of FMLs on liver transplantation patients. We compared the clinical improvements of the different surgical types. To elucidate the underlying mechanism, we conducted bioinformatic analysis based on transcriptome and single-cell profiles.
Results:
FMLs had a significantly greater hazard ratio (HR: 1.969, P=0.018) than did other marginal livers. A worse 90-day survival (Mortality: 12.3% vs. 5.0%, P=0.007) was observed in patients who underwent FML transplantation. Patients who received FMLs had a significant improvement in overall survival after IFLT (Mortality: 10.4% vs 31.3%, P=0.006). Pyroptosis and inflammation were inhibited in patients who underwent IFLT. The infiltration of natural killer cells was lower in liver grafts from these patients. Bulk transcriptome profiles revealed a positive relationship between IL-32 and Caspase 1 (R=0.73, P=0.01) and between IL-32 and Gasdermin D (R=0.84, P=0.0012).
Conclusions
FML is a more important negative prognostic parameter than other marginal liver parameters. IFLT might ameliorate liver injury in FMLs by inhibiting the infiltration of NK cells, consequently leading to the abortion of IL-32, which drives pyroptosis in monocytes and macrophages.
4.Lumbar plexus block combined with general anesthesia in treating postoperative delirium of hip fracture in elderly patients.
Yao XIAO ; Ke CHEN ; Ke-Wei TIAN ; Xu ZHOU ; Min LI ; Sen CHEN ; Zhen-Zhen ZHANG
China Journal of Orthopaedics and Traumatology 2023;36(8):731-736
OBJECTIVE:
To explore lumbar plexus nerve block combined with general anesthesia in elderly patients undergoing hip operation could improve analgesia effect, reduce consumption of analgesics, prevent inflammatory reaction, and avoid postoperative delirium(POD).
METHODS:
Totally 200 elderly patients underwent hip fracture surgery from February 2020 to September 2021 were selected and were divided into observation group and control group according to different anesthesia methods. There were 97 patients in observation group including 66 males and 33 females; aged (70.23±6.60) years old;body mass index (BMI) was (23.13±1.94) kg·m-2;19 patients with hemi arthroplasty, 46 patients with total hip arthroplasty, and 32 patients with femur intertrochanteric fixation;treated with lumbar plexus block combined with general anesthesia. There were 94 patients in control group, including 66 males and 33 females;aged (68.80±6.24) years old;BMI was (22.88±1.85) kg·m-2;14 patients with hemi arthroplasty, 39 patients with total hip arthroplasty, and 41 patients with femur intertrochanteric fixation;treated with only general anesthesia. Nine patients were separated due to the change of surgical protocol or chronic disease. The incidence of POD at 1, 2 and 3 days after surgery, mini-mental state examination (MMSE) score, visual analogue scale (VAS) in resting state, serum inflammatory factors levels [such as C-reactive protein(CRP), interleukin-1β(IL-1β), interleukin-6(IL-6), tumor necrosis factor-α(TNF-α)] at 1 d before operation, 1 and 6 h after surgery, consumption of sufentanil between two groups were compared.
RESULTS:
The incidences of POD in observation group were lower than control group at 1, 2 and 3 days of operation (P<0.05), MMSE score in observation group was higher than that of control group (P<0.05), VAS in observation group was lower than that of control group (P<0.01). The incidences of POD decreased and MMSE score were increaed in both groups day by day (P<0.01). The levels of CRP, IL-1β, IL-6 and TNF-α in observation group were lower than that of control group at 1 h after operation (P<0.01). The levels of CRP, IL-6 and TNF-α in observation group were lower than that of control group at 6 h after operation (P<0.01), while no statisitical difference in IL-1β between two groups(P>0.05). The consumption of sufentanil in observation group was lower than that of control group (P<0.01).
CONCLUSION
Compared with general anesthesia, lumbar plexus nerve block combined with general anesthesia for the operations of hip fracture in elderly patients has better analgesic effect, has advantages of slight inflammatory reaction, and could decrease consumption of opioid and incidence of POD.
Aged
;
Female
;
Male
;
Humans
;
Middle Aged
;
Emergence Delirium
;
Interleukin-6
;
Sufentanil
;
Tumor Necrosis Factor-alpha
;
Hip Fractures/surgery*
;
Anesthesia, General
;
Inflammation
;
Lumbosacral Plexus
6.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female
;
Humans
;
Adolescent
;
SARS-CoV-2
;
Smell
;
COVID-19/complications*
;
Cross-Sectional Studies
;
COVID-19 Vaccines
;
Incidence
;
Olfaction Disorders/etiology*
;
Taste Disorders/etiology*
;
Prognosis
7.Development and Validation of a Predictive Risk Model for Vision-threatening Diabetic Retinopathy in Patients with Type 2 Diabetes
Jin LUO ; Wen-yong HUANG ; Yu-ting LI ; Jian ZHANG ; Min-yu CHEN ; Shu-hui CHEN ; Jia-hui LIU ; Sheng-song HUANG
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(6):999-1007
ObjectiveTo develop and validate a predictive risk model for vision-threatening diabetic retinopathy in patients with type 2 diabetes using readily accessible clinical data, which may provide a convenient and effective prediction tool for early identification and referral of at-risk populations. MethodsA nomogram model was developed using a dataset obtained from patients with T2DM who participated in the Guangzhou Diabetic Eye Study from November 2017 to December 2020. Logistic regression was used to construct the model, and model performance was evaluated using receiver operating characteristic curve, Hosmer-Lemeshow test, calibration curve and decision curve analysis. The model underwent internal validation through the mean AUC of k-fold cross-validation method, and further external validation was conducted in the Dongguan Eye Study. ResultsA total of 2 161 individuals were included in the model development dataset, of whom 135 (6.25%) people were diagnosed with VTDR. Age (P<0.001,OR=0.927,95%CI:0.898~0.957) and body mass index (P<0.001,OR =0.845,95%CI:0.821~0.932) were found to be negatively correlated with VTDR, whereas diabetes duration (P<0.001,OR=1.064,95%CI:1.035~1.094), insulin use (P =0.045,OR =1.534,95%CI:1.010~2.332), systolic blood pressure (P<0.001,OR =1.019,95%CI:1.008~1.029), glycated hemoglobin (P<0.001,OR =1.484,95%CI:1.341~1.643), and serum creatinine (P<0.001,OR =1.017,95%CI:1.010~1.023) were positively correlated with VTDR. All these variables were included in the model as predictors. The model showed strong discrimination in the development dataset with an area under the receiver operating characteristic curve (AUC) of 0.797 and in the external validation dataset (AUC 0.762). The Hosmer-Lemeshow test(P>0.05)and the calibration curve displayed good agreement. Decision curve analysis showed that the nomogram produced net benefit in the two datasets. ConclusionsIndependent factors influencing VTDR include age, duration of diabetes mellitus, insulin use, body mass index, systolic blood pressure, glycosylated hemoglobin, and serum creatinine. The nomogram constructed using these variables demonstrates a high degree of predictive validity. The model can serve as a valuable tool for early detection and referral of VTDR in primary care clinics. Therefore, its application and promotion are highly recommended.
8.Artificial Intelligence in the Prediction of Gastrointestinal Stromal Tumors on Endoscopic Ultrasonography Images: Development, Validation and Comparison with Endosonographers
Yi LU ; Jiachuan WU ; Minhui HU ; Qinghua ZHONG ; Limian ER ; Huihui SHI ; Weihui CHENG ; Ke CHEN ; Yuan LIU ; Bingfeng QIU ; Qiancheng XU ; Guangshun LAI ; Yufeng WANG ; Yuxuan LUO ; Jinbao MU ; Wenjie ZHANG ; Min ZHI ; Jiachen SUN
Gut and Liver 2023;17(6):874-883
Background/Aims:
The accuracy of endosonographers in diagnosing gastric subepithelial lesions (SELs) using endoscopic ultrasonography (EUS) is influenced by experience and subjectivity. Artificial intelligence (AI) has achieved remarkable development in this field. This study aimed to develop an AI-based EUS diagnostic model for the diagnosis of SELs, and evaluated its efficacy with external validation.
Methods:
We developed the EUS-AI model with ResNeSt50 using EUS images from two hospitals to predict the histopathology of the gastric SELs originating from muscularis propria. The diagnostic performance of the model was also validated using EUS images obtained from four other hospitals.
Results:
A total of 2,057 images from 367 patients (375 SELs) were chosen to build the models, and 914 images from 106 patients (108 SELs) were chosen for external validation. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the model for differentiating gastrointestinal stromal tumors (GISTs) and non-GISTs in the external validation sets by images were 82.01%, 68.22%, 86.77%, 59.86%, and 78.12%, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in the external validation set by tumors were 83.75%, 71.43%, 89.33%, 60.61%, and 80.56%, respectively. The EUS-AI model showed better performance (especially specificity) than some endosonographers.The model helped improve the sensitivity, specificity, and accuracy of certain endosonographers.
Conclusions
We developed an EUS-AI model to classify gastric SELs originating from muscularis propria into GISTs and non-GISTs with good accuracy. The model may help improve the diagnostic performance of endosonographers. Further work is required to develop a multi-modal EUS-AI system.
9.Survey on awareness of occupational health knowledge and concept among front-line workers in the automotive manufacturing industry
Xinyang YU ; Min YANG ; Huiqing CHEN ; Junle WU ; Hao LUO ; Yingfeng GE ; Yuduan HAN ; Jinxin ZHANG
China Occupational Medicine 2023;50(4):410-414
Objective To investigate the awareness of occupational health knowledge and concept of front-line workers in the automobile manufacturing industry. Methods A total of 1 188 front-line workers from 47 automobile manufacturing enterprises in Guangdong Province were selected as the research subjects using the judgment sampling method. The awareness of occupational health knowledge and concept of the workers was investigated using the Personal Questionnaire for National Survey of Occupational Health Literacy for Key Populations. Results The median (25th and 75th percentiles) awareness of occupational health knowledge and concept among the research subjects was 56.00% (44.00%, 64.00%). The awareness was higher among male workers than female workers (P<0.05). The awareness was higher among married workers than workers with other marital status (P<0.05). The awareness of workers with an education level of middle school or below was lower than those in the senior high school and junior college group and bachelor's degree or above group (all P<0.05). The awareness of workers in the group with personal monthly income <5 000 was lower than that in the other two income groups with personal monthly income ≥5 000 (all P<0.05). The awareness of workers in medium and large enterprises was higher than that of workers in small and micro enterprises (all P<0.05). The awareness of workers in foreign-funded enterprises was higher than that in private enterprises and other enterprises (all P<0.05). The awareness of workers with job tenure >5-10 and >10 years was higher than that in workers with job tenure of 1-≤5 years (P<0.05). The awareness for the 25 items of occupational health knowledge and concept among the research subjects ranged from 6.14% to 96.72%, with an average awareness of 54.46% for the 25 items. Conclusion The awareness of occupational health knowledge and concept of front-line workers in automobile manufacturing industry is not high in general, and it is influenced by gender, marriage status, education level, personal monthly income, enterprise nature and scale, and job tenure.
10.Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial.
Binghe XU ; Qingyuan ZHANG ; Xichun HU ; Qing LI ; Tao SUN ; Wei LI ; Quchang OUYANG ; Jingfen WANG ; Zhongsheng TONG ; Min YAN ; Huiping LI ; Xiaohua ZENG ; Changping SHAN ; Xian WANG ; Xi YAN ; Jian ZHANG ; Yue ZHANG ; Jiani WANG ; Liang ZHANG ; Ying LIN ; Jifeng FENG ; Qianjun CHEN ; Jian HUANG ; Lu ZHANG ; Lisong YANG ; Ying TIAN ; Hongyan SHANG
Acta Pharmaceutica Sinica B 2023;13(5):2250-2258
Entinostat plus exemestane in hormone receptor-positive (HR+) advanced breast cancer (ABC) previously showed encouraging outcomes. This multicenter phase 3 trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese patients with HR + ABC that relapsed/progressed after ≥1 endocrine therapy. Patients were randomized (2:1) to oral exemestane 25 mg/day plus entinostat (n = 235) or placebo (n = 119) 5 mg/week in 28-day cycles. The primary endpoint was the independent radiographic committee (IRC)-assessed progression-free survival (PFS). The median age was 52 (range, 28-75) years and 222 (62.7%) patients were postmenopausal. CDK4/6 inhibitors and fulvestrant were previously used in 23 (6.5%) and 92 (26.0%) patients, respectively. The baseline characteristics were comparable between the entinostat and placebo groups. The median PFS was 6.32 (95% CI, 5.30-9.11) and 3.72 (95% CI, 1.91-5.49) months in the entinostat and placebo groups (HR, 0.76; 95% CI, 0.58-0.98; P = 0.046), respectively. Grade ≥3 adverse events (AEs) occurred in 154 (65.5%) patients in the entinostat group versus 23 (19.3%) in the placebo group, and the most common grade ≥3 treatment-related AEs were neutropenia [103 (43.8%)], thrombocytopenia [20 (8.5%)], and leucopenia [15 (6.4%)]. Entinostat plus exemestane significantly improved PFS compared with exemestane, with generally manageable toxicities in HR + ABC (ClinicalTrials.gov #NCT03538171).

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