1.Pharmacovigilance Signal Mining and Analysis of Ustekinumab versus Upadacitinib for Inflammatory Bowel Disease Based on the FAERS Database
Dong XIE ; Yu WANG ; Haojia LIN ; Qiuyue TU ; Hetong ZHANG ; Huizhen LI ; Qinghua YI ; Zhengxiang LI ; Hengjie YUAN ; Xiaocang CAO
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1376-1383
To analyze potential adverse drug events(ADEs) associated with ustekinumab and upadacitinib in the treatment of inflammatory bowel disease(IBD) based on an international authoritative database, thereby providing evidence for clinical medication safety. Data were extracted from the Food and Drug Administration Adverse Event Reporting System(FAERS) database using OpenVigil 2.1. ADE reports were collected for ustekinumab(from Q3 2017 to Q1 2025) and upadacitinib(from Q3 2019 to Q1 2025), where each drug was identified as the primary suspected medication for IBD. Signal detection and statistical analysis were performed using the reporting odds ratio(ROR) and proportional reporting ratio(PRR) methods. A total of 3648 ADE reports for ustekinumab and 3812 for upadacitinib, with each as the primary suspected drug in IBD treatment, were retrieved. Using the ROR-PRR combined detection method, relevant ADE signals were identified. High-frequency ADEs associated with ustekinumab included hypersensitivity reactions, various infections, and brain fog, while those associated with upadacitinib included acne, flatulence, and herpes zoster. System organ class(SOC) analysis of positive signals indicated that both drugs commonly caused ADEs in categories such as Infections and infestations, Gastrointestinal disorders, Nervous system disorders, Skin and subcutaneous tissue disorders, and Respiratory, thoracic, and mediastinal disorders. Among these, Infections and infestations were the most frequent SOC, involving preferred terms such as Escherichia sepsis and Pneumococcal pneumonia. Ustekinumab and upadacitinib exhibit distinct safety profiles in the treatment of IBD. In addition to known ADEs described in the prescribing information, ustekinumab requires close monitoring for hypersensitivity reactions, opportunistic infections, and potential neurological risks. For upadacitinib, attention should be paid to risks of acne, herpes zoster, hypercholesterolemia, and thrombotic events. These findings provide important safety information to support individualized clinical decision-making in IBD management.
2.Growing burden of atherosclerotic cardiovascular disease in China:An analysis on lifestyle and metabolic factors based on the Global Burden of Disease Study 2021
Qiuyue TU ; Xinyu PENG ; Ziyi HE ; Derong LIN ; Jianhua LIU ; Jingrong LIANG
Journal of Army Medical University 2025;47(22):2824-2836
Objective To analyze the burden of atherosclerotic cardiovascular disease(ASCVD)attributable to lifestyle and metabolic factors in China from 1990 to 2021 and predict its future trends,providing evidence for public health prevention and control.Methods Based on the Global Burden of Disease(GBD)2021 database,we extracted disability-adjusted life years(DALYs)of ASCVD attributable to 7 key risk factors:dietary,low physical activity,smoking,high body mass index(BMI),high fasting blood glucose,high low-density lipid cholesterol(LDL-C),and hypertension.Age-standardized DALY rates(ASDR)were also calculated to account for variations in age structure,and an ARIMA model was applied to predict future trends.Results ① Overall trend analysis showed the leading risk factor for ischemic heart disease(IHD)shifted from dietary risks in 1990 to hypertension in 2021,while hypertension and smoking remained the primary risk factors for ischemic stroke(IS)and peripheral artery disease(PAD),respectively.② In BRICS nations,hypertension was the dominant risk factor for both IHD and IS,whereas in China,smoking and high fasting blood glucose continued to be the major drivers of PAD burden.③ Sex-specific analysis revealed that hypertension was the leading risk factor for IHD and IS in both males and females.For PAD,smoking was the main risk factor in males,while high fasting blood glucose was for females.Age-stratified analysis revealed that in the 15-49 age group,dietary,high LDL-C and smoking were the primary factor for IHD,IS and PAD,respectively;in the 50-69 group,dietary predominated IHD risk,hypertension IS,and smoking PAD;and among those aged≥70 years,hypertension was the leading risk factor for both IHD and IS,and high fasting blood glucose was for PAD.④ ARIMA model forecasted that by 2035,DALYs for IHD,IS,and PAD will increase to 82.816 million,46.808 million,and 0.192 million person-years,respectively.Conclusion The ASCVD burden attributable to lifestyle and metabolic factors continues to rise in China from 1990 to 2021,and is projected to further increase by 2035.Countermeasures We suggest that current prevention and control priorities are enhanced management of metabolic factors,tailored interventions by sex and age,promotion of healthy lifestyles and tobacco control,and establishment of an integrated system of prevention-treatment-rehabilitation-research.
3.Development of three-dimensional digestive endoscope and the application to endoscopic submucosal dissection in living animals (with video)
Bingrong LIU ; Xiaopeng ZHANG ; Dan LIU ; Deliang LI ; Lixia ZHAO ; Jiyu ZHANG ; Yangyang ZHOU ; Kaipeng LIU ; Muhan LI ; Qiuyue TU ; Jinghao LI ; Miao SHI ; Yajuan LI ; Xuexin WANG
Chinese Journal of Digestive Endoscopy 2024;41(7):562-565
Objective:To develop and evaluate the efficacy and safety of a three-dimensional (3D) digestive endoscope for gastric endoscopic submucosal dissection (ESD) through animal experiments.Methods:Two Dutch pigs were utilized from the Zhengzhou University Animal Experiment Center for the study. ESD procedures were performed by two senior endoscopists, one using 3D glasses and the other utilizing a 3D high-definition head display. The success of ESD was assessed based on predefined criteria, including completion of surgical steps, complete detachment of the presumptive lesion, and effective bleeding control during and after the surgery. The number of successful procedures and incidences of perforation were recorded. The stereoscopic experience of the endoscopists, including both the primary endoscopist and the assistant, was also evaluated. Furthermore, the assessment encompassed any reported symptoms of eye discomfort, such as eye fatigue, ocular pain, and blurred vision. Additionally, the confidence level of the endoscopists in the mechanical aspects of the operation, as well as encountered issues during the endoscopic procedures, were documented.Results:Two ESD were successful and no perforation occurred. Feedback from endoscopists suggested that 3D digestive endoscopy offered clear images with enhanced three-dimensionality during surgery, clear sense of distance and layering, allowing for a precise judgment of bleeding points, which surpassed 2D capabilities. No eye discomfort was experienced by endoscopists or assistants during or after the procedures. While endoscopists exhibited high confidence in 3D digestive endoscopy, they noted issues with image blurring when the camera was positioned less than 10 mm from the gastrointestinal tract wall.Conclusion:Preliminary results show that 3D digestive endoscopes can provide excellent stereo imaging, improved positioning accuracy, and safety during live animal stomach ESD procedures, without significantly increasing endoscopists' eye discomfort. Nevertheless, efforts are needed to address image blurring concerns when the camera is close to the gastrointestinal tract wall.
4. A Single Center Clinical Study on 51 Patients With Gastrointestinal Hemangioma
Qiuyue TU ; Dan LIU ; Ziyu SHI ; Lixia ZHAO ; Bingrong LIU
Chinese Journal of Gastroenterology 2023;28(5):269-274
Background: Hemangioma is a vasogenic benign tumor commonly seen in the head and neck. However, it is rare in gastrointestinal tract and can cause symptoms such as gastrointestinal bleeding and abdominal pain, and it also can be life-threatening in severe cases. Aims: To analyze the clinical characteristics, treatment, and prognosis of gastrointestinal hemangioma, and to provide appropriate therapy for the diagnosis and treatment of gastrointestinal hemangioma. Methods: The patients with gastrointestinal hemangioma from August 2011 to October 2021 at the First Affiliated Hospital of Zhengzhou University were collected, and the clinical data, examination results, treatment and prognosis were analyzed retrospectively. Results: A total of 51 patients with gastrointestinal hemangioma were included, the ratio of male to female was 1.43:1, and the average age was (46.2±19.2) years old. Single gastrointestinal hemangioma was found in 45 patients (88.24%), and 18 lesions (35.29%) were in the esophagus, followed by the stomach (15.69%), small intestine (15.69%), colon (11.76%), and rectum (9.80%). The majority of patients were asymptomatic (50.98%), while 15 patients (29.41%) were presented by gastrointestinal bleeding. Thirty-two patients (62.75%) underwent endoscopic treatment, including 25 patients underwent endoscopic mucosal resection (EMR), 6 patients underwent endoscopic submucosal dissection (ESD), and 1 patient underwent endoscopic ligation. Nineteen patients (37.25%) underwent surgical surgery, including 5 patients underwent transrectal lesion resection, 1 patient underwent small intestinal lesion resection and 13 patients underwent resection of digestive tract. All patients recovered well after surgery. The average follow-up period was (61±32) months. One patient relapsed 1 year after surgery, 4 patients died of other diseases, and the remaining patients did not occur tumor recurrence, and 5 patients were lost to follow-up. Conclusions: Gastrointestinal hemangioma is rare and has no specific clinical symptoms. Endoscopy is important for its diagnosis, and endoscopic therapy is safe and effective for patients with indications.

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