2.The Role of Artificial Intelligence in Adverse Drug Reaction Monitoring: Current Status and Challenges
Yuge WEI ; Ronghao LI ; Chenyi SUN ; Congmin ZHU ; Ting CHEN ; Hong YANG ; Honglei LIU
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1363-1370
Adverse drug reactions (ADRs) significantly impact clinical medication safety. The timely identification and prediction of ADRs rely on the efficient analysis of real-world data, such as electronic health records, social media, and spontaneous reporting databases. In recent years, the rapid advancement of artificial intelligence, particularly large language models, in natural language processing, causal reasoning, and complex data mining has provided new technological means for real-time ADRs monitoring and individualized prediction. This paper summarizes the latest research achievements in AI-driven ADRs monitoring. Focusing on diverse data sources, including structured databases and electronic health records, it elaborates on the advantages andchallenges of AI in ADRs event extraction, relationship identification, causal analysis, and risk prediction. The aim is to provide a theoretical reference for constructing more intelligent and efficient ADRs monitoring systems.
3.Differences in inflammatory indicators and prognostic factors between pulmonary and extrapulmonary ARDS caused by sepsis
Honglei QI ; Xiaojuan YANG ; Xiaojun YANG ; Xigang MA ; Xiaohong WANG ; Huan DING ; Jinyuan ZHU
Chongqing Medicine 2025;54(6):1300-1306
Objective To investigate the influencing factors of pulmonary and extrapulmonary acute re-spiratory distress syndrome(ARDS)caused by sepsis.Methods A total of 126 patients with ARDS admitted to the Department of Critical Care Medicine,General Hospital of Ningxia Medical University,from January 2022 to June 2024 were selected.Patients were divided into pulmonary ARDS and extrapulmonary ARDS groups based on the etiology of ARDS.General data,inflammatory indicators,and prognostic outcomes were compared between the two groups.COX regression analysis was used to identify prognostic factors.Results A-mong the 126 patients,72 were diagnosed with pulmonary ARDS and 54 with extrapulmonary ARDS.The pulmonary ARDS group had significantly lower SOFA scores,fewer organ dysfunctions,a lower incidence of arrhythmia,shorter mechanical ventilation duration,higher Murray scores,and higher Charlson Comorbidity Index(CCI)compared to the extrapulmonary ARDS group(P<0.05).Inflammatory markers,including pro-calcitonin(PCT),C-reactive protein(CRP),interleukin(IL)-4,IL-6,IL-10,and tumor necrosis factor-α(TNF-α),were significantly lower in the pulmonary ARDS group,while interferon-γ(INF-γ)levels were higher(P<0.05).For pulmonary ARDS,CCI and TNF-α were identified as independent risk factors for prog-nosis(P<0.05),with the combination of CCI and TNF-α yielding the highest predictive accuracy(AUC=0.81,95%CI:0.71-0.91).For extrapulmonary ARDS,CCI and CRP were independent risk factors(P<0.05),and their combination achieved the highest predictive performance(AUC=0.91,95%CI:0.84-0.98).Conclusion Inflammatory profiles between pulmonary and extrapulmonary ARDS caused by sepsis are different.CCI and TNF-α are independent risk factors for mortality in pulmonary ARDS,while CCI and CRP are independent risk factors in extrapulmonary ARDS.
4.Clinical characteristics and genetic analysis of a case with 47,XYY Disorder of sex development due to variant of NR5A1 gene.
Yanan LIU ; Jie LI ; Qiqi XU ; Ying YANG ; Linlin HE ; Honglei DUAN
Chinese Journal of Medical Genetics 2025;42(8):931-936
OBJECTIVE:
To investigate the clinical phenotype and genetic etiology of a patient with tall stature and primary amenorrhea presenting with 47,XYY Disorder of sex development (DSD).
METHODS:
A female patient presenting with "tall stature and primary amenorrhea" at Nanjing Drum Tower Hospital in July 2024 was selected as the study subject. A retrospective study design was employed to collect the patient's clinical data. Peripheral venous blood sample was collected. Following the extraction of genomic DNA, genetic testing was performed including chromosomal karyotyping analysis, copy number variation sequencing (CNV-seq), multiplex PCR for the AZF regions and sex-determining genes Y (SRY), and whole-exome sequencing (WES). Candidate variants were validated by Sanger sequencing and classified for pathogenicity based on the guidelines from the American College of Medical Genetics and Genomics (ACMG). This study was approved by the Medical Ethics Committee of Nanjing Drum Tower Hospital (Ethics No.: 2022-451-01).
RESULTS:
The patient had a height of 188 cm and a body weight of 50 kg, in addition with infantile uterus, absent ovaries, and primary amenorrhea. G-banded karyotyping analysis of peripheral blood sample revealed 47,XYY. CNV-seq indicated Seq[GRCh37]Yp11.32q12×2. No deletion was detected in the AZF regions of Y chromosome, and SRY was positive. WES identified a heterozygous c.86C>A (p.Thr29Lys) variant of the NR5A1 gene, leading to substitution of threonine with lysine at position 29 of the encoded protein. Sanger sequencing confirmed the presence of the variant. According to the ACMG guidelines, this variant was classified as variant of uncertain significance (VUS) with supporting evidence (PS3_Moderate+PM5+PP3+PM2_Supporting+PS4_Supporting). Reviewing the nearly 60 years of previously reported cases, all 7 documented 47,XYY DSD patients were assigned a female social gender and presented with abnormal gonadal and external genitalia development. Among them, 5 cases underwent SRY testing, all of which were positive. Only 1 case underwent whole-exome sequencing (WES), but no pathogenic or likely pathogenic variants were identified.
CONCLUSION
This DSD patient presented with the clinical features of tall stature and primary amenorrhea. The NR5A1 gene variant c.86C>A (p.Thr29Lys) probably underlay the Disorder of sex development in this patient. Above finding has enriched the spectrum of pathogenic variants of the NR5A1 gene.
Humans
;
Female
;
Steroidogenic Factor 1/genetics*
;
DNA Copy Number Variations/genetics*
;
XYY Karyotype/genetics*
;
Karyotyping
;
Retrospective Studies
;
Phenotype
;
Sex Chromosome Disorders of Sex Development/genetics*
;
Sex Chromosome Disorders
5.Consensus statement on research and application of Chinese herbal medicine derived extracellular vesicles-like particles (2023 edition).
Qing ZHAO ; Tong WANG ; Hongbin WANG ; Peng CAO ; Chengyu JIANG ; Hongzhi QIAO ; Lihua PENG ; Xingdong LIN ; Yunyao JIANG ; Honglei JIN ; Huantian ZHANG ; Shengpeng WANG ; Yang WANG ; Ying WANG ; Xi CHEN ; Junbing FAN ; Bo LI ; Geng LI ; Bifeng LIU ; Zhiyang LI ; Suhua QI ; Mingzhen ZHANG ; Jianjian ZHENG ; Jiuyao ZHOU ; Lei ZHENG ; Kewei ZHAO
Chinese Herbal Medicines 2024;16(1):3-12
To promote the development of extracellular vesicles of herbal medicine especially the establishment of standardization, led by the National Expert Committee on Research and Application of Chinese Herbal Vesicles, research experts in the field of herbal medicine and extracellular vesicles were invited nationwide with the support of the Expert Committee on Research and Application of Chinese Herbal Vesicles, Professional Committee on Extracellular Vesicle Research and Application, Chinese Society of Research Hospitals and the Guangdong Engineering Research Center of Chinese Herbal Vesicles. Based on the collation of relevant literature, we have adopted the Delphi method, the consensus meeting method combined with the nominal group method to form a discussion draft of "Consensus statement on research and application of Chinese herbal medicine derived extracellular vesicles-like particles (2023)". The first draft was discussed in online and offline meetings on October 12, 14, November 2, 2022 and April and May 2023 on the current status of research, nomenclature, isolation methods, quality standards and research applications of extracellular vesicles of Chinese herbal medicines, and 13 consensus opinions were finally formed. At the Third Academic Conference on Research and Application of Chinese Herbal Vesicles, held on May 26, 2023, Kewei Zhao, convenor of the consensus, presented and read the consensus to the experts of the Expert Committee on Research and Application of Chinese Herbal Vesicles. The consensus highlights the characteristics and advantages of Chinese medicine, inherits the essence, and keeps the righteousness and innovation, aiming to provide a reference for colleagues engaged in research and application of Chinese herbal vesicles at home and abroad, decode the mystery behind Chinese herbal vesicles together, establish a safe, effective and controllable accurate Chinese herbal vesicle prevention and treatment system, and build a bridge for Chinese medicine to the world.
6.Influence of maternal autoimmune diseases and anticoagulants on fetal fraction of maternal plasma cell-free DNA
Xuemei CHEN ; Honglei DUAN ; Wanjun WANG ; Ying ZHANG ; Xiangyu ZHU ; Xing WU ; Ying YANG ; Peixuan CAO ; Mengyao NI ; Zihan JIANG ; Biyun XU ; Jie LI
Chinese Journal of Perinatal Medicine 2024;27(6):450-456
Objective:To investigate the influence of maternal autoimmune diseases and anticoagulants, including low-molecular-weight heparin (LMWH) and aspirin, on the fetal fraction of maternal plasma cell-free DNA of non-invasive prenatal testing (NIPT).Methods:A prospective cohort study was conducted on women with singleton pregnancies receiving NIPT in the Nanjing Drum Tower Hospital from March 2021 to July 2022. NIPT was carried out using a polymerase chain reaction (PCR)-free amplification platform. In this study, four types of maternal autoimmune diseases, which were antiphospholipid syndrome, undifferentiated connective tissue disease, Sj?gren's syndrome, and systemic lupus erythematosus (SLE), and two anticoagulants, LMWH and aspirin, were studied. Univariate and multivariate linear regression models were used to analyze the factors influencing fetal fraction of maternal plasma cell-free DNA.Results:A total of 4 102 singleton pregnant women were enrolled in the prospective cohort, and 3 948 were finally included after excluding the cases with unclear dosing time of LMWH or aspirin, other autoimmune diseases, conceiving through ovulation induction alone, and having true positive or failed NIPT result. There were 96 cases with antiphospholipid syndrome, 35 with undifferentiated connective tissue disease, 34 with Sj?gren's syndrome, and 18 with SLE. A total of 108 patients only received LMWH treatment, 121 only received aspirin treatment, and 113 received both LMWH and aspirin treatment. Univariate linear regression analysis showed that maternal body mass index at blood collection ( B=-0.423), conceived by assisted reproductive technology ( B=-0.803), male fetus ( B=-0.458), undifferentiated connective tissue disease ( B=1.774), and SLE ( B=3.467) had influence on the fetal fraction (all P<0.05). Multivariate linear regression analysis showed that maternal body mass index at blood collection ( B=-0.415), conceived by assisted reproductive technology ( B=-0.585), male fetus ( B=-0.322), SLE ( B=3.347) and undifferentiated connective tissue disease ( B=1.336) were factors influencing fetal fraction (all P<0.05). Conclusions:Maternal use of LMWH or aspirin does not affect fetal fraction when performing NIPT on a PCR-free amplification platform, but undifferentiated connective tissue disease and SLE are the influencing factors. Therefore, pregnant women should be informed before the NIPT that the fetal fraction of maternal plasma cell-free DNA may be affected by maternal autoimmune diseases.
7.Development of the Self-management Behavior Questionnaire for Middle-aged and Young Patients with Myocardial Infarction and its reliability and validity
Shan LIANG ; Yanping LIU ; Yuanmei QIN ; Linlin WANG ; Yanli DING ; Honglei YANG ; Jiajia WANG
Chinese Journal of Modern Nursing 2024;30(2):191-197
Objective:To develop the Self-management Behavior Questionnaire for Middle-aged and Young Patients with Myocardial Infarction and test its reliability and validity.Methods:Using social cognitive theory, self-efficacy theory, and self-management theory as theoretical frameworks, a preliminary questionnaire was formed through literature review, semi-structured interviews, and Delphi expert consultation. Convenience sampling was used to select middle-aged and young patients with myocardial infarction from the First Affiliated Hospital of Henan University of Chinese Medicine, Henan Provincial Chest Hospital, and the Second Affiliated Hospital of Zhengzhou University from June to July 2022 for investigation, and item analysis and exploratory factor analysis of the questionnaire were conducted. From August to November 2022, middle-aged and young patients with myocardial infarction from the Heart Center of the First Affiliated Hospital of Henan University of Chinese Medicine were selected for investigation, and confirmatory factor analysis and reliability testing of the questionnaire were conducted.Results:A total of 300 and 480 questionnaires were distributed, respectively, and 280 and 468 valid questionnaires were collected, with effective response rates of 93.33% (280/300) and 97.50% (468/480), respectively. The Self-management Behavior Questionnaire for Middle-aged and Young Patients with Myocardial Infarction included 31 items. The total Cronbach 's α coefficient of the questionnaire was 0.918, the half reliability coefficient was 0.853, and the retest reliability coefficient was 0.975. The content validity index of the questionnaire level was 0.965, and the content validity index of the item level was 0.830 to 1.000. Exploratory factor analysis extracted 6 common factors with a cumulative variance contribution rate of 69.795%. Confirmatory factor analysis showed that the model fitted well and the questionnaire factor structure was stable. Conclusions:The Self-management Behavior Questionnaire for Middle-aged and Young Patients with Myocardial Infarction developed in this study has good reliability and validity, which can provide references for medical and nursing staff to evaluate the self-management behavior of middle-aged and young patients with myocardial infarction.
8.PPARα affects hepatic lipid homeostasis by perturbing necroptosis signals in the intestinal epithelium.
Shufang NA ; Yanjie FAN ; HongLei CHEN ; Ling LI ; Guolin LI ; Furong ZHANG ; Rongyan WANG ; Yafei YANG ; Zixia SHEN ; Zhuang PENG ; Yafei WU ; Yong ZHU ; Zheqiong YANG ; Guicheng DONG ; Qifa YE ; Jiang YUE
Acta Pharmaceutica Sinica B 2024;14(11):4858-4873
Rapid turnover of the intestinal epithelium is a critical strategy to balance the uptake of nutrients and defend against environmental insults, whereas inappropriate death promotes the spread of inflammation. PPARα is highly expressed in the small intestine and regulates the absorption of dietary lipids. However, as a key mediator of inflammation, the impact of intestinal PPARα signaling on cell death pathways is unknown. Here, we show that Pparα deficiency of intestinal epithelium up-regulates necroptosis signals, disrupts the gut vascular barrier, and promotes LPS translocation into the liver. Intestinal Pparα deficiency drives age-related hepatic steatosis and aggravates hepatic fibrosis induced by a high-fat plus high-sucrose diet (HFHS). PPARα levels correlate with TRIM38 and MLKL in the human ileum. Inhibition of PPARα up-regulates necroptosis signals in the intestinal organoids triggered by TNF-α and LPS stimuli via TRIM38/TRIF and CREB3L3/MLKL pathways. Butyric acid ameliorates hepatic steatosis induced by intestinal Pparα deficiency through the inhibition of necroptosis. Our data suggest that intestinal PPARα is essential for the maintenance of microenvironmental homeostasis and the spread of inflammation via the gut-liver axis.
9.Epidemiological investigation of SARS-CoV-2 infection in maintenance hemodialysis patients in Jiangsu province during the outbreak of SARS-CoV-2
Guang YANG ; Yifei GE ; Yaoyu HUANG ; Jizhuang LOU ; Chunming JIANG ; Guoyuan LU ; Fengling CHEN ; Jiansong SHEN ; Xiaolan CHEN ; Houyong DAI ; Changhua LIU ; Min YANG ; Xiurong LI ; Zhuxing SUN ; Liang WANG ; Bin LIU ; Donghui ZHENG ; Yong XU ; Maojie CHEN ; Ling WANG ; Yilai ZHANG ; Xu ZHANG ; Jianqiang HE ; Liyuan ZHANG ; Huiting WAN ; Honglei GUO ; Jiahui YANG ; Wei XU ; Changying XING ; Huijuan MAO
Chinese Journal of Nephrology 2023;39(12):895-902
Objective:To investigate the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with maintenance hemodialysis (MHD) in Jiangsu province during SARS-CoV-2 pandemic in China from December 7, 2022 to January 27, 2023, and to analyze the influencing factors of all-cause death.Methods:It was a multi-center cross-sectional investigation. Structured questionnaire was used to collect patient information by medical staff of each hemodialysis center (room) as investigators. Part of the demography data and laboratory examination data came from the Jiangsu Province Hemodialysis Data Information System. MHD patients from hemodialysis centers (rooms) at all levels of medical institutions and independent hemodialysis institutions in Jiangsu province during the outbreak of SARS-CoV-2 infection were included, and the clinical characteristics and all-cause mortality of confirmed and suspected cases of SARS-CoV-2 infection were analyzed.Results:Questionnaire surveys and data analysis on 57 278 patients in 407 hemodialysis centers (rooms) were completed, accounting for 90.41% of the total number of MHD patients (63 357 cases) in Jiangsu province during the same period. There were 24 038 cases (41.97%) of SARS-CoV-2 infection and 14 805 cases (25.85%) of suspected infection, which were widely distributed in all dialysis centers in Jiangsu province. After clinical classification of 38 843 confirmed and suspected SARS-CoV-2 infection cases, 3 662 cases were severe and critical cases, accounting for 9.43% of the infected and suspected cases. Among the patients who had completed the questionnaires, there were 1 812 all-cause deaths, with an all-cause mortality rate of 3.16%. Multivariate logistic regression analysis showed that elderly (taking ≤50 years as a reference, 51-59 years: OR=1.583, 95% CI 1.279-1.933, P=0.001; 60-69 years: OR=3.972, 95% CI 3.271-4.858, P<0.001; 70-79 years: OR=7.236, 95% CI 5.917-8.698, P<0.001; ≥80 years: OR=11.738, 95% CI 9.459-14.663, P<0.001), male ( OR=1.371, 95% CI 1.229-1.529, P<0.001), and co-infection with hepatitis B virus (HBV) (positive serum HBV surface antigen, OR=0.629, 95% CI 0.484-0.817, P<0.001) were independent influencing factors for all cause mortality. Receiver-operating characteristic curve analysis showed that the area under the curve for male, age and current HBV infection prediction of all-cause death was 0.529 ( P<0.001), 0.724 ( P<0.001) and 0.514 ( P=0.042), respectively, and the cut-off value for age prediction of all-cause death was 65.5 years old. Compared with patients without HBV infection, MHD patients with HBV infection significantly reduced the proportion of severe and critically ill patients, all-cause hospitalizations and all cause deaths when infected with SARS-CoV-2 (4.99% vs. 6.41%, χ2=6.136, P=0.013; 8.90% vs. 11.44%, χ2=11.662, P<0.001; 2.01% vs. 3.37%, χ2=10.713, P=0.001, respectively). Conclusion:The MHD patients in Jiangsu province are susceptible to SARS-CoV-2. Elderly age and male gender are independent risk factors for death in MHD patients during the epidemic, while the HBV infection may be a protective factor for death of MHD patients infected with SARS-CoV-2.
10.Biograph Vision 600 PET performance testing and analysis
Honglei LI ; Qun WANG ; Sen YANG ; Jie LIU
Chinese Journal of Radiological Health 2023;32(6):668-672
Objective To test and analyze the performance of Biograph Vision 600 PET/CT according to the NEMA NU2—2012 standard to achieve reliable, repeatable, and inter-system comparable performance measurement, and to provide a basis for future equipment stability testing and status detection. Methods The Biograph Vision PET equipment features a detector based on silicon photomultipliers, with 3.2 mm lutetium oxyorthosilicate crystals and full cover of the scintillation region. The spatial resolution, sensitivity, noise-equivalent count rate, scatter fraction, coincidence count rate, image quality, scatter correction, and time-of-flight resolution of Biograph Vision PET were tested by referring to the test model and method of the NEMA NU2—2012 standard. Results The Biograph Vision 600 PET equipment showed lateral and axial spatial resolutions of 3.69 mm and 3.81 mm at 1 cm off-center of the field of view, respectively and of 4.29 mm and 4.48 mm at 10 cm, respectively. The sensitivity was 17.5 kcps/MBq. The time-of-flight resolution changed from 210 ps to 215 ps as the count rate increased to the peak noise equivalent count rate. The NEMA peak noise-equivalent count rate was 247 kcps at 30.3 kBq/ml. The corresponding scatter fraction was 34.8%. With the NEMA module, the overall image quality contrast range was 73.6%-92.8%, and the background variability was 2.3%-6.5%; the mean lung residual error was 3.4%; and the time-of-flight resolution was 210 ps. Conclusion This performance test was performed according to the NEMA NU2—2012 standard, showing that all parameters were better than the ex-factory standard, which can provide a reference for other institutions selecting equipment and also provide a basis for future equipment stability testing and status detection.

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