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.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.
4.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.
5.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.
6.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.
7.Third molar-related knowledge, attitudes, behaviors, and medical history of 904 Chinese adults: a cross-sectional survey.
Honglei QU ; Yang YANG ; Yi TIAN ; Zhibang LI ; Lijuan SUN ; Faming CHEN ; Beimin TIAN
Journal of Zhejiang University. Science. B 2023;24(10):896-904
This study investigated the perceptions and medical history of third molars (M3s) and assessed the prevalence of visible M3s (V-M3s) among 904 Chinese adults. The enrolled participants were interviewed to complete a structural questionnaire focused on sociodemographic information and their understanding of, attitudes toward, behaviors regarding, and medical history with respect to M3s. In addition, the number of V-M3s in the cohort was determined by oral examination. Logistic regression analysis was performed to explore the association between individuals' sociodemographic characteristics and their perception of M3s or the presence of V-M3s. The Chi-square test was used to compare the actions taken against symptomatic M3s and the corresponding outcomes among different groups divided according to respondents' sociodemographic factors. In total, 904 completed questionnaires were gathered and analyzed. Nearly half (43.9%) of the respondents knew nothing about M3s, and only 12.7% provided correct answers to all the questions asked. Male sex, older age, occupation involving physical labor, and no previous dental experience were active factors in unawareness of M3s. Male sex was also significantly associated with the presence of at least one V-M3 and negative behavior about symptomatic M3s. In terms of medical history, 192 participants reported having had at least one M3 extracted (438 in total), and 72.6% of the M3s were removed due to the presence of related symptoms or pathologies. In conclusion, the population investigated had a shortage of knowledge about M3s and adopted negative attitudes and actions about M3-related problems.
8.Association between perfluoroalkyl and polyfluoroalkyl substances and maternal thyroid-related hormones in pregnant women
Xin WANG ; Lan YANG ; Zhikai WANG ; Xing FENG ; Honglei JI ; Hong LIANG ; Xiuxia SONG ; Maohua MIAO
Journal of Environmental and Occupational Medicine 2023;40(6):661-666
Background Exposure to perfluoroalkyl and polyfluoroalkyl substances (PFAS) during pregnancy might affect thyroid-related hormone levels in pregnant women. However, most previous studies focused on the effects of PFAS containing 8-10 carbon atoms, and few studies have estimated the associations between PFAS with longer carbon chain and thyroid-related hormone levels. Objective To examine the associations between PFAS exposure and thyroid-related hormones in pregnant women. Methods The present study was based on the Jiashan Birth Cohort from September 2016 to April 2018. We analyzed 13 PFAS in maternal blood samples (n=781) by high-performance liquid chromatography-tandem mass spectrometry, as well as total triiodothyronine (T3), total thyroxine (T4), free T3 (FT3), free T4 (FT4), thyroid stimulating hormone (TSH), thyroglobulin antibody (TG-Ab), and thyroid peroxidase antibody (TPOAb) by electrochemiluminescence immunoassay. PFAS were divided into three groups:low concentration, medium concentration and high concentration according to the tertile of their concentrations. We estimated the associations between PFAS concentrations and thyroid-related hormones in pregnant women by multiple linear regression. Results In the multiple linear regression models, a change in perfluorododecanoic acid (PFDoA) concentrations from the low concentration group to the high concentration group was associated with a −0.10 (95%CI: −0.20, 0) nmol·L−1 change in T3, −0.15 (95%CI: −0.28, −0.02) pmol·L−1 change in FT3, and −3.02 (95%CI: −5.66, −0.39) pmol·L−1 change in FT4, respectively. A change in perfluorotridecanoic acid (PFTrDA) concentrations from the low concentration group to the high concentration group was associated with a −0.10 (95%CI: −0.20, 0) nmol·L−1 change in T3. Compared with the low concentration group, the concentration of T4 in the medium concentration group of perfluorohexane sulfonate (PFHxS) increased by 6.10 (95%CI: 0.44, 11.75) nmol·L−1. No statistically significant associations were found between PFAS and TSH concentration. The negative associations of PFAS with thyroid-related hormones were more pronounced in pregnant women with positive TG-Ab and/or TPOAb. Conclusion Exposure to PFAS during pregnancy may affect thyroid-related hormone homeostasis in pregnant women, and the effect is stronger in TG-Ab and/or TPOAb-positive pregnant women.
9.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.
10.Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
Mengyan WANG ; Yu XUE ; Fang DU ; Lili MA ; Liang-Jing LU ; Lindi JIANG ; Yi-Li TAO ; Chengde YANG ; Hui SHI ; Honglei LIU ; Xiaobing CHENG ; Junna YE ; Yutong SU ; Dongbao ZHAO ; Sheng-Ming DAI ; Jialin TENG ; Qiongyi HU
Chinese Medical Journal 2023;136(3):331-340
BACKGROUND:
Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.
METHODS:
The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.
RESULTS:
Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.
CONCLUSION:
Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.
TRIAL REGISTRATION
Chictr.org, ChiCTR2000039799.
Humans
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Quality of Life
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China
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Arthritis, Rheumatoid/drug therapy*
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Piperidines/therapeutic use*
;
Treatment Outcome
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Antirheumatic Agents/therapeutic use*
;
Pyrroles/therapeutic use*

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