1.Signal mining and analysis of adverse events for lecanemab based on the FAERS database
Wen ZHANG ; Min LI ; Erping LIU ; Wenting TAO ; Rui CAI ; Weixian ZHOU
Chinese Journal of Pharmacoepidemiology 2025;34(2):166-174
Objective To mine the risk signals of adverse drug events(ADEs)related to lecanemab through the U.S.Food and Drug Adminstration Adverse Event Reporting System(FAERS)database,to provide a reference for the safe clinical use of lecanemab.Methods Data on adverse events related to lecanemab from the fourth quarter,2010 to the second quarter 2024 in the FAERS were collected.Potential ADE signals were mined using the reporting odds ratio(ROR)method,Medicines and Healthcare Products Regulatory Agency(MHRA)method,Bayesian confidence propagation neural network(BCPNN)method and multi-item gamma Poisson shrinker(MGPS)method.The top 30 ADEs in terms of report frequency and signal strength,as well as ADEs categorized by system organ class(SOC),were statistically analyzed.Results A total of 868 adverse event reports related to lecanemab were collected,involving 1,986 instances of ADEs with 38 related ADE identified,the proportion of serious ADEs was 23.39%,and 87.15%of ADEs occurred in the first 3 months after the initiation of the drug.The top 30 PT signals in reported cases were headache,chills,fatigue,effusion type amyloid-related imaging abnormalities(ARIA-E),hemorrhage-type amyloid-related imaging abnormalities(ARIA-H),and so on.The top 30 signals in terms of signal intensity mainly included ARIA-E,ARIA-H,brain fog,infusion-related reactions.ADEs related to nervous system diseases were the most common.Fifteen new suspected or serious ADEs not recorded in the instructions were discovered,such as brain fog,formication,status epilepticus.Conclusion Risk assessment of patients'medication should be conducted before clinical use of lecanemab,especially in the first 3 months of the medication period,focus should be placed on monitoring common ADEs,such as ARIA-E,ARIA-H,infusion-related reactions.Attention also needs to be paid to the newly discovered suspected ADEs,to ensure the patients'medication safety.
2.Signal mining and analysis of adverse events for lecanemab based on the FAERS database
Wen ZHANG ; Min LI ; Erping LIU ; Wenting TAO ; Rui CAI ; Weixian ZHOU
Chinese Journal of Pharmacoepidemiology 2025;34(2):166-174
Objective To mine the risk signals of adverse drug events(ADEs)related to lecanemab through the U.S.Food and Drug Adminstration Adverse Event Reporting System(FAERS)database,to provide a reference for the safe clinical use of lecanemab.Methods Data on adverse events related to lecanemab from the fourth quarter,2010 to the second quarter 2024 in the FAERS were collected.Potential ADE signals were mined using the reporting odds ratio(ROR)method,Medicines and Healthcare Products Regulatory Agency(MHRA)method,Bayesian confidence propagation neural network(BCPNN)method and multi-item gamma Poisson shrinker(MGPS)method.The top 30 ADEs in terms of report frequency and signal strength,as well as ADEs categorized by system organ class(SOC),were statistically analyzed.Results A total of 868 adverse event reports related to lecanemab were collected,involving 1,986 instances of ADEs with 38 related ADE identified,the proportion of serious ADEs was 23.39%,and 87.15%of ADEs occurred in the first 3 months after the initiation of the drug.The top 30 PT signals in reported cases were headache,chills,fatigue,effusion type amyloid-related imaging abnormalities(ARIA-E),hemorrhage-type amyloid-related imaging abnormalities(ARIA-H),and so on.The top 30 signals in terms of signal intensity mainly included ARIA-E,ARIA-H,brain fog,infusion-related reactions.ADEs related to nervous system diseases were the most common.Fifteen new suspected or serious ADEs not recorded in the instructions were discovered,such as brain fog,formication,status epilepticus.Conclusion Risk assessment of patients'medication should be conducted before clinical use of lecanemab,especially in the first 3 months of the medication period,focus should be placed on monitoring common ADEs,such as ARIA-E,ARIA-H,infusion-related reactions.Attention also needs to be paid to the newly discovered suspected ADEs,to ensure the patients'medication safety.
3.Effect of stent-assisted thrombectomy combined with intermediate catheter aspiration in the treatment of acute basilar artery occlusive cerebral infarction
Jian DING ; Ruinan SONG ; Hailiang WANG ; Jie LIU ; Erping CUI
Journal of Xinxiang Medical College 2024;41(6):538-542
Objective To explore the clinical efficacy of stent-assisted thrombectomy combined with intermediate catheter aspiration in the treatment of acute basilar artery occlusive cerebral infarction.Methods Eighty patients with acute basilar artery occlusive cerebral infarction admitted to the Department of Neurology of Cangzhou People's Hospital from July 2022 to July 2023 were selected as the research subjects.The patients were divided into the control group(stent-assisted thrombectomy)and the observation group(stent-assisted thrombectomy combined with intermediate catheter aspiration)according to the treatment method,with 40 patients in each group.The neurological deficit of the patients in both groups was evaluated by using the National Institutes of Health Stroke Scale(NIHSS)before and after the intervention;the vascular recanalization of the patients was evaluated by using the modified thrombolysis in cerebral infarction(mTICI)grade;and the clinical prognosis of the patients was assessed by using the modified Rankin scale(mRS)at 3 months after treatment(mRS score ≤2:favorable prognosis;mRS score>2:poor prognosis).A 12-month postoperative follow-up was conducted to monitor the incidence of complications and the mortality rate.Results There was no significant difference in the NIHSS score of patients between the two groups before treatment(P>0.05);the NIHSS scores of patients in both groups at 24 hours and 3 months after treatment were significantly lower than those before treatment(P<0.01);the NIHSS scores of patients in the observation group at 24 hours and 3 months after treatment were significantly lower than those in the control group(P<0.01).There were a total of 22 patients with mTICI grades of 2b and 3 in the control group,and the first vascular recanalization rate was 55.0%(22/40);there were a total of 35 patients with mTICI grades of 2b and 3 in the observation group,and the first vascular recanalization rate was 87.5%(35/40);and the first vascular recanalization rate of patients in the observation group was significantly higher than that in the control group(x2=0.375,P>0.05).Three months after treatment,there were 13 patients in the control group with an mRS score of 0 to 2,and the favorable prognosis rate was 32.5%(13/40);there were 21 patients in the observation group with an mRS score of 0 to 2,and the favorable prognosis rate was 52.5%(21/40);the favorable prognosis rate of patients in the observation group was significantly higher than that in the control group(x2=6.619,P<0.05).During the 12-month follow-up,stroke-associated pneumonia occurred in 18 patients(45.0%),cerebral hernia occurred in 5 patients(12.5%),symptomatic intracranial hemorrhage occurred in 4 patients(10.0%),and 12 patients died,with a fatality rate of 30.0%in the control group;while in the observation group,stroke-associated pneumonia occurred in 10 patients(25.0%),cerebral hernia occurred in 4 patients(10.0%),symptomatic intracranial hemorrhage hemorrhage occurred in 2 patients(5.0%),and 8 patients died,with a fatality rate of 12.0%.There was no significant difference in the incidence of cerebral hernia and symptomatic intracranial hemorrhage between the observation group and control group(x2=0.125,0.721;P>0.05).The incidence of stroke-associated pneumonia and the fatality rate of patients in the observation group were significantly lower than those in the control group(x2=4.016,3.954;P<0.05).Conclusion Stent-assisted thrombectomy combined with intermediate catheter aspiration can effectively improve the first recanalization rate and enhance the neurological function and prognosis of patients with acute basilar artery occlusive cerebral infarction.
4.Progress in role of bile acid metabolism in depression
Hui LIU ; Baoying WANG ; Erping XU ; Ming BAI ; Jiduo SHEN ; Yucheng LI
Chinese Journal of Pathophysiology 2024;40(7):1351-1355
Bile acids not only play an important physiological role in regulating lipid metabolism,but also par-ticipate in the regulation of central nervous system.Numerous studies indicated that abnormal bile acid metabolism is closely related to depression,but the exact mechanism remains unclear.This study summarized the relationship between bile acid metabolism and depression and aimed to provide a new perspective for the study and treatment of depression.
5.Mechanism of Action of Coptidis Rhizoma and Ophiopogonis Radix in Delaying Diabetic Nephropathy Based on EGFR/PI3K/Akt Signaling Pathway
Shaoyu LI ; Man GONG ; Qiufang LI ; Liping DAI ; Guiqun WANG ; Qiuchen YANG ; Qiongqiong ZHANG ; Erping XU ; Yalin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(20):22-29
ObjectiveTo observe the effect of Coptidis Rhizoma and Ophiopogonis Radix on renal tissue injury and epidermal growth factor receptor (EGFR)/phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway in rats with diabetic nephropathy (DN) and explore its possible mechanism of delaying DN. MethodThirty-six male Wistar rats were randomly divided into a normal group (6 rats) and a model group (30 rats). The model group was fed with a high-fat and high-sugar diet combined with streptozotocin (STZ) to establish a rat model of type 2 diabetes. After the successful preparation of the model, the rats were randomly divided into the model group, low, medium, and high dose groups of Coptidis Rhizoma and Ophiopogonis Radix (100, 200, 400 mg·kg-1), and metformin group (200 mg·kg-1). After administration, the levels of fasting blood glucose (FBG), 24 h urine protein (24 h-UTP), creatinine (SCr), urea nitrogen (BUN), and uric acid (UA) were detected. Hematoxylin-eosin (HE) staining and Masson staining were used to observe the pathological changes of renal tissue in rats. Western blot and Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) were used to detect the related protein expression of EGFR, PI3K, and Akt and their mRNA expression levels in the renal tissue of rats in each group. ResultsCompared with the normal group, the levels of FBG, SCr, BUN, UA, 24 h-UTP, and kidney index in the model group were significantly increased (P<0.01), most renal tubular epithelial cells were necrotic, and the content of collagen in glomeruli was significantly increased (P<0.01). Compared with the model group, the above indexes of rats in each administration group were improved to varying degrees. The FBG, SCr, BUN, UA, 24 h-UTP, and kidney index of rats in each dose group and metformin group were significantly decreased (P<0.01, P<0.05). The necrosis degree of renal tubular epithelial cells was reduced, and the fibrosis area was decreased (P<0.01). There related protein and mRNA expressions of EGFR, PI3K, and Akt were significantly increased (P<0.05, P<0.01). ConclusionCoptidis Rhizoma and Ophiopogonis Radix can alleviate renal tissue injury in rats with DN, and their mechanism may be related to the regulation of the EGFR/PI3K/Akt signaling pathway.
6.Identification of Chemical Components and Components Absorbed into Blood of Sishen Pills
Qiuchen YANG ; Qiongqiong ZHANG ; Fang WANG ; Erping XU ; Liping DAI ; Ying CUI ; Lingling LI ; Yan-Ing ZHANG ; Yalin LIU
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(11):1234-1249
OBJECTIVE To identify and classify the chemical components and components absorbed into blood of Sishen Pills u-sing ultra-high performance liquid chromatography-quadrupole-orbitrap high resolution mass spectrometry.METHODS SD rats were divided into blank group and drug administration group.The rats in drug administration group were given water extract of Sishen Pills formula intragastrically,and blank and drug-containing plasma were collected respectively.A Hypersil GOLD VANQUISH column(2.1 mm×100 mm,1.9 μm)was used,with 0.1%formic acid water acetonitrile as the mobile phase,gradient elution,volume flow rate of 0.3 mL·min-1,and column temperature of 35℃.Electrospray ion source(ESI)with positive and negative ion scanning mode was used for chromatographic separation and mass spectrometry data acquisition.The chemical components of Sishen Pills were identi-fied by comparing the exact molecular mass,fragment ion information and relative retention time with the map of reference substance,matching with the self-established database and combining with literature reports.On this basis,the components absorbed into blood of Sishen Pills were analyzed by comparing the blank plasma and drug-containing plasma.RESULTS A total of 181 chemical compo-nents were identified from Sishen Pills,mainly including flavonoids,alkaloids,lignans and other components.A total of 49 prototype blood components were identified from the plasma samples,mainly including flavonoids,alkaloids and other components.CONCLU-SION A variety of chemical components in Sishen Pills and drug-containing plasma are comprehensively,accurately and quickly i-dentified,and all of them are assigned to the various medicinal materials in the prescription.This study provides reference for the qual-ity control,basic research on medicinal effect materials and clinical application of Sishen Pills.
7.Protective Effect of Aqueous Extract of Arctium lappa Roots on HCl/EtOH-induced Acute Gastric Ulcer in Rats Based on Akt/NF-κB Signaling Pathway
Bingdi CUI ; Hui GUO ; Man GONG ; Xiaoqian LIU ; Erping XU ; Liping DAI ; Zhimin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(2):1-9
ObjectiveTo investigate protective effect of Arctium lappa root aqueous extract (ALR-AE) on hydrochloric acid/ethanol (HCl/EtOH)-induced acute gastric ulcer in rats based on protein kinase B/nuclear transcription factor-κB (Akt/NF-κB) signaling pathway. MethodRats were randomly divided into 5 groups, namely normal group, model group, ranitidine group (35 mg·kg-1), ALR-AE low dose group (50 mg·kg-1, ALR-AE-L group) and ALR-AE high dose group (100 mg·kg-1, ALR-AE-H group). Different doses of ALR-AE were orally administered twice daily for three consecutive days before the animals were subjected to HCl/EtOH (60% ethanol in 150 mmol·L-1 HCl) to induce acute gastric ulcer. For the gastric tissue samples, the ulcer surface was recorded by electronic imaging technique, and then the ulcer inhibition rate was calculated using ImageJ 1.8.0, hematoxylin-eosin (HE) and periodic acid-Schiff (PAS) staining were used to observe the pathological changes and mucoprotein distribution, respectively. The levels of oxidative stress factors of malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) in rat gastric tissues were determined by colorimetric method, the levels of pro-inflammatory mediators of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and IL-1β were determined by enzyme linked immunosorbent assay (ELISA), protein levels of phosphorylation and non-phosphorylation of Akt, NF-κB p65, NF-κB inhibitor protein α (IκBα) and IκB kinase α (IKKα) were evaluated by Western blot. ResultCompared with the normal group, the gastric tissue of the model group was severely damaged, and the area of gastric ulcer were significantly enlarged (P<0.01), the levels of MDA, TNF-α, IL-6 and IL-1β in gastric tissue were significantly increased (P<0.01), levels of GSH-Px and SOD were significantly decreased (P<0.01), and phosphorylation levels of Akt, NF-κB p65, IKKα and IκBα in gastric tissue were significantly increased (P<0.01). Compared with the model group, ALR-AE significantly attenuated HCl/EtOH-induced gastric tissue damage, significantly increased ulcer inhibition rate (P<0.01), and dose-dependently reduced the levels of MDA, TNF-α, IL-6 and IL-1β (P<0.05, P<0.01), and elevated GSH-Px and SOD levels (P<0.01), ALR-AE-L group could significantly inhibit the phosphorylation levels of Akt (P<0.05), and ALR-AE-H group could significantly inhibit phosphorylation levels of Akt, NF-κB p65, IKKα and IκBα (P<0.05, P<0.01). ConclusionALR-AE has a significant protective effect on HCl/EtOH-induced acute gastric ulcers in rats, and its mechanism may be related to the inhibition of inflammatory mediator expression and reduction of oxidative stress levels mediated by Akt/NF-κB signaling pathway.
8.Protective Effect of Ethanolic Extract of Hemsleya chinensis on HCl/Ethanol-induced Acute Gastric Ulcer in Rats Based on p38 MAPK/NF-κB Signaling Pathway
Yang ZHANG ; Hui GUO ; Feihe LIAN ; Xi XIANG ; Qingxia LI ; Xiaoqian LIU ; Zhimin WANG ; Liping DAI ; Erping XU
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(2):37-44
ObjectiveTo investigate the mechanism of protective effect of ethanol extracts of Hemsleya chinensis (HC-EE) on hydrochloric acid/ethanol (HCl/EtOH)-induced acute gastric ulcer in rats. MethodLipopolysaccharide (LPS)-induced RAW264.7 cells were used to evaluate inhibitory effect of HC-EE on the production of inflammatory mediators in vitro. A rat acute gastric ulcer model induced by HCl/EtOH (60% ethanol in 150 mmol·L-1 HCl) was used to evaluate protective effect of HC-EE on acute gastric ulcer. Rats were divided into five groups, including normal group, model group, HC-EE low dose (HC-EE 30, 30 mg·kg-1) group, HC-EE high dose (HC-EE 60, 60 mg·kg-1) group and ranitidine (35 mg·kg-1) group. For model and drug-treated groups, vehicle solvent or drugs were orally administered twice daily for 7 consecutive days before the rats were subjected to HCl/EtOH to induce acute gastric ulcer. After being anesthetized, ulcer surface of each rat was obtained and recorded using electronic imaging technology, and the ulcer inhibition rate was calculated by ImageJ 1.8.0. Hematoxylin-eosin (HE) and periodic acid-Schiff (PAS) staining were used to observe the pathological histological changes in rats. Content of nitric oxide (NO) in cell culture medium was measured by the Griess method. The levels of interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), IL-6, vascular cell adhesion molecule-1 (VCAM-1) and prostaglandin E2 (PGE2) in rat serum (or cell culture medium) were determined by enzyme linked immunosorbent assay (ELISA). The protein expressions of phosphorylation (p)-p38 mitogen activated protein kinase (MAPK)/p38 MAPK and p-nuclear transcription factor-κB (NF-κB) p65/NF-κB p65 in rat gastric tissue were detected by Western blot. ResultIn vitro assay showed HC-EE could significantly down-regulate the expressions of NO, TNF-α, IL-1β, IL-6 and VCAM-1 in LPS-induced cells (P<0.05, P<0.01). In vivo experimental results showed that, compared with the normal group, gastric tissue of the model group was severely damaged, and the area of gastric ulcer was significantly enlarged, levels of TNF-α, IL-6 were significantly increased (P<0.01), and the level of PGE2 was significantly decreased (P<0.01), the phosphorylation levels of of p38 MAPK, NF-κB p65 in gastric tissue were significantly increased (P<0.01). Compared with the model group, HC-EE dose-dependently improved HCl/EtOH-induced gastric tissue injury and inflammatory cell infiltration, and it could increase ulcer inhibition rate, significantly decreased the release of TNF-α and IL-6 (P<0.01), HC-EE 60 group could increase the content of PGE2 (P<0.05), and significantly inhibit the phosphorylation levels of p38 MAPK and NF-κB p65 (P<0.05, P<0.01). ConclusionHC-EE can exert protective effect on HCl/EtOH-induced acute gastric ulcer in rats, and its mechanism may be related to the inhibition of expression of inflammatory mediators mediated by p38 MAPK/NF-κB signaling pathway.
9.Countermeasure analysis on the education of large medical imaging equipment metrology for the major of Biomedical Engineering
Zedong YAN ; Wei GUO ; Juan LIU ; Yuanzhe LI ; Xiaoyu MA ; Erping LUO ; Chi TANG
Chinese Journal of Medical Education Research 2023;22(5):689-693
Based on the analysis of current situation of the metrological education of large medical imaging equipment in colleges and universities at home, the advantages of major of Biomedical Engineering (BME) and the internal relation with the requirement of personnel training of metrology were systematically investigated. The necessity of carrying out education of large medical imaging equipment metrology for BME students in colleges and universities was elucidated. The specific thoughts and countermeasures were also proposed from curriculum establishment, teaching design, textbook compilation, conditional construction and teaching staff, respectively. The study is hopeful to provide guidance and help for the education of the large medical imaging equipment metrology in colleges and universities.
10.Analysis of family management level and its influencing factors of family with bronchiolitis obliterans children
Min YI ; Xiaoyan TAN ; Xia WU ; Lina ZHONG ; Erping XIAO ; Shuyu YI ; Li LI ; Huayan LIU
Chinese Journal of Practical Nursing 2023;39(27):2133-2139
Objective:To investigate the family management level of children with bronchiolitis obliterans and analyze its influencing factors, so as to provide reference for clinical medical staff to adopt targeted nursing and health education programs.Methods:This was a cross-sectional study. From January 1, 2019, to April 30, 2022, 201 families of bronchiolitis obliterans children hospitalized in Hunan Children's Hospital were selected as the research objects, and the General Data Questionnaire, Family Management Scale, Coping Style Scale of Parents, and Chronic Disease-Related Health Literacy Scale was used to investigate. Single-factor analysis and multiple regression analysis were used to analyze the influencing factors of bronchiolitis obliterans children's family management level.Results:The total score of bronchiolitis obliterans children's family management was (179.67 ± 9.92) points, the total score for parents' coping style was (177.14 ± 22.19) points, and the total score for health literacy was (102.95 ± 8.60) points. Multiple regression analysis showed that age, disease course, family residence, parents' education level, family monthly income, parents' coping style, and health literacy level were the influencing factors of family management level (all P<0.05). Conclusions:The family management ability of parents of children with bronchiolitis obliterans needs to be further improved. It is suggested that medical staff should formulate corresponding measures according to the age, course of the disease, family residence, parents' education level, etc., carry out targeted health education and home management training, improve the parents' health literacy level, and guide them to deal with diseases positively, to improve their family management level and promote the recovery of children's diseases.

Result Analysis
Print
Save
E-mail