INTRODUCTION: Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD. METHODS: In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging. RESULTS: A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline. CONCLUSIONS: Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies. REGISTRATION ClinicalTrials.gov , NCT07034222.
Humans ; Alzheimer Disease/drug therapy* ; Male ; Female ; Aged ; Middle Aged ; Cognitive Dysfunction/drug therapy* ; Aged, 80 and over ; Amyloid beta-Peptides/metabolism* ; Biomarkers ; East Asian People

OBJECTIVES: To investigate the role and mechanism of fibroblast growth factor (FGF) 19 in inflammation-induced injury of vascular endothelial cells caused by high glucose (HG). METHODS: Human umbilical vein endothelial cells (HUVECs) were randomly divided into four groups: control, HG, FGF19, and HG+FGF19 (n=3 each). The effect of different concentrations of glucose and/or FGF19 on HUVEC viability was assessed using the CCK8 assay. Flow cytometry was utilized to examine the impact of FGF19 on HUVEC apoptosis. Levels of interleukin-6 (IL-6), inducible nitric oxide synthase (iNOS), total superoxide dismutase (T-SOD), and malondialdehyde (MDA) were measured by ELISA. Real-time quantitative PCR and Western blotting were used to determine the mRNA and protein expression levels of vascular endothelial growth factor (VEGF), nuclear factor erythroid 2 related factor 2 (Nrf2), and heme oxygenase-1 (HO-1). Cells were further divided into control, siRNA-Nrf2 (siNrf2), HG, HG+FGF19, HG+FGF19+negative control, and HG+FGF19+siNrf2 groups (n=3 each) to observe the effect of FGF19 on oxidative stress injury in HUVECs induced by high glucose after silencing the Nrf2 gene. RESULTS: Compared to the control group, the HG group exhibited increased apoptosis rate, increased IL-6, iNOS and MDA levels, and increased VEGF mRNA and protein expression, along with decreased T-SOD activity and decreased mRNA and protein expression of Nrf2 and HO-1 (P<0.05). Compared to the HG group, the HG+FGF19 group showed reduced apoptosis rate, decreased IL-6, iNOS and MDA levels, and decreased VEGF mRNA and protein expression, with increased T-SOD activity and increased Nrf2 and HO-1 mRNA and protein expression (P<0.05). Compared to the HG+FGF19+negative control group, the HG+FGF19+siNrf2 group had decreased T-SOD activity and increased MDA levels (P<0.05). CONCLUSIONS FGF19 can alleviate inflammation-induced injury in vascular endothelial cells caused by HG, potentially through the Nrf2/HO-1 signaling pathway.
Humans ; NF-E2-Related Factor 2/genetics* ; Signal Transduction ; Human Umbilical Vein Endothelial Cells/drug effects* ; Fibroblast Growth Factors/pharmacology* ; Heme Oxygenase-1/physiology* ; Apoptosis/drug effects* ; Glucose ; Inflammation ; Interleukin-6/analysis* ; Vascular Endothelial Growth Factor A/genetics* ; Nitric Oxide Synthase Type II/analysis* ; Cells, Cultured

Turning to critical illness is a common stage of various diseases and injuries before death. Patients usually have complex health conditions, while the treatment process involves a wide range of content, along with high requirements for doctor′s professionalism and multi-specialty teamwork, as well as a great demand for time-sensitive treatments. However, this is not matched with critical care professionals and the current state of medical care in China. Telemedicine, which shortens the distance of medical professionals and the gap of disease diagnosis and treatments in various regions through electronic information, can effectively solve the current problem. Therefore, there is an urgent need to develop a standardized, high-quality visualization telemedicine round system .Therefore, experts have been organized to search domestic and foreign literature on telemedicine round for critically ill patients and to form this consensus based on clinical experiences so as to further improve the level of critical care treatments in regions.

Objective To quantify the volume and movement of cardiac substructures by using coronary computed tomography angiography(CCTA)to provide guidance for the design of deep inspiratory breath-holding radiation therapy for left breast cancer and the protection of organs at risk.Methods Totally 18 female patients who received conventional chest plain scan and CCTA were selected to simulate the design process of radiotherapy plan for left breast cancer patients with internal mammary lymph nodes.Retrospective reconstruction of CCTA data was performed for each patient,with 10 phase images(with an interval of 10％)within a R-R cardiac cycle(10％-100％)to simulate the true range of motion of the heart.The heart,left atrium(LA),left ventricle(LV),right atrium(RA),right ventricle(RV),left anterior descending artery(LAD),left circumflex coronary artery(LCX)and right coronary artery(RCA)were contoured at each phase.The distances from the centroid position to the average position of LAD,LCX and RCA were measured at each phase in the superior-inferior(SI),anterior-posterior(AP)and left-right(LR).The average volume and range of volume changes of LA,LV,RA,RV and heart were analyzed within a cardiac cycle.The expansion margins of planning organs at risk volume(PRV)were calculated.SPSS 19.0 software was used for statistical analysis.Results The following average absolute displacements were found in SI,AP and LR coordinates:(1.8±0.7)mm,(1.2±0.5)mm and(1.5±0.5)mm for LAD,respectively;(2.1±0.7)mm,(1.5±0.6)mm and(1.9±0.7)mm for LCX,respectively;(1.6±0.5)mm,(2.2±0.9)mm and(2.2±0.8)mm for RCA,respectively.The volume changes of LA,LV,RA,RV and heart within a cardiac cycle ranged from 34.3 to 63.9 cm3,122.1 to 154.3 cm3,29.3 to 53.6 cm3,57.2 to 94.3 cm3 and 480.1 to 515.4 cm3,respectively.The theoretical expansion margins of LAD,LCX and RCA in all the three directions were within 2 mm.Conclusion The ranges of movement and volume changes of cardiac substructure are quantitati-vely displayed,and references are provided for the planning of deep inspiratory breath-holding radiation therapy for left breast cancer and the protection of organs at risk.[Chinese Medical Equipment Journal,2025,46(3):54-58]

Objective To investigate the effect of long non-coding RNA(lncRNA)nuclear enriched abundant transcript 1(NEAT1)on the chondrocyte pyroptosis signaling axis in osteoarthritis(OA)and its potential mechanism.Methods Knee joint cartilage tissues were collected from 6 OA patients and 6 healthy individuals.The targeting relationship between miR-26a and lncRNA NEAT1 was predicted by TargetScan 7.2 and StarBase,and the targeting regulatory effect of lncRNA NEAT1 and miR-26a was verified by dual luciferase reporter assays.The cultured chondrocyte lines were divided into the control group(without drug intervention),IL-1β group(with 10 μg/L of IL-1β for inducing OA in vitro),IL-1β+NEAT1-EV group(with 10 μg/L of IL-1β and transfected with 20 μg/L of NEAT1-EV),IL-1β+NEAT1-OE group(with 10 μg/L of IL-1β and transfected with 20 μg/L of NEAT1-OE),IL-1β+NEAT1-OE+mimic-NC(with 10 μg/L of IL-1β and co-transfected with 20 μg/L of NEAT1-OE and 50 μg/L of mimic-NC),and IL-1β+NEAT1-OE+mimic(with 10 μg/L of IL-1β and co-transfected with 20 μg/L of NEAT1-OE and 50 μg/L of miR-26a mimic).The expression levels of lncRNA NEAT1 and miR-26a in OA cartilage tissues and cells were detected using qRT-PCR.The cell viability was determined using CCK-8 assay.The expression of Caspase1 and cleaved-Caspase1,as well as the pyroptosis markers[NOD-like receptor family pyrin domain containing 3(NLRP3),interleukin-18(IL-18)and cleaved-Gasdermin D]were detected using Western blot.Results In the OA cartilage tissue,the expression level of lncRNA NEAT1 was higher than that in the normal cartilage tissue,while the expression level of miR-26a was lower than that in the normal cartilage group(P<0.05).The dual luciferase reporter assays confirmed the targeted regulatory effect of lncRNA NEAT1 and miR-26a.Compared with the control group,the IL-1β group showed upregulation of lncRNA NEAT1,cleaved-Caspase1,NLRP3,IL-18,and cleaved-Gasdermin D expression levels(P<0.05),downregulation of miR-26a expression level(P<0.05),and a decrease of cell viability(P<0.05).Compared with the IL-1β+NEAT1-EV group,the IL-1β+NEAT1-OE group exhibited upregulation of lncRNA NEAT1,cleaved-Caspase1,NLRP3,IL-18,and cleaved-Gasdermin D expression levels(P<0.05),downregulation of miR-26a expression level(P<0.05),and a decrease of cell viability(P<0.05).Compared with the IL-1β+NEAT1-OE+mimic-NC group,the IL-1β+NEAT1-OE+mimic group showed downregulation of cleaved-Caspase1,NLRP3,IL-18,and cleaved-Gasdermin D expression levels,upregulation of miR-26a expression level(P<0.05),and an increase of cell viability(P<0.05).Conclusion lncRNA NEAT1 activates the chondrocyte pyroptosis signaling axis mediated by Caspase1 in OA by the targeted inhibition of miR-26a.

Objective To analyze the risk factors for increased drainage volume after open transforaminal lumbar interbody fusion(TLIF),and to establish a predictive model and then validate it.Methods The clinical data of 680 patients who underwent open TLIF at the General Hospital of Northern Theater Command from January 2016 to December 2019 were collected and the patients were randomly divided into the training group(n=476)and the validation group(n=204).Taking the predictive factors screened out by LASSO regression analysis as independent variables,a multivariate Logistic regression predictive model was constructed.The model was internally validated through the receiver operating characteristic(ROC)curve,Hosmer-Lemeshow goodness-of-fit test,and calibration curve,and its clinical utility was assessed via decision curve analysis(DCA).Results LASSO regression analysis screened out four predictive variables:age,number of surgical segments,operative duration,and intraoperative blood loss.The multivariate Logistic regression predictive model demonstrated that age≥60 years,number of surgical segments≥4,operative duration≥2 hours,and intraoperative blood loss≥200 mL were independent influencing factors for the increased postoperative drainage volume in patients undergoing TLIF(P<0.05).ROC curve analysis revealed an area under the curve(AUC)of 0.816(95%CI:0.798 to 0.867)in the training group and 0.783(95%CI:0.685 to 0.823)in the validation group,indicating that the predictive model had good discriminatory ability.Additionally,the Hosmer-Lemeshow goodness-of-fit test and calibration curve indicated that the predictive model had a good degree of fit,and the predicted probability was basically consistent with the actual probability,demonstrating a good calibration.The DCA results confirmed that this predictive model could be applied in clinical practice.Conclusion The risk factors for increased drainage volume after open TLIF include age,number of surgical segments,operative duration,and intraoperative blood loss.The predictive model established based on these factors demonstrates good performance,and it can be applied in clinical guidance for the selection of drainage tube removal time after TLIF.

Objective:To evaluate the clinical value and safety of an intraperitoneal chemotherapy port technique in patients with gastric cancer and peritoneal metastases undergoing intraperitoneal chemotherapy.Methods:This was a retrospective, descriptive case analysis. From November 2022 to October 2024, patients diagnosed with gastric cancer and peritoneal metastases at Wuxi Branch of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine with an expected survival >3 months, underwent laparoscopic exploration combined with implantation of an intraperitoneal chemotherapy port [PORT-A-CATH II system (Model 21-4055-24)] implantation. The procedure was as follows: (1) after laparoscopic exploration, a 4-cm skin incision was made at a predetermined site and a subcutaneous pocket created by dissecting to the muscle fascia and removing subcutaneous fat as needed to position the port septum 0.5-1.0 cm from the skin surface; (2) under direct laparoscopic visualization, the abdominal cavity was punctured and a guidewire inserted, followed by an 8.5 Fr sheath, through which a catheter with three trimmed side holes was placed after removal of the sheath; (3) the catheter length in the abdominal cavity was adjusted to 25–30 cm and the catheter trimmed, and connected to the port base, ensuring it extended beyond the connector's visible hole; (4) the whole port was placed within the subcutaneous pocket, and non-absorbable sutures used to create a double purse-string suture at the catheter's abdominal entry, forming an anti-reflux ring; (5) non-absorbable sutures were used to securely fix the port to the fascia through its four base holes and the exposed catheter segments on the fascia sutured and buried; (6) patency was confirmed by injecting saline and followed by intermittent skin closure provided there was no bleeding; and (7) the catheter tip was positioned in the pelvic cavity under laparoscopic guidance. Postoperatively, the patients underwent normothermic intraperitoneal and systemic treatment. The port infusion protocol involved disinfecting the skin (>10 cm diameter) around the port, confirming the puncture site, inserting a Huber needle vertically at 90° to the port base, infusing 100 mL saline to ensure patency, followed by continuous infusion of 1000 mL paclitaxel solution, and sealing with 20 mL saline before removing the needle. No saline flushing was required between chemotherapy infusions. The primary outcomes were the incidence and management of complications post-port implantation.Results:The study cohort comprised 225 patients with gastric cancer and peritoneal metastases. Using standardized port implantation and postoperative puncture procedures, the complication rate during follow-up was 14.2% (32/225), including effusion in 14 patients (6.2%), port infection in 10 (4.4%), incision dehiscence in four (1.8%), port inversion in two (0.9%), hematoma in one (0.4%), and catheter rupture in one (0.4%). Seventy-five percent (24/32) of patients with complications recovered and continued using the port after conservative treatments (e. g., aspiration of effusions, antibiotic therapy, incision management), whereas the remaining 25.0% (8/32) with complications required surgical removal of the port because the treatment was ineffective. The presence of preoperative ascites ( P=0.019) and peritoneal cancer index score>15 ( P=0.038) were significantly associated with development of complications. Conclusions:Our standardized procedure for intraperitoneal chemotherapy port implantation is safe and feasible for patients with gastric cancer and peritoneal metastases, having a low overall complication rate. Most complications can be successfully managed with conservative treatment, the device thus providing reliable support for intraperitoneal chemotherapy.

Objective To quantify the volume and movement of cardiac substructures by using coronary computed tomography angiography(CCTA)to provide guidance for the design of deep inspiratory breath-holding radiation therapy for left breast cancer and the protection of organs at risk.Methods Totally 18 female patients who received conventional chest plain scan and CCTA were selected to simulate the design process of radiotherapy plan for left breast cancer patients with internal mammary lymph nodes.Retrospective reconstruction of CCTA data was performed for each patient,with 10 phase images(with an interval of 10％)within a R-R cardiac cycle(10％-100％)to simulate the true range of motion of the heart.The heart,left atrium(LA),left ventricle(LV),right atrium(RA),right ventricle(RV),left anterior descending artery(LAD),left circumflex coronary artery(LCX)and right coronary artery(RCA)were contoured at each phase.The distances from the centroid position to the average position of LAD,LCX and RCA were measured at each phase in the superior-inferior(SI),anterior-posterior(AP)and left-right(LR).The average volume and range of volume changes of LA,LV,RA,RV and heart were analyzed within a cardiac cycle.The expansion margins of planning organs at risk volume(PRV)were calculated.SPSS 19.0 software was used for statistical analysis.Results The following average absolute displacements were found in SI,AP and LR coordinates:(1.8±0.7)mm,(1.2±0.5)mm and(1.5±0.5)mm for LAD,respectively;(2.1±0.7)mm,(1.5±0.6)mm and(1.9±0.7)mm for LCX,respectively;(1.6±0.5)mm,(2.2±0.9)mm and(2.2±0.8)mm for RCA,respectively.The volume changes of LA,LV,RA,RV and heart within a cardiac cycle ranged from 34.3 to 63.9 cm3,122.1 to 154.3 cm3,29.3 to 53.6 cm3,57.2 to 94.3 cm3 and 480.1 to 515.4 cm3,respectively.The theoretical expansion margins of LAD,LCX and RCA in all the three directions were within 2 mm.Conclusion The ranges of movement and volume changes of cardiac substructure are quantitati-vely displayed,and references are provided for the planning of deep inspiratory breath-holding radiation therapy for left breast cancer and the protection of organs at risk.[Chinese Medical Equipment Journal,2025,46(3):54-58]

Objective To investigate the effect of long non-coding RNA(lncRNA)nuclear enriched abundant transcript 1(NEAT1)on the chondrocyte pyroptosis signaling axis in osteoarthritis(OA)and its potential mechanism.Methods Knee joint cartilage tissues were collected from 6 OA patients and 6 healthy individuals.The targeting relationship between miR-26a and lncRNA NEAT1 was predicted by TargetScan 7.2 and StarBase,and the targeting regulatory effect of lncRNA NEAT1 and miR-26a was verified by dual luciferase reporter assays.The cultured chondrocyte lines were divided into the control group(without drug intervention),IL-1β group(with 10 μg/L of IL-1β for inducing OA in vitro),IL-1β+NEAT1-EV group(with 10 μg/L of IL-1β and transfected with 20 μg/L of NEAT1-EV),IL-1β+NEAT1-OE group(with 10 μg/L of IL-1β and transfected with 20 μg/L of NEAT1-OE),IL-1β+NEAT1-OE+mimic-NC(with 10 μg/L of IL-1β and co-transfected with 20 μg/L of NEAT1-OE and 50 μg/L of mimic-NC),and IL-1β+NEAT1-OE+mimic(with 10 μg/L of IL-1β and co-transfected with 20 μg/L of NEAT1-OE and 50 μg/L of miR-26a mimic).The expression levels of lncRNA NEAT1 and miR-26a in OA cartilage tissues and cells were detected using qRT-PCR.The cell viability was determined using CCK-8 assay.The expression of Caspase1 and cleaved-Caspase1,as well as the pyroptosis markers[NOD-like receptor family pyrin domain containing 3(NLRP3),interleukin-18(IL-18)and cleaved-Gasdermin D]were detected using Western blot.Results In the OA cartilage tissue,the expression level of lncRNA NEAT1 was higher than that in the normal cartilage tissue,while the expression level of miR-26a was lower than that in the normal cartilage group(P<0.05).The dual luciferase reporter assays confirmed the targeted regulatory effect of lncRNA NEAT1 and miR-26a.Compared with the control group,the IL-1β group showed upregulation of lncRNA NEAT1,cleaved-Caspase1,NLRP3,IL-18,and cleaved-Gasdermin D expression levels(P<0.05),downregulation of miR-26a expression level(P<0.05),and a decrease of cell viability(P<0.05).Compared with the IL-1β+NEAT1-EV group,the IL-1β+NEAT1-OE group exhibited upregulation of lncRNA NEAT1,cleaved-Caspase1,NLRP3,IL-18,and cleaved-Gasdermin D expression levels(P<0.05),downregulation of miR-26a expression level(P<0.05),and a decrease of cell viability(P<0.05).Compared with the IL-1β+NEAT1-OE+mimic-NC group,the IL-1β+NEAT1-OE+mimic group showed downregulation of cleaved-Caspase1,NLRP3,IL-18,and cleaved-Gasdermin D expression levels,upregulation of miR-26a expression level(P<0.05),and an increase of cell viability(P<0.05).Conclusion lncRNA NEAT1 activates the chondrocyte pyroptosis signaling axis mediated by Caspase1 in OA by the targeted inhibition of miR-26a.

Objective To analyze the risk factors for increased drainage volume after open transforaminal lumbar interbody fusion(TLIF),and to establish a predictive model and then validate it.Methods The clinical data of 680 patients who underwent open TLIF at the General Hospital of Northern Theater Command from January 2016 to December 2019 were collected and the patients were randomly divided into the training group(n=476)and the validation group(n=204).Taking the predictive factors screened out by LASSO regression analysis as independent variables,a multivariate Logistic regression predictive model was constructed.The model was internally validated through the receiver operating characteristic(ROC)curve,Hosmer-Lemeshow goodness-of-fit test,and calibration curve,and its clinical utility was assessed via decision curve analysis(DCA).Results LASSO regression analysis screened out four predictive variables:age,number of surgical segments,operative duration,and intraoperative blood loss.The multivariate Logistic regression predictive model demonstrated that age≥60 years,number of surgical segments≥4,operative duration≥2 hours,and intraoperative blood loss≥200 mL were independent influencing factors for the increased postoperative drainage volume in patients undergoing TLIF(P<0.05).ROC curve analysis revealed an area under the curve(AUC)of 0.816(95%CI:0.798 to 0.867)in the training group and 0.783(95%CI:0.685 to 0.823)in the validation group,indicating that the predictive model had good discriminatory ability.Additionally,the Hosmer-Lemeshow goodness-of-fit test and calibration curve indicated that the predictive model had a good degree of fit,and the predicted probability was basically consistent with the actual probability,demonstrating a good calibration.The DCA results confirmed that this predictive model could be applied in clinical practice.Conclusion The risk factors for increased drainage volume after open TLIF include age,number of surgical segments,operative duration,and intraoperative blood loss.The predictive model established based on these factors demonstrates good performance,and it can be applied in clinical guidance for the selection of drainage tube removal time after TLIF.