1.Three-dimensional Electrical Impedance Tomography for Monitoring Gastric Hemorrhage
Zi-Han ZHAO ; Bo SUN ; Jing-Shi HUANG ; Zhi-Wei LI ; Yang WU ; Nan LI ; Jia-Feng YAO ; Tong ZHAO
Progress in Biochemistry and Biophysics 2026;53(4):1062-1075
ObjectiveGastric hemorrhage is one of the most common and life-threatening emergencies of the upper digestive tract. Early identification and continuous monitoring are essential for reducing rebleeding rates and mortality, particularly within the critical early hours after onset. Although endoscopy and radiological imaging can accurately localize bleeding sites, these approaches are invasive, resource-intensive, and unsuitable for continuous bedside monitoring. Electrical impedance tomography (EIT), as a noninvasive and radiation-free functional imaging technique, offers real-time visualization of conductivity distribution and has the potential for detecting intragastric bleeding based on the electrical contrast between blood and surrounding gastric tissues. In this study, a three-dimensional gastric EIT (3D-gEIT) framework is proposed to achieve noninvasive, real-time, and dynamic monitoring of gastric hemorrhage, with emphasis on spatial localization and quantitative volume assessment. MethodsA three-dimensional upper-abdominal simulation model incorporating the stomach, gastric wall, gastric contents, and surrounding tissues was established. Three electrode configurations, namely the dual layer ring, the four layer staggered ring, and the opposed dual plane array, were designed and systematically compared to evaluate their influence on depth sensitivity and spatial resolution. Based on the Tikhonov-Noser hybrid regularization scheme, a region-clustering constraint was introduced to develop the TK-Noser-RCC algorithm. This approach aggregates spatially adjacent elements with similar conductivity variations, thereby enhancing structural continuity and suppressing isolated noise artifacts. To validate the proposed framework, an upper-abdominal physical phantom was constructed using agar to simulate background tissue conductivity. Hemispherical high-conductivity inclusions with volumes ranging from 10 ml to 50 ml were attached to the inner gastric wall to mimic localized bleeding under different gastric filling states. Boundary voltages were acquired under a 120 kHz excitation current and reconstructed using the TK-Noser-RCC algorithm. Furthermore, an in vivo animal experiment was performed using a porcine model with adult-scale abdominal dimensions. A total of 100 ml of autologous blood was injected incrementally into the stomach to simulate progressive gastric hemorrhage, and time-difference EIT reconstruction was conducted at each injection stage to assess the dynamic system response under physiological conditions. ResultsSimulation results demonstrated that the opposed dual-plane electrode array achieved superior depth sensitivity distribution and spatial resolution. For a 40 ml hemorrhage model, the average ICC and SSIM improved by 55.9% and 38.8% compared with the dual-layer ring configuration, and by 64.0% and 39.5% compared with the four-layer staggered configuration. The proposed region-clustering constraint significantly enhanced reconstruction stability. Under added Gaussian noise of 40 dB and 30 dB, ICC values remained approximately 0.85, indicating effective artifact suppression and preservation of boundary integrity. In physical phantom experiments, reconstructed hemorrhage volumes increased approximately linearly with the preset hemispherical volumes, and the reconstructed high-conductivity regions closely matched the actual bleeding locations. Both empty-stomach and full-stomach conditions were evaluated, demonstrating that the opposed dual-plane configuration maintained stable imaging performance across varying gastric contents. In the animal experiment, reconstructed low-impedance regions expanded progressively with increasing injected blood volume. The spatial localization of the hemorrhage remained stable throughout the procedure, and no significant artifacts were observed. Quantitative analysis showed that reconstructed volume and average conductivity variation exhibited an approximately linear growth trend with injected blood volume, confirming the sensitivity of the system to dynamic intragastric conductivity changes. ConclusionThe proposed 3D-gEIT framework enables quantitative reconstruction of gastric hemorrhage volume and spatial distribution with improved depth sensitivity, structural continuity, and noise robustness compared with conventional EIT approaches. By integrating optimized electrode configuration and a region-clustering-constrained reconstruction algorithm, the system provides stable dynamic monitoring under both controlled phantom conditions and in vivo physiological environments. This method offers a noninvasive, real-time, and low-cost imaging strategy for early diagnosis, postoperative monitoring, and bedside surveillance of gastric bleeding.
2.Metabolomics Reveals Mechanism of Jatrorrhizine in Treating Ulcerative Colitis in Mice
Shengqi NIU ; Liwei LANG ; Xing LI ; Haotian LI ; Shizhang WEI ; Manyi JING ; Yanling ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):211-218
ObjectiveTo investigate the effects of jatrorrhizine on endogenous metabolites and metabolic pathways in the mouse model of ulcerative colitis. MethodsThirty male C57BL/6J mice were randomly divided into the normal group, the model group, the low-dose and high-dose jatrorrhizine groups (0.04, 0.16 g·kg-1), and the mesalazine group (0.52 g·kg-1)The mouse model of ulcerative colitis was established with 3% dextran sulfate sodium (DSS) and treated with different doses of jatrorrhizine by gavage. The changes in body weight, colon length, disease activity index (DAI), and colonic histopathology were analyzed to evaluate the therapeutic effects of jatrorrhizine. UPLC-Q-TOF/MS was employed to determine the serum and fecal levels of metabolites in mice. Metabolomics methods were used to screen the differential metabolites, on the basis of which the potential therapeutic mechanism of jatrorrhizine on DSS-induced ulcerative colitis in mice was investigated. ResultsAfter intervention with jatrorrhizine, the model mice showed significantly decreased DAI(P<0.05,P<0.01), recovered colon length,(P<0.05,P<0.01) and alleviated histopathology of the colon. The metabolomics study screened out 13 differential metabolites in the serum and 8 differential metabolites in the feces. The pathway enrichment analysis predicted three potential metabolic pathways: Biosynthesis of unsaturated fatty acids, phenylalanine, tyrosine and tryptophan biosynthesis, and phenylalanine metabolism. ConclusionJatrorrhizine may treat ulcerative colitis by regulating the biosynthesis and metabolism of amino acids and the synthesis of unsaturated fatty acids.
3.Material Basis of Anti-Inflammatory Efficacy and Mechanism of Action of Bushen Tongdu Prescription Based on UPLC-LTQ-Orbitrap-MS and Network Pharmacology
Yan RONG ; Lulu JING ; Hongping HOU ; Huijun WANG ; Lihua CHEN ; Yunxin CHEN ; Liang LI ; Li LIN ; Xiaoqin LUO ; Haiyu ZHAO ; Xiaolu WEI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):152-161
ObjectiveThis paper aims to investigate the material basis of the anti-inflammatory efficacy and mechanism of action of Bushen Tongdu prescription (BSTDP). MethodsThe chemical components of BSTDP and its blood-absorbed components in vivo were systematically identified by using ultra-performance liquid chromatography-linear ion trap-electrostatic field orbitrap high-resolution mass spectrometry (UPLC-LIT-Orbitrap-MS). Network pharmacology was employed to screen blood-absorbed bioactive components and potential targets of this formula. A protein-protein interaction (PPI) network of core targets was constructed to conduct enrichment analysis. Molecular docking was further utilized to verify the binding affinity between key components and targets. The inflammatory model was established and verified in vivo by using a transgenic zebrafish Tg (mpx: GFP). At three days post-fertilization (3 dpf), larvae of zebrafish were randomly assigned to blank group, model group, positive drug dexamethasone acetate group (75 μmol·L-1), and BSTDP groups with low, medium, and high doses (500, 1 000, and 2 000 mg·L-1). The distribution and quantity of neutrophils in the yolk sac region were observed under a fluorescence microscope. The mRNA expression levels of key genes in the toll-like receptor 4 (TLR4)/myeloid differentiation factor 88 (MyD88)/nuclear factor kappa-B (NF-κB) signaling pathway and inflammatory factors including interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) were detected by Real-time quantitative polymerase chain reaction (Real-time PCR). ResultsA total of 120 chemical components were identified in BSTDP, among which 26 original components were confirmed by using serum pharmacochemical methods. A total of 227 common targets linking rheumatoid arthritis (RA) and the blood-absorbed components were screened by network pharmacology. It is suggested that pseudobrucine, vomicine, sinapine, rehmannioside, cinnamyl alcohol glycoside, and methylephedrine exert anti-inflammatory effects by acting on core targets including protein kinase B1 (Akt1), signal transducer and activator of transcription 3 (STAT3), tumor necrosis factor (TNF), TLR4, mitogen-activated protein kinase 14 (MAPK14), and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit α (PIK3CA), thereby modulating multiple signaling pathways such as TLR4 and NF-κB. In vivo verification in zebrafish demonstrates that the maximum tolerable concentration of Bushen Tongdu Formula is 2 000 mg·L-1. Compared to those in the blank group, zebrafish in the model group showed a significantly higher number of neutrophils in the yolk sac region (P<0.01) and rising mRNA levels of TLR4, MyD88, NF-κB, TNF-α, IL-6, and IL-1β (P<0.01). Compared to that in the model group, the number of neutrophils was significantly reduced in BSTDP groups with medium and high doses, as well as the dexamethasone acetate group (P<0.05, P<0.01). There was no statistically significant difference in the low dose group. The mRNA expression levels of TLR4, MyD88, NF-κB, TNF-α, IL-6, and IL-1β were significantly down-regulated (P<0.05, P<0.01). ConclusionThis paper identifies the material basis of the efficacy of BSTDP, demonstrating that the formula can exert an anti-inflammatory effect through the TLR4/MyD88/NF-κB signaling pathway. The results provide scientific experimental evidence for its further clinical application.
4.Material Basis of Anti-Inflammatory Efficacy and Mechanism of Action of Bushen Tongdu Prescription Based on UPLC-LTQ-Orbitrap-MS and Network Pharmacology
Yan RONG ; Lulu JING ; Hongping HOU ; Huijun WANG ; Lihua CHEN ; Yunxin CHEN ; Liang LI ; Li LIN ; Xiaoqin LUO ; Haiyu ZHAO ; Xiaolu WEI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):152-161
ObjectiveThis paper aims to investigate the material basis of the anti-inflammatory efficacy and mechanism of action of Bushen Tongdu prescription (BSTDP). MethodsThe chemical components of BSTDP and its blood-absorbed components in vivo were systematically identified by using ultra-performance liquid chromatography-linear ion trap-electrostatic field orbitrap high-resolution mass spectrometry (UPLC-LIT-Orbitrap-MS). Network pharmacology was employed to screen blood-absorbed bioactive components and potential targets of this formula. A protein-protein interaction (PPI) network of core targets was constructed to conduct enrichment analysis. Molecular docking was further utilized to verify the binding affinity between key components and targets. The inflammatory model was established and verified in vivo by using a transgenic zebrafish Tg (mpx: GFP). At three days post-fertilization (3 dpf), larvae of zebrafish were randomly assigned to blank group, model group, positive drug dexamethasone acetate group (75 μmol·L-1), and BSTDP groups with low, medium, and high doses (500, 1 000, and 2 000 mg·L-1). The distribution and quantity of neutrophils in the yolk sac region were observed under a fluorescence microscope. The mRNA expression levels of key genes in the toll-like receptor 4 (TLR4)/myeloid differentiation factor 88 (MyD88)/nuclear factor kappa-B (NF-κB) signaling pathway and inflammatory factors including interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) were detected by Real-time quantitative polymerase chain reaction (Real-time PCR). ResultsA total of 120 chemical components were identified in BSTDP, among which 26 original components were confirmed by using serum pharmacochemical methods. A total of 227 common targets linking rheumatoid arthritis (RA) and the blood-absorbed components were screened by network pharmacology. It is suggested that pseudobrucine, vomicine, sinapine, rehmannioside, cinnamyl alcohol glycoside, and methylephedrine exert anti-inflammatory effects by acting on core targets including protein kinase B1 (Akt1), signal transducer and activator of transcription 3 (STAT3), tumor necrosis factor (TNF), TLR4, mitogen-activated protein kinase 14 (MAPK14), and phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit α (PIK3CA), thereby modulating multiple signaling pathways such as TLR4 and NF-κB. In vivo verification in zebrafish demonstrates that the maximum tolerable concentration of Bushen Tongdu Formula is 2 000 mg·L-1. Compared to those in the blank group, zebrafish in the model group showed a significantly higher number of neutrophils in the yolk sac region (P<0.01) and rising mRNA levels of TLR4, MyD88, NF-κB, TNF-α, IL-6, and IL-1β (P<0.01). Compared to that in the model group, the number of neutrophils was significantly reduced in BSTDP groups with medium and high doses, as well as the dexamethasone acetate group (P<0.05, P<0.01). There was no statistically significant difference in the low dose group. The mRNA expression levels of TLR4, MyD88, NF-κB, TNF-α, IL-6, and IL-1β were significantly down-regulated (P<0.05, P<0.01). ConclusionThis paper identifies the material basis of the efficacy of BSTDP, demonstrating that the formula can exert an anti-inflammatory effect through the TLR4/MyD88/NF-κB signaling pathway. The results provide scientific experimental evidence for its further clinical application.
5.Development of a nomogram-based risk prediction model for chronic obstructive pulmonary disease incidence in community-dwelling population aged 40 years and above in Shanghai
Yixuan ZHANG ; Yiling WU ; Jinxin ZANG ; Xuyan SU ; Xin YIN ; Jing LI ; Wei LUO ; Minjun YU ; Wei WANG ; Qi ZHAO ; Qin WANG ; Genming ZHAO ; Yonggen JIANG ; Na WANG
Shanghai Journal of Preventive Medicine 2025;37(8):669-675
ObjectiveTo develop a nomogram-based risk prediction model for chronic obstructive pulmonary disease (COPD) incidence among the community-dwelling population aged 40 years old and above, so as to provide targeted references for the screening and prevention of COPD. MethodsBased on a natural population cohort in suburban Shanghai, a total of 3 381 randomly selected participants aged ≥40 years underwent pulmonary function tests between July and October 2021. Cox stepwise regression analysis was used to develop overall and gender-specific risk prediction models, along with the construction of corresponding risk nomograms. Model predictive performance was evaluated using the C-indice, area under the curve (AUC) values, and Brier score. Stability was assessed through 10-fold cross-validation and sensitivity analysis. ResultsA total of 3 019 participants were included, with a median follow-up duration of 4.6 years. The COPD incidence density was 17.22 per 1 000 person-years, significantly higher in males (32.04/1 000 person-years) than that in females (7.38/1 000 person-years) (P<0.001). The overall risk prediction model included the variables such as gender, age, education level, BMI, smoking, passive smoking, and respiratory comorbidities. The male-specific model incorporated the variables such as age, BMI, respiratory comorbidities, and smoking, while the female-specific model included age, marital status, respiratory comorbidities, and pulmonary tuberculosis history. The C-indices for the overall, male-specific, and female-specific models were 0.829, 0.749, and 0.807, respectively. The 5-year AUC values were 0.785, 0.658, and 0.811, with Brier scores of 0.103, 0.176, and 0.059, respectively. Both 10-fold cross-validated C-indices and sensitivity analysis (excluding participants with a follow-up duration of <6 months) yielded C-indices were above 0.740. ConclusionThis study developed concise and practical overall and gender-specific COPD risk prediction models and corresponding nomograms. The models demonstrated robust performance in predicting COPD incidence, providing a valuable reference for identifying high-risk populations and formulating targeted screening and personalized management strategies.
6.National Multicenter Analysis of Serotype Distribution and Antimicrobial Resistance of Salmonella in China, 2021—2022
Qianqing LI ; Yanan NIU ; Pu QIN ; Honglian WEI ; Jie WANG ; Cuixin QIANG ; Jing YANG ; Zhirong LI ; Weigang WANG ; Min ZHAO ; Qiuyue HUO ; Kaixuan DUAN ; Jianhong ZHAO
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1120-1130
To analyze the distribution of serotypes and antimicrobial resistance of clinical Non-duplicate A total of 605 Clinically isolated
7.Ancient and Modern Literature Analysis and Key Information Research of Classic Formula Qingfeitang
Lyuyuan LIANG ; Jinyan ZHANG ; Jialei CAO ; Jing TANG ; Mengmeng GENG ; Yiqing ZHAO ; Hejia WAN ; Yiping WANG ; Bingqi WEI ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):179-189
Qingfeitang, specialized in resolving phlegm to stop cough and producing fluid to moisten dryness, is a classic prescription inherited and developed by physicians of successive generations and has been included in the Catalogue of Ancient Classic Prescriptions (First Batch) published by the National Administration of Traditional Chinese Medicine (TCM) in 2018. Relevant ancient books data and modern literature were collected by bibliometrics to analyze the historic origin, formula composition, herb origin, preparation methods, processing methods, clinical effect, and indications of Qingfeitang. The key information of Qingfeitang was summarized to provide reference for the clinical application of the decoction. In this study, a total of 43 pieces of effective data on relevant ancient literature, including 35 ancient TCM books, were collected based on a systematic collation of relevant historic and modern literature. Results showed that "Qingfeitang" was originated from the "Renshen Qingfeitang" recorded in the Taiping Holy Prescriptions for Universal Relief from the Qing dynasty. The name of "Qinfeitang" was first recorded in the Yeshi Luyanfang written by YE Dalian in the Song dynasty. We suggested the modern dosage and usage of Qingfeitang as follows: "Scutellariae Radix of 5.60 g, Platycodon grandiflora, Poria, Tangerine, Fritillaria, and Cortex Mori of 3.73 g respectively, Angelicae Sinensis Radix, Asparagi Radix, Gardeniae Fructus, Armeniacae Semen Amarum, and Ophiopogonis Radix of 2.61 g respectively, Schisandra of 1 g, and Glycyrrhizae Radix et Rhizoma of 1.12 g, and they were taken 3 times daily. The above formula is recommended to be decocted with 400 mL of water, with 3.37 g ginger and 6 g jujubae fructus, to 320 mL, and taken after a meal, three times per day". Qingfeitang has the effect of resolving phlegm to stop cough and producing fluid to moisten dryness, specialized in treating cough, asthma, rash, and other symptoms in ancient times. Modern applications are mainly focused on the respiratory system, used for treating diseases such as bronchopneumonia and cough. The above research results provide a reference basis for the later development and research of Qingfeitang.
8.Programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in patients with advanced non-small cell lung cancer: A retrospective, multicenter, observational study.
Yuequan SHI ; Xiaoyan LIU ; Anwen LIU ; Jian FANG ; Qingwei MENG ; Cuimin DING ; Bin AI ; Yangchun GU ; Cuiying ZHANG ; Chengzhi ZHOU ; Yan WANG ; Yongjie SHUI ; Siyuan YU ; Dongming ZHANG ; Jia LIU ; Haoran ZHANG ; Qing ZHOU ; Xiaoxing GAO ; Minjiang CHEN ; Jing ZHAO ; Wei ZHONG ; Yan XU ; Mengzhao WANG
Chinese Medical Journal 2025;138(14):1730-1740
BACKGROUND:
This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting.
METHODS:
This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate.
RESULTS:
A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs.
CONCLUSIONS
A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.
Humans
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Carcinoma, Non-Small-Cell Lung/metabolism*
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Male
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Female
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Retrospective Studies
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Middle Aged
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Lung Neoplasms/metabolism*
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Aged
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B7-H1 Antigen/metabolism*
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Programmed Cell Death 1 Receptor/metabolism*
;
Adult
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Aged, 80 and over
;
Immune Checkpoint Inhibitors/therapeutic use*
9.Associations between statins and all-cause mortality and cardiovascular events among peritoneal dialysis patients: A multi-center large-scale cohort study.
Shuang GAO ; Lei NAN ; Xinqiu LI ; Shaomei LI ; Huaying PEI ; Jinghong ZHAO ; Ying ZHANG ; Zibo XIONG ; Yumei LIAO ; Ying LI ; Qiongzhen LIN ; Wenbo HU ; Yulin LI ; Liping DUAN ; Zhaoxia ZHENG ; Gang FU ; Shanshan GUO ; Beiru ZHANG ; Rui YU ; Fuyun SUN ; Xiaoying MA ; Li HAO ; Guiling LIU ; Zhanzheng ZHAO ; Jing XIAO ; Yulan SHEN ; Yong ZHANG ; Xuanyi DU ; Tianrong JI ; Yingli YUE ; Shanshan CHEN ; Zhigang MA ; Yingping LI ; Li ZUO ; Huiping ZHAO ; Xianchao ZHANG ; Xuejian WANG ; Yirong LIU ; Xinying GAO ; Xiaoli CHEN ; Hongyi LI ; Shutong DU ; Cui ZHAO ; Zhonggao XU ; Li ZHANG ; Hongyu CHEN ; Li LI ; Lihua WANG ; Yan YAN ; Yingchun MA ; Yuanyuan WEI ; Jingwei ZHOU ; Yan LI ; Caili WANG ; Jie DONG
Chinese Medical Journal 2025;138(21):2856-2858
10.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
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
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Alzheimer Disease/drug therapy*
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Male
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Female
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Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People

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