1.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*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Cognitive Dysfunction/drug therapy*
;
Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
;
East Asian People
2.Transesophageal echocardiography assessment of mitral valve for patients with atrial septal defects undergoing surgical repair.
Yuxi LI ; Xin MENG ; Wei BAI ; Liang CAO ; Guomeng JIANG ; Jianlong YANG ; Xuezeng XU ; Liwen LIU
Journal of Zhejiang University. Medical sciences 2025;54(2):191-198
OBJECTIVES:
To investigate the application of transesophageal echocar-diography assessment for mitral valve in patients with atrial septal defects undergoing repair surgery.
METHODS:
The study group comprised of thirty-two adult patients with atrial septal defect who underwent thoracoscopic repair surgery at the First Affiliated Hospital of the Air Force Medical University from March to September 2022. Two-dimensional and real-time three-dimensional transesophageal ultrasonography of the mitral valve were performed after anesthesia. The parameters of the mitral valve structure at the late diastolic and late systolic stages were recorded, including anteroposterior and left-right annular diameters, anterior and posterior valves lengths, the vertical distance from the coaptation point of leaflet zone 2 during systole to the annular plane (mitral valve coaptation depth) and mitral valve coaptation length. Data from 32 patients with normal intracardiac structure and no mitral valve regurgitation (control group) were also collected and compared with those of the study group. Concurrent mitral valvoplasty was performed during the atrial septal defect repair surgery for 7 patients with significant mitral valve structural abnormalities and 2 patients with significantly increased mitral regurgitation after cardiac resuscitation. The study group was followed up with transthoracic echocardiography for 2 years postoperatively.
RESULTS:
In the study group, 26 (81.3%) patients had varying degrees of mitral valve morphological abnormalities. Among them, 10 (31.3%) patients had short mitral valve coaptation length or depth, 12 (37.5%) patients had closure point malposition, and 4 (12.5%) patients had different bulge of anterior and posterior leaflets. Compared with the control group, the study group had significantly smaller systolic and diastolic mitral left-right annular diameter, mitral posterior valves lengths, mitral coaptation length or depth (all P<0.05), a higher pulmonary systemic flow ratio (P<0.01), and a lower maximum blood flow velocity across the mitral valve (P<0.05). After 2 years of follow-up, among the 9 patients who underwent concurrent mitral valvoplasty, the mitral valve maintained no or little regurgitation, and the average mitral valve pressure difference was less than 5 mmHg (1 mmHg=0.133 kPa). Among the 23 patients without concurrent mitral valvoplasty, 2 patients had moderate regurgitation 1 year after surgery, with a pulmonary/systemic flow ratio larger than 2.8.
CONCLUSIONS
Patients with large atrial septal defects often have abnormal mitral valve structure. Therefore transesophageal echocardiography is recommended for mitral valve assessment during the surgery. If significant mitral valve structural abnormalities are detected, concurrent mitral valvoplasty is recommended.
Humans
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Heart Septal Defects, Atrial/diagnostic imaging*
;
Echocardiography, Transesophageal/methods*
;
Mitral Valve/surgery*
;
Adult
;
Female
;
Male
;
Middle Aged
;
Mitral Valve Insufficiency/diagnostic imaging*
3.A cisplatin prodrug-based self-assembling ozone delivery nanosystem sensitizes radiotherapy in triple-negative breast cancer.
Tianyue XU ; Dan ZHENG ; Meixu CHEN ; Linlin SONG ; Zhihui LIU ; Yan CHENG ; Yujie ZHAO ; Liwen HUANG ; Yixuan LI ; Zhankun YANG ; Cong LI ; Biao DONG ; Jing JING ; Hubing SHI
Acta Pharmaceutica Sinica B 2025;15(5):2703-2722
Lacking therapeutic targets highlights the crucial roles of chemotherapy and radiotherapy in the clinical management of triple-negative breast cancer (TNBC). To relieve the side effects of the chemoradiotherapy combination regimen, we design and develop a self-assembled micelle nanosystem consisting of perfluorocarbon chain-modified cisplatin prodrug. By incorporating perfluorodecalin, this nanosystem can effectively carry ozone and promote irradiation-derived reactive oxygen species (ROS) production. By leveraging the perfluorocarbon sidechain, the nanosystem exhibits efficient internalization by TNBC cells and effectively escapes from lysosomal entrapment. Under X-ray irradiation, ozone-generated ROS disrupts the intracellular redox balance, thereby facilitating the release of cisplatin in a reduction-responsive manner mediated by reduced glutathione. Moreover, oxygen derived from ozone decomposition enhances the efficacy of radiotherapy by alleviating tumor hypoxia. Notably, the combination of irradiation with ozone-loaded cisplatin prodrug nano system synergistically prompts antitumor efficacy and reduces cellular/systemic toxicity in vitro and in vivo. Furthermore, the combo regimen remodels the tumor microenvironment into an immune-favored state by triggering immunogenic cell death and relieving hypoxia, which provides a promising foundation for a combination regimen of immunotherapy. In conclusion, our nanosystem presents a novel strategy for integrating chemotherapy and radiotherapy to optimize the efficacy and safety of TNBC clinical treatment.
4.Puerarin alleviates rheumatoid arthritis in rats by modulating TAK1-mediated TLR4/NF-κB signaling pathway.
Maiyuan XU ; Ni LI ; Jiayi LI ; Tao ZHANG ; Liwen MA ; Tao LIN ; Haonan YU ; Ning WU ; Zunqiu WU ; Li HUANG
Journal of Southern Medical University 2025;45(10):2231-2239
OBJECTIVES:
To explore the therapeutic mechanism of puerarin for alleviating synovitis in rats with collagen-induced arthritis (CIA).
METHODS:
In a SD rat model of CIA, we tested the effects of daily gavage of puerarin at low, moderate and high doses (10, 30, and 100 mg/kg, respectively) for 3 weeks, with tripterygium glycosides (GTW, 10 mg/kg) as the positive control, on swelling in the hind limb joints regions evaluated by arthritis index scoring. Mass fraction of the liver of the rats was calculated, and pathologies in joint synovial membrane were observed with HE staining. The expressions of transforming growth factor β‑activated kinase-1 (TAK1), Toll-like receptor 4 (TLR4), and nuclear factor kappa-Bp65 (NF‑κB p65) at the mRNA and protein levels in the synovial tissues were detected using Real-time PCR and Western blotting.
RESULTS:
Compared with those in the model group, the rats in GTW group and high-dose puerarin group showed significantly reduced mass fraction of the liver. Treatment with GTW and puerarin at the 3 doses all significantly alleviated plantar swelling, lowered arthritis index scores, and improved synovitis in CIA rats (P<0.05), and the effects of puerarin showed an obvious dose dependence. Both GTW and puerarin treatments significantly lowered TAK1, TLR4, and NF‑κB p65 mRNA and protein expressions in the synovium of CIA rats.
CONCLUSIONS
Puerarin alleviates synovium damages in CIA rats possibly by suppressing the TLR4/NF‑κB signaling pathway via downregulating TAK1 expression.
Animals
;
Toll-Like Receptor 4/metabolism*
;
Rats, Sprague-Dawley
;
Rats
;
MAP Kinase Kinase Kinases/metabolism*
;
Signal Transduction/drug effects*
;
Arthritis, Rheumatoid/drug therapy*
;
NF-kappa B/metabolism*
;
Isoflavones/therapeutic use*
;
Male
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Arthritis, Experimental/drug therapy*
;
Transcription Factor RelA/metabolism*
;
Synovial Membrane/metabolism*
5.Investigation and determination of relative correction factor of pre-vitamin D
Jieming SHI ; Cheng WANG ; Liwen ZHANG ; Shunling DONG ; Jian LE ; Song YUAN ; Yihong LU ; Dandan WANG ; Wankui XU ; Shufeng ZHENG
Drug Standards of China 2024;25(2):147-153
Objective:To determine the relative correction factor of pre-vitamin D and simplify the calculation method of vitamin D assay.Methods:By studying the calculation method of vitamin D content in drug standards of various countries,HPLC was used to determine the relative correction factor of pre-vitamin D,and the influencing factors of determination were investigated.Results:The relative correction factors of pre-vitamin D at 254 nm and 265nm wavelength were determined by statistical analysis of 7 laboratories in China.Conclusion:Using the pre-vi-tamin D relative correction factor method to calculate the total amount of vitamin D simplified the experimental steps can be simplified by the pre-vitamin D relative correction factor method to calculate the total amount of vitamin D and the random operating errors can be avoided.The method is rapid and accurate,and lay a solid foundation for further improving the standard of vitamin D preparations.
6.Research progress on difficulties of bladder cancer treatment based on tumor-associated macrophages
Jun'an QIAN ; Liwen LUO ; Qiming XU ; Kai DENG ; Chunhui WANG
Chongqing Medicine 2024;53(17):2682-2686
Bladder cancer ranks 12th in the statistical spectrum of death from malignant tumor pa-tients,its incidence rate is high,the patients population is showing a trend of youthfulness,moreover it is easy to develop metastasis and recurrence.In recent years,the immunotherapy has been gradually promoted in the patients with advanced bladder cancer who cannot receive the cisplatin chemotherapy or who are resistant to chemotherapy,in particular,the immune checkpoint inhibitors(ICIs)represented by programmed cell cleath-1(PD-1)/programmed cell cleath-ligand 1(PD-L1)are dominant,although ICIs represented by PD-1/PD-L1 has achieved good efficacy in immunotherapy.However,due to the increase in immune escape events,only a-bout 30%of patients benefit from immunotherapy.Therefore,there is an urgent need to develop the treatment regimen for the patients with bladder cancer immune escape.Recently,the tumor microenvironment(TME)has become a research hotspot,especially the immunosuppressive cells in TME.There are 5 types of cells with immunosuppressive function in TME:tumor-associated macrophages(TAMs),regulatory T cells(Tregs),bone marrow-derived suppressor cells(MDSCs),tumor-associated central granulocytes(MDSCs)and tumor-associated fibroblasts(CAFs),which play an important role in tumor immune escape.This paper elaborated the composition and function of TAMs in TME and prospects the tumor promoting mechanism of bladder cancer TAMs and targeted treatment of bladder cancer TAMs.
8.Different Characteristics of Psychological and Sleep Symptoms Across Social Media Addiction and Internet Gaming Disorder in Chinese Adolescents- A Network Analysis
Wanling ZHANG ; Liwen JIANG ; Minglan YU ; Rong MA ; Tingting WANG ; Xuemei LIANG ; Rongfang HE ; Chun XU ; Shasha HU ; Youguo TAN ; Kezhi LIU ; Bo XIANG
Psychiatry Investigation 2024;21(7):782-791
Objective:
Previous research has explored a variety of mental disorders associated with Internet Gaming Disoder (IGD) and Social Media Addiction (SMA). To date, few studies focused on the network characteristics and investigated mood and sleep symptoms across SMA and IGD of adolescence at a group-specific level. This study aims to identify different characteristics of IGD and SMA and further determine the group-specific psychopathology process among adolescents.
Methods:
We conducted a cross-sectional study to recruit a cohort of 7,246 adolescents who were scored passing the cutoff point of Internet Gaming Disorder Scale-Short Form and Bergen Social Media Addiction Scale, as grouped in IGD and SMA, or otherwise into the control group. Patient Health Questionnaire-9, Generalized Anxiety Disorder 7-item, and Pittsburgh Sleep Quality Index were assessed for the current study, and all assessed items were investigated using network analysis.
Results:
Based on the analytical procedure, the participants were divided into three groups, the IGD group (n=789), SMA group (n=713) and control group (n=5,744). The edge weight bootstrapping analysis shows that different groups of networks reach certain accuracy, and the network structures of the three groups are statistically different (pcontrol-IGD=0.004, pcontrol-SMA<0.001, pIGD-SMA<0.001). The core symptom of SMA is “feeling down, depressed, or hopeless”, while IGD is “feeling tired or having little energy”.
Conclusion
Although IGD and SMA are both subtypes of internet addiction, the psychopathology processes of IGD and SMA are different. When dealing with IGD and SMA, different symptoms should be addressed.
9.Effect of immersive virtual reality training combined with occupational therapy in treatment of stroke patients with unilateral neglect
Jing YUAN ; Nian WANG ; Hua LIN ; Zhilan LIU ; Guo LI ; Wei CHENG ; Liwen QIU ; Bing XU
Journal of Clinical Medicine in Practice 2024;28(2):18-22
Objective To observe the effect of immersion virtual reality (IVR) training combined with occupational therapy (OT) in the treatment of stroke patients with unilateral neglect. Methods Fifty stroke patients with unilateral neglect in Shanghai Fourth Rehabilitation Hospital were randomly divided into IVR plus OT group and OT group, with 25 cases in each group. The OT group received conventional OT for unilateral neglect, and the IVR plus OT group received IVR training and OT. Both groups were treated for 4 weeks. Before and after treatment, the Catherine Bergego Scale (CBS), line cancellation test, star cancellation test, and drawing clock test were used to evaluate unilateral neglect symptoms; the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Barthel index (BI) were used to evaluate motor function of upper extremity and activities of daily living. Results After treatment, the results of CBS, line cancellation test, star cancellation test, drawing clock test, FMA-UE and BI scores were significantly improved when compared with those before treatment in both groups, and the improvement effects in the IVR plus OT group were significantly better than those in the OT group (
10.Analysis and prevention of heat-related diseases in beach volleyball events of the 19th Hangzhou Asian Games
Liwen DU ; Xueqi ZHU ; Qi ZHENG ; Leiyun SHI ; Yizhi CHEN ; Hongyun DING ; Jianwei XU ; Yunfeng CHEN ; Aichun ZHU ; Changlu LI
Chinese Journal of Emergency Medicine 2023;32(12):1645-1649
Objective:To analyze the occurrence characteristics of heat-related diseases in the 19th Hangzhou Asian Games beach volleyball events, strengthen the ability of prevention and early identification of heat-related diseases, and provide reference for the holding of large-scale outdoor events in summer and reasonable allocation of medical resources.Methods:The medical insurance of heat-related diseases of relevant personnel in the beach volleyball competition from September 19 to September 28, 2023 was retrospectively analyzed, and the incidence of heat-related diseases in the personnel involved in Asia was analyzed.Results:During the beach volleyball competition in Ningbo Region of the Hangzhou Asian Games, a total of 103 people were provided with health services in the medical service field (61 people had mild discomfort due to excessive outdoor temperature; Other cold, minor injury, bandage 42 people); Medical services provided 44 times (4 referrals). Among them, 11 cases were sports injury and trauma (29.5%), 11 cases were heat stroke and other related symptoms (25%), 6 cases were sunburn (13.6%), 10 cases were oral diseases of five senses (22.8%), 4 cases were upper respiratory tract infection (9.1%).Conclusions:The holding of large-scale outdoor events in summer should focus on heat-related diseases, and it is necessary to effectively do the corresponding planning work in advance in terms of reasonable allocation of medical resources and targeted training of professionals.


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