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*
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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
2.Pathologic Diagnosis of a Pituicytoma in a Han-Wistar Rat
Minbo HOU ; Tiantian CUI ; Naying SU ; Miaomiao ZHANG ; Yongmin JIAO ; Jianyan YAN ; Xijie WANG ; Ohira TOKO
Laboratory Animal and Comparative Medicine 2023;43(6):654-658
A case of pituicytoma was observed in a Han-Wistar rat from the control group of a 2-year carcinogenicity study. No obvious abnormality were found in clinical observation and necropsy. Hematoxylin and Eosin (HE) staining results showed that nodular hyperplasia in the pars nervosa of the pituitary, which was well demarcated and compressed the adjacent normal tissue. The tumor cells were similar to the glial cells with round or oval nuclei, cytoplasm rich in eosinophilic or vacuole. The tumor cells differentiated well, with no obvious cell pleomorphism and visible mitotic figures. Some tumor cells were arranged in a pseudorosette formation. Immunohistochemical staining (IHC) analysis confirmed positive expression of Glial fibrillary acidic protein (GFAP) and S-100 protein. The tumor was diagnosed as the spontaneous benign pituicytoma combining the HE and IHC staining results.
3.α-amylase detection methods and applications.
Chinese Journal of Biotechnology 2023;39(3):898-911
α-amylase is an endonucleoside hydrolase that hydrolyzes the α-1, 4-glycosidic bonds inside polysaccharides, such as starch, to generate oligosaccharides, dextrins, maltotriose, maltose and a small amount of glucose. Due to the importance of α-amylase in food industry, human health monitoring and pharmaceuticals, detection of its activity is widely required in the breeding of α-amylase producing strains, in vitro diagnosis, development of diabetes drugs, and the control of food quality. In recent years, many new α-amylase detection methods have been developed with improved speed and sensitivity. This review summarized recent processes in the development and applications of new α-amylase detection methods. The major principle of these detection methods were introduced, and their advantages and disadvantages were compared to facilitate future development and applications of α-amylase detection methods.
Humans
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alpha-Amylases/chemistry*
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Polysaccharides
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Oligosaccharides
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Starch
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Maltose
4. Effectiveness of eradication regimen based on the bacterial susceptibility and CYP2C19 genotype in children with refractory Helicobacter pylori infection
Yuanda ZHANG ; Qingwei DONG ; Shaohui ZHANG ; Fang GU ; Yu ZHANG ; Haobin SONG ; Naying ZUO ; Sisi ZHANG ; Lei MA ; Zhaolu DING
Chinese Journal of Pediatrics 2020;58(1):41-45
Objective:
To evaluate the effectiveness of eradication therapy based on
5.Interhemispheric functional connectivity changes in early Parkinson disease with the symptom asymmetry
Naying HE ; Huawei LING ; Kemin CHEN ; Yong ZHANG ; Bei DING ; Juan HUANG ; Fuhua YAN
Chinese Journal of Radiology 2014;48(8):621-626
Objective To investigate changes of the interhemispheric coordination integrity in patients with hemi-parkinsonism using resting-state functional magnetic resonance imaging(rs-fMRI) homotopy technique called voxel-mirrored homotopic connectivity(VMHC).Methods Sixteen Parkinson disease(PD) patients with right body side motor symptom onset(RPD),15 patients with left side onset(LPD),and 19 age-,gender-,and education-matched healthy controls(HC) were included in this study.rs-fMRI scanning and pre-processed the raw data were performed.Then by using analysis of variance(ANOVA) and two sample t tset,we performed VMHC analyses on rs-fMRI data of these participants(P<0.05,corrected with AlphaSim,clusters≥16 voxels).Exploratory linear correlations analyses were performed between the VMHC of regions showing significant group differences and the clinical features of LPD or RPD patients.Results Compared with HCs,patients with LPD had significantly reduced VMHC in visual regions,sensorimotor regions,and the cerebellar cortex(voxels size of 17-77,t=-5.06--3.42,P<0.05).Patients with RPD exhibited decreased VMHC in the prefrontal cortex and sensorimotor regions.Both LPD and RPD groups had increased VMHC in subcortical regions.When compared with the RPD group,the LPD group displayed decreased VMHC in the visual regions,sensorimotor regions(voxels=16 and 18; t=-3.68and-3.87,respectively,both P<0.05) and increased VMHC in the supramarginal gyrus(voxels=4,t=4.72,P<0.05);ROI-based correlation analyses indicated that the VMHC in the inferior occipital gyrus and the postcentral gyrus was negatively correlated with the BDI-Ⅱ scores in the LPD group(r=-0.58 and-0.59,respectively; both P<0.05),and positively correlated with the MMSE scores(r=0.56 and 0.52,respectively;both P<0.05).In the RPD group,a positive correlation was found for the VMHC in the supramarginal gyrus and the illness duration(r=0.56,P<0.05) and for the VMHC in the postcentral gyrus and the(mini-mental state exam) MMSE(r=0.53,P<0.05).Conclusions The differential pattern of deficits in the interhemispheric coordination integrity in hemi-parkinsonism reflected by VMHC may provide insights into the neurological pathophysiology underlying the asymmetry of symptom appearance in PD.

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