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.Expert consensus on prognostic evaluation of cochlear implantation in hereditary hearing loss.
Xinyu SHI ; Xianbao CAO ; Renjie CHAI ; Suijun CHEN ; Juan FENG ; Ningyu FENG ; Xia GAO ; Lulu GUO ; Yuhe LIU ; Ling LU ; Lingyun MEI ; Xiaoyun QIAN ; Dongdong REN ; Haibo SHI ; Duoduo TAO ; Qin WANG ; Zhaoyan WANG ; Shuo WANG ; Wei WANG ; Ming XIA ; Hao XIONG ; Baicheng XU ; Kai XU ; Lei XU ; Hua YANG ; Jun YANG ; Pingli YANG ; Wei YUAN ; Dingjun ZHA ; Chunming ZHANG ; Hongzheng ZHANG ; Juan ZHANG ; Tianhong ZHANG ; Wenqi ZUO ; Wenyan LI ; Yongyi YUAN ; Jie ZHANG ; Yu ZHAO ; Fang ZHENG ; Yu SUN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(9):798-808
Hearing loss is the most prevalent disabling disease. Cochlear implantation(CI) serves as the primary intervention for severe to profound hearing loss. This consensus systematically explores the value of genetic diagnosis in the pre-operative assessment and efficacy prognosis for CI. Drawing upon domestic and international research and clinical experience, it proposes an evidence-based medicine three-tiered prognostic classification system(Favorable, Marginal, Poor). The consensus focuses on common hereditary non-syndromic hearing loss(such as that caused by mutations in genes like GJB2, SLC26A4, OTOF, LOXHD1) and syndromic hereditary hearing loss(such as Jervell & Lange-Nielsen syndrome and Waardenburg syndrome), which are closely associated with congenital hearing loss, analyzing the impact of their pathological mechanisms on CI outcomes. The consensus provides recommendations based on multiple round of expert discussion and voting. It emphasizes that genetic diagnosis can optimize patient selection, predict prognosis, guide post-operative rehabilitation, offer stratified management strategies for patients with different genotypes, and advance the application of precision medicine in the field of CI.
Humans
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Cochlear Implantation
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Prognosis
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Hearing Loss/surgery*
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Consensus
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Connexin 26
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Mutation
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Sulfate Transporters
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Connexins/genetics*
3.Study on optimum ventilation cross section of ultra-clean bench based on finite element simulation
Jing-Jing DU ; Si-Yuan YU ; Yun-Shuo YANG
Chinese Medical Equipment Journal 2024;45(2):28-34
Objective To explore the data on the optimum ventilation cross section for the ultra-clean bench with finite element simulation software to meet the requirements of experimental personnel in normal conditions.Methods Firstly,a finite element model for the vertical flow ultra-clean bench was constructed with SolidWorks software,then fluid dynamics simulation for the model was carried out with Flow Simulation software to analyze the gas flow rate,ventilation volume and ventilation interference of the cross section in case of different openings of the adjustable baffle(the distance of the lower edge of the baffle from the clean desktop),finally the suitable baffle openning was determined through comprehensive analysis.Results Simulation results showed that the gas flow rate and ventilation interfence decreased with the increase of th baffle openning,and the ventilation volume peaked when the baffle openning was 225 mm and had the average value being 376.002 m3/h.Conclusion The ventilation interference,gas flow rate and ventilation volume prove to have optimum results in case the baffle openning is 225 mm and the ventilation cross-sectional area is 0.248 m2.[Chinese Medical Equipment Journal,2024,45(2):28-34]
4.m1A inhibition fuels oncolytic virus-elicited antitumor immunity via downregulating MYC/PD-L1 signaling
Li SHUJIN ; Feng TIAN ; Liu YUANTONG ; Yang QICHAO ; Song AN ; Wang SHUO ; Xie JUN ; Zhang JUNJIE ; Yuan BIFENG ; Sun ZHIJUN
International Journal of Oral Science 2024;16(3):486-498
N1-methyladenosine(m1A)RNA methylation is critical for regulating mRNA translation;however,its role in the development,progression,and immunotherapy response of head and neck squamous cell carcinoma(HNSCC)remains largely unknown.Using Tgfbr1 and Pten conditional knockout(2cKO)mice,we found the neoplastic transformation of oral mucosa was accompanied by increased m1A modification levels.Analysis of m1A-associated genes identified TRMT61A as a key m1A writer linked to cancer progression and poor prognosis.Mechanistically,TRMT61A-mediated tRNA-m1A modification promotes MYC protein synthesis,upregulating programmed death-ligand 1(PD-L1)expression.Moreover,m1A modification levels were also elevated in tumors treated with oncolytic herpes simplex virus(oHSV),contributing to reactive PD-L1 upregulation.Therapeutic m1A inhibition sustained oHSV-induced antitumor immunity and reduced tumor growth,representing a promising strategy to alleviate resistance.These findings indicate that m1A inhibition can prevent immune escape after oHSV therapy by reducing PD-L1 expression,providing a mutually reinforcing combination immunotherapy approach.
5.Polysaccharides from Chinese herbal medicine: a review on the hepatoprotective and molecular mechanism.
Jifeng LI ; Haolin GUO ; Ying DONG ; Shuo YUAN ; Xiaotong WEI ; Yuxin ZHANG ; Lu DONG ; Fei WANG ; Ting BAI ; Yong YANG
Chinese Journal of Natural Medicines (English Ed.) 2024;22(1):4-14
Polysaccharides, predominantly extracted from traditional Chinese medicinal herbs such as Lycium barbarum, Angelica sinensis, Astragalus membranaceus, Dendrobium officinale, Ganoderma lucidum, and Poria cocos, represent principal bioactive constituents extensively utilized in Chinese medicine. These compounds have demonstrated significant anti-inflammatory capabilities, especially anti-liver injury activities, while exhibiting minimal adverse effects. This review summarized recent studies to elucidate the hepatoprotective efficacy and underlying molecular mechanisms of these herbal polysaccharides. It underscored the role of these polysaccharides in regulating hepatic function, enhancing immunological responses, and improving antioxidant capacities, thus contributing to the attenuation of hepatocyte apoptosis and liver protection. Analyses of molecular pathways in these studies revealed the intricate and indispensable functions of traditional Chinese herbal polysaccharides in liver injury management. Therefore, this review provides a thorough examination of the hepatoprotective attributes and molecular mechanisms of these medicinal polysaccharides, thereby offering valuable insights for the advancement of polysaccharide-based therapeutic research and their potential clinical applications in liver disease treatment.
Humans
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Drugs, Chinese Herbal/pharmacology*
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Liver Diseases/drug therapy*
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Antioxidants
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Polysaccharides/therapeutic use*
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Medicine, Chinese Traditional
6.Study on the impact of aging on the brain activity patterns in auditory speech comprehension dual-route regions
Yi LIU ; Younuo CHEN ; Songjian WANG ; Liu YANG ; Yuan WANG ; Shuo WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(9):909-915
Objective:To elucidate the patterns of neural activity alterations associated with auditory speech comprehension across the lifespan and the impact of varying listening environments on these dynamics.Methods:Functional near-infrared spectroscopy (fNIRS) was employed to measure the concentration of oxygenated hemoglobin in the brains of 93 adults aged from 20 to 70 with normal hearing. These participants were recruited from Beijing Tongren Hospital, affiliated with Capital Medical University, between March 2021 and February 2023. Brain activity was recorded as subjects passively listened to sentences in both silent and noise conditions with varying signal-to-noise ratios (SNR). The alterations in brain activity were analyzed to delineate the age-related trends under different auditory conditions. Statistical analysis was performed using SPSS 22.0 software.Results:The bilateral primary auditory cortex, superior temporal gyrus, and Wernicke′s area, critical for sound signal discrimination and perception, exhibited enhanced activity post-stimulus presentation. Broca′s area, pivotal for speech production, demonstrated an initial decrease in activity followed by an increment after stimulus onset. The ventral middle temporal gyrus and dorsal postcentral gyrus showed augmented activity in later time windows. Furthermore, it was observed that in quiet conditions and at low noise levels (SNR=10 dB), auditory cortical activity diminished with age. With increasing noise levels (SNR=5 dB), compensatory brain regions (right ventral middle temporal gyrus and dorsal postcentral gyrus) showed enhanced activity with advancing age. As noise intensity further escalated (SNR=0, SNR=-5 dB), not only did auditory cortical activity decline, but also the activity in regions associated with semantic processing and motor functions reduced with age.Conclusion:During auditory speech comprehension, dual-pathway brain regions exhibit distinct activity patterns. With heightened noise exposure, an increasing number of brain regions are influenced by aging, manifesting as a general decline in activity in most dual-pathway regions, alongside a selective augmentation in some compensatory regions on the right hemisphere.
7.The clinical efficacy of Da Vinci robot versus video-assisted thoracoscopic surgery in the treatment of posterior mediastinal tumors: A retrospective cohort study
Feng WANG ; Yuhang YUAN ; Chenhan WANG ; Wenteng HU ; Li HE ; Wenwen YANG ; Shuo SUN ; Min ZHANG ; Biao HAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(05):695-701
Objective To compare the short-term clinical effects of Da Vinci robot-assisted thoracic surgery (RATS) and video-assisted thoracoscopic surgery (VATS) in the treatment of posterior mediastinal tumors, and to explore the advantages of RATS posterior mediastinal tumor resection. Methods The clinical data of patients who underwent posterior mediastinal tumors resection through the lateral chest approach admitted to the same medical group in the Department of Thoracic Surgery of the First Hospital of Lanzhou University between January 2019 to January 2023 were retrospectively analyzed. According to the different surgical methods, the patients were divided into a RATS group and a VATS group. The clinical data were compared between the two groups. Results A total of 85 patients were included in this study. There were 39 patients in the RATS group, including 25 females and 14 males, with an average age of 47.6±13.0 years, and 46 patients in the VATS group, including 14 males and 32 females, with an average age of 45.3±14.7 years. All patients completed the operation successfully. The hospitalization cost in the RATS group was significantly higher than that in the VATS group (P<0.001), and the white blood cell count and neutrophilic granulocyte percentage on the first day after operation in the RATS group were lower than those in the VATS group, and the differences were statistically significant (P<0.05). The operative time, intraoperative bleeding, postoperative hospital stay, white blood cell count and neutrophil percentage on the third postoperative day, visual analogue scale score on the first and third postoperative days, duration of analgesic pump use, postoperative 12 h oxygen saturation (no oxygen inhalation), postoperative down bed time, total thoracic drainage volume, duration of drainage tube retention, and postoperative complication rates were not statistically different between the two groups (P>0.05). There was no perioperative death, conversion to thoracotomy or serious perioperative complications in both groups. Conclusion RATS resection of posterior mediastinal tumor via lateral thoracic approach is safe and feasible, and its short-term effect is similar to that of VATS via lateral thoracic single-hole approach. It is worth further comparative study to explore its benefit and cost performance.
8.Advances in preoperative predictive indicators for microvascular invasion in hepatocellular carcinoma
Siqiao SHAN ; Siyuan WANG ; Dongliang YANG ; Nan JIANG ; Mingyu LIN ; Tao ZHANG ; Xueli YUAN ; Shuo JIN ; Jianping ZENG
Chinese Journal of Hepatobiliary Surgery 2024;30(9):705-709
Hepatocellular carcinoma (HCC) is characterized by high postoperative recurrence and mortality rates. In recent years, researchers have identified a significant correlation between microvascular invasion (MVI) and early postoperative recurrence and metastasis of HCC, making it a focal point of HCC research. Accurate preoperative prediction of MVI occurrence and the implementation of relevant interventions (such as expanded resection) could provide substantial benefits to patients. This study analyzes global research over the past decade on MVI predictive indicators based on tumor biological characteristics, genetic measurements, imaging examinations, and tumor markers. The aim is to use these predictive indicators to objectively forecast the occurrence of MVI, thereby aiding in preoperative individual assessments and enhancing treatment plans.
9.Simultaneous content determination of fifteen constituents in Binglang Sixiao Pills by HPLC
Yuan WANG ; Yuan-Shuo YANG ; Si-Zhi LI ; Jia-Meng ZHAO
Chinese Traditional Patent Medicine 2024;46(8):2493-2498
AIM To establish an HPLC method for the simultaneous content determination of gallic acid,catechin,epicatechin,rhein 8-O-β-D-glucoside,chlorogenic acid,chrysophanol 8-O-β-D-glucoside,emodin-8-O-β-D-glucoside,emodin-3-methyl ether-8-O-β-D-glucoside,aloe emodin,rhein,cyperotundone,luteolin,α-cyperone,emodin,chrysophanol and emodin-3-methyl ether in Binglang Sixiao Pills.METHODS The analysis was performed on a 30℃thermostatic Kromasil C18 column(250 mm×4.6 mm,5 μm),with the mobile phase comprising of methanol-0.1%formic acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 260 nm.Subsequently,cluster analysis and principal component analysis were made.RESULTS Fifteen constituents showed good linear relationships within their own ranges(r>0.999 0),whose average recoveries were 96.00%-101.00%%with the RSDs of 0.50%-1.50%.Various batches of samples were clustered into two categories,and four principal components demonstrated the accumulative variance contribution rate of 90.004%.CONCLUSION This simple,accurate and reproducible method can be used for the quality control of Binglang Sixiao Pills.
10.Left Atrial Myocardial Fibrosis Assessment by 3D High-resolution Late Gadolinium Enhancement MRI in Patients With Atrial Fibrillation:a Feasibility Study
Leyi ZHU ; Shuo YUAN ; Yining WANG ; Kang AN ; Wenjing YANG ; Haojie LI ; Gang YIN ; Shihua ZHAO ; Minjie LU ; Zhe ZHENG
Chinese Circulation Journal 2024;39(7):703-709
Objectives:To investigate the clinical feasibility of three-dimensional(3D)high-resolution late gadolinium enhancement(LGE)MRI in accessing left atrial myocardial fibrosis in patients with atrial fibrillation(AF). Methods:A total of 34 AF patients referred for hybrid surgical ablation were retrospectively enrolled in this study.3D-LGE-MRI images were acquired by Siemens 3.0 T machine and analyzed by ADAS post-processing software by two experienced radiologists to obtain parameters such as the area and the area percentage of LGE.Regional analysis was performed by one of the two radiologists at ten left atrial segments.The Kappa test was used to assess the agreement for scoring image quality,and the interclass correlation coefficient(ICC)was used to evaluate the interobserver agreement of LGE parameters.The parameters of left atrial morphology,area(and area percentage)of LGE,and location of LGE were compared between patients with persistent AF and paroxysmal AF. Results:Images of all 34 patients were considered to have diagnostic value.The scores of the overall image quality and the clarity of the left atrial wall evaluated by two radiologists were(2.88±0.64)points and(3.26±0.75)points(radiologist 1),(2.97±0.58)points and(3.24±0.70)points(radiologist 2),respectively.The corresponding Kappa values were 0.724 and 0.859.Both the area and the area percentage of LGE showed good consistency among observers,and the ICCs were 0.969 and 0.950,respectively.The difference in the area of LGE and the area percentage of LGE between patients with paroxysmal and persistent atrial fibrillation was similar(both P>0.05).Compared with patients with paroxysmal AF,patients with persistent AF had a higher Utah stage and more severe myocardial fibrosis in the right inferior pulmonary vein antrum and the left atrial septum(all P<0.05). Conclusions:3D high-resolution LGE-MRI provides a non-invasive way to visualize and quantify left atrial myocardial fibrosis.The extent of left atrial fibrosis in patients with persistent AF is more severe than that in patients with paroxysmal AF,with a preferential distribution in the right inferior pulmonary vein antrum and the left atrial septum.

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