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
;
Connexins/genetics*
3.Analysis of influencing factors of post-traumatic stress disorder in hospitalized patients with placenta previa
Tingting LI ; Lingyun PENG ; Tong FANG
Journal of Shenyang Medical College 2024;26(1):63-67
Objective:To investigate the influencing factors of post-traumatic stress disorder(PTSD)in hospitalized patients with placenta previa.Methods:A total of 110 hospitalized patients with placenta previa admitted to our hospital from Oct 2019 to Jan 2023 were selected,and the occurrence of PTSD during hospitalization was evaluated by using Post-Traumatic Stress Disorder Checklist-Civilian Version(PCL-C),and relevant data were collected.Multivariable logistic regression analysis was used to analyze the influencing factors of PTSD in these patients.Results:Among 110 patients,41 cases developed PTSD(37.27% ).Univariable analysis showed that the type of pregnant women(primigravida),optimistic tendency,family support,psychological resilience and personality traits were associated with PTSD in hospitalized patients with placenta previa(P<0.05).Other information such as age,gestational age,parity,unplanned pregnancy and education level were not associated with PTSD(P>0.05).Multivariable logistic regression analysis showed that primiparas and introversion were risk factors for PTSD(OR>1,P<0.05),and higher optimism tendency,higher degree of family support and higher psychological resilience were protective factors for PTSD in hospitalized patients with placenta previa(OR<1,P<0.05).Conclusions:The incidence of PTSD is higher in hospitalized patients with placenta previa.The risk factors of PTSD are primiparas,low level of optimistic tendency,low degree of family support,low psychological resilience and introversion.
4.Research progress in the performance of clear aligner attachment materials
Lingyun CAO ; Jiarong YAN ; Fang HUA ; Hong HE
Chinese Journal of Stomatology 2024;59(1):105-109
For most patients undergoing clear aligner treatment, it could be necessary to bond multiple attachments on their tooth surfaces. The clear aligner attachment is designed to enhance aligner retention, transmit orthodontic forces, and make the programmed tooth movement more predictable. Materials such as restorative resin, orthodontic bonding adhesive, flowable resin, and resin-modified glass ionomer cement are currently used for attachment bonding. But there is currently no conclusion as to which material suits most. The objective of this review is to look into the studies published in recent years, in order to explore the optimal material option for making clear aligner attachments.
5.Effects of moxibustion on CD4+T-cell proliferation by G6PD-mediated pentose phosphate pathway in adjuvant arthritis rats
Liang ZHANG ; Lingyun ZHAO ; Yiying LONG ; Jianan CAO ; Qirui QU ; Qingze WU ; Li LIU ; Xiaorong CHANG ; Kun AI ; Fang QI ; Yanping YANG
Journal of Acupuncture and Tuina Science 2024;22(4):273-279
Objective:To observe the effects of moxibustion on the levels of glucose-6-phosphate dehydrogenase(G6PD)and reduced nicotinamide adenine dinucleotide phosphate(NADPH)in the plasma and spleen and the CD4+T-cell number in the spleen of rats with adjuvant arthritis,thus to explore the mechanism in rheumatoid arthritis(RA)treatment with moxibustion by regulating the CD4+T-cell proliferation through G6PD-mediated pentose phosphate pathway. Methods:Twenty-seven male Sprague-Dawley rats were randomly divided into a blank group,a model group,and a moxibustion group,with 9 rats in each group.Incomplete Freund's adjuvant was used to induce inflammation in the model group and the moxibustion group.The blank group and the model group were not intervened.In the moxibustion group,suspended moxibustion was performed at bilateral Zusanli(ST36),Guanyuan(CV4),and Ashi points for 30 min,once a day for 24 times in total.Hematoxylin-eosin staining was used to evaluate the histopathological changes of rat synovial tissue;the swelling degree of the rat toes was observed by measuring the toe volume;G6PD and NADPH in the spleen and plasma were detected by Western blotting and enzyme-linked immunosorbent assay.Flow cytometry was used to detect the CD4+T-cell number in the spleen. Results:Compared with the blank group,the levels of G6PD and NADPH in the plasma and spleen and the CD4+T-cell number in the spleen were significantly increased in the model group(P<0.01 or P<0.05).Compared with the model group,the NADPH level in the spleen and plasma and the CD4+T-cell number in the spleen in the moxibustion group decreased significantly(P<0.05 or P<0.01),and the G6PD level in the plasma decreased significantly(P<0.05),but there was no significant difference in the G6PD level in the spleen(P>0.05). Conclusion:Moxibustion can regulate immunity and improve joint synovial inflammation in RA.The mechanism may be that the G6PD-mediated pentose phosphate pathway reduces the production of metabolite NAPDH in CD4+T cells,thereby inhibiting the proliferation of naive CD4+T cells.
6.Short-term clinical and echocardiographic outcomes of the novel domestic transcatheter edge-to-edge repair Neonova? system in patients with mitral regurgitation
Yun YANG ; He LI ; Wenqian WU ; Xiaoke SHANG ; Shu CHEN ; Yucheng ZHONG ; Manwei LIU ; Lin HE ; Zhenxing SUN ; Ziming ZHANG ; Yi ZHOU ; Xin ZHANG ; Nianguo DONG ; Lingyun FANG ; Mingxing XIE
Chinese Journal of Ultrasonography 2023;32(1):51-59
Objective:To investigate short-term safety, efficacy and the learning curve of this self-developed novel transcatheter valve repair system (Neonova?) in patients with mitral regurgitation, and explore the role of perioperative echocardiography.Methods:Ten patients who visited the Union Hospital of Tongji Medical College, Huazhong University of Science and Technology from June 2021 to March 2022 and met the inclusive criteria were prospectively enrolled. All the patients were at high risk of surgery with moderate to severe or severe mitral regurgitation (MR). Clamps of Neonova? were implanted under guidance of transesophageal echocardiography and digital subtraction angiography. Clinical outcomes, echocardiography indexes and learning curves of this technique were evaluated immediately after intervention, 7 d, 1 month and 3 months post-intervention.Results:The technical success rate was 100% with MR relieved in all patients immediately after intervention. The device and procedural success rates were both 90.0% with 1 patient received surgical replacement at 37 days post-intervention while the others′ reduced to mild (8/9) and moderate (1/9) MR. New York Heart Association class and the Kansas City Cardiomyopathy Questionnaire improved significantly (all P<0.001). Mean mitral valve pressure gradient didn′t increase significantly after intervention when compared with that before intervention( P=0.324), and no mitral stenosis was observed. Left ventricular end-diastolic diameter decreased significantly ( P=0.008) during follow up.Procedure duration ranged from 60 to 300 (175.8±75.2)minutes. The simple linear regression model between procedure volume and duration showed that procedure duration decreased significantly with the increase of procedure volume ( F=15.857, P=0.004). Conclusions:Neonova? implantation can improve MR severity and clinical symptoms safely and effectively. Transthoracic echocardiography and transesophageal echocardiography are essential for perioperative management of transcatheter mitral valve repair.
7.Research progress on e cigarette use among adolescents and associated factors
DENG Hui, ZHANG Lingyun, FANG Ling, YAN Xiaotao, ZHENG Pinpin
Chinese Journal of School Health 2023;44(5):791-795
Abstract
E cigarette has become more and more popular among adolescents, and the awareness and use of e cigarettes among middle and high school students have shown a significant upward trend. E cigarette use is not only harmful to adolescent health, but also may become a gateway to other addictive substances. Individual characteristics, products features, environment and other factors were associated with e cigarette use among adolescents. The purpose of the review is to understand the current status and associated factors of adolescent e cigarette use, so as to provide scientific suggestions for the prevention of e cigarette use among adolescents.
8.Research progress on the application of deep learning in cephalometric analysis
CAO Lingyun ; YAN Jiarong ; TANG Bojun ; ZHAO Tingting ; HUA Fang ; HE Hong
Journal of Prevention and Treatment for Stomatological Diseases 2023;31(1):58-62
In orthodontic and orthognathic practice, cephalometric analysis is an integral tool throughout the clinical process. However, as landmark identification is still unautomated, both the conventional and semiautomated approaches are open to considerable subjectivity and could be time-consuming for inexperienced clinicians. Deep learning (DL), a state-of-the-art artificial intelligence (AI) technique, is highly effective in image recognition. In recent years, many studies have focused on the application of DL in cephalometric analysis, including automated landmark detection, automated diagnosis, cervical vertebral maturation stage determination, adenoid hypertrophy analysis and upper airway identification. Studies show that DL can effectively improve the efficiency of cephalometric analysis. In most studies, the accuracy of DL can reach more than 80%, and its difference from the gold standard is clinically acceptable, demonstrating good potential for future applications. However, most studies are limited to landmark detection, and the broadness and richness of the training dataset are limited. Future studies should broaden the research scope, improve the algorithm, elevate the richness of the datasets, and combine DL with other AI algorithms to improve its accuracy, stability and generalizability.
9.Construction of competency index system for community chronic disease management specialist nurses
Fang LIU ; Lingyun WANG ; Weiwei LIU
Chinese Journal of Modern Nursing 2023;29(23):3109-3115
Objective:To construct a competency index system for community chronic disease management specialist nurses in China, so as to provide reference for future training and assessment of specialist nurses in community chronic disease management.Methods:With the competency iceberg model as the theoretical framework, the competency index system of community chronic disease management specialist nurses was initially constructed through literature analysis and semi-structured interview. From January to April 2022, 30 nursing experts were selected for two rounds of expert consultation, and indicators at all levels were screened, modified, and improved to establish a competency index system for community chronic disease management specialist nurses. The enthusiasm of experts was expressed by the questionnaire recovery rate, the authority of experts was expressed by the expert authority coefficient, and the coordination of expert opinions was reflected by the Kendal harmony coefficient.Results:The effective response rates of the two rounds of expert consultation questionnaires were both 100.00% (30/30), and the expert authority coefficients were all 0.91. The Kendal concordance coefficient of the two rounds of consultation was 0.330 and 0.448, respectively ( P<0.01). The final competency index system for community chronic disease management specialist nurses included 4 first level indicators, 17 second level indicators, and 63 third level indicators. Conclusions:The competency index system for community chronic disease management specialist nurses is scientific and reliable, and can provide reference for the training and assessment of community chronic disease management specialist nurses in China.
10.Development, reliability and validity of the Sexual Health Education Needs Assessment Scale for Breast Cancer Patients
Ping ZHU ; Xiuxiu YANG ; Meixiang WANG ; Fang CHENG ; Yi PEI ; Lingyun SHI ; Xinxin LIU ; Yanyan LIAO ; Wenbo ZHU ; Liuliu ZHANG
Chinese Journal of Modern Nursing 2023;29(28):3815-3822
Objective:To develop the Sexual Health Education Needs Assessment Scale for Breast Cancer Patients and test its reliability and validity.Methods:Guided by Maslow's hierarchy of needs theory and knowledge, belief, and practice theory, an initial scale was formed through literature review, semi-structured interviews and Delphi expert consultation. Through cognitive interviews with 9 patients, the scale was further revised and improved to form a clinical trial version. From December 2021 to September 2022, 397 breast cancer patients from 9 ClassⅢ hospitals in 6 provinces, municipalities and autonomous regions were selected by convenience sampling to conduct a questionnaire survey, test the reliability and validity of the scale and grade it.Results:The Sexual Health Education Needs Assessment Scale for Breast Cancer Patients included four dimensions and 32 items in total. Exploratory factor analysis extracted a total of four common factors, with a cumulative variance contribution rate of 72.258%. The content validity index of the scale was 0.865, and the content validity index of each item was 0.929 to 1.000. The correlation coefficients between each dimension of the scale and the total scale were 0.789 to 0.956, and the correlation coefficients between dimensions were 0.635 to 0.863. The Cronbach's α coefficient of the total scale was 0.979, and the Cronbach's α coefficients of each dimension were 0.897 to 0.969. The half reliability of the total scale was 0.941, and the half reliability of each dimension was 0.851 to 0.946. The total score of the scale was 32 to 160, with 32 to 77 being at a low level, 78 to 117 being at a medium level, and 118 to 160 being at a high level.Conclusions:The developed Sexual Health Education Needs Assessment Scale for Breast Cancer Patients has good reliability and validity, and is suitable for breast cancer patients' sexual health education needs assessment.


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