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
;
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.Novel biallelic MCMDC2 variants were associated with meiotic arrest and nonobstructive azoospermia.
Hao-Wei BAI ; Na LI ; Yu-Xiang ZHANG ; Jia-Qiang LUO ; Ru-Hui TIAN ; Peng LI ; Yu-Hua HUANG ; Fu-Rong BAI ; Cun-Zhong DENG ; Fu-Jun ZHAO ; Ren MO ; Ning CHI ; Yu-Chuan ZHOU ; Zheng LI ; Chen-Cheng YAO ; Er-Lei ZHI
Asian Journal of Andrology 2025;27(2):268-275
Nonobstructive azoospermia (NOA), one of the most severe types of male infertility, etiology often remains unclear in most cases. Therefore, this study aimed to detect four biallelic detrimental variants (0.5%) in the minichromosome maintenance domain containing 2 ( MCMDC2 ) genes in 768 NOA patients by whole-exome sequencing (WES). Hematoxylin and eosin (H&E) demonstrated that MCMDC2 deleterious variants caused meiotic arrest in three patients (c.1360G>T, c.1956G>T, and c.685C>T) and hypospermatogenesis in one patient (c.94G>T), as further confirmed through immunofluorescence (IF) staining. The single-cell RNA sequencing data indicated that MCMDC2 was substantially expressed during spermatogenesis. The variants were confirmed as deleterious and responsible for patient infertility through bioinformatics and in vitro experimental analyses. The results revealed four MCMDC2 variants related to NOA, which contributes to the current perception of the function of MCMDC2 in male fertility and presents new perspectives on the genetic etiology of NOA.
Humans
;
Male
;
Azoospermia/genetics*
;
Meiosis/genetics*
;
Spermatogenesis/genetics*
;
Adult
;
Exome Sequencing
;
Microtubule-Associated Proteins/genetics*
;
Alleles
;
Infertility, Male/genetics*
3.Clinical sub-phenotypes of acute kidney injury in children and their association with prognosis.
Lian FENG ; Min LI ; Zhen JIANG ; Jiao CHEN ; Zhen-Jiang BAI ; Xiao-Zhong LI ; Guo-Ping LU ; Yan-Hong LI
Chinese Journal of Contemporary Pediatrics 2025;27(1):47-54
OBJECTIVES:
To investigate the clinical sub-phenotype (SP) of pediatric acute kidney injury (AKI) and their association with clinical outcomes.
METHODS:
General status and initial values of laboratory markers within 24 hours after admission to the pediatric intensive care unit (PICU) were recorded for children with AKI in the derivation cohort (n=650) and the validation cohort (n=177). In the derivation cohort, a least absolute shrinkage and selection operator (LASSO) regression analysis was used to identify death-related indicators, and a two-step cluster analysis was employed to obtain the clinical SP of AKI. A logistic regression analysis was used to develop a parsimonious classifier model with simplified metrics, and the area under the curve (AUC) was used to assess the value of this model. This model was then applied to the validation cohort and the combined derivation and validation cohort. The association between SPs and clinical outcomes was analyzed with all children with AKI as subjects.
RESULTS:
In the derivation cohort, two clinical SPs of AKI (SP1 and SP2) were identified by the two-step cluster analysis using the 20 variables screened by LASSO regression, namely SPd1 group (n=536) and SPd2 group (n=114). The simplified classifier model containing eight variables (P<0.05) had an AUC of 0.965 in identifying the two clinical SPs of AKI (P<0.001). The validation cohort was clustered into SPv1 group (n=156) and SPv2 group (n=21), and the combined derivation and validation cohort was clustered into SP1 group (n=694) and SP2 group (n=133). After adjustment for confounding factors, compared with the SP1 group, the SP2 group had significantly higher incidence rates of multiple organ dysfunction syndrome and death during the PICU stay (P<0.001), and SP2 was significantly associated with the risk of death within 28 days after admission to the PICU (P<0.001).
CONCLUSIONS
This study establishes a parsimonious classifier model and identifies two clinical SPs of AKI with different clinical features and outcomes.The SP2 group has more severe disease and worse clinical prognosis.
Humans
;
Acute Kidney Injury/diagnosis*
;
Prognosis
;
Male
;
Female
;
Child
;
Child, Preschool
;
Phenotype
;
Infant
;
Logistic Models
;
Adolescent
4.Expert consensus on orthodontic treatment of patients with periodontal disease.
Wenjie ZHONG ; Chenchen ZHOU ; Yuanyuan YIN ; Ge FENG ; Zhihe ZHAO ; Yaping PAN ; Yuxing BAI ; Zuolin JIN ; Yan XU ; Bing FANG ; Yi LIU ; Hong HE ; Faming CHEN ; Weiran LI ; Shaohua GE ; Ang LI ; Yi DING ; Lili CHEN ; Fuhua YAN ; Jinlin SONG
International Journal of Oral Science 2025;17(1):27-27
Patients with periodontal disease often require combined periodontal-orthodontic interventions to restore periodontal health, function, and aesthetics, ensuring both patient satisfaction and long-term stability. Managing these patients involving orthodontic tooth movement can be particularly challenging due to compromised periodontal soft and hard tissues, especially in severe cases. Therefore, close collaboration between orthodontists and periodontists for comprehensive diagnosis and sequential treatment, along with diligent patient compliance throughout the entire process, is crucial for achieving favorable treatment outcomes. Moreover, long-term orthodontic retention and periodontal follow-up are essential to sustain treatment success. This expert consensus, informed by the latest clinical research and practical experience, addresses clinical considerations for orthodontic treatment of periodontal patients, delineating indications, objectives, procedures, and principles with the aim of providing clear and practical guidance for clinical practitioners.
Humans
;
Consensus
;
Orthodontics, Corrective/standards*
;
Periodontal Diseases/complications*
;
Tooth Movement Techniques/methods*
;
Practice Guidelines as Topic
5.Design and implementation of online continuing education platform for transfusion medicine
Haiying LI ; Xin LI ; Lixue CHEN ; Jinlian LUO ; Xiaodan PENG ; Jintong ZHONG ; Le BAI ; Nannan ZHANG ; Zebo YU ; Xue HU
Chinese Journal of Medical Education Research 2025;24(3):419-425
To provide in-service medical technicians and nurses with convenient access to continuing education resources in transfusion medicine, reduce transfusion-related adverse events, and ensure the safety, rationalization, and effectiveness of clinical transfusion, we designed and developed an online transfusion continuing education platform. The platform was based on the new managed code programming model.NET Core and the powerful functions of hypertext preprocessor PHP 7.4, addressing current issues in transfusion online continuing education. Through in-depth analysis of student attributes, learning behaviors, and teaching behaviors, a comprehensive online continuous teaching quality evaluation index system was established. This system not only facilitates the quantitative assessment of teaching quality but also successfully integrates the two core functions of teaching and management, thereby achieving unified online teaching.
6.Single-cell transcriptomic insights into endosulfan-induced liver injury:Key pathways and inflammatory responses
Pan HUANG ; Yunmeng BAI ; Chaohua ZHOU ; Xiaoru ZHONG ; Ashok IYASWAMY ; Peng CHEN ; Xu WEI ; Wei ZHANG ; Chuanbin YANG ; Jigang WANG
Liver Research 2025;9(2):144-156
Background and aims:Environmental pollutants,particularly organochlorine insecticides like endosulfan(ENDO),are increasingly linked to liver toxicity and related diseases.Despite its widespread historical use,the mechanisms underlying ENDO-induced liver damage remain poorly understood.This study aims to elucidate the cellular and molecular mechanisms of ENDO-induced hepatotoxicity.Methods:C57BL/6 mice were exposed to ENDO for two weeks.Single-cell RNA sequencing(scRNA-seq)was subsequently performed on mouse livers to explore ENDO-induced hepatotoxicity at the single-cell level.Differentially expressed genes(DEGs)across cell types and treatments were identified and then subjected to pathway enrichment to uncover key biological processes affected by ENDO.Transcription factor(TF)regulatory network,pseudotime trajectory,and cellular communication analysis were used to explore the molecular and cellular changes after ENDO exposure.Results:ENDO not only caused direct hepatocyte injury but also activated hepatic stellate cells and lymphocytes,triggering inflammatory responses with upregulation of multiple key chemokines and cytotoxic genes.Additionally,ENDO exposure led to the recruitment and activation of myeloid cells,contributing to the inflammatory milieu.An increase in intercellular communication and changes to the hepatic microenvironment,especially the interaction between activated hepatic stellate cells and CD8+T cells were observed,further implicating these processes in ENDO-induced liver damage.Conclusions:This study provides new insights into the cellular and molecular mechanisms underlying liver injury induced by organochlorine insecticides like ENDO.Key genes and pathways involved in ENDO-associated liver toxicity have been identified at a single-cell resolution.These findings suggest that altered cellular communications and inflammatory responses may play pivotal roles in the pathogenesis of ENDO-induced liver injury.
7.Interpretation of Standards for Control of Healthcare-associated infections outbreak(WS/T 524-2025)
Zhong CHEN ; Shenting LIN ; Bing BAI ; Tieying HOU
Chinese Journal of Nosocomiology 2025;35(22):3370-3373
The management of healthcare-associated infections(HAIs)outbreak is a critical component of hospi-tal infection prevention and control,playing a vital role in safeguarding the patients and healthcare workers.The"Standards for Control of Healthcare-Associated Infection Outbreaks(2025 edition)"that was issued by the Na-tional Health Commission was interpreted from the perspectives of scientific validity,applicability and operability.It covers the aspects such as the background of the revision,main contents(including management re-quirements,epidemiological survey,control effect evaluation.It is stressed on the role of information management systems in enhancing the capability for early detection and early warning of HAIs outbreaks.New additions include emergency response procedures for exposures to unconventional pathogens in healthcare settings,outlining specific response measures and key action points.The standard clarifies that infections evolve dynamically and must be cat-egorized based on whether the outbreak pathogen has a defined incubation period.It defines the longest incubation period for assessing effective outbreak control and establishes criteria for identifying new cases.This standard ap-plies to medical institutions of all levels and types and can also be referenced for the control of infection outbreak in temporary special settings during the prevalence of infectious diseases.
8.Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury (version 2025)
Kai HUANG ; Lunhao BAI ; Qing BI ; Hong CHEN ; Jiwu CHEN ; Xuesong DAI ; Wenyong FEI ; Weili FU ; Zhizeng GAO ; Lin GUO ; Yinghui HUA ; Jingmin HUANG ; Suizhu HUANG ; Xuan HUANG ; Jian LI ; Qiang LI ; Shuzhen LI ; Yanlin LI ; Yunxia LI ; Zhong LI ; Ning LIU ; Yuqiang LIU ; Wei LU ; Hongbin LYU ; Haile PAN ; Xiaoyun PAN ; Chao QI ; Weiliang SHEN ; Luning SUN ; Jin TANG ; Zimin WANG ; Bide WANG ; Ru WANG ; Shaobai WANG ; Licheng WEI ; Weidong XU ; Yongsheng XU ; Jizhou YANG ; Liang YANG ; Rui YANG ; Hongbo YOU ; Tengbo YU ; Jiakuo YU ; Bing YUE ; Hua ZHANG ; Hui ZHANG ; Qingsong ZHANG ; Xintao ZHANG ; Jiajun ZHAO ; Lilian ZHAO ; Qichun ZHAO ; Song ZHAO ; Jiapeng ZHENG ; Jiang ZHENG ; Zhi ZHENG ; Jingbin ZHOU ; Jinzhong ZHAO
Chinese Journal of Trauma 2025;41(4):325-338
With the rapid development of competitive sports, the incidence of anterior cruciate ligament (ACL) injury is on the rise. Such injuries may shorten athletes′ career and lead to other long-term adverse consequences. Although athletes generally recover well after ACL reconstruction, many still struggle to return to their pre-injury performance levels. Advances in the understanding of ACL anatomy and injury mechanisms, along with the evolution of surgical techniques and rehabilitation methods, have provided more individualized and tailored options for athletes following ACL injuries. However, there is currently no consensus in China regarding surgical and rehabilitation strategies for competitive athletes aiming to return to sports after ACL injuries. To this end, the Sports Medicine Committee of the Chinese Research Hospital Association and the Editorial Board of the Chinese Journal of Trauma jointly formulated the Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury ( version 2025), and presented 14 recommendations covering surgical indications, preoperative rehabilitation, surgical timing, surgical strategies and postoperative rehabilitation strategies, aiming to improve the surgical treatment and rehabilitation system for ACL injuries in competitive athletes and facilitate their return to high-level sports performance after injury.
9.Design and implementation of online continuing education platform for transfusion medicine
Haiying LI ; Xin LI ; Lixue CHEN ; Jinlian LUO ; Xiaodan PENG ; Jintong ZHONG ; Le BAI ; Nannan ZHANG ; Zebo YU ; Xue HU
Chinese Journal of Medical Education Research 2025;24(3):419-425
To provide in-service medical technicians and nurses with convenient access to continuing education resources in transfusion medicine, reduce transfusion-related adverse events, and ensure the safety, rationalization, and effectiveness of clinical transfusion, we designed and developed an online transfusion continuing education platform. The platform was based on the new managed code programming model.NET Core and the powerful functions of hypertext preprocessor PHP 7.4, addressing current issues in transfusion online continuing education. Through in-depth analysis of student attributes, learning behaviors, and teaching behaviors, a comprehensive online continuous teaching quality evaluation index system was established. This system not only facilitates the quantitative assessment of teaching quality but also successfully integrates the two core functions of teaching and management, thereby achieving unified online teaching.
10.Interpretation of Standards for Control of Healthcare-associated infections outbreak(WS/T 524-2025)
Zhong CHEN ; Shenting LIN ; Bing BAI ; Tieying HOU
Chinese Journal of Nosocomiology 2025;35(22):3370-3373
The management of healthcare-associated infections(HAIs)outbreak is a critical component of hospi-tal infection prevention and control,playing a vital role in safeguarding the patients and healthcare workers.The"Standards for Control of Healthcare-Associated Infection Outbreaks(2025 edition)"that was issued by the Na-tional Health Commission was interpreted from the perspectives of scientific validity,applicability and operability.It covers the aspects such as the background of the revision,main contents(including management re-quirements,epidemiological survey,control effect evaluation.It is stressed on the role of information management systems in enhancing the capability for early detection and early warning of HAIs outbreaks.New additions include emergency response procedures for exposures to unconventional pathogens in healthcare settings,outlining specific response measures and key action points.The standard clarifies that infections evolve dynamically and must be cat-egorized based on whether the outbreak pathogen has a defined incubation period.It defines the longest incubation period for assessing effective outbreak control and establishes criteria for identifying new cases.This standard ap-plies to medical institutions of all levels and types and can also be referenced for the control of infection outbreak in temporary special settings during the prevalence of infectious diseases.

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