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.Impact of returned migration experience on prevalence of non-suicidal self-injury behavior and its association with relevant psychosocial factors among middle school students
Xiantao YANG ; Rong WU ; Yuan LUO ; Pengyu REN ; Yu LIU ; Fengjiao RAN ; Xi LUO ; Manting GU ; Zheng YAN
Chinese Mental Health Journal 2025;39(10):888-894
Objective:To examine the impact of returned migration experience on the prevalence of non-sui-cidal self-injury(NSSI)and its associations with childhood emotional maltreatment(EM),social support and sleep quality.Methods:A total of 3 901 middle school students in Guizhou Province were investigated with the Adoles-cent NSSI behavior Questionnaire,Childhood Trauma Questionnaire-short Form(CTQ-SF),Adolescent Social Sup-port Scale,and Pittsburgh Sleep Quality Index(PSQI).Results:The prevalence of NSSI among middle school students in Guizhou province was 22.8%,with the rate of 27.3%among returned migrant middle school students.Social support and sleep quality partially mediate the relationship between childhood EM and NSSI in mid-dle school students,with effect sizes of 0.06.The EM scores of returned migrant middle school students(β=-0.62)and non-returned migrant middle school students(β=-0.50)were negatively correlated with social sup-port scores in childhood.The sleep quality scores of returned migrant students(β=0.22)and non-returned migrant students(β=0.14)were positively correlated with NSSI scores.Conclusion:The prevalence of NSSI in returned migrant students is higher.Social support and sleep quality play an important role in the relationship between child-hood EM and NSSI in middle school students.The relationship between childhood EM and social support,sleep quality and NSSI in returned migrant middle school students is stronger than that in non-returned migrant middle school students.
3.Characteristics and factors affecting treatment in hospitalized patients with abnormal uterine bleeding in sub-plateau region
Dan-feng DU ; Ru-juan WANG ; Rong-qun CHA ; Ping JIANG ; Li-qin WANG ; Xi CHEN ; Li-na YANG ; Zhi-yong WU
Fudan University Journal of Medical Sciences 2025;52(3):408-415,423
Objective To investigate the clinical characteristics of women with abnormal uterine bleeding(AUB)in sub-plateau regions and analyze the factors affecting their treatment methods.Methods AUB patients who were hospitalized from Jan 1,2018 to Dec 31,2022,in a sub-plateau region(Yongping County People's Hospital of Yunnan Province)with an average altitude of 1 620 meters were selected.The general clinical characteristics of the patients were summarized,and patients were classified into two categories(with or without uterine structural lesion)and nine subtypes(PALM-COEIN)according to the FIGO recommended etiological classification guidelines.Then the patients were divided into groups based on the presence or absence of uterine structural lesions,ethnic group(Han and minority),conservative drug treatment and surgical treatment groups,blood transfusion and non-blood transfusion groups.Binary Logistic regression analysis was used to identify factors affecting treatment methods.Results A total of 481 AUB patients enrolled,and the delayed consultation rate was as high as 80.46%,and the proportion of overweight and obese patients was 49.90%,which was higher than the average level among Chinese women.The main cause was AUB-O(AUB-ovulatory dysfunction),accounting for 78.59%of cases,the proportion of patients with delayed medical treatment was higher than those without delayed medical treatment(82.17%vs.74.47%).Patients who received blood transfusion were significantly younger,had lower hemoglobin(HGB)levels,fewer pregnancies,and lower BMI compared to those in the non-blood transfusion group(P<0.05).Univariate analysis showed that the surgical treatment group had older age,longer onset time,higher HGB levels,more pregnancies and deliveries,higher BMI,a higher proportion of Han ethnicity patients,lower rates of non-blood transfusion,higher rates of hypertension,and more uterine structural lesions compared to the conservative drug treatment group.Multivariate regression analysis revealed that blood transfusion treatment reduced the probability of surgical treatment.Age and uterine structural lesions were risk factors for requiring surgical treatment,for each additional year of age,the risk of undergoing surgical treatment increased by 10%.The risk of requiring surgical treatment for patients with uterine structural lesions was 2.987 times higher than for those without.Conclusion AUB patients in this sub-plateau regions have a high rate of delayed consultation and a high proportion of overweight and obesity,with AUB-O being the primary cause.Older age and the presence of uterine structural lesions were risk factors for requiring surgical treatment.
4.Effects of Rutong Ruanjian Tablets on angiogenesis in a rat model of preneoplastic breast cancer of Liver-Qi Stagnation and Blood Stasis Pattern via DLL4/Notch1/Hes1 pathway
Hua YANG ; Jun-yao LONG ; Jie GONG ; Bing-bing LU ; Xi ZOU ; Yu-rong WU ; Li-fang LIU ; Hui LIU ; Qi-hua CHEN
Chinese Traditional Patent Medicine 2025;47(3):774-781
AIM To investigate the effects of Rutong Ruanjian Tablets on angiogenesis in cancer tissues of rats with preneoplastic breast cancer(PBC).METHODS 60 female SD rats were randomly divided into a blank group of 10 rats and a model group of 50 rats for the establishment of the PBC models of Liver-Qi Stagnation and Blood Stasis Pattern with 9 weeks of oral administration of 7,12-dimethylbenz[a]anthracene(DMBA)and cervical ligation.After successful modeling,the rats were randomly divided into the model group,the tamoxifen group(3.2 mg/kg),the Rutong Ruanjian Tablets group(128 mg/kg),the 3,5-difluorobenzoyl group(DAPT,5 mg/kg),and the Rutong Ruanjian Tablets(128 mg/kg via gavage)+DAPT(5 mg/kg intraperitoneal injection)group,for 1 month corresponding drug administration,with 10 rats in each group.Then the rats had their cancer progression and syndrome scores observed;their angiogenesis evaluated by assessment of microvascular density(MVD);their vascular endothelial growth factor(VEGF)expression assessed by immunohistochemistry;and their mRNA and protein expressions of proteins related to the DLL4/Notch1/Hes1 pathway measured using RT-qPCR,immunohistochemistry and Western blot.RESULTS During carcinogenesis of rats induced by DMBA,there was gradual disappearance of E-cadherin expression and consistency of HE staining result with the PBC progression confirming the success of the modeling.Compared with the blank group,the model group showed increased MVD values,mRNA expression of Notch1 and Hes1,and protein expressions of VEGF,DLL4,Notch1 and Hes1(P<0.05,P<0.01).Compared with the model group,the Rutong Ruanjian Tablets group exhibited reduced MVD values,mRNA expression of Notch1 and Hes1,and protein expressions of VEGF,DLL4,Notch1 and Hes1(P<0.05,P<0.01).The Rutong Ruanjian Tablets+DAPT group showed reduced mRNA expression of Notch1 and Hes1,and protein expressions of DLL4,Notch1 and Hes1 compared to the Rutong Ruanjian Tablets group(P<0.05,P<0.01).CONCLUSION Rutong Ruanjian Tablets can inhibit angiogenesis and attenuate cancer progression in PBC rats of Liver-Qi Stagnation and Blood Stasis Pattern,and the mechanism may lie in the downregulation of DLL4/Notch1/Hes1 signaling pathway related proteins.
5.Psychological stress-activated NR3C1/NUPR1 axis promotes ovarian tumor metastasis.
Bin LIU ; Wen-Zhe DENG ; Wen-Hua HU ; Rong-Xi LU ; Qing-Yu ZHANG ; Chen-Feng GAO ; Xiao-Jie HUANG ; Wei-Guo LIAO ; Jin GAO ; Yang LIU ; Hiroshi KURIHARA ; Yi-Fang LI ; Xu-Hui ZHANG ; Yan-Ping WU ; Lei LIANG ; Rong-Rong HE
Acta Pharmaceutica Sinica B 2025;15(6):3149-3162
Ovarian tumor (OT) is the most lethal form of gynecologic malignancy, with minimal improvements in patient outcomes over the past several decades. Metastasis is the leading cause of ovarian cancer-related deaths, yet the underlying mechanisms remain poorly understood. Psychological stress is known to activate the glucocorticoid receptor (NR3C1), a factor associated with poor prognosis in OT patients. However, the precise mechanisms linking NR3C1 signaling and metastasis have yet to be fully elucidated. In this study, we demonstrate that chronic restraint stress accelerates epithelial-mesenchymal transition (EMT) and metastasis in OT through an NR3C1-dependent mechanism involving nuclear protein 1 (NUPR1). Mechanistically, NR3C1 directly regulates the transcription of NUPR1, which in turn increases the expression of snail family transcriptional repressor 2 (SNAI2), a key driver of EMT. Clinically, elevated NR3C1 positively correlates with NUPR1 expression in OT patients, and both are positively associated with poorer prognosis. Overall, our study identified the NR3C1/NUPR1 axis as a critical regulatory pathway in psychological stress-induced OT metastasis, suggesting a potential therapeutic target for intervention in OT metastasis.
6.Susceptible Windows of Prenatal Ozone Exposure and Preterm Birth: A Hospital-Based Observational Study.
Rong Rong QU ; Dong Qin ZHANG ; Han Ying LI ; Jia Yin ZHI ; Yan Xi CHEN ; Ling CHAO ; Zhen Zhen LIANG ; Chen Guang ZHANG ; Wei Dong WU ; Jie SONG
Biomedical and Environmental Sciences 2025;38(2):255-260
7.Clinical and genetic analysis of a patient with FSIP2 compound heterozygous variants causing multiple morphological abnormalities of sperm flagella.
Yao-Qi CHEN ; Li-Qi XU ; Yi-Bo DAI ; Liang-Yu YAO ; Shen-Ming YANG ; Lu-Yu HUANG ; Xi YANG ; Yi YU ; Jing-Ming YANG ; Ke-Rong WU
National Journal of Andrology 2025;31(5):395-402
OBJECTIVE:
The aim of this study is to analyze the clinical features and genetic etiology of a patient with multiple morphological abnormalities of the sperm flagella (MMAF) retrospectively.
METHODS:
A severely oligospermic patient from the Reproductive Center of the First Affiliated Hospital of Ningbo University was selected as the study subject. Clinical data and examination results were collected. High-throughput sequencing and bioinformatics were used to analyze the genetic etiology. And Sanger sequencing was employed to validate findings in the family. Transmission electron microscopy (TEM) was used to observe the sperm ultrastructure, and immunofluorescence analysis was performed to examine the localization of FSIP2 protein in the sperm.
RESULTS:
The patient presented with severe oligospermia, and sperm morphology displayed MMAF. TEM revealed fibrous sheath and 9+2 microtubule structural disruptions in the sperm. Sequencing identified compound heterozygous variants in the FSIP2 gene (c.17798C > T, c.5927T > G), inherited from the father and mother, respectively. According to the guidelines of the American College of Medical Genetics and Genomics, the variants were classified as pathogenic. The patient's spouse underwent intracytoplasmic single sperm injection, resulting in one embryo, but no clinical pregnancy occurred after embryo transfer.
CONCLUSION
This study reported the mutation of FSIP2 gene c.17798C > T, c.5927T > G in a patient with MMAF. These findings expand the mutational spectrum of the FSIP2 gene and provide insights for genetic and assisted reproductive counseling for patients with MMAF.
Humans
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Male
;
Sperm Tail/pathology*
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Heterozygote
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Oligospermia/genetics*
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Spermatozoa
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Mutation
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Infertility, Male/genetics*
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Adult
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Pedigree
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Retrospective Studies
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Sperm Injections, Intracytoplasmic
8.Comparative analysis of fine needle aspiration cytology and histopathology in axil-lary lymph nodes
Boya ZHAI ; Zhendong HUANG ; Jinxing ZHOU ; Yan WU ; Lei XI ; Cong WANG ; Zhihong ZHANG ; Rong RONG
Chinese Journal of Clinical and Experimental Pathology 2025;41(4):469-473
Purpose To investigate the role of ultrasound-guided fine needle aspiration cytology(US-FNAC)in the diagnosis of breast cancer.Methods Fine needle aspiration cytology(FNAC)samples of 203 patients with breast cancer were selected and prepared by liquid-based cytology.The results of histopathology after neoadjuvant therapy were used as the gold standard to compare with the diagnostic results of FNAC samples,and then evaluated the diagnos-tic coincidence rate of FNAC samples.Results Of 203 axillary lymph node FNAC samples,111 cases were diagnosed as positive,38 cases were diagnosed as suspicious for positivity,and 54 cases were diagnosed as negative.The diag-nostic accuracy of FNAC was 85.2%,the sensitivity of FNAC was 98.0%,and the specificity of FNAC was 90.0%.Conclusion FNAC has high sensitivity and accuracy in the diagnosis of axillary lymph node metastasis.Sentinel lymph node biopsy is recommended for patients with negative FNAC but clinically and radiographically suspected lymph node metastasis.
9.Comparative study on analgesic effect of bupivacaine liposome and ropivacaine on quadratus lumborum block in patients undergoing laparoscopic total hysterectomy
Huan-xi XU ; Xiong-xiong PAN ; Rong MA ; Xu XU ; Xian-rui LI ; Hao WU
Journal of Regional Anatomy and Operative Surgery 2025;34(10):892-896
Objective To clarify the differences in the effects of bupivacaine liposome and ropivacaine on quadratus lumborum block in patients undergoing laparoscopic total hysterectomy.Methods A total of 70 patients who underwent laparoscopic total hysterectomy at Suqian First People's Hospital Affiliated to Nanjing Medical University from January 2023 to October 2024 were selected as the research subjects.The patients were randomly divided into the control group and the observation group,with 35 cases in each group.Before general anesthesia,patients of the control group were given ropivacaine quadratus lumborum block,while patients of the observation group were given bupivacaine liposome quadratus lumborum block.The general conditions before and after operation,visual analogue scale(VAS)scores at different time points after operation,rescue analgesia,mini-mental state examination(MMSE)scores at different time points after operation,postoperative rehabilitation and analgesic adverse reactions were compared between the two groups.Results There was no statistically significant difference in the general conditions of patients in the two groups before and after the operation(P>0.05).At 24 hours,48 hours,and 72 hours after surgery,the abdominal resting VAS scores of patients in the observation group were significantly lower than those in the control group(P<0.05).The time of the first self-controlled use of the intravenous analgesic pump after surgery in the observation group was significantly later than that in the control group(P<0.05).The number of analgesic pump compressions and the rate of oxycodone rescue analgesia in the observation group were significantly fewer/lower than those in the control group within 48 hours after surgery(P<0.05).At 24 hours,48 hours,and 72 hours after surgery,the MMSE scores of patients in the observation group were significantly higher than those in the control group(P<0.05).The time for patients to get out of bed and move around after surgery and the recovery time of anal exhaust in the observation group were significantly earlier than those in the control group(P<0.05).There was no statistically significant difference in the incidence of postoperative analgesic adverse reactions between the two groups of patients(P>0.05).Conclusion Compared with the use of ropivacaine for quadratus lumborum block in patients undergoing laparoscopic total hysterectomy,bupivacaine liposome can provide a longer-lasting analgesic effect,reduce patients'dependence on intravenous analgesia,be conducive to protecting patients'cognitive function,accelerate the recovery of patients without increasing the incidence of adverse reactions.
10.Comparative study on analgesic effect of bupivacaine liposome and ropivacaine on quadratus lumborum block in patients undergoing laparoscopic total hysterectomy
Huan-xi XU ; Xiong-xiong PAN ; Rong MA ; Xu XU ; Xian-rui LI ; Hao WU
Journal of Regional Anatomy and Operative Surgery 2025;34(10):892-896
Objective To clarify the differences in the effects of bupivacaine liposome and ropivacaine on quadratus lumborum block in patients undergoing laparoscopic total hysterectomy.Methods A total of 70 patients who underwent laparoscopic total hysterectomy at Suqian First People's Hospital Affiliated to Nanjing Medical University from January 2023 to October 2024 were selected as the research subjects.The patients were randomly divided into the control group and the observation group,with 35 cases in each group.Before general anesthesia,patients of the control group were given ropivacaine quadratus lumborum block,while patients of the observation group were given bupivacaine liposome quadratus lumborum block.The general conditions before and after operation,visual analogue scale(VAS)scores at different time points after operation,rescue analgesia,mini-mental state examination(MMSE)scores at different time points after operation,postoperative rehabilitation and analgesic adverse reactions were compared between the two groups.Results There was no statistically significant difference in the general conditions of patients in the two groups before and after the operation(P>0.05).At 24 hours,48 hours,and 72 hours after surgery,the abdominal resting VAS scores of patients in the observation group were significantly lower than those in the control group(P<0.05).The time of the first self-controlled use of the intravenous analgesic pump after surgery in the observation group was significantly later than that in the control group(P<0.05).The number of analgesic pump compressions and the rate of oxycodone rescue analgesia in the observation group were significantly fewer/lower than those in the control group within 48 hours after surgery(P<0.05).At 24 hours,48 hours,and 72 hours after surgery,the MMSE scores of patients in the observation group were significantly higher than those in the control group(P<0.05).The time for patients to get out of bed and move around after surgery and the recovery time of anal exhaust in the observation group were significantly earlier than those in the control group(P<0.05).There was no statistically significant difference in the incidence of postoperative analgesic adverse reactions between the two groups of patients(P>0.05).Conclusion Compared with the use of ropivacaine for quadratus lumborum block in patients undergoing laparoscopic total hysterectomy,bupivacaine liposome can provide a longer-lasting analgesic effect,reduce patients'dependence on intravenous analgesia,be conducive to protecting patients'cognitive function,accelerate the recovery of patients without increasing the incidence of adverse reactions.

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