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.The value of coronary CT angiography-based traditional features and radiomics in identification of culprit plaques to cause acute myocardial infarction
Pei NIE ; Shuo ZHANG ; Yan DENG ; Shifeng YANG ; Xinxin YU ; Kaiyue ZHI ; He ZHU ; Peng LI ; Jingjing CUI ; Wenjing CHEN ; Yanmei WANG ; Yuchao XU ; Dapeng HAO ; Ximing WANG
Chinese Journal of Radiology 2025;59(9):1017-1028
Objective:To investigate the value of coronary CTA (CCTA)-based traditional features and radiomics of plaque in the identification of culprit lesions that caused acute myocardial infarction (AMI).Methods:This was a retrospective multicenter study. From July 2016 to November 2023, a total of 344 patients from the Affiliated Hospital of Qingdao University (training cohort, n=184), Shandong Provincial Hospital Affiliated to Shandong First Medical University (validation cohort, n=88) and Qilu Hospital of Shandong University (test cohort, n=72) who received percutaneous coronary intervention (PCI) due to AMI and underwent CCTA within 48 hours of AMI were enrolled. The culprit plaques and non-culprit plaques were identified using a combination of electrocardiogram, CCTA, and angiographic findings. The vessel, plaque location, plaque type, Coronary Artery Disease-Reporting and Data System (CAD-RADS) score, high-risk plaque characteristics, plaque length, plaque volume, and burden were analyzed, and 1 904 radiomics features were extracted for each plaque. The traditional imaging model, the radiomics model, and the combined model were established by using multivariate Logistic regression analysis. The area under the receiver operating characteristic curve (AUC) was used to evaluate the performance of each model in identifying culprit lesions. The DeLong test was used for the comparison of AUC between every two models. The net reclassification index (NRI) was used to evaluate the incremental value of the combined model to the traditional imaging model and the radiomics model. The decision curve analysis (DCA) was used to assess the clinical net benefit of these models. A correlation heatmap was used to evaluate the correlation between the radiomics score and traditional CCTA factors. The interpretable analysis of the decision process of the combined model was performed by the Shapley Additive exPlanations (SHAP). Results:In the validation cohort and the test cohort, the AUC of the traditional imaging model developed by the vessel, plaque type, positive remodeling and CAD-RADS score was 0.898 (95% CI 0.869-0.922) and 0.881 (95% CI 0.848-0.910), respectively. The radiomics model developed by six radiomics features was 0.863 (95% CI 0.831-0.891) and 0.863 (95% CI 0.827-0.864), respectively. The AUC of the combined model was 0.930 (95% CI 0.905-0.950)and 0.919 (95% CI 0.889-0.942), respectively. In the validation cohort and the test cohort, the AUC of the combined model was higher than that of the traditional imaging model ( Z=4.013, 4.272, P<0.001) and that of the radiomics model ( Z=4.819, 3.784, P<0.001), respectively. In the validation cohort, the combined model yielded an NRI of 20.43% (95% CI 10.43%-30.44%, P<0.001) and 20.21% (95% CI 9.62%-30.80%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. In the test cohort, the combined model yielded an NRI of 28.05% (95% CI 16.72%-39.38%, P<0.001) and 23.57% (95% CI 13.58%-33.56%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. DCA showed the combined model had the highest clinical net benefit. The correlation heatmap showed the radiomics score was not correlated or only weakly correlated with traditional CCTA factors. SHAP indicated the radiomics and CAD-RADS score contributed significantly to the model. Conclusion:The CCTA-based traditional features and radiomics of plaque have favorable performance for the identification of culprit plaques in patients with AMI.
3.Current status and biological characterization of avian paramyxovirus in wild birds in China
Lu CHEN ; Minghui ZHU ; Yufeng LIU ; Shuo LIU ; Yuteng CHEN ; Haiming WANG ; Wenming JIANG ; Jingjing WANG ; Hualei LIU ; Yang LI ; Xiaohui YU
Chinese Journal of Veterinary Science 2025;45(11):2351-2357
To understand the current epidemiological status and biological characteristics of avian paramyxoviruses(APMV)in wild birds in China,a total of 1 384 fecal samples of wild birds were collected in eight provinces(autonomous regions),including Ningxia,in 2023,to detect avian pa-ramyxovirus infections by viral isolation and RT-PCR.Positive samples were subjected to F gene sequence amplification and genetic evolutionary analyses.The results showed that 10 strains of APMV were isolated and identified from 1 384 wild bird feces samples with a positive rate of 0.72%.Out of the 10 strains,4 strains were APMV-1,which was in the same branch to the Ameri-can goose APMV-1 strain and had the homology ranging from 93%to 97.3%.Three strains of APMV-4 were in the same branch with the Russian duck APMV-4 strain and the Russian pintail APMV-4 strain,with homology ranging from 99.1%to 99.5%.Three strains were APMV-6,they were in the same branch with the Russian ruddy bladdered duck APMV-6 strain,with homology ranging from 98.7%to 99.20%.The intracerebral inoculatable pathogenicity index(ICPI)of the four strains for 1-day-old chicks ranged from 0 to 0.48,which was low in pathogenicity for chick-ens.The above results enriches the epidemiological information and the biological characteristics of avian paramyxovirus in wild birds in China,which provides a reference for the early warning,scien-tific prevention and control of this disease.
4.Exercise experience and needs of Parkinson's disease patients: a qualitative Meta-synthesis
Qingyang ZHU ; Yuanjing QIAO ; Yaoyao ZHU ; Yuehai YU ; Hao PEI ; Yuting WANG ; Shuo LIU
Chinese Journal of Modern Nursing 2025;31(1):36-42
Objective:To systematically integrate the qualitative research results on the exercise experience and needs of patients with Parkinson's disease at home and abroad, and to provide a reference for formulating exercise management plans that are in line with the feelings of patients with Parkinson's disease.Methods:Computer retrieval was conducted in databases including China National Knowledge Infrastructure, Wanfang Data, VIP, China Biology Medicine disc, Web of Science, PubMed, Cochrane Library, Medline, Embase, and ProQuest for qualitative studies on the exercise experience of patients with Parkinson's disease. The retrieval time limit was from the establishment of the databases to August 8, 2024.Results:A total of 14 articles were included, and 34 research results were extracted. Similar research results were grouped into 11 new categories and integrated into 4 integrated results, namely the incentive factors for patients with Parkinson's disease to participate in exercise, the perceived benefits of patients with Parkinson's disease in exercise, the perceived difficulties of patients with Parkinson's disease in exercise, and the needs of patients with Parkinson's disease to participate in exercise.Conclusions:Exercise has a positive effect on improving the physical and mental conditions of patients with Parkinson's disease. Medical staff should fully consider the needs of patients and formulate safe and reasonable exercise plans to improve the motor life ability of patients with Parkinson's disease.
5.ICU acquired weakness assessment tools: a scoping review
Yuting WANG ; Yuanjing QIAO ; Yuehai YU ; Yaoyao ZHU ; Hao PEI ; Shuo LIU ; Qingyang ZHU
Chinese Journal of Modern Nursing 2025;31(5):695-700
Objective:To summarize ICU acquired weakness (ICU-AW) assessment tools from both domestic and international sources, providing a reference for healthcare providers in evaluating ICU-AW.Methods:Using Arksey and O'Malley's framework for scope reviews, a computer search was conducted in PubMed, Web of Science, Embase, Cochrane Library, CINAHL, China National Knowledge Infrastructure, Wanfang Database, VIP, and China Biology Medicine disc for relevant information on ICU-AW assessment tools. The search period was from the establishment of the databases to March 31, 2024. Two researchers independently summarized and analyzed the included literature.Results:A total of 14 articles were included, of which seven focused on the development/construction of prediction models, and seven were related to assessment tools, involving 17 different ICU-AW assessment tools.Conclusions:Researchers should develop and construct ICU-AW risk assessment tools with low bias risk and high clinical applicability based on existing ICU-AW assessment tools, providing effective instruments for the precise health management of ICU patients.
6.Current status and biological characterization of avian paramyxovirus in wild birds in China
Lu CHEN ; Minghui ZHU ; Yufeng LIU ; Shuo LIU ; Yuteng CHEN ; Haiming WANG ; Wenming JIANG ; Jingjing WANG ; Hualei LIU ; Yang LI ; Xiaohui YU
Chinese Journal of Veterinary Science 2025;45(11):2351-2357
To understand the current epidemiological status and biological characteristics of avian paramyxoviruses(APMV)in wild birds in China,a total of 1 384 fecal samples of wild birds were collected in eight provinces(autonomous regions),including Ningxia,in 2023,to detect avian pa-ramyxovirus infections by viral isolation and RT-PCR.Positive samples were subjected to F gene sequence amplification and genetic evolutionary analyses.The results showed that 10 strains of APMV were isolated and identified from 1 384 wild bird feces samples with a positive rate of 0.72%.Out of the 10 strains,4 strains were APMV-1,which was in the same branch to the Ameri-can goose APMV-1 strain and had the homology ranging from 93%to 97.3%.Three strains of APMV-4 were in the same branch with the Russian duck APMV-4 strain and the Russian pintail APMV-4 strain,with homology ranging from 99.1%to 99.5%.Three strains were APMV-6,they were in the same branch with the Russian ruddy bladdered duck APMV-6 strain,with homology ranging from 98.7%to 99.20%.The intracerebral inoculatable pathogenicity index(ICPI)of the four strains for 1-day-old chicks ranged from 0 to 0.48,which was low in pathogenicity for chick-ens.The above results enriches the epidemiological information and the biological characteristics of avian paramyxovirus in wild birds in China,which provides a reference for the early warning,scien-tific prevention and control of this disease.
7.The value of coronary CT angiography-based traditional features and radiomics in identification of culprit plaques to cause acute myocardial infarction
Pei NIE ; Shuo ZHANG ; Yan DENG ; Shifeng YANG ; Xinxin YU ; Kaiyue ZHI ; He ZHU ; Peng LI ; Jingjing CUI ; Wenjing CHEN ; Yanmei WANG ; Yuchao XU ; Dapeng HAO ; Ximing WANG
Chinese Journal of Radiology 2025;59(9):1017-1028
Objective:To investigate the value of coronary CTA (CCTA)-based traditional features and radiomics of plaque in the identification of culprit lesions that caused acute myocardial infarction (AMI).Methods:This was a retrospective multicenter study. From July 2016 to November 2023, a total of 344 patients from the Affiliated Hospital of Qingdao University (training cohort, n=184), Shandong Provincial Hospital Affiliated to Shandong First Medical University (validation cohort, n=88) and Qilu Hospital of Shandong University (test cohort, n=72) who received percutaneous coronary intervention (PCI) due to AMI and underwent CCTA within 48 hours of AMI were enrolled. The culprit plaques and non-culprit plaques were identified using a combination of electrocardiogram, CCTA, and angiographic findings. The vessel, plaque location, plaque type, Coronary Artery Disease-Reporting and Data System (CAD-RADS) score, high-risk plaque characteristics, plaque length, plaque volume, and burden were analyzed, and 1 904 radiomics features were extracted for each plaque. The traditional imaging model, the radiomics model, and the combined model were established by using multivariate Logistic regression analysis. The area under the receiver operating characteristic curve (AUC) was used to evaluate the performance of each model in identifying culprit lesions. The DeLong test was used for the comparison of AUC between every two models. The net reclassification index (NRI) was used to evaluate the incremental value of the combined model to the traditional imaging model and the radiomics model. The decision curve analysis (DCA) was used to assess the clinical net benefit of these models. A correlation heatmap was used to evaluate the correlation between the radiomics score and traditional CCTA factors. The interpretable analysis of the decision process of the combined model was performed by the Shapley Additive exPlanations (SHAP). Results:In the validation cohort and the test cohort, the AUC of the traditional imaging model developed by the vessel, plaque type, positive remodeling and CAD-RADS score was 0.898 (95% CI 0.869-0.922) and 0.881 (95% CI 0.848-0.910), respectively. The radiomics model developed by six radiomics features was 0.863 (95% CI 0.831-0.891) and 0.863 (95% CI 0.827-0.864), respectively. The AUC of the combined model was 0.930 (95% CI 0.905-0.950)and 0.919 (95% CI 0.889-0.942), respectively. In the validation cohort and the test cohort, the AUC of the combined model was higher than that of the traditional imaging model ( Z=4.013, 4.272, P<0.001) and that of the radiomics model ( Z=4.819, 3.784, P<0.001), respectively. In the validation cohort, the combined model yielded an NRI of 20.43% (95% CI 10.43%-30.44%, P<0.001) and 20.21% (95% CI 9.62%-30.80%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. In the test cohort, the combined model yielded an NRI of 28.05% (95% CI 16.72%-39.38%, P<0.001) and 23.57% (95% CI 13.58%-33.56%, P<0.001) for identifying culprit lesions compared with the traditional imaging model and the radiomics model, respectively. DCA showed the combined model had the highest clinical net benefit. The correlation heatmap showed the radiomics score was not correlated or only weakly correlated with traditional CCTA factors. SHAP indicated the radiomics and CAD-RADS score contributed significantly to the model. Conclusion:The CCTA-based traditional features and radiomics of plaque have favorable performance for the identification of culprit plaques in patients with AMI.
8.Exercise experience and needs of Parkinson's disease patients: a qualitative Meta-synthesis
Qingyang ZHU ; Yuanjing QIAO ; Yaoyao ZHU ; Yuehai YU ; Hao PEI ; Yuting WANG ; Shuo LIU
Chinese Journal of Modern Nursing 2025;31(1):36-42
Objective:To systematically integrate the qualitative research results on the exercise experience and needs of patients with Parkinson's disease at home and abroad, and to provide a reference for formulating exercise management plans that are in line with the feelings of patients with Parkinson's disease.Methods:Computer retrieval was conducted in databases including China National Knowledge Infrastructure, Wanfang Data, VIP, China Biology Medicine disc, Web of Science, PubMed, Cochrane Library, Medline, Embase, and ProQuest for qualitative studies on the exercise experience of patients with Parkinson's disease. The retrieval time limit was from the establishment of the databases to August 8, 2024.Results:A total of 14 articles were included, and 34 research results were extracted. Similar research results were grouped into 11 new categories and integrated into 4 integrated results, namely the incentive factors for patients with Parkinson's disease to participate in exercise, the perceived benefits of patients with Parkinson's disease in exercise, the perceived difficulties of patients with Parkinson's disease in exercise, and the needs of patients with Parkinson's disease to participate in exercise.Conclusions:Exercise has a positive effect on improving the physical and mental conditions of patients with Parkinson's disease. Medical staff should fully consider the needs of patients and formulate safe and reasonable exercise plans to improve the motor life ability of patients with Parkinson's disease.
9.ICU acquired weakness assessment tools: a scoping review
Yuting WANG ; Yuanjing QIAO ; Yuehai YU ; Yaoyao ZHU ; Hao PEI ; Shuo LIU ; Qingyang ZHU
Chinese Journal of Modern Nursing 2025;31(5):695-700
Objective:To summarize ICU acquired weakness (ICU-AW) assessment tools from both domestic and international sources, providing a reference for healthcare providers in evaluating ICU-AW.Methods:Using Arksey and O'Malley's framework for scope reviews, a computer search was conducted in PubMed, Web of Science, Embase, Cochrane Library, CINAHL, China National Knowledge Infrastructure, Wanfang Database, VIP, and China Biology Medicine disc for relevant information on ICU-AW assessment tools. The search period was from the establishment of the databases to March 31, 2024. Two researchers independently summarized and analyzed the included literature.Results:A total of 14 articles were included, of which seven focused on the development/construction of prediction models, and seven were related to assessment tools, involving 17 different ICU-AW assessment tools.Conclusions:Researchers should develop and construct ICU-AW risk assessment tools with low bias risk and high clinical applicability based on existing ICU-AW assessment tools, providing effective instruments for the precise health management of ICU patients.
10.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.

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