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.Clinical outcome of kidney transplantation from DBD donors complicated with acute kidney injury
Hongyu WANG ; Hong WANG ; Songying SHEN ; He ZHAO ; Xingsong QIN ; Wei QIN ; Xinling QIAN ; Huijun DONG ; Yunfeng ZHAO ; Yafang WANG ; Peiliang LI
Organ Transplantation 2024;15(4):622-629
Objective To evaluate the clinical outcome of kidney transplantation from donation after brain death(DBD)donors complicated with acute kidney injury(AKI).Methods Clinical data of 216 DBD donors were retrospectively analyzed,and they were divided into the AKI group(n=69)and control group(n=147)according to the Kidney Disease:Improving Global Outcomes(KDIGO)guidelines.Donors in the AKI group were further divided into the KDIGO stage 1 and stage 2-3 subgroups.One hundred and thirty-five recipients were assigned into the AKI group and 288 recipients in the control group.Postoperative recovery of renal function and clinical outcomes of the recipients were recorded.The risk factors of delayed graft function(DGF)were identified.Results The highest serum creatinine(Scr)level,Scr level before procurement,the highest blood sodium level and blood sodium level before procurement in the AKI group were higher than those in the control group.The application duration of vasopressors in the AKI group was longer than that in the control group.In the AKI group,the amount of fluid resuscitation within 48 h was higher,the HCO3-level at admission was lower,and the incidence of diabetes insipidus and hypotension was higher than those in the control group.The highest Scr level and the Scr level before procurement in KDIGO stage 2-3 donors were significantly higher than those in KDIGO stage 1 counterparts(all P<0.05).Compared with the control group,the incidence of DGF and acute rejection was higher,the proportion of continuous renal replacement therapy was higher,the Scr level within postoperative 90 d was higher,and the urine amount within postoperative 3 d was less than those of recipients in the AKI group.Compared with KDIGO stage 1 recipients,KDIGO stage 2-3 recipients had higher Scr levels at postoperative 3,4,5 and 15 d,and less urine amount at postoperative 2 d(all P<0.05).Univariate analysis showed that donor age,the highest Scr level,the highest blood sodium level and the amount of fluid resuscitation within 48 h were the risk factors for DGF in recipients after kidney transplantation.Multivariate analysis showed that donor age was the independent risk factor for DGF in recipients after kidney transplantation(all P<0.05).Conclusions For the application of DBD donors complicated with AKI,active organ maintenance should be performed to alleviate AKI.It exerts no effect upon graft function and survival rate at postoperative 6 months,which may achieve equivalent efficacy as non-AKI donors and may be used as a source of extended criteria donor kidneys.
3.Clinical analysis of brain death determination in organ donors under veno-arterial extracorporeal membrane oxygenation assisted circulatory support
Songying SHEN ; Meiyun JIA ; Hong WANG ; Yunfeng ZHAO ; Huijun DONG ; He ZHAO ; Wei QIN ; Xingsong QIN ; Meng ZHAO ; Yajie LIU ; Hongyu WANG
Chinese Journal of Neuromedicine 2024;23(4):392-396
Objective:To summarize the experience of brain death determination under veno-arterial extracorporeal membrane oxygenation (VA-ECMO) assisted circulatory support, especially apnea test (AT) precautions, and to provide references for brain death determination in this scenario.Methods:In 78 patients who had VA-ECMO at Organ Transplant Center, Zhengzhou People's Hospital from October 2019 to December 2023, 8 organ donors had brain death determination under VA-ECMO assisted circulatory support. Baseline data, clinical data, and VA-ECMO data during AT trial were collected from these 8 patients to summarize the process of brain death determination.Results:Six of the 8 donors met the criteria of brain death; 10 EEG, 12 evoked potentials and 15 ATs were performed. Complications in ATs, including hypotension, decreased oxygenation and arrhythmia, were alleviated after timely improved VA-ECMO flow and applied cardiotonic and pressor drugs.Conclusion:AT is key for successful brain death determination in organ donors under VA-ECMO assisted circulatory support; therefore, complications should be closely monitored and managed.
4.Bibliometric analysis of JAK/STAT signaling pathway in rheumatoid arthritis
Xiaojun SU ; Wenju ZHU ; Qiang BAO ; Huan WANG ; Qian HE ; Jun MA ; Haidong WANG ; Xuemei TIAN ; Fuhai MA ; Haili SHEN ; Huijun YANG
China Modern Doctor 2024;62(20):1-4,8
Objective Based on the multi-software visual analysis of the literature on the effect of Janus kinase(JAK)/signal transducer and activator of transcription(STAT)signaling pathway on rheumatoid arthritis in the past decade,the development trend and research hotspot in this field are summarized.To provide researchers with new directions and ideas to promote the innovative development of the field.Methods The literatures related to JAK/STAT signaling pathway in rheumatoid arthritis were collected from the Web of Science Core Collection database from 2013 to 2023.CiteSpace and VOSviewer software were used to analyze the number of publications,countries,authors and keywords of 354 articles retrieved.Results The number of published papers in this field continues to increase.According to the author's research direction,the presentation of high-frequency words,and the attention to the preface and hot topics,it is suggested that this field focuses on gene expression,immune mechanism,inflammatory mechanism,pathway inhibitors,drug therapy,etc.Future research will focus on the safety,mechanism and controlled trials of pathway inhibitors and antirheumatic drugs.Conclusion The effect of JAK/STAT signaling pathway on rheumatoid arthritis has attracted much attention in the past,present and future.There are differences in the research of different teams in this field,and the regional development is unbalanced,suggesting that we should strengthen cooperation and exchanges,focus on the international frontier,and carry out more high-quality research to promote the development and progress of this field,and provide clinical basis.
5.Advances in relapse risk factors of anti-N-methyl-D-aspartate receptor encephalitis
Fang ZHANG ; Yuchen LI ; Huijun SHEN ; Yingshi GUO ; Jing WANG ; Jie WANG
Chinese Journal of Neurology 2023;56(1):106-110
Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is an autoimmune encephalitis mediated by anti-NMDAR antibody. Current studies have found that most patients with anti-NMDAR encephalitis have a good prognosis after immunotherapy and tumor therapy, but there are still 4.5%-36.4% patients with relapse. It is important to identify the risk factors for the prevention of relapse. This article aims to review the relapse risk factors of NMDAR encephalitis in order to provide help for the prevention of relapse.
6.Recent advance in experimental animal models of anti-N-methyl-D-aspartate receptor encephalitis
Yuchen LI ; Fang ZHANG ; Huijun SHEN ; Jing WANG ; Jie WANG
Chinese Journal of Neurology 2022;55(4):379-384
Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is an autoimmune encephalitis mediated by anti-NMDAR antibody. At present, the pathogenesis of the disease is not completely clear, and reliable animal models are of great significance for the study of its pathogenesis and pathophysiological process. The authors reviewed the reports of anti-NMDAR encephalitis′s animal models in recent years, and discussed the advantages and limitations of each model, in order to provide a more suitable animal model for further research on anti-NMDAR encephalitis.
7.The concentration of heavy metals in PM2.5 and its ecological risk assessment in an industrial zone of Shanghai
Yuanyuan JIN ; Xiaomei ZHANG ; Hong CHEN ; Huijun ZHAO ; Yiwen LU ; Yuetian SHEN ; Xingya KUANG
Shanghai Journal of Preventive Medicine 2022;34(3):252-255
Objective To study the composition and concentration of atmospheric particulate pollutants in four seasons in the industrial and clean living areas, and to provide a scientific basis for the strategy of controlling industrial pollution and atmospheric environment. Methods An industrial area dominated by the automobile industry in Shanghai and a relatively clean living area were selected. Samples were collected simultaneously in both areas and continuously for 7 days in the middle of each season. The composition and concentration of PM2.5 were determined, and the ecological risk of heavy metals in PM2.5 was evaluated by the potential ecological risk index method. Results We found PM2.5 concentration was associated with seasonal changes. The PM2.5 concentration in living areas was the highest in winter, followed by spring, and the lowest in summer. The PM2.5 concentration in industrial areas was the highest in spring, followed by winter, and the lowest in summer. The heavy metals in PM2.5 were the same, including Al, Cr, Mn, Ni, As, Cd, Hg and Pb. The content of Cr, Cd and Pb in PM2.5 in the industrial area is significantly higher than that in the living area. The potential ecological hazard coefficient of PM2.5 heavy metal Cd in the industrial zone was the highest, up to 189.47, and it was the main component of the total potential ecological hazard index of heavy metals. According to the total potential risk grade of heavy metals, the heavy metal Cd in the industrial area had different degrees of ecological harm with seasonal changes. The ecological harm degree of heavy metal Cd was the highest in winter, high in spring and autumn, and low in summer. Conclusion Although the concentration of PM2.5 in the industrial area is not higher than that in the living area, the content of Cr, Cd and Pb in the PM2.5 in the industrial area is significantly higher than that in the living area. The concentration of PM2.5 in the industrial area is mainly related to seasons, industrial production and human factors. The potential ecological harm coefficient of heavy metal Cd in PM2.5 is the highest in comparison with other heavy metals such as Cr, Hg and Pb, and it is the main component of the total potential ecological harm index ofheavy metals.
8.Association analysis of clinical characteristics and prognoses with cerebrospinal fluid antibody titer in patients with anti N-methyl- D-aspartic acid receptor encephalitis
Qian PANG ; Yuchen LI ; Jing WANG ; Fang ZHANG ; Huijun SHEN ; Jie WANG
Chinese Journal of Neuromedicine 2022;21(7):697-705
Objective:To explore the association analysis of clinical characteristics and prognoses with cerebrospinal fluid antibody titer in patients with anti N-methyl- D-aspartic acid (NMDA) receptor encephalitis. Methods:Thirty-eight patients with anti-NMDA receptor encephalitis, admitted to our hospital from June 2014 to March 2019, were chosen. According to the titer results of anti-NMDA receptor antibodies reported by the first cerebrospinal fluid specimens, they were divided into low antibody titer group (antibody titer 1:10 and 1:32) and high antibody titer group (antibody titer 1:100 and 1:320). The clinical characteristics and prognoses of these patients were compared.Results:Of these 38 patients, 14 were into the group of low antibody titer, and 24 were into the group of high antibody titer. Patients in the low antibody titer group had significantly higher incidences of headache and laloplegia, and statistically lower serum antibody positive rate ( P<0.05). There were no significant differences between the two groups in other prodromal symptoms including fever, respiratory symptoms and life events, other common clinical manifestations including psychobehavioral abnormalities or cognitive impairment, seizures, motor disorders and decreased consciousness level, staying in ICU or not, intubating endotracheal tube or not, length of stay in ICU, time from symptom onset to definite diagnosis, and occurrence of complications, skull MRI, EEG, and lab results, modified Rankin scale (mRS) scores at discharge, time required to recover to mRS score of 0-1 after discharge, and mRS scores at follow-up. Conclusion:Cerebrospinal fluid antibody titer has limited significance in evaluating disease severity and guiding diagnosis and treatment in patients with anti-NMDA receptor encephalitis at acute stage.
9.Efficacy of dental floss traction-assisted endoscopic submucosal dissection for gastric angle mucosal lesions (with video)
Huijun ZHUANG ; Xude SHEN ; Jinzhong CHEN ; Liqing YAO ; Hong SU ; Yongsheng ZHENG ; Tianxia LEI ; Weilin YANG ; Jianhai WU ; Jinhai CHEN ; Haixing WANG ; Yilin XIE
Chinese Journal of Digestive Endoscopy 2020;37(9):642-646
Objective:To study the efficacy of dental floss traction-assisted endoscopic submucosal dissection (ESD) for gastric angle mucosal lesions.Methods:Data of 127 patients with gastric angle mucosal lesions admitted to the endoscopic center of the First Affiliated Hospital of Xiamen University from January 2015 to December 2018 were retrospectively analyzed. According to the surgical methods, patients were divided into the dental floss traction-assisted ESD group (the traction group, n=51) and the traditional ESD group (the traditional group, n=76). The 41 fibrosis cases were further divided into the traction group (n=23) and the traditional group (n=18). The operation time, en block resection rate, curative resection rate and the incidence of adverse events such as bleeding, muscle layer injury and perforation were compared between the two groups.Results:There was no significant difference in age, sex, lesion size or morphology between the traction group and the traditional group ( P > 0.05). The operation time of the traction group was significantly shorter than that of the traditional group (65.4±36.5 min VS 103.5±43.2 min, P=0.012). The en block resection rate was higher in the traction group [100.00% (51/51) VS 90.79% (69/76), P=0.026], and the curative resection rate was higher too [94.12% (48/51) VS 81.58% (62/76), P=0.042]. The incidences of muscular layer damage [5.88% (3/51) VS 25.00% (19/76), P=0.010] and intraoperative bleeding [47.06% (24/51)VS 82.89% (63/76), P=0.010] were lower in the traction group. Perforation occurred in two patients (2.63%) of fibrosis in the traditional group; no perforation occurred in the traction group. There was no significant difference in the perforation incidence ( P=0.243). In the cases of fibrosis, the operation time of the traction group was significantly shorter compared with that of the traditional group (81.4±29.3 min VS 119.3±37.6 min, P=0.010). The en block resection rate and curative resection rate were also higher in the traction group [100.00% (23/23) VS 72.22% (13/18), P=0.007; 95.65% (22/23) VS 72.22% (13/18), P=0.035]. The incidences of muscular layer damage [8.70% (2/23) VS 72.22% (13/18), P=0.001] and intraoperative bleeding [78.26% (18/23) VS 100.00% (18/18), P=0.035] were lower in the traction group. Conclusion:The dental floss traction-assisted ESD is safe and effective for gastric angle mucosal lesions and fibrotic lesions, with shorter operation time, higher curative resection rate and lower incidence of adverse events.
10.Comparison the efficacy of minimally invasive surgery and traditional surgery in the treatment of multiple benign mammary lumps
Zhaocai YIN ; Zhenyu MEI ; Yong SHENG ; Jianping CHEN ; Wanjun ZHAO ; Qin LI ; Huijun FENG ; Zhongbing SHEN ; Hui PENG
International Journal of Surgery 2019;46(5):329-333
Objective To compare the clinical efficacy of minimally invasive surgery and traditional surgery in the treatment of multiple benign mammary lumps.Methods A retrospective study was conducted to select 158 patients with multiple benign breast masses admitted to Yijishan Hospital of Wannan Medical College from July 2016 to February 2018,all of them were female,average age was (28.3 ± 6.6) years old,range from 19 to 51 years old.The patients were divided into minimally invasive group (n =122) and traditional group (n =36) according to different surgical methods.The minimally invasive group was treated by minimally invasive rotary excision,while the traditional group was treated by traditional surgery.The operation time,number of incisions,average length of incisions,cumulative length of incisions and healing time of incisions were compared between the two groups.The incidence of local hematoma,local infection,breast deformity and local residual were compared after operation,and the satisfaction of the two groups was aslo compared.Normal distribution measurements were expressed by mean ± standard deviation (Mean ± SD),independent sample t test was used for inter-group comparison;non-normal distribution measurements were expressed by median (quartile spacing) [M(P25,P75)],Mann-Whitney U test was used for inter-group comparison.Chi-square test or Fisher exact probability test was used to compare the count data between the two groups.Results As compared to the traditional group,the minimally invasive group had shorter operation time (20.0 min vs 40.0 min,Z =-8.590,P < 0.001),less number of incisions (1.0 vs 2.0,Z =-4.423,P <0.001),smaller average surgical incision length (3.8 mm vs 35.5 mm,Z =-9.211,P < 0.001),smaller cumulative surgical incision length (4.0 mm vs 67.2 mm,Z =-9.130,P < 0.001),quicker postoperative recovery (4.0 d vs 7.0 d,Z =-9.334,P < 0.001).There were no significant differences between the two groups in incidence of postoperative hematoma (4.1% vs 2.8%,x2 =0.000,P =1.000),incidence of infection (0 vs 2.8%,P =0.228),incidence of postoperative breast shape change (1.6% vs 2.8%,x2 =0.000,P =1.000),and incidence of residual (0.8% vs 0,P =1.000).Psychological satisfaction of patients in minimally invasive group (95.1%) was significantly higher than that in traditional group (58.3%),the difference was statistically significant (P < 0.001).Conclusions Compared with traditional surgery,the application of minimally invasive surgery in the treatment of multiple benign mammary lumps has many advantages,such as shorter operation time,less number of incisions,smaller surgical incision length,quicker postoperative recovery and higher satisfaction of patients after operation.It has not significantly increased postoperative complications.It is worthy of clinical application and promotion.

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