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*
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Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
;
East Asian People
2.Five cases of corneal suture-associated infectious endophthalmitis
Yuan ZONG ; Ting ZHANG ; Hong ZHUANG ; Fengjuan GAO ; Rui JIANG ; Xin HUANG
Chinese Journal of Ocular Fundus Diseases 2022;38(5):366-370
Objective:To observe the clinical features and prognosis of eyes with corneal suture-related infective endophthalmitis.Methods:A retrospective interventional case series. From January 2020 to December 2021, 5 patients (5 eyes) with corneal suture-related infectious endophthalmitis diagnosed by ophthalmic examination at Department of Ophthalmology of the Eye-ENT Hospital of Fudan University were included in the study. Among them, there were 3 males and 2 females; all had unilateral disease; the mean age was 30.80±21.98 years. Sutures of 4 cases were secondary to lens related surgery and of 1 case was secondary to penetrating keratoplasty. Average retention time of corneal suture was 20.00±7.41 months. Of the 5 eyes, corneal sutures were removed in 1 eye due to redness and eye pain in another hospital; 3 eyes were loosened of the sutures in the remaining 4 eyes. The patients were given standard treatment for infectious endophthalmitis, including systemic and local anti-infective therapy; corneal suture removal, intraocular injection, and vitrectomy (PPV). In PPV, it was decided whether to give silicone oil filling according to the situation. The follow-up time after treatment was 11.00±7.38 months. The best corrected visual acuity (BCVA), B-mode ultrasound and microbial culture results of the affected eye before and after surgery were observed and analyzed.Results:Infiltrates, ulcers, or abscesses surrounding the suture may be seen on the cornea of the affected eye. B-mode ultrasonography showed vitreous opacity, preretinal cords, and spherical wall edema in the entire segment of the affected eye. The results of vitreous humor culture were positive in 3 eyes, which were Streptococcus viridis, Staphylococcus hominis subspecies, Staphylococcus epidermidis. After treatment, all the intraocular infections in the affected eyes were successfully controlled, and there were no cases of enucleation of ocular contents or enucleation. Before treatment, the BCVA of the affected eye was from no light perception to counting fingers; after treatment, 2 eyes had BCVA> 0.3.Conclusions:Infiltration, ulcers or abscesses around the sutures can be seen in the cornea of corneal suture-related infective endophthalmitis patients, which are related to the long-term retention of the sutures in the eye. Most of the affected eyes have loose sutures when they go to the doctor; timely treatment can effectively control the infection, and some eyes have good visual prognosis.
3.Matrix metalloproteinase-9 and neutrophil to lymphocyte ratio predict delayed perihematomal edema in patients with spontaneous intracerebral hemorrhage
Shuangshuang GU ; Dujuan SHA ; Fengjuan GAO ; Yunfei JIANG ; Jun WANG ; Jin LI
International Journal of Cerebrovascular Diseases 2021;29(2):114-119
Objective:To investigate the predictive value of matrix metalloproteinase-9 (MMP-9) and neutrophil to lymphocyte ratio (NLR) in delayed perihematomal edema (dPHE) after spontaneous intracerebral hemorrhage (sICH).Methods:Patients with sICH admitted to Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School within 24 h of onset from January 2018 to June 2020 were enrolled retrospectively. Serum MMP-9 levels and peripheral blood cell counts were detected, and NLR were calculated within 24 h of onset. dPHE was defined as an increase of 3 ml in absolute edema volume at 10-21 d after onset of sICH compared with that at 5-9 d. The demographic and baseline clinical and imaging data of the dPHE group and the non-dPHE group were compared. Multivariate logistic regression analysis was used to identify the independent predictors of dPHE. The receiver operating characteristic (ROC) curve was used to evaluate the predictive values of MMP-9 and NLR for dPHE. Results:A total of 195 patients with sICH (61.88±10.60 years old) were enrolled in the study. One hundred and forty-eight patients were males (75.9%). There were 53 patients (27.2%) in the dPHE group and 142 (72.8%) in the non-dPHE group. Univariate analysis showed that age, baseline hematoma volume, baseline National Institutes of Health Stroke Scale score, fasting blood glucose, high-sensitivity C-reactive protein, MMP-9, neutrophil count, NLR and the proportion of irregular hematoma in the dPHE group were significantly higher than those in the non-dPHE group (all P<0.05). Multivariate logistic regression analysis showed that after adjusting for confounding factors, higher MMP-9 (odds ratio [ OR] 4.291, 95% confidence interval [ CI] 2.041-6.590; P=0.007) and higher NLR ( OR 2.530, 95% CI 1.157-4.022; P=0.011) were all the independent predictors of dPHE. ROC curve analysis showed that the area under the curve of MMP-9 for predicting dPHE was 0.819 (95% CI 0.756-0.884; P<0.001), the optimal cut-off value was 164.0 μg/L, and the sensitivity and specificity were 86.79% and 66.90% respectively. The area under the curve of NLR for predicting dPHE was 0.788 (95% CI 0.719-0.856; P<0.001), the optimal cut-off value was 5.683, and the corresponding sensitivity and specificity were 77.36% and 71.13% respectively. Conclusions:sICH patients with higher baseline MMP-9 and NLR are more likely to develop dPHE. Early detection of MMP-9 and NLR in peripheral blood after admission can predict dPHE.
4.The progress in treatment of type 1 of Stargardt disease
Dandan WANG ; Fengjuan GAO ; Shenghai ZHANG ; Qing CHANG ; Gezhi XU ; Jihong WU
Chinese Journal of Ocular Fundus Diseases 2021;37(7):567-572
Stargardt disease (STGD) is one of the most prevalent inherited macular dystrophy, and most often occurs in child or adolescence. Irreversible vision loss is observed in almost all cases. Type 1 (STGD1) is one of the most common type. It is an autosomal recessive condition, caused by mutations in the Abca4 gene. In recent years, encouraging progress has been made in the treatment of STGD1. C20-D3-retinyl acetate (ALK- 001), fenretinide and ICR-14967 (A1120) as visual cycle modulators, StarGen as gene supplementation therapies, and the stem cell transplantation of human embryonic stem cell-derived retinal pigment epithelium cells are the most promising therapies. With the development of studies and clinical trials, the clinical application of various treatments of STGD1 are expected in the near feature, which are expected to save the vision of most patients.
5.knocking out mediated by CRISPR-Cas9 genome editing for PD-L1 attenuation and enhanced antitumor immunity.
Huan DENG ; Songwei TAN ; Xueqin GAO ; Chenming ZOU ; Chenfeng XU ; Kun TU ; Qingle SONG ; Fengjuan FAN ; Wei HUANG ; Zhiping ZHANG
Acta Pharmaceutica Sinica B 2020;10(2):358-373
Blocking the programmed death-ligand 1 (PD-L1) on tumor cells with monoclonal antibody therapy has emerged as powerful weapon in cancer immunotherapy. However, only a minority of patients presented immune responses in clinical trials. To develop an alternative treatment method based on immune checkpoint blockade, we designed a novel and efficient CRISPR-Cas9 genome editing system delivered by cationic copolymer aPBAE to downregulate PD-L1 expression on tumor cells specifically knocking out Cyclin-dependent kinase 5 () gene . The expression of PD-L1 on tumor cells was significantly attenuated by knocking out , leading to effective tumor growth inhibition in murine melanoma and lung metastasis suppression in triple-negative breast cancer. Importantly, we demonstrated that aPBAE/Cas9-Cdk5 treatment elicited strong T cell-mediated immune responses in tumor microenvironment that the population of CD8 T cells was significantly increased while regulatory T cells (Tregs) was decreased. It may be the first case to exhibit direct PD-L1 downregulation CRISPR-Cas9 genome editing technology for cancer therapy. It will provide promising strategy for preclinical antitumor treatment through the combination of nanotechnology and genome engineering.
6. The effect of research on the distance education in the mixed teaching mode of clinical skills
Yanping LI ; Liang LUO ; Yaxin LUO ; Xiaodi WU ; Yanan ZHANG ; Yongmei WANG ; Fengjuan JIN ; Yuan GAO ; Jie GAO ; Qi LI
Chinese Journal of Practical Nursing 2019;35(33):2621-2626
Objective:
To explore the effect of distance education in the teaching mode of medical clinical skills, and to provide theoretical and practical basis for finding a better teaching mode to promote the combination of theory and practice.
Methods:
A total of 172 trainees of clinical skill training in the training center were divided into the control group and the observation group (the observation group was divided into pre-class long-distance group, in-class long-distance group, after-class long-distance group). There were 43 trainees in each group. The control group adopted traditional teaching methods in clinical basic skills courses, and the observation group adopted mixed teaching mode under long-distance education. The satisfaction of teachers and students under the two teaching modes were investigated, and the performance of each group of students in skills, human-computer dialogue, and team first aid comprehensive test were compared.
Results:
There were significant differences in teacher satisfaction between the control group and the pre-class and in-class distance groups (
8.Application of micro-lectures combined with high simulation human in clinical skills teaching for nursing students
Yangping LI ; Liang LUO ; Fengjuan JIN ; Yanan ZHANG ; Yuan GAO ; Zhenkun HAN ; Hong CHEN
Chinese Journal of Practical Nursing 2018;34(24):1898-1902
Objective To explore the effect of micro-lectures withadvanced simulation man in improving the practical skills teaching of nursing students, so as to promote the students' post competency. Methods Totally the 186 nursing internswere divided into control group and observation group by random number method with 93 people in each group. The control group used the traditional teaching modein the teaching of practical skills.The observation group used the micro-lectures with high simulation teaching.Comparing the two groups of nursing students comprehensive assessment test simulation results in the theory, skills, scenarios, and nursing students the evaluation of the curriculum. Results The scores of the two groups were all above the qualification line, but the scores of the observation group were significantly higher than those of the control group (P<0.05). The theoretical examinations and the situation simulation comprehensive testswas(77.89 ± 7.79), (75.60 ± 7.92)points in control group, and (93.87 ± 3.90),(92.87 ± 4.08)points in observation group, there was significant difference between two groups (t=17.67, 18.70,all P=0.000). The curriculum evaluation results of improving learning initiative, active curriculum atmosphere, clear operation demonstration, exercise clinical thinking, improve the clinical interest were 81.72%(76/93), 72.04%(67/93), 93.55%(87/93), 60.22%(56/93), 67.74%(63/93)in control group, and 96.77%(90/93), 95.70%(89/93), 100.00%(93/93), 92.47%(86/93), 98.92%(92/93)in observation group, there was significant difference between two groups(χ2=20.39, P=0.016).Conclusions The effect is significant of micro-lectures combined with high simulation of human using in clinical skills teaching. Thismold can conducive to the cultivation of clinical thinking of nursing students, and improve clinical comprehensive ability, and promote the promotion of nursing students post competency.
9.Progress in research on pathogenic genes of retinitis pigmentosa
Fengjuan GAO ; Shenghai ZHANG ; Fangyuan HU ; Ping XU ; Jihong WU ; Gezhi XU
Chinese Journal of Ocular Fundus Diseases 2018;34(6):605-608
Retinitis pigmentosa (RP) is a group of hereditary blinding fundus diseases caused by abnormalities in photoreceptors of the retina.RP is highly heterogeneous in hereditary and cdinical phenotypes.It can be divided into simple type RP and syndrome type RP.The main inheritance patterns are autosomal dominant,autosomal recessive inheritance and X-linked inheritance.With the popularization and clinical application of gene sequencing technology,more and more disease-causing genes have been discovered,and these genes are mainly expressed in photoreceptor cells and retinal pigment epithelial cell.ln-depth understanding of RP pathogenic genes not only provides a theoretical basis for RP diagnosis and genetic counseling,but also provides guidance for RP gene therapy.
10.Anti-inflammatory effect of stem cells in the treatment of ischemic stroke
Fengjuan GAO ; Shane GAO ; Xu CHEN ; Jian SUN ; Junyi WANG
Chinese Journal of Tissue Engineering Research 2017;21(25):4088-4093
BACKGROUND: A large number of preclinical experimental data have shown that stem cells can regulate the immune function, and serve the function of cell replacement. OBJECTIVE: To summarize the anti-inflammatory effects of stem cells in the treatment of ischemic stroke, based on which, we further discuss the specific mechanisms. METHODS: We conducted a systematic and comprehensive search in PubMed, Elsevier, Springer, Wiley, Ovid, EBSCO databases. The range of retrieval time was from 2012 to 2017. The keywords were stem cells, stroke, inflammation, immune. Totally 110 articles were retrieved initially, and 47 articles were included in result analysis. RESULTS AND CONCLUSION: By reading extensive literature, we analyzed and summarized the research status quo of the anti-inflammatory effects of neural stem cells, mesenchymal stem cells and endothelial cells in the treatment of ischemic stroke. The mechanisms mainly include reducing focal inflammation, immune regulation, promoting the secretion of various neurotrophic factors, reducing secondary cell death, protecting neurons and promoting cell function recovery and further promoting the recovery of nerve function. The mechanisms underlying local immune regulation and anti-inflammatory effects of stem cells are mainly described as the shift from M1 to M2 macrophages under the intervention of stem cell factors, to intervene secreted immune cytokine profiles and exert effects on inhibition and polarization of glial cells. Further investigation is required on the anti-inflammatory effects and immune regulation of stem cell therapy for stroke.

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