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.Metformin alleviates renal tubular injury in diabetic kidney disease by activating mitophagy and inhibiting ferroptosis via HIF-1α/MIOX axis.
Qinrui WU ; Yanyan ZHAO ; Fengjuan HUANG
Journal of Pharmaceutical Analysis 2025;15(10):101284-101284
Renal tubular injury has emerged as a critical factor in the progression of diabetic kidney disease (DKD). Given renal tubules' high mitochondrial density and susceptibility to mitochondrial dysregulation and ferroptosis, targeting these pathways could offer therapeutic potential. Metformin (MET), a first-line therapy for type 2 diabetes mellitus (T2DM), exerts reno-protective effects by improving mitochondrial function and attenuating fibrosis; however, its role in regulating ferroptosis in DKD remains unclear. This study aimed to investigate the role of MET in modulating mitophagy and ferroptosis in diabetic kidneys. In diabetic mouse models, MET notably alleviated tubular injury by promoting mitophagy and reducing ferroptosis, as shown by increasing levels of phosphatase and tensin homolog (PTEN)-induced putative kinase 1 (PINK1) and Parkin, while decreased levels of malondialdehyde (MDA) and iron content. Mechanistically, MET downregulated the hypoxia-inducible factor-1alpha (HIF-1α)/myo-inositol oxygenase (MIOX) signaling axis in renal tubular epithelial cells (RTECs), thereby restoring mitophagy and inhibiting ferroptosis. These findings demonstrate that MET mitigates diabetic renal injury by promoting mitophagy and countering ferroptosis via suppressing the HIF-1α/MIOX pathway, highlighting its potential as a therapeutic intervention for halting DKD progression.
3.Self Precipitation Analysis of Erhuang Powder and Its Effect on HeLa Cells
Xinyi WANG ; Shuyu ZHAO ; Xiufeng YU ; Feng GUAN ; Weinan LI ; Fengjuan HAN ; Yanhong WANG
Chinese Journal of Modern Applied Pharmacy 2024;41(12):1604-1614
OBJECTIVE
To explore the self precipitation source of Erhuang powder, determine the content of related components and its efficacy on HeLa cells.
METHODS
Bifurcation study to identify the main compatibility of precipitating. The self precipitation, supernatant and extract of Erhuang powder were analyzed by UHPLC-Q-Exactive MS. The main compounds in Coptidis Rhizoma and Catechu, catechin, epicatechin, epicberberine, coptisine, berberine and palmatine were selected as controls. A analysis method of UHPLC for self precipitation, supernatant and extract of Erhuang powder was established and the related components were quantitatively determined. The effects of self precipitation, supernatant and extract on HeLa cells were evaluated by MTT method and flow cytometry.
RESULTS
A slight flocculation precipitate appeared when the decoction of Erhuang powder was mixed in pairs, while a large amount of flocculation appeared when the decoction of Coptidis Rhizoma and Catechu water was mixed. The self precipitation, supernatant and extract samples contained 39 compounds, which were mainly alkaloids and phenolic acids. The contents of catechin and berberine in the 6 index components were mostly, which accounted for 73.56% of the total content of the index components in self precipitation and 61.89% of the total content of the index components in extract. Inhibition effect on HeLa cells: extract ≈ self precipitation > supernatant, and inducing apoptosis: self precipitate ≈ extract, supernatant had no apoptosis-inducing effect.
CONCLUSION
Coptidis Rhizoma-Catechu is the main compatible formula for precipitation formation. The self precipitation and extracts of Erhuang powder are mainly alkaloids and phenolic acids, among which berberine and catechin are high in content and can be used as representative components. The effect of self-precipitation and extract on HeLa cells was better than that of supernatant. This basically indicates that the self precipitation components and pharmacological effects of Erhuang powder are similar to those of the extract.
4.Analysis of risk factors for hemorrhage during CT-guided lung biopsy based on a random forest model
Yong LI ; Xiaohui ZHAO ; Fang LIU ; Wenge XING ; Fengjuan LI ; Jinhai SHI ; Jiaxin LIU ; Chengmin YANG
Chinese Journal of Blood Transfusion 2024;37(10):1110-1114,1121
Objective To systematically analyze and identify key risk factors for postoperative pulmonary hemorrhage u-sing a combination of the random forest(RF)model and traditional logistic regression analysis,so as to provide data support for clinical practice.Methods This study included patients who underwent needle biopsy of lung masses from January 2020 to December 2023 in the Department of Interventional Therapy,Cancer Hospital,Tianjin Medical University.There were 844 cases,including 387 males and 457 females,ranging in age from 39 to 82 years.Clinical data and puncture-related characteristics were collected,including tumor size,puncture depth,puncture angle,presence of emphysema,lesion loca-tion in the lung,body position during puncture,whether the puncture passed through the interlobar fissure,and the number of punctures.The RF model was used to rank the importance of all variables,identifying those with the highest predictive value.Subsequently,a multivariate logistic regression model was applied to the top-ranked important variables to further e-valuate their independent impact on postoperative pulmonary hemorrhage.Results The RF model results showed that tumor size and puncture depth had the highest importance in predicting the risk of postoperative pulmonary hemorrhage.Multivari-ate logistic regression analysis further confirmed that smaller tumor size(HR:0.980,95%CI:0.971-0.989,P<0.05)was significantly associated with a lower risk of hemorrhage,while greater puncture depth(HR:1.146,95%CI:1.063-1.235,P<0.05)was closely related to a higher risk of hemorrhage.Additionally,other factors such as puncture angle,age,lesion location in the lung and presence of emphysema showed some influence but did not reach statistical significance in the multi-variate analysis.Conclusion This study successfully identified tumor size and puncture depth as independent risk factors for postoperative pulmonary hemorrhage by combining the RF model with multivariate logistic regression analysis.The appli-cation of the RF model improved the accuracy of feature selection,allowing us to focus on the most contributory predictive variables.These findings provide important support for preoperative risk assessment,suggesting that clinicians should priori-tize these key factors in preoperative evaluations to develop safer and more effective surgical plans,thereby reducing the risk of postoperative hemorrhage and other complications.
5.Research progress of depression trajectory in cancer patients
Huiyu LAN ; Xiaolian NONG ; Shihuan HUANG ; Fanrong LI ; Fengjuan ZHAO ; Xuemei YOU
Practical Oncology Journal 2024;38(4):262-267
Cancer patients generally suffer from depression,and long-term depression may exacerbate fatigue,sleep disor-ders,pain,and psychological distress,affecting the overall treatment effectiveness of cancer patients and ultimately impacting their quality of life and prognosis.Therefore,this article mainly reviews the research status and influencing factors of depression trajectories in cancer patients,providing reference for precise and personalized depression management for cancer patients.
6.Application of different preprotein converting subtilisin/kexin type 9 inhibitors in hypercholesterolemia
Delong ZHAO ; Haiyan ZHOU ; Fengjuan YUE ; Wei LI
Journal of Clinical Medicine in Practice 2024;28(9):29-33
Objective To explore the application value of different preprotein converting subtilisin/kexin type 9 (PCSK9) inhibitors in familial hypercholesterolemia(FH). Methods Patients with FH in our hospital were selected and divided into alirocumab group and evolocumab group according to the different PCSK9 inhibitors after excluding the confounding factors of baseline data such as gender and age by propensity score matching, 41 patients in each group were matched. Both groups were treated for 3 months. The therapeutic effect, and blood lipids levels[triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) index, apolipoprotein A1 (Apo A1), apolipoprotein B (Apo B)], coronary flow reserve[absolute coronary flow reserve (CFR), relative coronary flow reserve (rCFR), fractional flow reserve (FFR)], endothelial function indicators[serum nitric oxide (NO), endothelin-1 (ET-1), flow mediated dilatation (FMD)]and adverse reactions before and after treatment were compared between both groups. Results After three months of treatment, the overall standardized rate of LDL-C in the alirocumab group was 97.56 % (40/41), and 92.68 % in the evolocumab group, but there was no statistically significant difference between the two groups (
7.Fatty acid metabolism and ovarian cancer
Tingting FAN ; Danni DING ; Zixue ZHAO ; Yang YU ; Fengjuan HAN
Practical Oncology Journal 2023;37(5):429-433
Ovarian cancer is a common malignant tumor in the female reproductive system,and its pathogenesis and regulato-ry mechanisms are extremely complex and still unclear.Fatty acid metabolism mainly involves the processes of fatty acid uptake,syn-thesis,and oxidation.Previous studies have shown that fatty acid metabolism plays a unique role in the occurrence and development of ovarian cancer.Therefore,this article reviews existing literature and delves into the correlation between fatty acid metabolism and ovarian cancer,aiming to provide new perspectives and reflections on the mechanism of fatty acid metabolism and targeted treatment of ovarian cancer.
8.Endoscopic characteristics of colorectal laterally spreading tumors and the risk factors for carcinogenesis and submucosal invasion
Tianxiang ZHAO ; Fengjuan ZHANG ; Mingjun SUN
Chinese Journal of Digestive Endoscopy 2023;40(8):639-647
Objective:To analyze the endoscopic and pathological features of laterally spreading tumors (LST) and to explore the risk factors for carcinogenesis and submucosal invasion.Methods:From January 2019 to August 2021, the gender, age, endoscopic and pathological characteristics of patients with colorectal LST who underwent endoscopic treatment in the First Hospital of China Medical University were retrospectively analyzed. Univariate analysis was used to determine the risk factors for carcinogenesis and submucosal invasion, and the factors with significant differences were included in multivariate logistic regression analysis.Results:A total of 422 patients were enrolled, including 224 males and 198 females, with the mean age of 63.45±9.23 years. A total of 456 LST lesions were detected. The length of endoscopic resection specimens was 3.01 ± 0.48 cm and the length of lesions was 2.37±1.59 cm. One hundred and fifteen (25.2%) lesions were located in the rectum, 40 (8.8%) in the sigmoid colon, 26 (5.7%) in the descending colon, 109 (23.9%) in the transverse colon, 112 (24.6%) in the ascending colon, 54 (11.8%) in the caecum. Endoscopic submucosal dissection (ESD), endoscopic mucosal resection(EMR), EMR with pre-cutting, and ESD with snare were performed in 237 (52.0%), 95 (20.8%), 113 (24.8%) and 11 (2.4%) lesions. Hemorrhage occurred in 4 lesions and perforations occurred in 5. Pathological results showed 119 cases (26.1%) of low-grade intraepithelial neoplasia, 221 cases (48.5%) of high-grade intraepithelial neoplasia, 82 cases (18.0%) of intramucosal carcinoma, and 34 cases (7.5%) of submucosal invasive carcinoma. Multivariate logistic regression analysis showed that the size of the lesion more than 2 cm, the location of the lesion in the rectum, the endoscopic classification of LST-NG pseudodepressed type (LST-NG-PD), LST-G homogenous type (LST-G-H) and LST-G nodular mixed type (LST-G-M), and the presence of large nodules were independent risk factors for carcinogenesis. Endoscopic classification of LST-NG-PD and LST-G-M and the presence of large nodules were independent risk factors for submucosal infiltration.Conclusion:There are significant differences in the endoscopic and pathological features of the four subtypes of LST. The size and the location of the lesion, the endoscopic classification and the presence of large nodules are independent risk factors for carcinogenesis. Endoscopic classification and the presence of large nodules are independent risk factors for submucosal infiltration. Endoscopic treatment of LST is safe and effective with less complications. Different endoscopic treatment methods have their own advantages.
9.Regulation of Flavonoid Monomers on Signaling Pathways in Ovarian Cancer: A Review
Zhen ZHAO ; Jiayue XU ; Shaoxuan LIU ; Fengjuan HAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(19):222-230
Ovarian cancer is a malignant tumor of female reproductive system with high morbidity and mortality. Currently, ovarian cancer patients are mainly treated by primary debulking surgery combined with taxotere/cyclophosphamide (TC) chemotherapy, with the five-year survival rate of 36%-46%. Chinese medicinal materials play a positive role in preventing the occurrence and development of ovarian cancer via multiple targets. The flavonoid monomers in representative Chinese herbal medicines, such as Epimedii Folium, Scutellariae Radix, Curcumae Longae Rhizoma, Ginkgo Folium, Bupleuri Radix, and Longicerae Japonicae Flos, have been proved to have significant anti-tumor activity and been widely used in the treatment of malignant tumors. We reviewed the relevant literature and summarized that flavonoid monomers can regulate multiple signaling pathways to inhibit cell proliferation, block tumor cell cycle, induce apoptosis and autophagy, reduce the ability of cell invasion and migration, inhibit tumor angiogenesis, and reverse platinum resistance, thereby inhibiting the occurrence and development of ovarian cancer. Such pathways include phosphatidylinositol 3- kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway, Janus kinase (JAK)/signal transducer and activator of transcription 3 (STAT3) signaling pathway, mitogen-activated protein kinase (MAPK) signaling pathway, secreted glycoprotein (Wnt)/β-catenin signaling pathway, Notch signaling pathway, and nuclear factor kappaB (NF-κB) signaling pathway. By reviewing the regulatory effect of flavonoid monomers on the signaling pathways of ovarian cancer, we aim to provide a theoretical basis for the research on the roles of flavonoid monomers in inhibiting the occurrence and development of ovarian cancer.
10.On the application of standardized patient combined with situational simulation teaching in the course of Intensive and Critical Diseases Care among higher vocational college students
Ying XU ; Qiuxing HUANG ; Wenjuan SONG ; Meihua KUANG ; Fengjuan ZHAO ; Yu BI
Chinese Journal of Medical Education Research 2021;20(1):100-104
Objective:To explore the application effect of standardized patient combined with situational simulation teaching in the course of Intensive and Critical Diseases Care among higher vocational college students.Methods:A total of 66 nursing students in direction of intensive care from Batch 2015 and 60 ones from Batch 2016 were selected as the control group and the experiment group respectively. The control group adopted traditional teaching method, while the experiment group adopted the model of standardized patient combined with situational simulation teaching on the basis of traditional teaching methods. Before teaching, we designed the standard cases of the course, set up and trained the standardized patient team members. Then the standardized patient combined with situational simulation teaching was applied to the experimental teaching of the course. At the end of the course, the comparison of the theoretical examination score and the operational examination score of the two groups of students was made, and the self-designed questionnaire survey for the experimental group was used to evaluate the teaching effect.Results:The theoretical examination score [(82.80±4.17) points] and the operational examination score [(85.90±1.85) points] of students in the experiment group were higher than those of students in the control group [(80.74±3.15) points vs. (83.82±1.91) points], with significant differences ( P<0.01). The results of self-designed questionnaire survey showed that more than 90.0% of the students from the experiment group thought that this teaching mode could improve their interest in learning and subjective initiative; more than 76.7% thought that this teaching mode could improve their own abilities such as observation of disease changes, communication, teamwork and clinical thinking; more than 93.3% recognized the application of this teaching mode. Conclusion:The application of standardized patient combined with situational simulation teaching could improve the theoretical knowledge and operational skills of the students, and could also train the students' comprehensive quality such as clinical thinking, emergency handling ability, communication ability and so on, so as to improve the teaching effect.


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