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*
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Biomarkers
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East Asian People
2.PD-1 Inhibitor Combined with Azacitidine and HAG Regimen for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: A Prospective, Single-Arm, Phase II Clinical Study.
Cheng-Sen CAI ; Ru-Ju WANG ; Xiao-Yan XU ; Cheng-Yuan GU ; Hui-Zhu KANG ; Yue-Jun LIU ; Yue HAN
Journal of Experimental Hematology 2025;33(4):972-979
OBJECTIVE:
To evaluate the efficacy and safety of PD-1 inhibitor combined with azacitidine and HAG regimen in the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).
METHODS:
This study is a prospective, single-arm, phase II clinical trial that included R/R AML patients who met the inclusion criteria and were treated at The First Affiliated Hospital of Soochow University from December 2020 to August 2023. Patients could undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) after salvage therapy. The efficacy and safety were evaluated.
RESULTS:
Twenty patients were enrolled, including 14 males and 6 females, with an average age of (50.7±15.3) years. The overall response rate (ORR) after one cycle of the treatment was 75.0% (15/20), and 35.0% (7/20) of the patients achieved complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after two cycles of the treatment. Eight patients received allo-HSCT. The main adverse events were hematologic toxicities, and no grade 5 adverse events occurred.
CONCLUSION
The combination of PD-1 inhibitor, azacitidine, and the HAG regimen is a feasible and relatively safe treatment option for R/R AML, thus, to be worth further study.
Humans
;
Leukemia, Myeloid, Acute/drug therapy*
;
Azacitidine/administration & dosage*
;
Male
;
Female
;
Middle Aged
;
Prospective Studies
;
Adult
;
Hematopoietic Stem Cell Transplantation
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Programmed Cell Death 1 Receptor/antagonists & inhibitors*
;
Aged
3.Segmented Time Study and Optimization Strategy for Clinical Application of Ethos Online Adaptive Radiotherapy.
Dandan ZHANG ; Yuhan KOU ; Shilong ZHU ; Xiaoyu LIU ; Meng NING ; Peichao BAN ; Jinyuan WANG ; Changxin YAN ; Zhongjian JU
Chinese Journal of Medical Instrumentation 2025;49(2):134-140
OBJECTIVE:
To analyze the time characteristics of the Ethos online adaptive radiotherapy (OART) process in clinical practice and provide guidance for the comprehensive optimization of each stage of adaptive radiotherapy.
METHODS:
The study involved 61 patients with cervical, rectal, gastric, lung, esophageal, and breast cancers who underwent Ethos OART. The mean ± standard deviation of segmental time, total time, and target volume for these patients were tracked. The time characteristics for different cancer types were evaluated, and the average time for target and organ at risk (OAR) modifications was compared with the average target volume for each cancer type.
RESULTS:
Cervical cancer born the longest total treatment time, while breast cancer had the shortest. For all cancer types except breast cancer, the modification time for target and OAR was the most time-consuming segment. The average time for target and OAR modifications aligned with the trend of the average target volume.
CONCLUSION
The total treatment time for various cancers ranges from 15 to 35 minutes, indicating room for improvement.
Humans
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Radiotherapy Planning, Computer-Assisted/methods*
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Neoplasms/radiotherapy*
;
Female
4.Research Progress of Metal-Organic Frameworks-Aptasensors for Detection of Contaminants in Food and Medicine Homology Substances
Xing GUO ; Jin-Ju TIAN ; Xiao-Zhen TANG ; Xiao-Yue WANG ; Na SONG ; Jin-E WANG ; Chao ZHU
Chinese Journal of Analytical Chemistry 2025;53(4):547-560
In recent years,the market share of food and medicine homology substances has continued to grow,and various types of contamination issues have become the focus of attention both inside and outside the industry.The contamination not only affects the original medicinal quality,but also leads to the accumulation of toxic substances in the human body,causing acute and chronic severe hazards such as vomiting,poisoning and cancer.Therefore,the development of biosensors that can conveniently,accurately and sensitively detect various pollutants in food and medicine homology substances has become a research hotspot.Aptasensors based on metal-organic frameworks(MOFs)with advantages such as strong specificity,rapid response and simple operation,have been widely used in detection of various pollutants.This review focused on the research progress of aptasensors based on MOFs for detection of food and medicine homology contamination in the past few years,and provided a detailed comparison and analysis for detection of chemical pollutants(such as pesticide residues,heavy metal residues,mycotoxins,etc.)and microbial contamination in food and medicine homology substances.Besides,the development trend and possible challenges of MOFs aptasensors in detection of food and medicine homology substances in the future were discussed,which was anticipated to provide a reference for the development of new MOFs aptasensors.
5.Efficacy of tegoprazan versus esomeprazole in treatment of reflux esophagitis and analysis of influencing factors for treatment failure
Yanhong ZHU ; Shangzhi YAO ; Feng JU ; Meilin LI ; Xiaowei WANG
Journal of Clinical Medicine in Practice 2025;29(13):61-65
Objective To compare the efficacy of tegoprazan and esomeprazole in treatment of reflux esophagitis(RE)and analyze the influencing factors for treatment failure.Methods A total of 120 RE patients were selected as study subjects and divided into control group(treated with esome-prazole)and observation group(treated with tegoprazan)using random number table method,with 60 cases in each group.The clinical efficacy and gastroscopic efficacy of the two groups were com-pared.Based on the gastroscopic assessment results,the patients were divided into failure group(26 cases)and success group(94 cases).The clinical data of the failure group and the success group were collected and compared.Multivariate Logistic regression analysis was used to screen the influen-cing factors for treatment failure in RE patients.Results The total clinical effective rate in the ob-servation group was 93.33%(56/60),which was higher than 76.67%(46/60)in the control group(P<0.05).The total effective rate under gastroscopy in the observation group was 88.33%(53/60),which was higher than 68.33%(41/60)in the control group,and the difference was statistically significant(P<0.05).The proportions of patients with body mass index(BMI)>28 kg/m2,diabe-tes,a family history,Helicobacter pylori(Hp)infection,Los Angeles classification(LA classifica-tion)of gastroesophageal reflux disease(GERD)grade C to D,and treated with esomeprazole in the failure group were all higher than those in the success group,and the differences were statistically significant(P<0.05).Multivariate Logistic regression analysis showed that BMI>28 kg/m2,con-comitant diabetes,LA classification grade C to D,and treatment with esomeprazole were all inde-pendent risk factors for treatment failure in RE patients(P<0.05).Conclusion Tegoprazan has a significant clinical effect in treatment of RE,and its efficacy is superior to that of esomeprazole.BMI>28 kg/m2,concomitant diabetes,LA classification grade C to D,and treatment with esome-prazole are all risk factors for treatment failure in RE patients.
6.Effects of hawthorn leaves flavonoids on angiotensin Ⅱ-induced cardiac hypertrophy by regulating miR-21a-5p
Lin-Yan TIAN ; Ran ZHU ; Ju-Ping DAI ; Jia-Jia WANG ; Bin ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(15):2182-2186
Objective To explore the effect and mechanism of hawthorn leaves flavonoids(HLF)on angiotensin Ⅱ(Ang Ⅱ)-induced myocardial hypertrophy.Methods The H9c2 cells were divided into control group(normal culture),model group(100 nmol·L-1 Ang Ⅱ for 24 h),experimental-L,-M,-H groups(received 100 nmol·L-1 Ang Ⅱ for 24 h,then treated with 25,50 and 100 mg·L-1 HLF for 24 h,respectively),anti-miR-NC and anti-miR-21a-5p groups(transfected with anti-miR-NC and anti-miR-21a-5p,then treated with 100 nmol·L-1 Ang Ⅱ for 24 h),miR-NC+high-dose and miR-21a-5p+high-dose group(transfected with miR-NC and miR-21a-5p mimics,then treated with 100 nmol·L-1 Ang Ⅱ for 24 h+100 mg·L-1 HLF for 24 h).The cell viability was detected by cell counting kit-8.The cell apoptosis was measured by flow cytometry.The expression levels of miR-21a-5p was assessed by quantitative real-time polymerase chain reaction.The expression levels of cyclooxygenase-2(COX2)and prostaglandin E2(PGE2)was measured by Western blot.Results The cell viabilities of control,model group experimental-H groups were 1.03±0.09,0.51±0.05 and 0.93±0.08;cell apoptosis rates were(7.69±0.61)%,(23.04±1.82)%and(9.43±0.71)%;the expression levels of miR-21a-5p were 1.00±0.09,2.43±0.18 and 1.09±0.08;the relative expression levels of COX2 protein were 0.42±0.03,0.85±0.08 and 0.40±0.04;the relative expression levels of PGE2 protein were 0.34±0.03,0.75±0.07 and 0.35±0.03;the differences of above indexes were statistically significant between the model group and the control and experimental-H groups(all P<0.05).The cell viabilities of anti-miR-NC,anti-miR-21a-5p,miR-NC+high dose and miR-21a-5p+high dose groups were 0.52±0.04,1.12±0.08,0.94±0.09 and 0.57±0.04;the cell apoptosis rates were(23.04±1.82)%,(9.86±0.73)%,(9.47±0.64)%and(24.96±1.94)%;the expression levels of miR-21a-5p were 1.00±0.10,0.43±0.04,1.00±0.09 and 2.12±0.18;the relative expression levels of COX2 protein were 0.86±0.05,0.39±0.04,0.41±0.03 and 0.78±0.07;the relative expression levels of PGE2 protein were 0.74±0.06,0.38±0.07,0.36±0.02 and 0.71±0.05.Compared the anti-miR-21a-5p group with the anti-miR-NC group,compared the miR-21a-5p+high-dose group with the miR-NC+high-dose group,the differences of above indexes were statistically significant(all P<0.05).Conclusion HLF can inhibit Ang Ⅱ-induced myocardial hypertrophy by regulating the expression of miR-21a-5p and COX2/PGE2 pathway.
7.Mechanism of peimine improving chronic obstructive pulmonary disease induced by lipopolysaccharide combined with cigarette smoke in mice
Pei CHEN ; Xiao-Ju CHEN ; Zhu-Man DU ; Cao-Hui WANG
Acta Anatomica Sinica 2024;55(2):215-221
Objective To investigate the effects and mechanisms of peimine(PME)on chronic obstructive pulmonary disease(COPD)in mice.Methods The mice were randomly divided into 4 groups(20 mice in each group),control group,PME group,chronic obstructive pulmonary disease group and treatment group.Animal models of COPD were induced in mice by lipopolysaccharide combined with smoke.The effects of PME on COPD model mice was analyzed by HE staining,transmission electron microscopy and the ratio of wet/dry weight of mouse lung tissue.The effects of PME on COPD model mice were analyzed by HE staining,transmission electron microscopy and the ratio of wet/dry weight of mouse lung tissue.The effects of PME on inflammatory factor tumor necrosis factor(TNF)-α,interleukin(IL)-6 and IL-1β in lung tissue were analyzed by ELISA and Western blotting.The effects of PME on oxidative stress in lung tissue were analyzed by dihydroethidium(DHE)staining and Western blotting.The effects of PME on nuclear factor kappa-B(NF-κB)pathway and nuclear factor erythroid 2-related factor 2(Nrf2)pathway were analyzed by protein immunoblotting.Results Compared with the COPD group,PME treatment could significantly improve the lung tissue injury and the number of inflammatory cells in mice,and the wet/dry weight ratio of lung tissue was significantly reduced.Compared with the control group,the levels of TNF-α,IL-6 and IL-1β in the alveolar lavage fluid of COPD mice significantly increased,and the level of TNF-α,IL-6 and IL-1β in the alveolar lavage fluid of mice after PME treatment was significantly reduced.In addition,compared with the control group,the protein expression of TNF-α,IL-6 and IL-1β in the lung tissue of COPD mice significantly increased,and the level of TNF-α,IL-6 and IL-1β in the lung tissue of COPD mice after PME treatment were significantly reduced.Immunohistochemistry and Western blotting showed that the level of superoxide dismutase 2(SOD2)protein in COPD group was significantly lower than that in control group,while PME treatment could improve the level of superoxide dismutase protein.The analysis of MDA content in lung tissue showed that compared with the COPD group,the production of MDA in lung tissue of COPD mice was significantly inhibited after PME treatment.Protein Western blotting showed that PME treatment could prevent the phosphorylation of inhibitor of NF-κB(IκBα)and the transfer of NF-κB p65 to the cell nucleus,and the expression of Nrf2 and its main downstream target heme oxygenase-1(HO-1)in the lung tissue of mice treated with PME significantly increased.Conclusion PME is able to inhibit inflammation and oxidative stress and improve lung tissues damage in the COPD model in vivo and this protection effect might be both the Nrf2 pathway activation and NF-κB pathway inhibition.
8.Acromegaly with pregnancy: A case report and review of literature
Jianghua JU ; Huijuan ZHU ; Linjie WANG ; Hongbo YANG ; Yong YAO ; Lian DUAN
Chinese Journal of Endocrinology and Metabolism 2024;40(1):68-72
This article reports the diagnosis and treatment of a case of acromegaly in a pregnant patient who took bromocriptine during pregnancy and delivered successfully. A retrospective summary of the clinical data and treatment outcomes before and after two pregnancies of the patient is provided. The patient took bromocriptine during the second pregnancy, and her condition remained stable. A baby girl was delivered by caesarean section at full term. The article suggests that pregnancy in acromegaly patients, after the stabilization of the condition, can lead to favorable outcomes. The use of dopamine receptor agonists during pregnancy does not increase adverse events during the perinatal period.
9.Investigation of the relationship between metformin and sarcopenia-related traits based on Mendelian randomization
Yue ZHU ; Yinghui JU ; Yuying YANG ; Menglin WANG ; Rui WU
China Pharmacy 2024;35(22):2793-2798
OBJECTIVE To investigate the relationship between metformin and sarcopenia-related traits. METHODS Based on the data from publicly genome-wide association study-related databases, using single nucleotide polymorphisms strongly associated with metformin as instrumental variables, the two-sample Mendelian randomization (MR) analysis methods [inverse variance weighting (IVW) method, MR-Egger regression method and weighted median estimator method] were employed to investigate the relationship between metformin and three sarcopenia-related traits (low grip strength, muscle mass and walking speed). Cochran’s Q test was used to assess heterogeneity, MR-Egger intercept test was used to detect horizontal pleiotropy, and leave-one-out analysis was performed for sensitivity analysis. RESULTS The results of IVW method showed that metformin use was significantly associated with an increased risk of low grip strength (β=1.550, 95%CI was 0.389-2.711, P=0.009) and reduced limb muscle mass (right leg lean body mass: β=-0.665, 95%CI was -1.018--0.312, P<0.001; left leg lean body mass: β=-0.710, 95%CI was -1.049--0.371,P<0.001; right arm lean body mass: β=-0.471, 95%CI was -0.890--0.053, P=0.027; left arm lean body mass: β=-0.463, 95%CI was -0.865--0.061, P=0.024),but was not associated with walking speed. The results or causal effects of the other two methods are consistent with it. The Cochran’s Q test indicated some degree of heterogeneity in the result of this study. No horizontal pleiotropy was detected by the MR-Egger intercept test. The sensitivity analysis suggested that the results of this study were stable. CONCLUSIONS Metformin may increase the risk of sarcopenia.
10.Latent tuberculosis infection among close contacts of positive etiology pul-monary tuberculosis in Chongqing
Rong-Rong LEI ; Hong-Xia LONG ; Cui-Hong LUO ; Ben-Ju YI ; Xiao-Ling ZHU ; Qing-Ya WANG ; Ting ZHANG ; Cheng-Guo WU ; Ji-Yuan ZHONG
Chinese Journal of Infection Control 2024;23(3):265-270
Objective To investigate the current situation and influencing factors of latent tuberculosis infection(LTBI)among close contacts of positive etiology pulmonary tuberculosis(PTB)patients,provide basis for formula-ting intervention measures for LTBI.Methods A multi-stage stratified cluster random sampling method was used to select close contacts of positive etiology PTB patients from 39 districts and counties in Chongqing City as the study objects.Demographic information was collected by questionnaire survey and the infection of Mycobacterium tuberculosis was detected by interferon gamma release assay(IGRA).The influencing factors of LTBI were analyzed by x2 test and binary logistic regression model.Results A total of 2 591 close contacts were included,the male to female ratio was 0.69∶1,with the mean age of(35.72±16.64)years.1 058 cases of LTBI were detected,Myco-bacterium tuberculosis latent infection rate was 40.83%.Univariate analysis showed that the infection rate was dif-ferent among peoples of different age,body mass index(BMI),occupation,education level,marital status,wheth-er they had chronic disease or major surgery history,whether they lived together with the indicator case,and whether the cumulative contact time with the indicator case ≥250 hours,difference were all statistically significant(all P<0.05);infection rate presented increased trend with the increase of age and BMI(both P<0.001),and decreased trend with the increase of education(P<0.05).Logistic regression analysis showed that age 45-54 years old(OR=1.951,95%CI:1.031-3.693),age 55-64 years old(OR=2.473,95%CI:1.279-4.781),other occupations(OR=0.530,95%CI:0.292-0.964),teachers(OR=0.439,95%CI:0.242-0.794),students(OR=0.445,95%CI:0.233-0.851),junior high school education or below(OR=1.412,95%CI:1.025-1.944),BMI<18.5 kg/m2(OR=0.762,95%CI:0.586-0.991),co-living with indicator cases(OR=1.621,95%CI1.316-1.997)and cumu-lative contact time with indicator cases ≥250 hours(OR=1.292,95%CI:1.083-1.540)were the influential fac-tors for LTBI(all P<0.05).Conclusion The close contacts with positive etiology PTB have a high latent infection rate of Mycobacterium tuberculosis,and it is necessary to pay attention to close contacts of high age,farmers,and frequent contact with patients,and take timely targeted interventions to reduce the risk of occurrence of disease.

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