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 systemic inflammatory response index as a risk factor for all-cause and cardiovascular mortality among individuals with coronary artery disease: evidence from the cohort study of NHANES 1999-2018.
Dao-Shen LIU ; Dan LIU ; Hai-Xu SONG ; Jing LI ; Miao-Han QIU ; Chao-Qun MA ; Xue-Fei MU ; Shang-Xun ZHOU ; Yi-Xuan DUAN ; Yu-Ying LI ; Yi LI ; Ya-Ling HAN
Journal of Geriatric Cardiology 2025;22(7):668-677
BACKGROUND:
The association of systemic inflammatory response index (SIRI) with prognosis of coronary artery disease (CAD) patients has never been investigated in a large sample with long-term follow-up. This study aimed to explore the association of SIRI with all-cause and cause-specific mortality in a nationally representative sample of CAD patients from United States.
METHODS:
A total of 3386 participants with CAD from the National Health and Nutrition Examination Survey (NHANES) 1999-2018 were included in this study. Cox proportional hazards model, restricted cubic spline (RCS), and receiver operating characteristic curve (ROC) were performed to investigate the association of SIRI with all-cause and cause-specific mortality. Piece-wise linear regression and sensitivity analyses were also performed.
RESULTS:
During a median follow-up of 7.7 years, 1454 all-cause mortality occurred. After adjusting for confounding factors, higher lnSIRI was significantly associated with higher risk of all-cause (HR = 1.16, 95% CI: 1.09-1.23) and CVD mortality (HR = 1.17, 95% CI: 1.05-1.30) but not cancer mortality (HR = 1.17, 95% CI: 0.99-1.38). The associations of SIRI with all-cause and CVD mortality were detected as J-shaped with threshold values of 1.05935 and 1.122946 for SIRI, respectively. ROC curves showed that lnSIRI had robust predictive effect both in short and long terms.
CONCLUSIONS
SIRI was independently associated with all-cause and CVD mortality, and the dose-response relationship was J-shaped. SIRI might serve as a valid predictor for all-cause and CVD mortality both in the short and long terms.
3.68 Ga-DOTATOC,a new diagnostic agent for localization of somatostatin receptor positive neuroendocrine tumors
Si-Miao ZHAO ; Chao-Yang CHEN ; Ran WEI ; Xuan-Ling ZHANG ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(11):1654-1657
68Ga-DOTATOC injection is a radiopharmaceutical agent for positron emission tomography localization of somatostatin receptor positive neuroendocrine tumors(NETs)in adult and pediatric patients.68 Ga-DOTATOC binds to cells that express somatostatin receptors(SSTRs),including malignant neuroendocrine cells that overexpress SSTR2 receptor.Gallium-68 is a radionuclide used in positron emission tomography for tumor diagnosis.This paper introduces its the mechanism of action,pharmacokinetics,usage and dosage,clinical evaluation,safety and use in specific populations.
4.Surveillance of bacterial resistance in tertiary hospitals across China:results of CHINET Antimicrobial Resistance Surveillance Program in 2022
Yan GUO ; Fupin HU ; Demei ZHU ; Fu WANG ; Xiaofei JIANG ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Yuling XIAO ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Jingyong SUN ; Qing CHEN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yunmin XU ; Sufang GUO ; Yanyan WANG ; Lianhua WEI ; Keke LI ; Hong ZHANG ; Fen PAN ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Wei LI ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Qian SUN ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanqing ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Wenhui HUANG ; Juan LI ; Quangui SHI ; Juan YANG ; Abulimiti REZIWAGULI ; Lili HUANG ; Xuejun SHAO ; Xiaoyan REN ; Dong LI ; Qun ZHANG ; Xue CHEN ; Rihai LI ; Jieli XU ; Kaijie GAO ; Lu XU ; Lin LIN ; Zhuo ZHANG ; Jianlong LIU ; Min FU ; Yinghui GUO ; Wenchao ZHANG ; Zengguo WANG ; Kai JIA ; Yun XIA ; Shan SUN ; Huimin YANG ; Yan MIAO ; Mingming ZHOU ; Shihai ZHANG ; Hongjuan LIU ; Nan CHEN ; Chan LI ; Jilu SHEN ; Wanqi MEN ; Peng WANG ; Xiaowei ZHANG ; Yanyan LIU ; Yong AN
Chinese Journal of Infection and Chemotherapy 2024;24(3):277-286
Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in tertiary hospitals in major regions of China in 2022.Methods Clinical isolates from 58 hospitals in China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2022 Clinical &Laboratory Standards Institute(CLSI)breakpoints.Results A total of 318 013 clinical isolates were collected from January 1,2022 to December 31,2022,of which 29.5%were gram-positive and 70.5%were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species(excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi)was 28.3%,76.7%and 77.9%,respectively.Overall,94.0%of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 90.8%of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis showed significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 94.2%in the isolates from children and 95.7%in the isolates from adults.The resistance rate to carbapenems was lower than 13.1%in most Enterobacterales species except for Klebsiella,21.7%-23.1%of which were resistant to carbapenems.Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.1%to 13.3%.The prevalence of meropenem-resistant strains decreased from 23.5%in 2019 to 18.0%in 2022 in Pseudomonas aeruginosa,and decreased from 79.0%in 2019 to 72.5%in 2022 in Acinetobacter baumannii.Conclusions The resistance of clinical isolates to the commonly used antimicrobial agents is still increasing in tertiary hospitals.However,the prevalence of important carbapenem-resistant organisms such as carbapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a downward trend in recent years.This finding suggests that the strategy of combining antimicrobial resistance surveillance with multidisciplinary concerted action works well in curbing the spread of resistant bacteria.
5.Analysis of CSF3R Gene Mutations and Clinical Characteristics in Patients with t(8;21) Acute Myeloid Leukemia.
Miao CUI ; Qing-Yun LI ; Xu-Zhang LU ; Hong-Ying CHAO ; Xiao-Hui CAI ; Jie LIU ; Hai-Ying HUA ; Pin WU
Journal of Experimental Hematology 2023;31(4):1019-1025
OBJECTIVE:
To investigate the occurrence of CSF3R mutation in patients with t(8;21) acute myeloid leukemia (AML) and its correlation with some clinical parameters.
METHODS:
The clinical and laboratory data of 167 newly diagnosed AML patients with t(8;21) translocation were analyzed retrospectively. High-throughput DNA sequencing technology combined with Sanger sequencing method was used to detect 112 gene mutations. The occurrence of CSF3R gene mutation and its influence on the remission rate after chemotherapy were analyzed.
RESULTS:
Among 167 patients with t(8;21) AML, 15 patients (9.0%) carried CSF3R mutations, including 6 cases of membrane proximal region mutations and 9 cases of truncation mutations in the cytoplasmic tail. The most common coexisting mutations of CSF3R were KIT (40.0%), TET2 (33.3%), DNMT3A (26.7%), FLT3 (20.0%), CBL (20.0%), IDH1 (13.3%), etc. Compared with the wild type, the CSF3R mutant group had a higher mutation rate of DNA methylation-related genes(P <0.001). The median peripheral white blood cell (WBC) count of patients with CSF3R gene mutation was 5.80 (3.20-8.56)×109/L at initial diagnosis, which was significantly lower than 8.80 (5.26-19.92)×109/L of the CSF3R wild-type patients (P =0.017). There was no significant difference between the two groups in sex, median age, FAB classification, hemoglobin level, platelet count, etc. (P >0.05). The CR rate of the CSF3R gene mutation group (100%) was significantly higher than that of the wild-type group (86.8%), but the difference was not statistically significant (P >0.05). The CSF3R gene mutation group had a significantly higher CD19 positive rate and a higher -X rate than the wild group (86.7% vs 47.4%, P =0.004; 33.3% vs 13.2%, P =0.037).
CONCLUSION
There is a high incidence of CSF3R mutation in t (8;21) AML patients. The clinical characteristics and coexisting mutation genes of CSF3R mutation-positive patients are different from those of wild-type patients.
Humans
;
Retrospective Studies
;
Prognosis
;
Leukemia, Myeloid, Acute/genetics*
;
Mutation
;
Signal Transduction
;
Receptors, Colony-Stimulating Factor/genetics*
6.Current and recent cigarette smoking in relation to cardiovascular and non-cardiovascular mortality in an elderly male Chinese population.
Wen-Yuan-Yue WANG ; Xiao-Fei YE ; Chao-Ying MIAO ; Wei ZHANG ; Chang-Sheng SHENG ; Qi-Fang HUANG ; Ji-Guang WANG
Journal of Geriatric Cardiology 2023;20(8):567-576
OBJECTIVE:
To investigate the association between current and former smoking and the risk of mortality in elderly Chinese men.
METHODS:
Our study participants were elderly (≥ 60 years) men recruited in a suburban town of Shanghai. Cigarette smoking status was categorized as never smoking, remote (cessation > 5 years) and recent former smoking (cessation ≤ 5 years), and light-to-moderate (≤ 20 cigarettes/day) and heavy current smoking (> 20 cigarettes/day). Cox proportional hazards models and restricted cubic splines were used to examine the associations of interest.
RESULTS:
The 1568 participants had a mean age of 68.6 ± 7.1 years. Of all participants, 311 were never smokers, 201 were remote former smokers, 133 were recent former smokers, 783 were light-to-moderate current smokers and 140 were heavy current smokers. During a median follow-up of 7.9 years, all-cause, cardiovascular and non-cardiovascular deaths occurred in 267, 106 and 161 participants, respectively. Heavy current smokers had the highest risk of all-cause and non-cardiovascular mortality, with an adjusted hazard ratio (HR) of 2.30 (95% CI: 1.34-4.07) and 3.98 (95% CI: 2.03-7.83) versus never smokers, respectively. Recent former smokers also had a higher risk of all-cause (HR = 1.62, 95% CI: 1.04-2.52) and non-cardiovascular mortality (HR = 2.40, 95% CI: 1.32-4.37) than never smokers. Cox regression restricted cubic spline models showed the highest risk of all-cause and non-cardiovascular mortality within 5 years of smoking cessation and decline thereafter. Further subgroup analyses showed interaction between smoking status and pulse rate (≥ 70 beats/min vs. < 70 beats/min) in relation to the risk of all-cause and non-cardiovascular mortality, with a higher risk in current versus never smokers in those participants with a pulse rate below 70 beats/min.
CONCLUSIONS
Cigarette smoking in elderly Chinese confers significant risks of mortality, especially when recent former smoking is considered together with current smoking.
7.Clinical analysis of 6 critically ill children with acute chlorine poisoning.
Wen Miao XU ; Heng Miao GAO ; Ying Chao LIU ; Li Juan WANG ; Su Yun QIAN
Chinese Journal of Pediatrics 2022;60(2):124-128
Objective: To analyze the clinical characteristics and treatment of critically ill children with acute chlorine poisoning and explore the risk factors and effective strategies. Methods: This retrospective study collected the clinical data, including general state, clinical characteristics, treatment and follow-up(till 1 year and 6 months after discharge), of 6 critically ill children who were hospitalized in the Pediatric Intensive Care Unit of Beijing Children's Hospital due to acute chlorine poisoning in August 2019. Results: There were 6 children characterized by severe dyspnea in this accident, among whom 4 were boys and two girls, aged 4-12 years. When the accident occurred, they were within 5 m of the chlorine source. These patients underwent tracheal intubation and mechanical ventilation in 3.5-7.0 h after poisoning. The child who was the closest to the chlorine source (1.5 m) and took the longest time (5 min) to evacuate was the most severe one. He suffered hypoxia which could not be corrected by conventional mechanical ventilation and severe shock, then had veno-arterial extracorporeal membrane oxygenation(ECMO) treatment started 10 h after the accident. All the 6 children in this study survived. Following-up found no growth and developmental abnormality. The pulmonary function tests were normal except for one case with increased small airway resistance due to previous suspected asthma, and the lung CT, electhoencephalogram, and brain magnetic resonance imaging were all normal. Conclusions: Severe chlorine poisoning is mainly characterized by respiratory failure. Mechanical ventilation is often required within a few hours after poisoning. When conventional mechanical ventilation is ineffective, ECMO could save live. Timely treatment could improve prognosis.
Child
;
Chlorine
;
Critical Illness
;
Extracorporeal Membrane Oxygenation
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Female
;
Humans
;
Male
;
Respiratory Insufficiency/therapy*
;
Retrospective Studies
8.Impairment of TRPC1-BK complex in diabetic rat coronary artery.
Manqing SUN ; Lingling QIAN ; Lingfeng MIAO ; Ying WU ; Xiaoyu LIU ; Shipeng DANG ; Xu TANG ; Zhenye ZHANG ; Chao WANG ; Qiang CHAI ; Fu YI ; Jianfeng HAO ; Ruxing WANG
Chinese Medical Journal 2022;135(15):1873-1875
9.Risk factors for acute kidney injury after hematopoietic stem cell transplantation in children: a retrospective study.
Jian LIU ; Zhi-Wei CHEN ; Ying-Jie WANG ; Yu-Miao MAI ; Hui-Hui HU ; Bing REN ; Ying-Chao WANG ; Yu-Feng LIU
Chinese Journal of Contemporary Pediatrics 2022;24(10):1136-1142
OBJECTIVES:
To investigate the risk factors for acute kidney injury (AKI) after hematopoietic stem cell transplantation (HSCT) in children.
METHODS:
A retrospective analysis was performed on the medical data of 111 children who underwent HSCT from January 2018 to January 2020. A multivariate logistic regression analysis was used to identify the risk factors for AKI. The Kaplan-Meier survival analysis was used to compare the prognosis in children with different grades of AKI.
RESULTS:
Graft-versus-host disease (grade Ⅱ-Ⅳ) (OR=4.406, 95%CI: 1.501-12.933, P=0.007), hepatic veno-occlusive disease (OR=4.190, 95%CI: 1.191-14.740, P=0.026), and thrombotic microangiopathy (OR=10.441, 95%CI: 1.148-94.995, P=0.037) were closely associated with the development of AKI after HSCT. The children with stage Ⅲ AKI had a lower 1-year survival rate than those without AKI or with stage Ⅰ AKI or stage Ⅱ AKI (28.6%±12.1% vs 82.8%±5.2%/81.7%±7.4%/68.8%±11.6%; P<0.05).
CONCLUSIONS
Children with stage Ⅲ AKI after HSCT have a higher mortality rate. Graft-versus-host disease, hepatic veno-occlusive disease, and thrombotic microangiopathy are closely associated with the development of AKI after HSCT.
Child
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Humans
;
Retrospective Studies
;
Hematopoietic Stem Cell Transplantation/adverse effects*
;
Graft vs Host Disease/complications*
;
Risk Factors
;
Acute Kidney Injury/therapy*
;
Thrombotic Microangiopathies/complications*
10.Application of initial anti-infectives and trends in children with septic shock.
Gang LIU ; Yu Lei Chen ZHENG ; Na TAN ; Li Juan WANG ; Ying Chao LIU ; Heng Miao GAO ; Su Yun QIAN
Chinese Journal of Pediatrics 2022;60(12):1288-1294
Objective: To investigate the pathogen composition, initial anti-infectives and pathogen coverage, and trends over the last 5 years in children with septic shock in pediatric intensive care unit (PICU). Methods: The single-center retrospective study included 257 children with septic shock who were admitted to PICU of Beijing Children's Hospital, Capital Medical University from 2017 to 2021. The causitive pathogen composition, initial use of anti-infective drugs, pathogen coverage, and changes in recent years were analyzed. The children were divided into sufficient and insufficient coverage groups according to whether the pathogen were sufficiently covered by initial anti-infectives; community-and hospital-acquired groups; and with and without underlying disease groups. T test, rank-sum test and Chi-square test were used for comparison between the groups to investigate the differences in pathogen, treatment and prognosis. Results: A total of 257 septic shock children were included, with 162 males and 95 females, aged 36 (12, 117) months. The pathogen positive rate was 64.6% (166/257) and the in-hospital mortality was 27.6% (71/257). In the 208 pathogen-positive samples, bacteria was the most common (57.7%, 120/208) with G-negative bacteria predominating (55.8%, 67/120), followed by viruses (26.0%, 54/208). Nearly 99.2% (255/257) of the children were treated with antibacterial at the beginning, of whom 47.1% (121/257) were treated with carbapenems combined with vancomycin or linezolid. The proportion of 3 or more antibacterial combinations was higher in children with underlying diseases and hospital-acquired septic shock than in those without underlying disease or community-acquired septic shock (27.4% (49/179) vs. 14.1% (11/78), 29.4% (52/177) vs. 10.0% (8/80), χ2=5.35,11.56,all P<0.05). The proportion of initial combination of carbapenem and vancomycin or linezolid reduced from 52.5% (21/40) to 41.3% (19/46), and of adequate pathogen coverage increased from 40.0% (16/40) to 58.7% (27/46) in the last five years. Conclusions: The initial use of antibacterial drugs is common in children with septic shock in PICU, especially in those with hospital-acquired septic shock and underlying diseases. In recent years, antimicrobial combinations have decreased, but the pathogen coverage has improved, indicating that drug selection is more reasonable and accurate.
Child
;
Female
;
Male
;
Humans
;
Shock, Septic/drug therapy*
;
Linezolid
;
Vancomycin
;
Retrospective Studies
;
Anti-Infective Agents/therapeutic use*
;
Anti-Bacterial Agents/therapeutic use*
;
Carbapenems

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