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.Oral health-related quality of life status and risk factors in patients with mental disorders.
Xuemei YANG ; Hongyu WANG ; Yonghua TANG ; Chengjun YIN ; Jingya YU ; Xiaoqin BI
West China Journal of Stomatology 2025;43(1):84-91
OBJECTIVES:
This study aims to explore the current status and risk factors of oral health-related quality of life OHRQoL in patients with mental disorders and provide evidence for effective intervention measures.
METHODS:
A total of 397 patients diagnosed with mental illness were selected by convenience sampling, and investigation was carried out using general data questionnaire, health literacy in dentistry-14 (HeLD-14), oral health impact profile-14 (OHIP-14), and oral health status checklist.
RESULTS:
The total score of OHIP-14 in patients with mental disorders was 8(2, 14). The score of HeLD-14 was negatively correlated with the score of OHIP-14 (r=-0.142, P<0.01). The results of multiple linear regression showed that six variables including annual family income, schizophrenia, sweets, frequency of visits to the dentist, dental caries, and missing teeth affected OHRQoL of patients with mental disorders (P<0.05).
CONCLUSIONS
The poor OHRQoL of psychiatric patients is associated with many factors. Medical personnel should pay attention to their oral health problems and develop targeted oral care programs throughout the course of disease to improve oral health and related quality of life of patients.
Humans
;
Quality of Life
;
Oral Health
;
Mental Disorders
;
Risk Factors
;
Surveys and Questionnaires
;
Male
;
Female
;
Dental Caries
;
Adult
;
Middle Aged
;
Schizophrenia
3.Associations of short-term ambient particulate matter exposure and MTNR1B gene with triglyceride-glucose index:A family-based study
Huangda GUO ; Hexiang PENG ; Siyue WANG ; Tianjiao HOU ; Yixin LI ; Hanyu ZHANG ; Mengying WANG ; Yiqun WU ; Xueying QIN ; Xun TANG ; Jing LI ; Dafang CHEN ; Yonghua HU ; Tao WU
Journal of Peking University(Health Sciences) 2024;56(3):375-383
Objective:To explore the effects of short-term particulate matter(PM)exposure and the melatonin receptor 1B(MTNR1B)gene on triglyceride-glucose(TyG)index utilizing data from Fang-shan Family-based Ischemic Stroke Study in China(FISSIC).Methods:Probands and their relatives from 9 rural areas in Fangshan District,Beijing,were included in the study.PM data were obtained from fixed monitoring stations of the National Air Pollution Monitoring System.TyG index was calculated by fasting triglyceride and glucose concentrations.The associations of short-term PM exposure and rs10830963 polymorphism of the MTNR1B gene with the TyG index were assessed using mixed linear models,in which covariates such as age,sex,and lifestyles were adjusted for.Gene-environment inter-action analysis was furtherly performed using the maximum likelihood methods to explore the potential effect modifier role of rs10830963 polymorphism in the association of PM with TyG index.Results:A total of 4 395 participants from 2 084 families were included in the study,and the mean age of the study participants was(58.98±8.68)years,with 53.90%females.The results of association analyses showed that for every 10 μg/m3 increase in PM2.5 concentration,TyG index increased by 0.017(95%CI:0.007-0.027),while for per 10 μg/m3 increment in PM1o,TyG index increased by 0.010(95%CI:0.003-0.017).And the associations all had lagged effects.In addition,there was a positive association between the rs10830963 polymorphism and the TyG index.For per increase in risk allele G,TyG index was elevated by 0.040(95%CI:0.004-0.076).The TyG index was 0.079(95%CI:0.005-0.152)higher in carriers of the GG genotype compared with carriers of the CC genotype.The inter-action of rs10830963 polymorphism with PM exposure had not been found to be statistically significant in the present study.Conclusion:Short-term exposure to PM2.5 and PM10 were associated with higher TyG index.The G allele of rs10830963 polymorphism in the MTNR1B gene was associated with the elevated TyG index.
4.Prognosis and risk factors of IgA vasculitis nephritis in children
Xueqing MA ; Yonghua HE ; Jinyun PU ; Wenpei LIANG ; Panpan SHAO ; Jianhua ZHOU ; Yu ZHANG ; Jinhui TANG ; Tonglin LIU ; Huiqing YUAN ; Liru QIU
Chinese Journal of Pediatrics 2024;62(12):1184-1190
Objective:To investigate the prognosis and risk factors of IgA vasculitis nephritis (IgAVN) in children.Methods:A retrospective cohort study was conducted. Clinical data were collected from 264 children who were pathologically diagnosed with IgAVN at Department of Pediatric Nephrology, Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology, between January 2011 and December 2017. All patients had a follow-up period of more than 3 years. Clinical characteristics, renal pathology, 3-year and 5-year prognosis were analyzed. The patients were grouped based on gender, age of onset (≤6 years, >6-9 years, and >9 years), pathological classification (≤Ⅲ and>Ⅲ),whether the prognosis was complete remission at 3 and 5 years. Independent sample t-tests, ANOVA or chi-squared test were used for intergroup comparisons. Spearman correlation analysis was applied for ordinal data, and multivariate Logistic regression was used to analyze factors affecting the prognosis. Receiver operating characteristic (ROC) curve was utilized to evaluate the predictive value of these factors. Results:Of the 264 children with IgAVN, 153 were male and 111 were female, the age of onset was 8.3 (6.7, 10.3) years, 118 patients (45%) with onset age >6-9 years accounted for the highest proportion. All patients presented with skin purpura and renal involvement, primarily manifesting as hematuria and/or proteinuria. Microscopic hematuria was observed in 253 patients (95.8%), while 246 patients (93.2%) showed proteinuria. In 256 patients (97.0%), hematuria or proteinuria urinalysis was detected within 6 months of skin purpura onset, and 243 patients (92.0%) underwent renal biopsy within 6 months of renal involvement. The most common clinical subtype in 264 IgAVN children was hematuria and proteinuria (204 cases, 77.3%), with grade Ⅲ being the predominant pathological classification (181 cases, 68.6%). Among children ≤6 years old, the 3-year complete remission rate was higher in males than in females (83.9% (26/31) vs. 7/16, χ2=8.12, P=0.012). Factors independently associated with poor 5-year prognosis included time from hematuria or proteinuria urinalysis to renal biopsy >6 months, elevated serum cholesterol levels, and incomplete remission 3 years post-biopsy ( OR=5.41, 1.39, 6.02, 95% CI 1.40-20.86, 1.04-1.84, 2.61-13.88, all P<0.05). The serum cholesterol has a predictive value for 5-year prognosis ( P=0.020, AUC=0.62, 95% CI 0.52-0.71, Youden index=0.27, cutoff=4.37). Conclusions:For children with IgAVN aged≤6 years, the 3-year prognosis is better in males than in females. Time from hematuria or proteinuria urinalysis to renal biopsy >6 months, elevated serum cholesterol levels, and incomplete remission at 3 years post-biopsy may be independent risk factors for poor 5-year prognosis in children with IgAVN.
5.Evolution and development of potent monobactam sulfonate candidate IMBZ18g as a dual inhibitor against MDR Gram-negative bacteria producing ESBLs.
Zhiwen LI ; Zhihao GUO ; Xi LU ; Xican MA ; Xiukun WANG ; Rui ZHANG ; Xinxin HU ; Yanxiang WANG ; Jing PANG ; Tianyun FAN ; Yonghua LIU ; Sheng TANG ; Haigen FU ; Jingpu ZHANG ; Yinghong LI ; Xuefu YOU ; Danqing SONG
Acta Pharmaceutica Sinica B 2023;13(7):3067-3079
A series of new monobactam sulfonates is continuously synthesized and evaluated for their antimicrobial efficacies against Gram-negative bacteria. Compound 33a (IMBZ18G) is highly effective in vitro and in vivo against clinically intractable multi-drug-resistant (MDR) Gram-negative strains, with a highly druglike nature. The checkerboard assay reveals its significant synergistic effect with β-lactamase inhibitor avibactam, and the MIC values against MDR enterobacteria were reduced up to 4-512 folds. X-ray co-crystal and chemoproteomic assays indicate that the anti-MDR bacteria effect of 33a results from the dual inhibition of the common PBP3 and some class A and C β-lactamases. Accordingly, preclinical studies of 33a alone and 33a‒avibactam combination as potential innovative candidates are actively going on, in the treatment of β-lactamase-producing MDR Gram-negative bacterial infections.
6.Predictive value of preoperative blood parameters on the efficacy of microscopic varicocele ligation for infertility patients with varicocele
Ruixiao LI ; Qisheng TANG ; Yonghua LEI ; Guojun WU ; Jianxin NI
Journal of Chinese Physician 2022;24(11):1687-1691
Objective:To investigate the predictive value of preoperative blood parameters on the efficacy of microscopic varicocele ligation in the treatment of infertility patients with varicocele.Methods:The clinical data of 110 patients with varicocele admitted to Xi′an People′s Hospital and Tangdu Hospital of Air Force Military Medical University from June 2016 to January 2021 were analyzed retrospectively. Successful operation was defined as the restoration of all semen parameters (sperm concentration, forward motility, morphology, etc.) to normal values 6 months after operation. The patients were divided into effective treatment group (group A, 78 cases) and ineffective treatment group (group B, 32 cases). The blood parameters of the two groups were compared before operation. Spearman correlation analysis was used to determine the relationship between blood parameters [neutrophil/lymphocyte ratio (NLR) and mean platelet volume (MPV)] and the success of microscopic varicocele ligation. The predictive value of blood parameters (NLR and MPV) to the success of microscopic varicocele ligation was analyzed by receiver operating characteristic (ROC) curve.Results:There was no significant difference in clinical characteristics, and sex hormone levels between the two groups before operation (all P>0.05); There were statistically significant differences in NLR and MPV in blood parameters between the two groups (both P<0.05), and there was no significant differences in other blood parameters (both P>0.05). There was no significant difference in semen parameters between the two groups before operation (all P>0.05). After operation, the semen volume, semen concentration, forward movement and sperm morphology of patients in group A were significantly improved compared with those before operation (all P<0.05), while the parameters of patients in group B had no significant difference compared with those before operation (all P>0.05). There was a negative correlation between preoperative NLR and the success rate of spermatic vein ligation ( r=-0.719, P<0.01), and a positive correlation between MPV and the success rate of spermatic vein ligation ( r=0.522, P<0.01). The ROC curve was used to analyze the threshold of predictive variables for the success of spermatic vein ligation. The optimal critical value of NLR was 2.01 ( P<0.01), and the optimal critical value of MPV was 11.45 ( P<0.01). Conclusions:Low NLR (<2.01) and high MPV (>11.45) may be useful preoperative predictive tools for identifying the group of infertile varicocele patients who would benefit most from microscopic spermatic vein ligation.
7.Applications of microsimulation model for cost-effectiveness analysis on screening in epidemiology
Qiuping LIU ; Jiamin WANG ; Chao GONG ; Pei GAO ; Xun TANG ; Yonghua HU
Chinese Journal of Epidemiology 2022;43(6):931-937
Microsimulation model simulates individuals and estimates transition probabilities within the population using individual participant data. This approach could deal with the heterogeneous characteristics among the people or personal history of diseases and may be relevant in addressing cost-effectiveness problems of screening for complex conditions in epidemiology. This paper introduces the general principles, basic steps involved in implementation, analytic methods, and other related issues of the microsimulation model. Based on a practical research case of estimating the cost-effectiveness of microalbuminuria screening for chronic kidney disease in the United States, critical points in applications of the microsimulation model for cost-effectiveness analysis of screening were discussed in detail, including model development, model analysis, and the interpretation of the results. The microsimulation model considers the dynamic nature of complex diseases by estimating a broad range of individual characteristics and increasingly used to provide insights into complex problems that the Markov model does not efficiently address. For better supporting evidence-informed decision-making in public health, future studies should be aware of the accuracy of parameters in the decision-analytic model and the transparency of the models and results, as well as complying with the relevant reporting standards.
8.Applications of Markov model for cost-effectiveness analysis of screening in epidemiology
Qiuping LIU ; Pei GAO ; Xun TANG ; Yonghua HU
Chinese Journal of Epidemiology 2021;42(4):728-734
Cost-effectiveness analysis of screening in epidemiology is essential for public health decision-making. This paper describes the general principles, basic steps involved in implementation, analytic methods and other related issues of Markov model. Based on a practical research case of evaluating the cost-effectiveness of primary open-angle glaucoma screening in a Chinese population, key points in applications of Markov model for cost-effectiveness analysis of screening were discussed in detail, including model development, parameters definition, available software, base case analysis, sensitivity analysis and the interpretation of the results. For better supporting evidence-informed decision making in public health, future studies should be aware of the accuracy of parameters in Markov models and the transparency of the models and results, as well as complying with the relevant reporting standards.
9.Clinical application of short-type single balloon enteroscope to endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y anastomosis
Jun CAO ; Dehua TANG ; Xiwei DING ; Yonghua SHEN ; Lei WANG ; Xiaoping ZOU
Chinese Journal of Digestive Endoscopy 2021;38(2):138-142
Objective:To evaluate the short-type single balloon enteroscope (SBE) to endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y anastomosis.Methods:Data of 10 patients with Roux-en-Y anastomosis who received short-type SBE assisting ERCP (14 times of ERCP, the short-type SBE group) from May 2019 to September 2019 and 55 patients who received conventional SBE assisting ERCP (87 times of ERCP, the conventional SBE group) from March 2016 to April 2019 were collected in Nanjing Drum Tower Hospital. Success rates and mean time of reaching the blind loop, diagnosis and treatment success rates, procedure time and complication incidence in the two groups were compared.Results:The mean time to reach the blind loop was significantly shorter in short-type SBE group than that in the conventional SBE group (17.1 min VS 23.4 min, P = 0.04). There were no significant differences in success rates of reaching the blind loop[100.0%(14/14) VS 95.4%(83/87)], the success rates of diagnosis and treatment[both 100.0% (14/14) VS 100.0% (83/83)], the mean procedure time (62.6 min VS 64.3 min) or complication incidence [21.4%(3/14) VS 16.1% (14/83) ] between the two groups (all P>0.05). Conclusion:ERCP assisted by either type of SBE is safe and effective in patients with Roux-en-Y anastomosis. However, short-type SBE is faster to reach the blind loop because of its unique design and easier manipulation.
10.Exploration and construction of the new generation of intelligent ICU unit based on 5G and artificial intelligence technology
Xiaoxia HUANG ; Yao LI ; Haotian CHEN ; Jiaying TANG ; Xu WANG ; Qiang LI ; Fangmin GE ; Dong CHEN ; Yonghua CHU ; Jianping YE ; Lanlan WU ; Shuaifeng LÜ ; Mao ZHANG
Chinese Journal of Emergency Medicine 2021;30(10):1269-1273
Objective:To explore the new generation of intelligent ICU Unit based on 5G and artificial intelligence technology.Methods:This study was conducted at the Second Affiliated Hospital, Zhejiang University School of Medicine from May 2019 to August 2020. Based on a multidisciplinary team including medical, nursing, hospital management, clinical medical engineering, 5G technology, information technology, artificial intelligence technology, logistics service, etc, was assembled to intelligently design and reconstruct an intelligent ICU Unit of Emergency ICU.Results:Based on 5G technology, a new intelligent ICU unit environment was constructed to realize remote and high-speed interaction of multi-dimensional information in ICU, including intelligent assistance of remote monitoring, remote ward rounds, remote consultation and family visits. An intelligent hospital infection prevention and control system was established including automatic identification and alarm of hand hygiene and personal protection.Conclusions:The new generation of intelligent ICU unit combined with 5G and artificial intelligence technology has changed the mode of medical service for critically ill patients and improved the service level, which is worthy of further exploration and application.

Result Analysis
Print
Save
E-mail