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
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East Asian People
2.Effect of Video-based Educational Intervention Combined with Maternal Presence on Perioperative Adverse Outcomes in Preschool Children under General Anesthesia
Jiayu TAN ; Fengqiu GONG ; Wenqi HUANG ; Xia FENG ; Qiongfang ZHU ; Yubo KANG ; Wenyan WU ; Xiuhong LI
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(3):519-527
ObjectiveTo investigate the effect of video-based educational intervention combined with maternal presence on perioperative adverse outcomes in preschool children undergoing general anesthesia, including cooperation in anesthesia induction, perioperative anxiety, pain and agitation during recovery. MethodsA total of 300 preschool children scheduled for general anesthesia in our hospital from June to December 2023 were randomly assigned to control group (n=150) and intervention group (n=150). The control group received routine recovery care. For the intervention group, in addition to routine recovery care, a preoperative visit was scheduled one day before surgery. During this visit, mothers were guided to watch anesthesia videos with their children. During the waiting period in the operating room and 30 minutes after awakening, the mothers were guided to accompany the children for more than 30 minutes. Recovery conditions were recorded using the surgical anesthesia information system, and the children’s anesthetic induction compliance, perioperative anxiety, pain, and agitation were evaluated and recorded using the modified Yale Preoperative Anxiety Scale (m-YPAS), the Induction Compliance Scale (ICC), the Children’s Pain Behavior Scale (FLACC), and the Pediatric Agitation and Emergence Delirium Scale (PAED). ResultsOn the preoperative visit day, there were no statistically significant differences in baseline data between the two groups (P > 0.05). For perioperative anxiety, the m-YPAS scores of the intervention group were significantly lower than those of the control group, both when entering the operating room waiting area (35.27±6.48 vs. 41.79±6.68, P < 0.05) and 30 minutes after postoperative recovery (20.13±7.05 vs. 35.75±9.51, P < 0.05). In terms of anesthesia induction cooperation, the ICC scores of the intervention group were significantly lower than those of the control group (1.84±0.95 vs. 3.17±0.62, P < 0.05), and the proportion of good induction cooperation was significantly higher than that of the control group (24.00% vs. 12.67%, P < 0.05). There was no significant difference in awakening duration between the two groups, but the intervention group had a significantly shorter length of stay in the post-anesthesia care unit than the control group (0.90±0.29 hours vs. 1.29±0.42 hours, P < 0.001). For perioperative agitation, the PAED scores of the intervention group were significantly lower than those of the control group (entering in the operating room waiting area: 8.5 vs. 9.2, P < 0.05; 30 minutes after postoperative recovery: 4.2 vs. 7.8, P < 0.05). In terms of pain scores, the FLACC scores of the intervention group were also significantly lower than those of the control group, both when entering the operating room waiting area ( 5.3 vs. 6.7, P < 0.05; 30 minutes after postoperative recovery: 2.1 vs. 4.9, P < 0.05). ConclusionsVideo-based educational intervention combined with maternal presence reduces the perioperative anxiety, pain and agitation of preschool children undergoing general anesthesia, and improved the compliance of anesthesia induction. It is recommended to promote this intervention measure in clinical practice.
3.Expert consensus on the diagnosis and treatment of cemental tear.
Ye LIANG ; Hongrui LIU ; Chengjia XIE ; Yang YU ; Jinlong SHAO ; Chunxu LV ; Wenyan KANG ; Fuhua YAN ; Yaping PAN ; Faming CHEN ; Yan XU ; Zuomin WANG ; Yao SUN ; Ang LI ; Lili CHEN ; Qingxian LUAN ; Chuanjiang ZHAO ; Zhengguo CAO ; Yi LIU ; Jiang SUN ; Zhongchen SONG ; Lei ZHAO ; Li LIN ; Peihui DING ; Weilian SUN ; Jun WANG ; Jiang LIN ; Guangxun ZHU ; Qi ZHANG ; Lijun LUO ; Jiayin DENG ; Yihuai PAN ; Jin ZHAO ; Aimei SONG ; Hongmei GUO ; Jin ZHANG ; Pingping CUI ; Song GE ; Rui ZHANG ; Xiuyun REN ; Shengbin HUANG ; Xi WEI ; Lihong QIU ; Jing DENG ; Keqing PAN ; Dandan MA ; Hongyu ZHAO ; Dong CHEN ; Liangjun ZHONG ; Gang DING ; Wu CHEN ; Quanchen XU ; Xiaoyu SUN ; Lingqian DU ; Ling LI ; Yijia WANG ; Xiaoyuan LI ; Qiang CHEN ; Hui WANG ; Zheng ZHANG ; Mengmeng LIU ; Chengfei ZHANG ; Xuedong ZHOU ; Shaohua GE
International Journal of Oral Science 2025;17(1):61-61
Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans
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Dental Cementum/injuries*
;
Consensus
;
Diagnosis, Differential
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Cone-Beam Computed Tomography
;
Tooth Fractures/therapy*
4.Early warning method for invasive mechanical ventilation in septic patients based on machine learning model.
Wanjun LIU ; Wenyan XIAO ; Jin ZHANG ; Juanjuan HU ; Shanshan HUANG ; Yu LIU ; Tianfeng HUA ; Min YANG
Chinese Critical Care Medicine 2025;37(7):644-650
OBJECTIVE:
To develop a method for identifying high-risk patients among septic populations requiring mechanical ventilation, and to conduct phenotypic analysis based on this method.
METHODS:
Data from four sources were utilized: the Medical Information Mart for Intensive Care (MIMIC-IV 2.0, MIMIC-III 1.4), the Philips eICU-Collaborative Research Database 2.0 (eICU-CRD 2.0), and the Anhui Medical University Second Affiliated Hospital dataset. The adult patients in intensive care unit (ICU) who met Sepsis-3 and received invasive mechanical ventilation (IMV) on the first day of first admission were enrolled. The MIMIC-IV dataset with the highest data integrity was divided into a training set and a test set at a 6:1 ratio, while the remaining datasets were served as validation sets. The demographic information, comorbidities, laboratory indicators, commonly used ICU scores, and treatment measures of patients were extracted. Clinical data collected within first day of ICU admission were used to calculate the sequential organ failure assessment (SOFA) score. K-means clustering was applied to cluster SOFA score components, and the sum of squared errors (SSE) and Davies-Bouldin index (DBI) were used to determine the optimal number of disease subtypes. For clustering results, normalized methods were employed to compare baseline characteristics by visualization, and Kaplan-Meier curves were used to analyze clinical outcomes across phenotypes.
RESULTS:
This study enrolled patients from MIMIC-IV dataset (n = 11 166), MIMIC-III dataset (n = 4 821), eICU-CRD dataset (n = 6 624), and a local dataset (n = 110), with the four datasets showing similar median ages and male proportions exceeding 50%; using 85% of the MIMIC-IV dataset as the training set, 15% as the test set, and the rest dataset as the validation set. K-means clustering based on the six-item SOFA score was performed to determine the optimal number of clusters as 3, and patients were finally classified into three phenotypes. In the training set, compared with the patients with phenotype II and phenotype III, those with phenotype I had the more severe circulatory and respiratory dysfunction, a higher proportion of vasoactive drug usage, more obvious metabolic acidosis and hypoxia, and a higher incidence of congestive heart failure. The patients with phenotype II was dominated by respiratory dysfunction with higher visceral injury. The patients with phenotype III had relatively stable organ function. The above characteristics were consistent in both the test and validation sets. Analysis of infection-related indicators showed that the patients with phenotype I had the highest SOFA score within 7 days after ICU admission, initial decreases and later increases in platelet count (PLT), and higher counts of neutrophils, lymphocytes, and monocytes as compared with those with phenotype II and phenotype III, their blood cultures had a higher positivity rates for Gram-positive bacteria, Gram-negative bacteria and fungi as compared with those with phenotype II and phenotype III. The Kaplan-Meier curve indicated that in the training, test, and validation sets, the 28-day cumulative mortality of patients with phenotype I was significantly higher than that of patients with phenotypes II and phenotype III.
CONCLUSIONS
Three distinct phenotypes in septic patients receiving IMV based on unsupervised machine learning is derived, among which phenotype I, characterized by cardiorespiratory failure, can be used for the early identification of high-risk patients in this population. Moreover, this population is more prone to bloodstream infections, posing a high risk and having a poor prognosis.
Humans
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Machine Learning
;
Sepsis/therapy*
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Respiration, Artificial
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Intensive Care Units
;
Organ Dysfunction Scores
;
Male
;
Female
;
Middle Aged
;
Adult
5.Progress on the role of intestinal flora metabolite butyrate in primary nephrotic syndrome
International Journal of Pediatrics 2025;52(5):295-298
The intestinal flora is a vast and complex microbial system,and its dysregulation may be associated with the occurrence and progression of various diseases.Nephrotic syndrome is a kidney disease characterized by massive proteinuria,hypoalbuminemia,edema,and hyperlipidemia.Some studies have found alterations in the intestinal flora of patients with nephrotic syndrome.Short-chain fatty acids produced by intestinal flora metabolism,particularly butyrate,may influence the occurrence and progression of nephrotic syndrome by regulating immune responses and inflammatory processes through their effects on the differentiation and function of regulatory T cells.These findings provide insights for exploring the pathophysiology of nephrotic syndrome and developing novel therapeutic strategies.
6.The strategies of early diagnosis and management of primary renal tubular disease in children
Yulin KANG ; Wenyan HUANG ; Lei YIN ; Wei ZHOU ; Yufeng LI ; Jia RAO ; Yuanyuan LIU ; Yachun LI ; Song MAO ; Wenjing SHI
International Journal of Pediatrics 2025;52(6):359-363
Childhood primary renal tubular diseases are chronic kidney diseases characterized by impaired renal tubular reabsorption. Primary renal tubular disease has diverse clinical manifestations and lacks of specificity. Laboratory tests are limited,making it prone to missed diagnosis and misdiagnosis. Based on the current knowledge of renal tubular diseases,authors propose early warning signals of renal tubular diseases such as family history of primary tubular diseases,unexplained polyhydramnios during pregnancy,polydipsia,polyuria,delayed growth and development or rickets,decreased muscle strength and tone,unexplained electrolyte disturbance,hyperuricemia,acid-base disturbance,positive urine sugar test,renal tubular proteinuria,urinary imaging examination suggesting kidney stones,calcium deposition,renal cysts and early onset of eye,ear,joint and neuron injury.Meanwhile,some universal management strategies for primary renal tubular disease are proposed,emphasizing the importance of multidisciplinary collaboration,genetic testing and individualized intervention to improve the long-term prognosis of childhood primary renal tubular diseases.
7.Progress on mechanisms of hydroxychloroquine in the treatment of immune-related renal diseases
International Journal of Pediatrics 2025;52(9):577-582
Hydroxychloroquine is a classical antimalarial agent that has been widely used in the treatment of autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis due to its notable anti-inflammatory and immunomodulatory effects. In recent years,increasing attention has been paid to the therapeutic potential of hydroxychloroquine in immune-related kidney diseases,including lupus nephritis,IgA nephropathy,and renal ischemia-reperfusion injury. Although clinical studies have shown encouraging results,the underlying mechanisms of hydroxychloroquine remain incompletely understood. Emerging evidence suggests that hydroxychloroquine may exert renal protective effects through multiple immunoregulatory pathways. These include inhibition of lysosomal acidification and autophagy,modulation of innate immune signaling via Toll-like receptors,suppression of NLRP3 inflammasome activation,and reduction of NADPH oxidase activity and oxidative stress. Moreover,hydroxychloroquine can downregulate the production of pro-inflammatory cytokines such as IL-6,tumor necrosis factor-alpha(TNF-α),and interferon-α(IFN-α),contributing to a reduction in renal inflammation. Additional mechanisms involve the modulation of the Th17/Treg cell balance and the inhibition of neutrophil extracellular trap formation,which further supports its role in modulating immune responses,attenuating renal inflammation,and preserving kidney function. This article provides a concise review of the mechanisms of hydroxychloroquine in immune-related renal diseases.
8.Attach importance to the diagnosis and treatment of crystalline nephropathies in children
International Journal of Pediatrics 2025;52(10):647-652
Crystalline nephropathy is a kidney disorder characterized by crystal deposition in the renal tubules and interstitium,leading to renal dysfunction. Clinical manifestations include polydipsia,polyuria,renal function abnormalities,with or without crystalluria. The pathogenesis involves direct and indirect cytotoxicity caused by crystal deposition,inflammatory kidney injury,tubular obstruction,oxidative stress and inflammatory responses,which further promote renal fibrosis. It represents a significant cause of both acute and chronic renal failure. In adults,it is primarily induced by medications and secondary factors,while it is relatively rare and mainly caused by genetic and metabolic disorders in children. Diagnosis relies on clinical presentation,urinalysis,and medical imaging,while confirmatory diagnosis requires renal biopsy. Currently,due to the limitid awareness of pediatric crystalline nephropathy,it is essential to enhance pediatrician' understanding of this disease for early and precise diagnosis and treatment,thereby improving prognosis and reducing the risk of end-stage renal disease.
9.Research progress in quality and safety detection technologies for bear bile powder
Caishun HUANG ; Tingting HUO ; Zhihong LI ; Sujuan WANG ; Suying YUAN ; Wenyan ZHENG ; Changwei LAI
International Journal of Traditional Chinese Medicine 2025;47(11):1639-1644
In recent years, research on the quality and safety detection of bear bile powder has mainly involved three aspects. First, the identification of active components and substitutes. Quantitative analysis of bile acids and other components is performed using HPLC, HPLC-tandem mass spectrometry, and other techniques, combined with near-infrared spectroscopy, X-ray diffraction, and polymerase chain reaction to identify adulteration. Isotope fingerprint analysis and glycosylation modification detection are used to distinguish natural products from biosynthetic substitutes, revealing significant differences in δ13C values and the proportion of specific glycosylation modifications between natural bear bile powder and synthetic products. Second, the detection of veterinary drug residues, mainly based on ultra-high performance liquid chromatography-tandem mass spectrometry, which can screen over 100 types of residues, but targeted purification strategies are needed to address interference from the bile acid matrix. Thirdly, heavy metal detection, mainly using inductively coupled plasma mass spectrometry and atomic absorption spectrometry, has revealed that contamination is associated with the breeding environment, with significant regional differences. Related detection technologies are gradually evolving from single-target analysis to multi-modal and intelligent approaches. Existing research faces issues, such as matrix effect interference, lack of international standards, and ethical controversies. It is suggested that future efforts should focus on the interdisciplinary application of detection technologies, develop rapid detection methods such as non-invasive monitoring and microfluidic chips, promote the standardization and equivalence evaluation of synthetic alternatives, and establish a full-chain quality control system integrating spatially resolved mass spectrometry imaging, artificial intelligence, and big data.
10.Analysis and prevention of influencing factors for work-related musculoskeletal disorders among bus drivers
Yaling ZOU ; Jie ZHANG ; Wenyan HUANG ; Shiqi QIU ; Jintong HE ; Ning JIA ; Zhongxu WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(4):269-274
Objective:To investigate the occurrence of work-related musculoskeletal disorders (WMSDs) in bus drivers in Zhuhai City, analyze the ergonomic factors, and explore the prevention and control measures of WMSDs.Methods:From March to May 2023, 1675 active bus drivers from 5 branches of a bus group in Zhuhai were selected by stratified sampling method. The incidence of WMSDs among bus drivers in the past 12 months was investigated by using the modified Chinese Version of Musculoskeletal Disorders Questionnaire. The influencing factors of WMSDs were analyzed by χ2 test and generalized linear model. Results:The total incidence of WMSDs in bus drivers in the past 12 months was 47.2% (790/1675) , and the incidence of WMSDs in neck and shoulder and lower back was 36.9% (618/1675) and 31.7% (531/1675) , respectively. The χ2 test showed that there were statistically significant differences in the incidence of WMSDs among bus drivers with different individual factors such as body mass index (BMI) , physical exercise and looking down at mobile phones ( P<0.05) . There were significant differences in the incidence of WMSDs in the neck and shoulder of bus drivers with different years of service and number of stops on their routes ( P<0.05) . There were statistically significant differences in the incidence of WMSDs in the lower back of bus drivers with different one-way driving time, shift patterns, and rest breaks during work ( P<0.05) . Abnormal BMI, professional working years >12 years, uncomfortable working posture, frequent turning, slightly forward neck posture, large forward neck posture and long shoulder posture were the risk factors for WMSDs of bus drivers ( P<0.05) , and comfortable seat was the protective factor ( P<0.05) . One-way driving time >70 min, shift work schedules, uncomfortable working posture, slightly forward back posture, and frequent turning were the risk factors leading to lower back WMSDs ( P<0.05) , and physical exercise, comfortable driving cabin space, and seat comfort were the protective factors ( P<0.05) . Conclusion:The total incidence of WMSDs in bus drivers is higher, and ergonomic factors are related to the occurrence of WMSDs. In the implementation of bus driving space comfort, human-computer interaction interface friendliness and seat comfort, employers should be reasonable allocation of fitness facilities, regular training, reasonable shift organization and other measures to prevent and control the occurrence of bus drivers WMSDs.

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