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
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Female
;
Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
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East Asian People
2.The developmental trajectory and influencing factors of kinesiophobia among post-percutaneous coronary intervention patients
Ruinan XIA ; Rui WANG ; Junfeng ZHANG ; Xiaofang ZOU ; Runfeng ZOU
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(1):43-50
Objective:To explore the developmental trajectory and influencing factors of kinesiophobia in patients undergoing percutaneous coronary intervention (PCI) .Methods:By convenient sampling, totally 217 patients undergoing PCI who enrolled from two tertiary hospitals in Guangdong Province from March 2022 to July 2023. The demographic data of the patients was collected , and kinesiophobia was measured using the Tampa scale for kinesiophobia heart(TSK-SV-Heart) at one day pre-discharge, 2 weeks, 1 month, and 4 months post-discharge. Data analysis was conducted using SPSS 25.0 and Mplus 8.7 softwares. Growth mixture modelling, chi-square test, and polynomial Logistic regression were used for data processing and analysis.Results:Three different kinesiophobia trajectory classes were identified in patients within 4 months after PCI: sustained high level of kinesiophobia group (C1 group, 22.6%(49/217)), moderate level of kinesiophobia with a rapid decrease group (C2 group, 47.4%(103/217)), and rapid decrease of kinesiophobia followed an increase group (C3 group, 30.0%(65/217)). Polynomial Logistic regression results showed that, females ( B=1.136, OR=3.113, 95% CI=1.155-8.389) , patients with NYHA Ⅱ/Killip class Ⅱ or above ( B=1.135, OR=3.112, 95% CI=1.380-7.017) were more likely to develop into the C1 compared with the C2 group. Compared with the C3 group, patients with NYHA Ⅱ/Killip class Ⅱ or above ( B=3.322, OR=27.712, 95% CI=5.251-146.244), and patients with coronary heart disease(CHD) more than two years ( B=3.855, OR=47.250, 95% CI=2.146-1 040.535)were more likely to develop into the C1 group. Compared with the C3 group, patients with NYHA Ⅱ/Killip class Ⅱ or above ( B=-2.187, OR=0.112, 95% CI=0.022-0.565), patients with three or more comorbidities ( B=-2.711, OR=0.066, 95% CI=0.008-0.528), and patients with CHD more than two years ( B=-2.376, OR=0.093, 95% CI=0.011-0.783) were more likely to develop into the C2 group. Conclusion:Kinesiophobia level in patients undergoing PCI presents a curvilinear decrease within 4 months after PCI.Different kinesiophobia trajectory classes can be observed. Sex, NYHA/Killip class, course of CHD, and comorbidity affect the development trajectory of different subgroups.
3.Clinical Observation of Modified Huanglian Wendantang in Treatment of Cardiovascular Risk Factors in Patients with Metabolic Syndrome Under Guidance of Treating Disease before Its Onset
Yi HAN ; Yubo HAN ; Guoliang ZOU ; Ruinan WANG ; Chunli YAO ; Xinyu DONG ; Li LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):142-149
ObjectiveTo observe the clinical effect of modified Huanglian Wendantang on cardiovascular risk factors in patients with metabolic syndrome under the guidance of treating disease before its onset. MethodsA total of 82 patients with metabolic syndrome treated in the First Affiliated Hospital of Heilongjiang University of Chinese Medicine from July 2023 to July 2024 were selected and allocated into an observation group (41 cases) and a control group (41 cases) by the random number table method. The control group received routine treatment, and the observation group was treated with modified Huanglian Wendantang on the basis of routine treatment. Both groups were treated for 8 weeks. The therapeutic effects on TCM symptoms after treatment in the two groups were evaluated. The levels of obesity degree indicators, blood pressure indicators, glucose and lipid metabolism indicators, inflammatory factors, and vascular endothelial function indicators before and after treatment in the two groups were measured, and the treatment safety was evaluated. ResultsAfter treatment, the total response rate of TCM symptoms in the observation group was 97.56% (40/41), which was higher than that (87.80%, 36/41) in the control group (χ2=5.205, P<0.05). After treatment, both groups showed declines (P<0.05) in systolic blood pressure (SBD), diastolic blood pressure (DBP), triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), fasting blood glucose, 2-hour postprandial blood glucose (2 h PG), glycosylated hemoglobin (HbA1c), fasting insulin (FINS), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), leptin (LEP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), endothelin-1 (ET-1), and inducible nitric oxide synthase (iNOS). Moreover, the declines in the observation group were more obvious than those in the control group (P<0.05, P<0.01). After treatment, both groups showed elevated levels of high density lipoprotein cholesterol (HDL-C), adiponectin (ADP), nitric oxide (NO), and endothelial nitric oxide synthase (eNOS) (P<0.05), and the above indexes in the observation group were higher than those in the control group (P<0.01). ConclusionUnder the guidance of the thought of treating disease before its onset, modified Huanglian Wendantang was used to treat patients with metabolic syndrome. The decoction improved the clinical efficacy by ameliorating IR to improve insulin sensitivity, reducing inflammation, and protecting the vascular endothelial function. It inhibits cardiovascular risk factors without inducing adverse reactions, being worthy of clinical application and promotion.
4.The developmental trajectory and influencing factors of kinesiophobia among post-percutaneous coronary intervention patients
Ruinan XIA ; Rui WANG ; Junfeng ZHANG ; Xiaofang ZOU ; Runfeng ZOU
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(1):43-50
Objective:To explore the developmental trajectory and influencing factors of kinesiophobia in patients undergoing percutaneous coronary intervention (PCI) .Methods:By convenient sampling, totally 217 patients undergoing PCI who enrolled from two tertiary hospitals in Guangdong Province from March 2022 to July 2023. The demographic data of the patients was collected , and kinesiophobia was measured using the Tampa scale for kinesiophobia heart(TSK-SV-Heart) at one day pre-discharge, 2 weeks, 1 month, and 4 months post-discharge. Data analysis was conducted using SPSS 25.0 and Mplus 8.7 softwares. Growth mixture modelling, chi-square test, and polynomial Logistic regression were used for data processing and analysis.Results:Three different kinesiophobia trajectory classes were identified in patients within 4 months after PCI: sustained high level of kinesiophobia group (C1 group, 22.6%(49/217)), moderate level of kinesiophobia with a rapid decrease group (C2 group, 47.4%(103/217)), and rapid decrease of kinesiophobia followed an increase group (C3 group, 30.0%(65/217)). Polynomial Logistic regression results showed that, females ( B=1.136, OR=3.113, 95% CI=1.155-8.389) , patients with NYHA Ⅱ/Killip class Ⅱ or above ( B=1.135, OR=3.112, 95% CI=1.380-7.017) were more likely to develop into the C1 compared with the C2 group. Compared with the C3 group, patients with NYHA Ⅱ/Killip class Ⅱ or above ( B=3.322, OR=27.712, 95% CI=5.251-146.244), and patients with coronary heart disease(CHD) more than two years ( B=3.855, OR=47.250, 95% CI=2.146-1 040.535)were more likely to develop into the C1 group. Compared with the C3 group, patients with NYHA Ⅱ/Killip class Ⅱ or above ( B=-2.187, OR=0.112, 95% CI=0.022-0.565), patients with three or more comorbidities ( B=-2.711, OR=0.066, 95% CI=0.008-0.528), and patients with CHD more than two years ( B=-2.376, OR=0.093, 95% CI=0.011-0.783) were more likely to develop into the C2 group. Conclusion:Kinesiophobia level in patients undergoing PCI presents a curvilinear decrease within 4 months after PCI.Different kinesiophobia trajectory classes can be observed. Sex, NYHA/Killip class, course of CHD, and comorbidity affect the development trajectory of different subgroups.
5.Study on the current situation and latent profile analysis of nurses'voice behavior
Jingfang XIAO ; Ruinan XIA ; Rui WANG ; Meifen DAI ; Xiaofang ZOU
Chinese Journal of Nursing 2024;59(1):93-99
Objective To analyze the current situation and latent profiles of nurses'voice behavior in nurses,and explore the influencing factors of different types.Methods Through convenience sampling,812 nurses who worked in tertiary hospitals from 5 cities in Guangdong Province during April 2022 to June 2022 were recruited.The demographic questionnaire,the Voice Behavior Scale,the Humble Leadership Scale,and the Team Psychological Safety Climate Scale were used for investigation.Latent profile analysis was used to explore the latent profiles of nurses'voice behavior.The influencing factors of latent profiles were identified by multivariate Logistic regression.Results The total score of the voice behavior in 812 nurses is(37.04±5.88).Voice behaviors in nurses is divided into 3 latent classes,namely"conservation group"(27.83%),"balanced-risky group"(61.95%),and"the challenge group"(10.22%).The influencing factors include recruitment type,whether to assist in department management,humble leadership,team psychological safety climate(all P<0.05).Conclusion The level of nurses'voice behavior is upper medium with heterogeneity,which can be divided into 3 latent profiles.Nurses managers should focus on nurses with conservation group and balanced-risky group and conduct early targeted prevention and care according to characteristics and influencing factors of different latent profile.
6.Effect of minocycline on polarization of types M1/M2 microglia in spinal cord in rats after spinal nerve ligation
Zhihong CHENG ; Song FENG ; Xia WANG ; Ruinan NI ; Yang GUO ; Yu XIANG ; Zhengwei YANG ; Bin PENG
Journal of Army Medical University 2024;46(15):1740-1750
Objective To investigate the effect of minocycline(Mino)on the polarization of types M1/M2 microglia(pro-and anti-inflammatory type)in the spinal dorsal horn of rats with neuropathic pain(NP)induced by spinal nerve ligation(SNL)and its underlying mechanism.Methods A total of 36 adult male SD rats were randomly stratified into Sham-operation(Sham)group,SNL group and Mino+SNL group by stratified random sampling based on body weight.Mechanical pain threshold and cold nociceptive thresholds of rat hind paw were measured in 1 d before and 14 d after modelling.Spinal cord tissue at the lumbar 5(L5)segment was taken at 14 d after modelling,and the total number of microglia as well as the numbers of M1 and M2 microglia in the spinal dorsal horn were measured with immunohistochemistry and stereology.With aid of bioinformatics techniques,the core target in the spinal cord,Cst7,was selected.Then,the protein levels of microglia marker Iba-1,M1 microglia marker iNOS,M2 microglia marker CD206,Cst7 encoded protein cystatin F(CF)and pathway CatS/CX3CL1/CX3CR1 were detected with Western blotting.The expression levels of TNF-α,IL-6 and IL-10 in the spinal cord tissues were measured with ELISA.Results The mechanical pain and cold nociceptive thresholds were both significantly higher in the M+SNL group than the SNL group at 7~14 d after modelling(P<0.01).The total number of microglia and the numbers of M1/M2 microglia in the spinal dorsal horn as well as the expression levels of CatS,CX3CL1,CX3CR1,TNF-α,IL-6,and IL-10 in the spinal cord tissues were obviously increased,and the expression level of CF was notably decreased in the SNL model group than the Sham group(P<0.01).While,Mino treatment remarkably reversed above phenomena,with decreased total number of microglia and number of M1 microglia as well as expression levels of CatS,CX3CL1,CX3CR1,TNF-α and IL-6,and increased number of M2 microglia as well as CF and IL-10 levels when compared with the SNL group(P<0.05).Conclusion Mino alleviates SNL induced neuropathic pain,probably through up-regulating CF in the microglia,and thus inhibiting the CatS/CX3CL1/CX3CR1 signaling pathway,promoting the conversion of microglia from type M1 to M2 to balance the imbalance in the M1/M2 polarization,and thus reducing neuroinflammation.
7.Study on the Lipid-Regulating Mechanism of Zexie Decoction on Hyperlipidemia Model Mice Based on the miR21/PI3K-Akt/SREBP Pathway
Aixia JU ; Shuang SUN ; Ruinan WANG ; Yubo HAN ; Yusheng ZHOU ; Jing CHEN ; Li LIU ; Qiuhong LI
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(9):917-931
OBJECTIVE To explore the lipid-regulating mechanism of the classic prescription Zexie Decoction on hyperlipidemia model mice.METHODS ELISA method was used to detect the four blood lipid indexes,liver function indicators and cholesterol acyltransferase levels in serum.HE and Oil Red O staining were used to determine the pathology of liver tissue.Network pharmacology was used to predict the lipid-lowering related targets of Zexie Decoction,and the GO function and KEGG pathway enrichment analyses of the intersection targets were realized.PCR chip technology was used to detect the target genes for network pharmacology screening,and qPCR and Western blot were used to detect gene and protein expression levels.RESULTS Zexie Decoction significantly regula-ted the four blood lipid indexes in hyperlipidemia model mice,improved the increase in liver damage indicators caused by high lipids,and had a reverse regulatory effect on the key enzymes HMGR and CYP7A1 of lipid metabolism and the lipid transporters ABCA1 and Apo-A1 in liver tissue.HE and Oil Red O staining showed that Zexie Decoction improved the pathological morphology of liver tissue,reduced lipid deposition in liver tissue,and significantly decreased the positive area ratio(P<0.01).The PCR chip obtained 44 re-verse-regulated genes,GO functional enrichment analysis obtained 266 entries,and KEGG pathway enrichment analysis screened 99 signaling pathways.The results of qPCR and Western blot showed that Zexie Decoction significantly downregulated the expression of PIK3CG,AKT1,and IL-6 genes(P<0.05,P<0.01),upregulated the expression of ABCG1 gene(P<0.05),downregulated PI3Kinase p110β,p-AKT(Ser473)and SREBP-1c protein expression levels(P<0.01),and reversely regulated miR21-5p(P<0.01).CONCLUSION Zexie Decoction has a significant regulatory effect on lipid metabolism in hyperlipidemia model mice and can improve liver damage caused by hyperlipidemia.Its lipid-regulating effect may be related to regulating cholesterol metabolism and transport in the body,and is closely linked to the miR21/PI3K-Akt/SREBP pathway.The lipid-regulating effect of the whole formula of Zexie Decoction is better than that of a single herb.
8.Effect of stent-assisted thrombectomy combined with intermediate catheter aspiration in the treatment of acute basilar artery occlusive cerebral infarction
Jian DING ; Ruinan SONG ; Hailiang WANG ; Jie LIU ; Erping CUI
Journal of Xinxiang Medical College 2024;41(6):538-542
Objective To explore the clinical efficacy of stent-assisted thrombectomy combined with intermediate catheter aspiration in the treatment of acute basilar artery occlusive cerebral infarction.Methods Eighty patients with acute basilar artery occlusive cerebral infarction admitted to the Department of Neurology of Cangzhou People's Hospital from July 2022 to July 2023 were selected as the research subjects.The patients were divided into the control group(stent-assisted thrombectomy)and the observation group(stent-assisted thrombectomy combined with intermediate catheter aspiration)according to the treatment method,with 40 patients in each group.The neurological deficit of the patients in both groups was evaluated by using the National Institutes of Health Stroke Scale(NIHSS)before and after the intervention;the vascular recanalization of the patients was evaluated by using the modified thrombolysis in cerebral infarction(mTICI)grade;and the clinical prognosis of the patients was assessed by using the modified Rankin scale(mRS)at 3 months after treatment(mRS score ≤2:favorable prognosis;mRS score>2:poor prognosis).A 12-month postoperative follow-up was conducted to monitor the incidence of complications and the mortality rate.Results There was no significant difference in the NIHSS score of patients between the two groups before treatment(P>0.05);the NIHSS scores of patients in both groups at 24 hours and 3 months after treatment were significantly lower than those before treatment(P<0.01);the NIHSS scores of patients in the observation group at 24 hours and 3 months after treatment were significantly lower than those in the control group(P<0.01).There were a total of 22 patients with mTICI grades of 2b and 3 in the control group,and the first vascular recanalization rate was 55.0%(22/40);there were a total of 35 patients with mTICI grades of 2b and 3 in the observation group,and the first vascular recanalization rate was 87.5%(35/40);and the first vascular recanalization rate of patients in the observation group was significantly higher than that in the control group(x2=0.375,P>0.05).Three months after treatment,there were 13 patients in the control group with an mRS score of 0 to 2,and the favorable prognosis rate was 32.5%(13/40);there were 21 patients in the observation group with an mRS score of 0 to 2,and the favorable prognosis rate was 52.5%(21/40);the favorable prognosis rate of patients in the observation group was significantly higher than that in the control group(x2=6.619,P<0.05).During the 12-month follow-up,stroke-associated pneumonia occurred in 18 patients(45.0%),cerebral hernia occurred in 5 patients(12.5%),symptomatic intracranial hemorrhage occurred in 4 patients(10.0%),and 12 patients died,with a fatality rate of 30.0%in the control group;while in the observation group,stroke-associated pneumonia occurred in 10 patients(25.0%),cerebral hernia occurred in 4 patients(10.0%),symptomatic intracranial hemorrhage hemorrhage occurred in 2 patients(5.0%),and 8 patients died,with a fatality rate of 12.0%.There was no significant difference in the incidence of cerebral hernia and symptomatic intracranial hemorrhage between the observation group and control group(x2=0.125,0.721;P>0.05).The incidence of stroke-associated pneumonia and the fatality rate of patients in the observation group were significantly lower than those in the control group(x2=4.016,3.954;P<0.05).Conclusion Stent-assisted thrombectomy combined with intermediate catheter aspiration can effectively improve the first recanalization rate and enhance the neurological function and prognosis of patients with acute basilar artery occlusive cerebral infarction.
9.Differences and similarities in the prevention and treatment of cerebral small vessel disease and stroke
Journal of Apoplexy and Nervous Diseases 2024;41(1):7-13
Cerebral small vessel disease is a series of complex and heterogeneous cerebrovascular syndromes caused by various etiological factors that affect small vessels in the brain. Due to a lack of typical symptoms, the diagnosis of cerebral small vessel disease relies mainly on magnetic resonance imaging, and the neuroimaging findings can include recent small subcortical infarcts, lacunes of presumed vascular origin, white matter hyperintensities of presumed vascular origin, perivascular spaces, cerebral microbleeds, cortical superficial siderosis, and brain atrophy. Currently, the pathogenic mechanism of cerebral small vessel disease remains unclear, and specific treatment is also lacking. Given its similarities with stroke in risk factors and histopathological characteristics, stroke prevention and treatment approaches, such as antihypertensive and antiplatelet therapies, can be applied to the treatment of cerebral small vessel disease. However, due to the differences between the two conditions, stroke treatments cannot be fully suitable for cerebral small vessel disease, and an individualized comprehensive assessment is needed. This review presents the management of cerebral small vessel disease and stroke, highlighting their similarities and differences.
Stroke
10.Chain mediating effect of team psychological safety atmosphere and professional calling in the relationship between humble leadership and voice behavior among clinical nurses
Ruinan XIA ; Rui WANG ; Xiaofang ZHOU ; Yutao LAN ; Meifen DAI
China Occupational Medicine 2023;50(6):694-700
{L-End}Objective To explore the chain mediating effect of team psychological safety atmosphere and professional calling in the relationship between humble leadership and voice behavior. {L-End}Methods A total of 812 nurses from five medical institutions in Guangdong Province were selected as the research subjects using the convenience sampling method. The Team Psychological Safety Atmosphere Scale, the Professional Calling Scale, the Hospital Version of Humble Leadership Scale and the Voice Behavior Scale were used to investigate the perceived team psychological safety atmosphere and sense of professional calling, the perceived humble leadership style and voice behavior of the nurses. {L-End}Results The score of team psychological safety atmosphere, professional calling, humble leadership, and voice behavior of 812 nurses was (58.0±7.6), (44.6±8.0), (50.4±9.2) and (37.0±5.9), respectively, with the scoring rate of 72.5%, 74.3%, 80.0%, and 74.0%, respectively. Bootstrap analysis showed that humble leadership could positively influence voice behavior [standardized effect value (β)=0.28, 95% confidence interval (CI) 0.20-0.35]. Humble leadership could influence voice behavior through the separate mediating effects of team psychological safety atmosphere (β=0.13, 95%CI 0.09-0.18), professional calling (β=0.07, 95%CI 0.04-0.11), and the chain mediating effect of team psychological safety atmosphere and professional calling(β=0.06, 95%CI 0.04-0.08). {L-End}Conclusion The voice behavior of clinical nurses is at a moderately high level. Humble leadership can directly influence voice behavior and can influence voice behavior through the mediating effects of team psychological safety atmosphere and professional calling. Nursing managers can inspire the work passion of clinical nurses by changing their own leadership style and creating a good atmosphere for voicing opinions.

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