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

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.

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.

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

Objective:To explore the endoscopic features of early gastric cancer (EGC) related to non-curative endoscopic resection, and to construct an assessment model to quantify the risk of non-curative resection.Methods:From August 2006 to October 2019, 378 lesions that underwent endoscopic resection and were diagnosed pathological as EGC in the Department of Gastroenterology, Peking Union Medical College Hospital were included in this case-control study.Seventy-eight (20.6%) non-curative resection lesions were included in the observation group, and 234 lesions which selected from 300 lesions of curative resection were included in the control group according to the difference of operation year ±1 with the observation group, and the ratio of 1∶3 of the observation group to the control group. Univariate and multivariate logistic regression analysis were performed to explore the risk factors for non-curative resection. The independent risk factor with the minimum β coefficient was assigned 1 point, and the remaining factors were scored according to the ratio of their β coefficient to the minimum. A predictive model was established to analyze the 378 lesions.The non-curative resection rates of lesions of different scores were calculated. Results:Univariate analysis showed that the lesion diameter, the location, redness, ulcer or ulcer scar, fold interruption, fold entanglement, and invasion depth observed with endoscopic ultrasonography (EUS) were associated with non-curative resection of EGC lesions ( P<0.05), and contact or spontaneous bleeding may be associated with non-curative resection ( P=0.068). Multivariate logistic regression analysis showed that submucosal involvement (VS confined to the mucosa: β=0.901, P=0.011, OR=2.46, 95% CI: 1.23-4.92), lesion diameter of 3-<5 cm (VS <3 cm: β=0.723, P=0.038, OR=2.06, 95% CI: 1.04-4.09), lesion diameter of ≥5 cm (VS <3 cm: β=2.078, P=0.003, OR=7.99, 95% CI: 2.02-31.66), location in the upper 1/3 of the stomach (VS lower 1/3: β=1.540, P<0.001, OR=4.66, 95% CI: 2.30-9.45), and fold interruption ( β=2.287, P=0.008, OR=1.93, 95% CI: 0.95-3.93) were independent risk factors for non-curative resection of EGC lesions. The factor of lesion diameter of 3-<5 cm and submucosal involvement were assigned 1 point respectively, location in the upper 1/3 of the stomach was assigned 2 points, diameter of ≥5 cm and fold interruption were assigned 3 points respectively, and other factors were assigned 0 point. Then the analysis of 378 lesions showed that the probability of non-curative resection at ≥2 points was 41.9% (37/93), 4 times as much as that at 0 [11.5% (25/217)]. Conclusion:EGC lesions with diameter ≥3 cm, located in the upper 1/3 of the stomach, interrupted folds or submucosal involvement are highly related to non-curative resection. The predictive model based on these factors achieves satisfactory efficacy, but it still needs further validation in larger cohorts.

Objective: To study the effects of endoscopic submucosal dissection(ESD) on long-term quality of life (QOL) and gastric function of patients with distal early gastric cancer (EGC), compared with those of surgery. Methods: Patients with EGC who received ESD or surgical resection in Peking Union Medical College Hospital over 1 year ago were selected to be followed up. QLQ-C30, SF-36, EQ-5D and dyspeptic symptom rating scale were used to evaluate QOL. Five-hour gastric emptying rate was used to evaluate distal gastric function. Electronic gastroscopy was used to observe whether the anastomotic stoma was stenotic. According to the age at resection, 1 to 1 matching was performed between the distal 1/3 gastric ESD (E_P) group and the distal subtotal gastrectomy (S_P) group, and then the QOL and gastric function between the two groups were compared. Results: Twenty-five patients were included in group E_P and group S_P respectively. According to QLQ-C30, the scores of cognitive function were 83.3 (83.3, 83.3) in group E_P and 83.3 (83.3, 100.0) in group S_P (P=0.056). The proportion of patients with symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) between the two groups were not statistically different. There was no statistical difference in the scores of EQ-5D and SF-36 between the two groups. According to dyspeptic symptom rating scale, 56.0% patients in group E_Phad burning sensation, but only 28.0% in group S_P had this symptom (P=0.054). 20.0% of patients in group S_Preported nausea, while only 4.0% in group E_P had this symptom (P=0.084). Gastric emptying results showed that the proportion of patients with abnormal 5-hour gastric emptying rate was 31.8% in group E_P, while there was no abnormal emptying in group S_P (P=0.003). Gastroscopy results showed that one patient in group E_P had pyloric stenosis, but 5-hour gastric emptying rate was normal. All anastomotic stomas in group S_p were unobstructed. Conclusion ESD and surgical resection for distal EGC show similar long-term effects on QOL of patients. But the long-term gastric emptying function may decrease after distal gastric ESD.

Objective: To develop the Chinese primipara social capital scale (C-PSCS), and to evaluate its validity and reliability. Methods: The items of C-PSCS were developed based on Social Capital Scale by the World Bank and Social Network Scale. This scale was modified according to the characteristics of primiparas. We selected 10 experts who specialized in related field, and two rounds of seminars about content, cultural compatibility, primiparas' characteristics, and practicability. The finally C-PSCS included four dimensions: social trust, social reciprocity, social network, and social participation. Using purposive sampling to select 1 100 primiparas in their third trimesters (gestational weeks from 30 to 36 weeks). The validity analyses included content validity, construct validity and discriminant validity. The reliability analyses included Cronbach' α coefficient, and split-half reliability. Results: 1 035 questionnaires (94.09%) were qualified and the completion time was (13.23 ± 2.53) minutes. The total score of scale was 195.38 ± 45.98, and scores for social trust, social reciprocity, social network, and social participation were 30.26 ± 4.25, 22.84 ± 4.21, 34.23 ± 7.47, and 108.05 ± 41.96, respectively. The common factor cumulative variance contribution rates of each dimension were from 52.92% to 69.37%, which achieved more than 50% of the approved standard, and all the items held factor loading >0.5 in its relevant common factor, it had good construct validity. The scale had a good content validity, the r values between each dimensions and total scale were range from 0.57 to 0.81, P<0.01. For the high-score group, scores for social trust, social reciprocity, social network, and social participation dimensions were 32.89±3.19, 25.65±3.48, 38.27±6.59, 119.94±36.61, respectively, which were higher than low-score group (27.77±3.58, 20.18±2.91, 30.40±6.13, 96.76 ± 43.60), t-values were -24.23, -27.46, -19.90, and -9.24, respectively, P<0.001. It had good discriminant validity. The Cronbach'α coefficient for the total scale and four dimensions were from 0.76 to 0.86, and whose split-half reliability were from 0.68 to 0.84. Conclusion The validity and reliability of C-PSCS were excellent, and could be used to evaluate the social capital situation on the Chinese primiparas.

The purpose of this investigation was to develop Pluronic F-127 coated N-trimethyl chitosan nanoparticles(F-S NPs)of insulin as the model drug and asses their penetration of the mucosal barriers. Single factor screening was used to optimize the formulations of nanoparticles and the nanoparticles were characterized. Their particle size, Zeta potential, encapsulation efficiencies and drug loading were assayed to be(240. 6±6. 51)nm, (10. 42±1. 60)mV, (43. 39±2. 83)% and(3. 39±0. 57)%, respectively. The impact of PF-127 on mucin binding in vitro and nanoparticles′s transport in freshly obtained mucus were also evaluated. The mucin affinity of F-S NPs was significantly reduced when compared to that of the N-trimethyl chitosan nanoparticles(S NPs), i. e. , 28% of the latter. And F-S NPs was found to have an improved mucosal penetrating capability. Mucus-secreting HT29-MTX-E12(E12)cell monolayer was selected to investigate their cellular uptake. F-S NPs exhibited higher penetration coefficient than both free insulin and S NPs in mucus-secreting epithelium cells, i. e. , 16-fold and 1. 4-fold, respectively. Data suggest that F-S NPs be potential carriers to cross mucosal barriers and enhance the cellular uptake of insulin.

OBJECTIVETo investigate the clinical and laboratory features of very long chain acyl-CoA dehydrogenase deficiency ( VLCADD ) and the correlations between its genotype and phenotype.

METHODEleven patients diagnosed as VLCADD of Shanghai Jiaotong University School of Medicine seen from September 2006 to May 2014 were included. There were 9 boys and 2 girls, whose age was 2 d-17 years. Analysis was performed on clinical features, routine laboratory examination, and tandem mass spectrometry (MS-MS) , gas chromatography mass spectrometry (GC-MS) and genetic analysis were conducted.

RESULTAll cases had elevated levels of blood tetradecanoylcarnitine (C14:1) recognized as the characteristic biomarker for VLCADD. The eleven patients were classified into three groups: six cases in neonatal onset group, three in infancy onset group form patients and two in late onset group. Neonatal onset patients were characterized by hypoactivity, hypoglycemia shortly after birth. Infancy onset patients presented hepatomegaly and hypoglycemia in infancy. The two adolescent patients showed initial manifestations of exercise intolerance or rhabdomyolysis. Six of the eleven patients died at the age of 2-8 months, including four neonatal onset and two infant onset patients, with one or two null mutations. The other two neonatal onset patients were diagnosed since early birth through neonatal screening and their clinical manifestation are almost normal after treatments. Among 11 patients, seventeen different mutations in the ACADVL gene were identified, with a total mutation detection rate of 95.45% (21/22 alleles), including eleven reported mutations ( p. S22X, p. G43D, p. R511Q, p. W427X, p. A213T, p. C215R, p. G222R, p. R450H, p. R456H, c. 296-297delCA, c. 1605 + 1G > T) and six novel mutations (p. S72F, p. Q100X, p. M437T, p. D466Y, c. 1315delG insAC, IVS7 + 4 A > G). The p. R450H was the most frequent mutation identified in three alleles (13.63%, 3/22 alleles), followed by p. S22X and p. D466Y mutations which were detected in two alleles (9.09%, 2/22 alleles).

CONCLUSIONThe ACADVL gene mutations were heterozygous in our patients. The mortality of neonatal onset form and infant onset form is much higher than the late onset form patients, suggesting a certain correlation between the genotype and phenotype was found. The earlier diagnosis and treatment of VLCADD are of vital importance for the improvement of the prognosis of the patients.

Acyl-CoA Dehydrogenase, Long-Chain ; deficiency ; genetics ; Adolescent ; Age of Onset ; Alleles ; Asian Continental Ancestry Group ; Child ; Child, Preschool ; China ; Female ; Genetic Testing ; Genotype ; Heterozygote ; Humans ; Infant ; Infant, Newborn ; Lipid Metabolism, Inborn Errors ; complications ; genetics ; Male ; Mitochondrial Diseases ; complications ; genetics ; Muscular Diseases ; complications ; genetics ; Mutation ; Neonatal Screening ; Phenotype ; Prognosis ; Rhabdomyolysis ; etiology ; Spectrum Analysis ; Tandem Mass Spectrometry