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 We aimed to establish and evaluate a rat model of post-infectious irritable bowel syndrome(PI-IBS)with the pattern of liver depression and spleen deficiency coupled with dampness.Methods First,200 rats were randomly divided into the normal group,the infection group,the infection+stress group,the infection+stress+external dampness group,and the acetic acid+stress group(n=40 rats per group)for eight weeks.The rats were treated with Trichinella spiralis infection,chronic restraint stress,an artificial high-humidity climate,and/or acetic acid enema.Weight growth rate,24-hour food intake and water intake,and the fecal moisture percentage were recorded.The open field test and the sucrose consumption test were used to determine the behavioral characteristics of rats in each group.The abdominal withdrawal reflex(AWR)test was used to determine visceral sensitivity.The contents of 5-hydroxytryptamine(5-HT)and aquaporin 4(AQP4)in colon tissue were detected by ELISA.Results Compared with the normal group,the weight growth rate of rats in the infection+stress+external dampness group and the acetic acid+stress group was lower from Week 1 to Week 8 of modeling.The 24-hour food intake of rats in the infection+stress+external dampness group and the infection+stress group was lower than that in the normal group from Week 2 to Week 8 of modeling.At the end of week 2 of modeling,the 24-hour water intake of rats in the infection+stress+external dampness group,the acetic acid+stress group,and the infection+stress group was lower than that in the normal group.The fecal moisture percentage of rats in the infection+stress+external dampness group was higher than that in the normal group at the end of Week 1,6,and 8(P＜0.05).At the end of Week 4 of modeling,the total distance in the open field test in the infection+stress+external dampness group and the acetic acid+stress group was shorter than that in the normal group.The sugar preference rate in the infection+stress+external dampness group was lower than that in the normal group at the end of 1,4,and 8 weeks and lower than that in the acetic acid+stress group at the end of Week 4 and 8(P＜0.05).The AWR scores of rats in the infection+stress+external dampness group were higher than those in the normal group after week 1 at 60 and 80 mmHg(1 mmHg≈0.133 kPa),after Week 4 at 40,60,and 80 mmHg,and after Week 6 and 8 at 20,40,and 80 mmHg(P＜0.05).At the end of Week 2 and 4,a large number of inflammatory cells were infiltrated in the colonic mucosa of the intervention groups,and the inflammation score was higher than that of the normal group(P＜0.05).At the end of weeks 6 and 8,the inflammatory cell infiltration in the intestinal mucosa of the intervention groups was not obvious,and the colonic mucosa returned to normal.At the end of weeks 6 and 8,the 5-HT content was higher in the infection+stress group,the infection+stress+external dampness group,and the acetic acid+stress group than in the normal group(P＜0.05).After Week 4,the AQP4 content was lower in the infection+stress+external dampness group and the acetic acid+stress group than that in the normal group(P＜0.05).After week 6,compared to the normal group,the AQP4 content was lower in all groups except for the acetic acid+stress group,and the AQP4 content in the infection+stress+external dampness group was lower than that in the acetic acid+stress group.After week 8,only in the infection+stress+external dampness group the AQP4 content was lower than in the normal group(P＜0.05).Conclusion The combination of Trichinella spiralis infection,chronic restraint stress,and an artificial high-humidity climate can be used to prepare a relatively stable and reliable rat model of PI-IBS with the pattern of liver depression and spleen deficiency with dampness.

Objective To investigate the predicting value of intermedin (IMD) for the prognosis of elderly sepsis patients.Methods A retrospective analysis was conducted. Forty-one patients with sepsis, aged ≥65 years, and admitted to geriatrics intensive care unit of Aerospace Center Hospital from April 2015 to December 2016 were enrolled. Thirty healthy patients were studied as control during the same time. The expression of C-reactive protein (CRP), procalcitonin (PCT) and IMD were tested within 24 hours during hospitalization, and the acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ) score and prognosis was evaluated. According to APACHE Ⅱ score, patients were divided into 3 groups, 10-20 score, 21-30 score, and > 30 score group. And based on the prognosis, the patients were divided into death group and survival group. The differences of expression levels of CRP, PCT and IMD in each group were assessed. The relationship of IMD and infection index was analyzed by Pearson correlation. Receiver operating characteristic curve (ROC) was used to evaluate the prognostic value of CRP, PCT and IMD in patients with sepsis.Results Compared with the control group, the levels of CRP, PCT and IMD were significantly higher in the sepsis patients [CRP (mg/L): 114.71±40.08 vs. 4.03±2.68, PCT (μg/L): 1.338±0.812 vs. 0.007±0.001, IMD (ng/L):43.03±9.67 vs. 16.77±2.06, allP < 0.01]. With the increase of APACHE Ⅱ score, the levels of PCT and IMD were gradually increased. In APACHE Ⅱ 10-20 score, 21-30 score, > 30 score groups, PCT (μg/L) were 0.397±0.129, 1.164±0.326, and 1.999±0.888, respectively (F = 19.392,P = 0.000); IMD (ng/L) were 29.12±5.60, 40.48±4.40,52.75±4.73, respectively (F = 33.310,P = 0.000). There was no significant difference in CRP among APACHE Ⅱ score groups (F = 2.137,P = 0.132). The level of IMD was positively correlated with CRP and PCT (r1 = 0.351,P1 = 0.024;r2 = 0.617,P2 = 0.000), and there was no correlation with temperature and white blood cell count (r1 = 0.063,P1 = 0.697;r2 = 0.064,P2 = 0.692). The expression of PCT and IMD in the death groups were significantly higher than the survival group [PCT (μg/L): 1.547±0.883 vs. 1.043±0.608, IMD (ng/L): 47.44±8.23 vs. 36.80±8.13, bothP < 0.05], while CRP was not significantly different. The area under the ROC curve [AUC (95% confidence interval, 95%CI)] of IMD was larger than that of PCT and CRP [0.809 (0.675-0.943) vs. 0.680 (0.511-0.849), 0.664 (0.490-0.838)]; when cut-off value of IMD was 41.58 ng/L, the sensitivity was 75.0% and the specificity was 82.4%.Conclusions The levels of CRP, PCT and IMD were increased in elderly sepsis patients, and IMD and PCT can better reflect the severity of sepsis. IMD is more valuable in predicting the prognosis of sepsis patients.

Objective To investigate perfusion imaging and parameters of normal pancreas by dual-source CT and to evaluate the appropriate perfusion imaging scan.Methods Sixty-six subjects with normal pancreas underwent low-dose pancreatic perfusion and plain scan.CT images were sent to a separate workstation via a network.The blood flow (BF)and blood volume (BV)of pancreas head,body and tail were measured using the VPCT Body software and analyzed by one-way ANOVA.Then the time-density curve of pancreas was drawn,and the enhancement peak time and the corresponding CT value were also measured.Results The average BF values of pancreas head,body and tail were (1 1 6.09 ± 31.83)mL·100 g-1 ·min-1 ,(1 1 9.72±32.50)mL·100 g-1 ·min-1 , (1 14.65±31.42)mL·100 g-1 ·min-1 ,and the mean BV values were (29.83 ±1 9.07)mL/100 g,(30.39 ± 1 9.38)mL/100 g, (28.82±1 9.22)mL/100 g,respectively.The perfusion parameters in different pancreatic parts were not statistically different.The mean enhancement peak time was (27.92 s±4.52)s,(28.02±5.34)s in pancreas head,(27.40±4.36)s in pancreas body,(27.34±4.57)s in pancreas tail.On plain image,the average CT value of pancreas was (41.43±5.88)HU.However,on enhanced image,the mean CT value was (95.96±18.44)HU in normal pancreas [(96.73±19.71)HU in pancreas head,(98.45±17.52)HU in body,(92.69±18.1 7)HU in tail].Conclusion The perfusion parameters including blood flow and blood volume in pancreatic head,body and tail are identical. The mean enhancement peak time is (27.92±4.52)s,and the corresponding enhancement CT value is (95.96±18.44)HU.

Objective To evaluate the value of DWI and ADC value in monitoring the chemotherapy response of advanced gastric carcinoma dynamically.Methods 42 advanced gastric carcinoma patients who were confirmed by histopathology underwent T2 WI and DWI examinations at pre-chemotherapy,post-chemotherapy 3 d,7 d,30 d and 60 d respectively.The longest diameters of tumor pre-chemotherapy and post-chemotherapy 60 d were measured on axial T2 WI,meanwhile the ADC values at different time points were calculated.The mean ADC value among pre-and post-chemotherapy of each group (PR and SD)was compared.Results The ADC value of PR group increased gradually.The mean ADC value before therapy was statistically lower than those at differ-ent time points post-chemotherapy (P < 0.05).The ADC value of SD group increased gradually from pre-chemotherapy to post-chemotherapy 30 d,and then the ADC value decreased at post-chemotherapy 60 d.The differences of the mean ADC values in differ-ent time points were statistically significant (P < 0.05).Conclusion DWI and ADC value can dynamically,quantitatively and early detect and monitor the chemotherapy response of advanced gastric carcinoma.

Objective To investigate the clinical effect of Xuesaitong soft capsule in the treatment of cerebral apoplexy in cerebral infarction patients.Methods One hundred and twelve patients with cerebral infarction were selected as our subjects,who were in out-patient clinic of Affiliated Hospital of Hebei United Univemity from Jan.to Sep.in 2010.The patients were randomly divided into experimemal group(84 cases) and control group(28 cases) and they were received Xuesaitong soft capsule or Ginkgo leaf capsule for 28d.To meet the program data set(PPS) and a full analysis of data set(FAS),and compared NIHSS Stroke Scale score of the measured values of the diachronic changes at 0,14,28 d and the difference before and after treatment in the treatment of two groups of patients.Statistical analysis was done by SPSS13.5 software.Results PPS and FAS analysis showed that there were no statistic significance at each time of treated section in terms of the practical change value of cerebral apoplexy measuring scale between the experimental group and control group ((PPS:F between group:0.500,0.21 8,0.012 ; FAS:F between group:0.506,0.231,0.049 ; P ＞ 0.05).The practical change value of cerebral apoplexy measuring scale decreased obviously at 0 d and 28 d after treatment.The analysis of variance of repeated measured data indicated that there were obviously statistic significance(PPS:F inner group:13.89、31.18 ; FAS:F inner group:14.80,34.04 ;P ＜ 0.05).The analysis results were concordance through FAS and PPS.Conclusion The clinical effect of Xuesaitong soft capsule for cerebral infarction patients with cerebral apoplexy is safe,and it was suggested to apply in clinic.

Objective To assess the value of apparent diffusion coefficient (ADC)in clinic ,pathology and prognosis of rectal cancer. Methods The MRI and DWI findings of 109 patients with pathological proved rectal adenocarcinoma were retrospectively analyzed. DWI with b=0 s/mm2 and b= 1 000 s/mm2 were acquired.Mean tumor ADCs were measured and compared between subgroups stratified by histologic differentiation grades,T-stage,N-stage,mesorectal fascia status and presence of lymphangiovascular or peri-neral invasion.Results Mean tumor ADCs were significantly different when comparing groups stratified by histologic differentiation grades,T-stage,mesorectal fascia status and presence of lymphangiovascular invasion.Tukey’s post hoc test showed that the differences of mean ADCs between good-moderate differentiated group and moderate differentiated group(P =0.996),moderate-poor differentiated group and poor differentiated group(P =0.957)were not significant.The differences among other groups of differentia-tion grades differed significantly(P <0.05).In the T-stage groups,the mean ADCs of T1 stage tumor was significantly higher than that of T3 stage tumor(P <0.05).There were no significant differences among other T-stage groups(P >0.05).There were no sig-nificant differences among N0,N1 and N2 in N-stage groups(P >0.05).Conclusion ADC values can reflect pathologic and prognos-tic features of rectal cancer.

Objective To study the imaging manifestations and clinical significance of simple cochlear nerve canal(CNC)stenosis. Methods The HRCT findings of 14 patients(1 7 ears)with simple CNC stenosis diagnosed sensorineural hearing loss(SNHL)were retrospectively analyzed.The width of CNC and internal auditory canal was measured and compared with the normal ears,the data were statisti-cally analyzed by SPSS1 6.0.Thin-sliced MRI of internal auditory canal (axial and oblique sagittal position)was performed in 8 cases. Results HRCT displayed obvious CNC stenosis in all 14 patients(1 7 ears),2 ears with cochlear nerve canal atresia.Width of CNC and internal auditory canal was (0.5±0.3)mm and (4.6±1.0)mm,it was (2.1±0.2)mm and (5.1 ±1.3)mm in normal ears (1 1 ears),the width of CNC was of significant difference between normal ears and ears with SNHL,and there was no statistical sig-nificant difference in width of internal auditory canal.12 ears(from 1 7 ears with simple CNC stenosis)were lacking of fissure in the cribriform area,1 1 ears(normal ear)were existence of fissure in the cribriform area;cochlear nerves were not shown in 8 patients with MRI examination.Conclusion CNC stenosis can be isolated from internal auditory canal stenosis,MRI could display cochlear nerve dysplasia(CND).

Objective To investigate the value of dynamic contrast-enhanced quantitative parameters of pancreatic cancer at 3.0T MR.Methods 27 patients with pathologically proved pancreatic cancers were underwent DCE-MR at a 3.0 T scanner.AToft with Vp model was used to quantify K trans ,k ep ,Ve and Vp in the pancreatic cancer and normal pancreatic tissues.All parameters among different tissues were analyzed and compared by SPSS1 7.0.Results The K trans 、k ep 、Ve 、Vp values of pancreatic cancer were(0.303± 0.321)min,(1.387±1.486)min,(25.07±10.98)%and(3.420±4.692)% respectively ,while those values of normal pancreatic tis-sue were (1.235±0.777)min,(9.277 ± 7.996 )min,(1 7.89 ± 8.882 )%,and(7.1 96 ± 6.704)%,respectively.The differences be-tween the four parameters of pancreatic cancer and normal pancreatic tissue were statistically significant(F =33.188,25.414,6.984, 5.78,P <0.05).Conclusion Quantitative parameters of DCE-MRI accurately reflect changes in tumor blood perfusion and microcir-culation,they may be helpful to differentiate the atypical lesion.

The on-site labeling and localization tracking of membrane proteins in pathogenic bacteria are tedious work. In order to develop a novel protein labeling technology at super resolution level (nanometer scale) using the photoactivatable localization microscopy (PALM), the chimeric protein of the outer membrane protein A (OmpA) of Mycobacterium tuberculosis and the photoactivatable mEos2m protein were expressed in the non-pathogenic Mycobacterium smegmatis. The recombinant bacteria were fixed on slide, activated by 405 nm laser and subject to PALM imaging to capture photons released by the fusion protein. Meanwhile, colony and cell morphology were visualized under regular fluorescent stereomicroscope and upright fluorescent microscope to characterize fluorescence conversion and protein localization. The fusion proteins formed a "belt"-like structure on cell membrane of M. smegmatis under PALM, providing direct evidence of on-site imaging of membrane proteins. Expression of fusion protein did not compromise the localization properties of OmpA. Thus, mEos2m could be used as a labeling probe to track localizations of non-oligomer oriented membrane proteins. This indicates non-pathogenic M. smegmatis could be served as a model strain to characterize the function and localization of the proteins derived from pathogenic M. tuberculosis. This is the first report using PALM to characterize localization of membrane proteins.
Bacterial Outer Membrane Proteins ; analysis ; chemistry ; Fluorescent Dyes ; Light ; Microscopy ; methods ; Mycobacterium smegmatis ; chemistry ; Mycobacterium tuberculosis ; chemistry ; Nanotechnology ; methods ; Staining and Labeling ; methods ; Stochastic Processes