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 assess the effectiveness of a 6-month Ba Duan Jin exercise program in improving the balance of community-dwelling older adults.Methods:A two arms, parallel-group, cluster randomized controlled trial was conducted in 1 028 community residents aged 60-80 years in 40 communities in 5 provinces of China. Participants in the intervention group (20 communities, 523 people) received Ba Duan Jin exercise 5 days/week, 1 hour/day for 6 months, and three times of falls prevention health education, and the control group (20 communities, 505 people) received falls prevention health education same as the intervention group. The Berg balance scale (BBS) score was the leading outcome indicator, and the secondary outcome indicators included the length of time of standing on one foot (with eyes open and closed), standing in a tandem stance (with eyes open and closed), the closed circle test, and the timed up to test.Results:A total of 1 028 participants were included in the final analysis, including 731 women (71.11%) and 297 men (28.89%), and the age was (69.87±5.67) years. After the 3-month intervention, compared with the baseline data, the BBS score of the intervention group was significantly higher than the control group by 3.05 (95% CI: 2.23-3.88) points ( P<0.001). After the 6-month intervention, compared with the baseline data, the BBS score of the intervention group was significantly higher than the control group by 4.70 (95% CI: 4.03-5.37) points ( P<0.001). Ba Duan Jin showed significant improvement ( P<0.05) in all secondary outcomes after 6 months of exercise in the intervention group compared with the control group. Conclusions:This study showed that Ba Duan Jin exercise can improve balance in community-dwelling older adults aged 60-80. The longer the exercise time, the better the improvement.

Objective:To analyze the changes of fasting plasma glucose(FPG)level before and after menopause.Methods:Kailuan health checkup cohort was used to extract data of women aged≥18 years who participated in the first physical examination of Kailuan physical examination cohort and had menopausal age at the end of the seventh physical examination. A total of 3 749 women with 22 057 physical examination records were included in the analysis. Natural logarithmic transformation was applied to FPG, and a segmented linear mixed-effects model was used to analyze the changes in ln-transformed FPG before and after menopause. Additionally, an interaction analysis was performed to assess the multiplicative effect of baseline age and baseline body mass index(BMI)on ln-transformed FPG concerning pre- and post-menopausal periods.Results:The average age of the first physical examination for women in this study was (45.63±4.52)years, the median menopausal age was 51(50~53)years, and the median number of physical examinations was 6(5~7)times. The results of the piecewise linear mixed effect model showed that lnFPG increased from 1 year before menopause, with an average annual increase of 0.021 mmol/L, and continued to increase from menopause to 5 years after menopause, with an average annual increase of 0.007 mmol/L. LnFPG tended to be stable after 5 years of menopause. Baseline age could affect the changes of lnFPG before and after menopause, and there was a negative multiplicative interaction between baseline age ≥45 years and the time period from 6 years to 1 year before menopause( P=0.032). Women with baseline age ≥45 years had a higher average annual increase in lnFPG from 1 year before menopause to 5 years after menopause than women with baseline age <45 years( P<0.05). On lnFPG, there was a positive multiplicative interaction between baseline BMI and time segments around menopause. Compared to women with BMI <24.0 kg/m 2, obese women displayed more annual increase in lnFPG from 6 years to 1 year before menopause as well as from menopause to 5 years after menopause( P<0.05). Conclusions:Menopause has an adverse impact on FPG, with the most significant changes occurring within the period of one year before menopause and up to five years after menopause. Age and BMI significantly influence the changes in FPG before and after menopause.

Objective:To compare the imaging quality and metabolic quantitative parameters of pulmonary nodules between Q. Flex whole information five-dimensional (5D) and conventional three-dimensional (3D) PET/CT imaging for clinical evaluation.Methods:Fifty-four patients (30 males, 24 females, age: 60(42, 75) years; 78 solid pulmonary nodules (maximum diameter≤3 cm) with abnormal uptake of 18F-FDG) from Tianjin Cancer Hospital Airport Hospital between June 2022 and August 2022 were enrolled in this retrospective study. All patients underwent 5D scanning and 3D, 5D reconstruction. Image quality scores, signal-to-noise ratio (SNR), SUV max, SUV mean and metabolic tumor volume (MTV) of pulmonary nodules of 5D group and 3D group were evaluated and compared with χ2 test and Wilcoxon signed rank test. Correlation of quantitative parameters between 2 groups were analyzed by using Spearman rank correlation analysis. Results:Thirty-five of 78(45%) pulmonary nodules with image quality score≥4 were found in 5D group, which were more than those in 3D group (22/78(28%); χ2=4.67, P=0.031). Meanwhile, SNR, SUV max, SUV mean, and MTV were significantly positively correlated between the 2 groups ( rs values: 0.86, 0.86, 0.85, and 0.95, all P<0.001). SNR, SUV max and SUV mean of pulmonary nodules in 5D group were significantly higher than those in 3D group, which were 37.46(18.42, 62.00) vs 32.72(16.97, 54.76) ( z=-4.07, P<0.001), 9.71(5.48, 13.82) vs 8.96(4.82, 12.63) ( z=-3.05, P<0.001) and 6.30(3.39, 8.94) vs 5.61(2.99, 7.63)( z=-4.07, P<0.001) respectively. MTV of pulmonary nodules in 5D group was significantly lower than that in 3D group, which was 1.72(0.66, 2.74) cm 3vs 1.98(1.06, 4.63) cm 3 ( z=-7.13, P<0.001). Quantitative parameters of lower lung field and nodules with maximum diameters of >10 mm and ≤20 mm based on 5D scanning changed most significantly compared with those based on 3D scanning ( z values: from -5.23 to -2.48, all P<0.05). Conclusion:Q. Flex 5D PET significantly improves the quantitative accuracy of SUV and MTV of pulmonary nodules, and the improvement of image quality is substantial without increasing the radiation dose, which has clinical practical value.

Objective To explore the relationship between serum Krüppel-like factor 5(KLF5)and actinin-4 with prognosis of hepatocellular carcinoma(HCC)treated with transcatheter arterial chemoembolization(TACE).Methods From March 2015 to March 2020,130 HCC patients admitted into the Second Affiliated Hospital were collected as study subjects and divided into HCC group and 86 patients with liver cirrhosis were collected as control group.After 3 years of postoperative follow-up,HCC patients were sub-divided into survival group(n=38)and mortality group(n=92)based on their survival outcomes.ELISA was applied to detect the level of serum KLF5 and actinin-4 in each group and analyzed the correlation between serum KLF5 and actinin-4 levels.Cox regression was applied to analyze the risk factors affecting the prognostic mortality of HCC patients;Receiver operating char-acteristic curve(ROC)was plotted to evaluate the predictive value of serum KLF5 and actinin-4 levels for the prognostic mortality of HCC patients.Results The serum level of KLF5 and actinin-4 in the mortality group was significantly higher than those in the survival group(P＜0.05);There was a positive correlation between serum level of KLF5 and actinin-4 in HCC patients(P＜0.001);Low differentiation,staging(CNLC)stage IIIa of China liver cancer staging(CNLC),vascular invasion and elevated level of KLF5 and actinin-4 were risk factors for prognostic mortality in HCC patients(P＜0.05);The area under the curve(AUC)of serum KLF5 and acti-nin-4 alone and in combination for predicting mortality in HCC patients was 0.835,0.866,and 0.936,respec-tively,showing a high level of combined predicting function(Zcombination-KLF5=2.792,P=0.005,Zcombi-nation-actinin-4=2.014,P=0.044).Conclusions Serum level of KLF5 and actinin-4 l found in HCC patients has a high predictive value for prognosis.

Objective:To explore the effect of augmented renal clearance(ARC)on 24-hour area under the concentration-time curve to minimum inhibitory concentration ratio(AUC 24/MIC)of vancomycin and prognosis in critical children, thus to provide proposal for individual dosage regimen. Methods:Sixty-five critical children treated with vancomycin, who suffered from sepsis/septic shock, were brought into this retrospective cohort study.According to estimate glomerular filtration rate, these children were divided into ARC group ( n=27) and normal group ( n=38). The influencing factor of AUC 24/MIC of vancomycin and therapy prognosis for two groups were detected and analyzed. Results:There were no significant differences between two groups in basic setting (age, sex, weight), scores of pediatric sequential organ failure assessment and pediatric risk of mortality Ⅲ, infection markers (C-reactive protein and procalcitonin), glutamic-pyruvic transaminase, hypoproteinemia, usage of diuretic and vasoactive agent( P>0.05). The patients from ARC group showed lower levels than those from normal group in AUC 24/MIC of vancomycin[375.2(300.8, 489.4) vs. 443.6(412.3, 593.2), Z=2.263, P=0.024] and it′s target achievement ratio (TAR)(40.7% vs. 76.3%, χ2=8.440, P=0.005). When usage of diuretic and vasoactive agent, the AUC 24/MIC of ARC group was lower than that of normal group( P<0.05). But there was no significant difference between ARC group and normal group regarding hypoproteinemia( P>0.05). The days of body temperature steady at least 48 hours[7.0(5.5, 9.0)d vs. 6.0(5.0, 8.0)d], the length of hospital stay[39.0(21.0, 58.0)d vs. 20.5(16.0, 28.0)d], the length of PICU stay[14.0(9.0, 31.5)d vs. 10.0(5.0, 15.0)d] were longer than those in normal group( P<0.05). There were no significant differences between ARC group and normal group regarding days of ventilation and infectious markers decreased at least 50%, as well as 28-days mortality( P>0.05). The multivariable analysis showed that the presence of ARC, hypoproteinemia, use of diuretics and vasoactive agent were significantly associated with AUC 24/MIC of vancomycin( P<0.05). Conclusion:ARC may down regulate levels of AUC 24/MIC and TAR of vancomycin.During ARC period, the usage of diuretic and vasoactive agent could affect the AUC 24/MIC of vancomycin.Individual dosage regimen should be employed for critical children suffered with ARC.

Objective:To explore the effects of an improved perioperative diet management based on the concept of enhanced recovery after surgery (ERAS) in patients undergoing total hip arthroplasty (THA) .Methods:From May 2020 to May 2022, convenience sampling was used to select 320 patients who underwent their first unilateral THA at the First Affiliated Hospital of Zhengzhou University. According to the random number table method, patients were divided into control group ( n=160) and observation group ( n=160). The control group adopted a routine perioperative diet management, while the observation group improved the perioperative diet management based on the ERAS concept, and nurses performed preoperative fasting and postoperative diet and drinking water nursing according to the plan. We compared the preoperative hunger and thirst between two groups of patients, and recorded the gastrointestinal function such as postoperative anal exhaust and defecation time, bowel sound recovery time, postoperative nausea and vomiting degree, and post eating nausea and vomiting degree between the two groups. Results:The number of preoperative hunger and thirst patients in the observation group was less than that in the control group, and the postoperative exhaust time, defecation time, and bowel sound recovery time were shorter than those in the control group ( P<0.05). The degree of nausea and vomiting after eating after surgery was lower than that in the control group. The differences were all statistically significant ( P<0.05) . Conclusions:The improved perioperative diet management based on ERAS has good clinical effects in THA patients, reducing perioperative discomfort and promoting postoperative gastrointestinal function recovery.

Objective:To analyze the early clinical features of children with coronavirus disease 2019 (COVID-19) in order to further improve the understanding of the disease.Methods:A total of 312 children with COVID-19 under 16 years old who were first diagnosed in the children′s fever clinic at Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine from March to May 2022 were retrospectively analyzed.The epidemiology, early clinical features and blood routine results of children were described, and the blood routine results among different age groups were compared.Results:The median age of 312 children was 3.15(1.47, 6.51) years.The proportion of infection rate of children with different ages from high to low were 1~3 years old, > 6 years old, 3~6 years old and ≤ 1 year old.Only 17 (5.4%) cases had underlying diseases.Additionally, 70.2% patients had definite positive case reports in their residential communities, and 65.1% showed a familial cluster.Moreover, 96.2% patients had fever and 52.9% patients had respiratory symptoms.The main symptoms are fever (96.2%), cough (38.1%), runny nose (20.2%), vomiting (14.7%), sore throat (11.5%), poor appetite (6.7%), nasal congestion (4.5%), expectoration (4.5%), convulsion (4.2%), diarrhea (3.8%), etc.Among 309 children, 11.3% patients had increased white blood cell count, especially in children over 6 years old ( P=0.006); 31.7% patients had decreased lymphocyte count and 32.4% had increased C-reactive protein.The positive rate of point-of-care testing was as high as 99%. Conclusion:Children with COVID-19 in Shanghai had the characteristics of familial cluster.The main symptoms are fever and respiratory symptoms.Most of the blood routine leukocytes have no obvious changes, and a few have lymphopenia and C-reactive protein elevation.Point-of-care testing detection can help the children′s fever clinic to early screen COVID-19.

IF1 (ATPIF1) is a nuclear DNA-encoded mitochondrial protein whose activity is inhibition of the F

Objective:To investigate the acute kidney injury(AKI) after cardiopulmonary bypass surgery for cyanotic congenital heart diseases(C-CHD) as well as and acyanotic congenital heart diseases(A-CHD)and its possible influencing factors.Methods:One hundred and three patients with CHD admitted to PICU of Xinhua Hospital Affiliated to Shanghai Jiaotong University were enrolled from July 1, 2017 to September 30, 2019.The patients were divided into C-CHD group( n=36)and A-CHD group( n=67). The preoperative general data and information related to the operation of two groups were recorded.Hemodynamic data, oxygen metabolism index, dose of vasoactive drugs during or after operation and liquid equilibrium were assessed after surgery.The incidence and stage of AKI were calculated.Multivariate Logistic regression was used to analyze the relationship between hemodynamic index and oxygen metabolism index and AKI.The predictive value of hemodynamics and oxygen metabolism for AKI after cardiac surgery was analyzed by receiver operating characteristic curve (ROC). Results:A total of one hundred and three patients were enrolled including sixty-two males and forty-one females, the median age was 7(4, 24) months old.The preoperative hemoglobin and hematocrit in the C-CHD group were higher than those in the A-CHD group( P<0.05). Compared with the A-CHD group, the C-CHD group had higher American Society of Anesthesiologists Grades and Risk Adjustment for Congenital Heart Surgery Grades, longer operation time and cardiopulmonary bypass time( P<0.05). Central venous pressure in C-CHD group was higher than that in A-CHD group, and C-CHD group had higher dose of vasoactive drugs after surgery( P<0.05). Compared with the C-CHD group, blood lactic acid was lower and arterial oxygen partial pressure was higher in the A-CHD group( P<0.05). Fifty patients developed AKI in the PICU, and the incidence of AKI in the A-CHD group was higher than that in the C-CHD, but there was no statistical significance(53.7% vs.38.9%, P>0.05). Multivariate Logistic regression analysis showed that partial arterial oxygen pressure and arterial oxygen satiety were independent risk factors for AKI( P<0.05). The large circulation index could not directly reflect the renal perfusion.Compared with using hemodynamic index or oxygen metabolism index alone to predict the occurrence of AKI 48 h after the operation, the combined application of the two methods had higher predictive value for AKI. Conclusion:Compared with patient with A-CHD, patients with C-CHD have higher tolerance to renal damage caused by surgery, and the kidney of patient with C-CHD have higher tolerance to postoperative fluid load and demand lower oxygen consumption.It is of great clinical significance to evaluate the changes of hemodynamics and oxygen metabolism after cardiac surgery for the prevention and treatment of renal injury.