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

In this study, we constructed a series of recombinant Fc variants of immunoglobulin G4 (IgG4), screened the fragment crystallizable (Fc) variants with significantly prolonged serum half-lives, and analyzed the relationship between mutation site and half-life, aiming to provide a theoretical basis for the development of IgG4 antibodies and Fc fusion protein-based drugs. Nine gene sites were selected for mutation, and different mutation sites were combined. The variant expression plasmids pET24b-Fc were constructed by molecular cloning and point mutation. The plasmids were transformed into Escherichia coli BL21(DE3) for the expression of different recombinant proteins of Fc. Fc2 and Fc3 variants had slightly lower recombinant protein yields, and the expression of other variants was not affected. The toxicity of different Fc variants was determined by cell counting kit-8 (CCK-8) and calcein acetoxymethyl ester/ propidium iodide (calcein AM/PI) in vitro and enzyme-linked immuno sorbent assay (ELISA) in vivo. The results showed that the recombinant Fc variants had good biocompatibility and safety. Finally, the Fc variants were labeled with fluorescent markers, and the effects of different mutations on their serum half-lives were investigated by in vivo experiments. The Fc5 variant with prolonged serum half-life was successfully screened out, which provided a theoretical and practical basis for the optimal design of IgG4 subtype antibody and Fc fusion protein drugs.
Immunoglobulin G/blood* ; Immunoglobulin Fc Fragments/biosynthesis* ; Half-Life ; Animals ; Escherichia coli/metabolism* ; Humans ; Recombinant Fusion Proteins/biosynthesis* ; Recombinant Proteins/biosynthesis* ; Mice

Objective:To analyze the dietary patterns of Chinese adults and explore the relationship with serum uric acid (SUA) and hyperuricemia (HUA).Methods:A total of 9 358 adults were selected in the 2018 China Health and Nutrition Survey. Dietary intake data were collected by three consecutive 24-hour dietary recalls and weighing method. The social demographic information of the survey subjects was obtained through questionnaire surveys. The dietary patterns were extracted using factor analysis, and the relationship between dietary patterns and SUA was analyzed using multiple linear regression analysis. The correlation between HUA and dietary patterns was analyzed using logistic regression analysis models.Results:Four dietary patterns were identified: northern (high intakes of wheat, other cereals,and tubers); modern (high intakes of fruit, dairy, eggs, and nuts); southern (high intakes of rice and vegetables);animal food-wine (high intake of organ meats, seafood, and wine). The multiple linear regression analysis results showed that the northern pattern was negatively correlated with SUA ( β=-0.438, 95% CI: -0.500--0.376); the modern pattern was negatively correlated with SUA ( β=-0.134, 95% CI: -0.219--0.049); the southern model was significantly correlated with higher SUA ( β=0.146, 95% CI: 0.079-0.214); the animal food-wine pattern was positively correlated with SUA ( β=0.188, 95% CI: 0.123-0.252). Logistic regression analysis showed that compared with the northern model score Q1 group, the risk of developing HUA was reduced in Q3 and Q4 groups, with ORs values of 0.777 (95% CI: 0.650-0.929) and 0.509 (95% CI: 0.423-0.613), respectively; and compared with the modern model score Q1 group, the higher the scores in Q3 and Q4 groups, the HUA was lower, with ORs of 0.793 (95% CI: 0.660-0.953) and 0.768 (95% CI: 0.631-0.934), respectively. Compared with the animal food-wine pattern score Q1 group, the risk of developing HUA was increased in both Q3 and Q4 groups ( Q3 group: OR=1.224, 95% CI: 1.012-1.480; Q4 group: OR=1.312, 95% CI: 1.086-1.584). Conclusions:Dietary patterns are associated with HUA. The northern and modern patterns are related to lower SUA levels and reduced risk of HUA, while the animal food-wine pattern increases the risk of HUA.

Objective: To understand the current situation of snack consumption among children and adolescents in China and its relationship with overweight and obesity, so as to provide a basis for formulating strategies of preventing and controlling overweight and obesity in children and adolescents in China. Methods: A total of 1 882 children and adolescents aged 6-17 years old, choosed from 15 provinces, autonomous regions and municipalities according to China Health and Nutrition Survey in 2018, were selected. Snack consumption was investigated by the 24 hour dietary retrospective method for three consecutive days. The pattern of snack consumption was explored by cluster analysis, and the relationship between snack consumption and overweight and obesity was analyzed by Logistic regression. Results: The snack consumption rate was 60.6%, and the percentage of daily energy intake from snacks was 2.4%. Snack consumption characteristics could be divided into four modes. Mode 1 was characterized by daily intake of medium amount of fruit, Mode 2 was characterized by daily intake of small amount of fruit and baked goods, Mode 3 was characterized by daily intake of small amount of fruit, and Mode 4 was characterized by daily intake of medium amount of milk and small amount of fruit. After adjusting the relevant covariates such as energy intake, compared with those who did not eat snacks, the OR (95% CI ) values of the risk of overweight and obesity in different snack consumption patterns were 1.56(0.93- 2.58 ), 0.81( 0.51- 1.24), 1.24(0.94-1.63) and 1.00(0.60-1.63), respectively; the OR (95% CI ) values of percentage of daily energy intake from snacks from low to high quartiles were 1.17(0.81-1.68), 1.32(0.92-1.89), 1.12(0.77-1.61) and 1.00(0.69-1.45), respectively. There was no statistically significant difference( P >0.05). Conclusion The proportion of Chinese children and adolescents consuming snacks is relatively high, mainly including fruit and its products, milk and its products and baked goods. No association between snack consumption and overweight and obesity has been found.

Objective:To evaluate the effect of urinary albumin creatinine ratio (UACR) on diabetic retinopathy (DR) in patients with type 2 diabetes. Receiver operating characteristic (ROC) curve was applied to find the cut-off value of UACR for diagnosing DR.Methods:A prospective cohort study of 2 490 patients with type 2 diabetes was conducted with a mean follow-up of 7 years ranging from 3 to 10 years. Dilated fundus examination was performed once a year, and patient history and clinical data were collected and analyzed. Patients were divided into three groups according to the UACR: Q1, normal urinary albumin group (UACR<30 mg/g), Q2, microalbuminuria group (30 mg/g≤UACR≤299 mg/g), and Q3, macroalbuminuria group (UACR>300 mg/g), respectively. Cox regression analysis was used to explore the influence of UACR and other factors on DR, and ROC curve was drawn to evaluate the value of UACR in diagnosis of DR.Results:Cox regression analysis showed that UACR was the risk factor of DR( HR=1.108, 95% CI 1.023-1.241, P<0.001). It showed that the patients in Q3 group had the highest risk of proliferative DR ( HR=3.128, 95% CI 2.025-4.831, P<0.001), the patients in Q2 group followed( HR=1.918, 95% CI 1.355-2.714, P<0.001), and the patients in Q1 group were the lowest. ROC curve analysis showed that area under UACR curve was 0.746(95% CI 0.681-0.812, P<0.001), and the cut-off value, sensitivity, and specificity for the diagnosis of PDR were 54.12mg/g, 0.769, and 0.653, respectively. Conclusion:The UACR can predict the progression of PDR in type 2 diabetes patients, therefore it may be used as a preliminary predictor for the progression of DR.

Objective:To analyze the effects of different blood pressure variables and their variabilities on diabetic nephropathy(DN)in patients with type 2 diabetes.Methods:This prospective cohort study included 3 050 type 2 diabetic patients without DN at baseline from Lee′s clinic in Taiwan, China. The metabolic parameters of patients were regularly checked, and urine albumin creatinine ratio(UACR)were evaluated annually. The average follow-up period was 7 years(3-10 years). The means and standard deviations(SD)of systolic blood pressure(SBP), diastolic blood pressure(DBP), pulse pressure(PP), and mean arterial pressure(MAP)were calculated. According to whether SBP-Mean was higher or lower than 130 mmHg(1 mmHg=0.133 kPa) and SBP-SD was higher or lower than 11.06 mmHg(average SBP-SD), these patients were divided into four groups: Q1(SBP-Mean<130 mmHg, SBP-SD<11.06 mmHg); Q2(SBP-Mean<130 mmHg, SBP-SD≥11.06 mmHg); Q3(SBP-Mean≥130 mmHg, SBP-SD<11.06 mmHg); Q4(SBP-Mean≥130 mmHg, SBP-SD≥11.06 mmHg). In the same way, according to whether PP-Mean was higher or lower than 80 mmHg(average PP-Mean)and PP-SD was higher or lower than 6.48 mmHg(average PP-SD), the patients were divided into Q1-Q4 groups.Results:After adjusting age, sex, and diabetes duration, Cox regression analysis showed that SBP-Mean, SBP-SD, PP-Mean, and PP-SD were the risk factors of DN. After the stratification according to SBP-Mean and SBP-SD, the patients in Q4 group( HR=1.976, P<0.001)had the highest risk while those in Q1 group displayed the lowest risk for DN. Additionally, the patients in Q3 group( HR=1.614, P<0.001)imposed a higher risk than that in Q2 group( HR=1.408, P<0.001). By stratificating the patients based on PP-Mean and PP-SD, the patients in Q4 group revealed the highest risk of DN( HR=1.370, P<0.001)while those in Q1 group had the lowest risk. In addition, the patients in Q3 group( HR=1.266, P<0.001)had a higher risk of DN compared with those in Q2 group( HR=1.212, P<0.001). Conclusion:SBP and PP variabilities are the predictors of DN in patients with type 2 diabetes.

Objective: To understand the malnutrition status and trends among children and adolescents, and to provide evidence for improving the nutritional status of children and adolescents in 9 provinces of China. Methods: A total of 5 746 children and adolescents aged 7-17 years old from the "China Health and Nutrition Survey" in 2000, 2006, 2011, 2015 and 2018 were selected as the subjects. Variance analysis and Chi square test were used to analyze the BMI of children and adolescents with different characteristics and different types of malnutrition. Linear regression model was used to analyze the trends of BMI, stunting and wasting, and overweight and obesity in children and adolescents with different characteristics. Results: From 2000 to 2018, the BMI of children and adolescents aged 7-17 increased from 17.66 kg/m 2 to 19.08 kg/m 2 ( F =22.88, P <0.05). The prevalence of overweight and obesity increased in both males and females( t =16.65,11.01, P <0.05). Comparison of the rates of wasting and Growth Retardation and overweight and obesity among children and adolescents aged 7-17 years in nine provinces in 2000, 2006,2 011, 2015 and 2018, the difference was statistically significant ( χ 2 wasting and grouth retardation =85.46, 29.55, 41.09, 29.86, 45.29; χ 2 overweight and obesity = 109.12 , 52.21, 98.23, 68.27, 52.49, P <0.05). Conclusion The prevalence of stunting and wasting of children and adolescents aged 7-17 in 9 provinces of China decreased. The prevalence of overweight and obesity showed an upward trend in 9 provinces of China. There were regional differences among the prevalence of stunting and wasting, as well as overweight and obesity. Active intervention strategies and measures should be taken to improve malnutrition and focus on the prevention of obesity in children and adolescents in China.

Objective:To investigate the influence of environmental factors on body mass index of children and adolescents in China.Methods:Using data from the China Health and Nutrition Survey, the research object to 7 - 17 years old children and adolescents who participated in 2000, 2006, 2011, and 2015 round of survey with complete data, a total of 6 626 children and adolescents (male 3 473, female 3 153) were investigated under univariate analysis for each environmental factor variable before using Partial Least Square Regression fitting a linear model for further screening. Finally, we fitted a three-level linear mixed-effects model distinct by urban and rural area for analysis.Results:The three-level null model, log likelihood=-17 034.68, χ 2=483.06, P<0.001. Intern-class correlation coefficient ( ICC) showed that community-level was 9.97%, and both community and individual were 39.38%. The three-level model also showed that urban model's urbanization index ( β=-0.05, 95% CI: -0.09--0.01, P<0.05), the park location ( β=-0.88, 95% CI: -1.72 - -0.04, P<0.05), 15 - 17 age group ( β=-1.04, 95% CI:-1.78 - -0.30, P<0.05) were negatively correlated with BMI. The distance to the gym ( β=0.12, 95% CI: 0.02 - 0.22, P<0.05), the number of home TV sets ( β=0.50, 95% CI: 0.08 - 0.92, P<0.05) and the frequency of parents' alarm of fiction TV program contents ( β=1.85, 95% CI: 0.70 - 3.00, P<0.05) were correlated with BMI. Rural urbanization index ( β=-0.04, 95% CI:-0.07 - -0.01, P<0.05). Rural per capita income ( β=-7.29e -4, 95% CI:-1.00e -3 - -6.77e -5, P<0.05), parents' restricted frequency of watching TV ( β=-1.29, 95% CI:-2.36 - -0.21, P<0.05), adipo-energy ratio ( β=-0.03, 95% CI:-0.06 - -1.00e -3, P<0.05) were negatively correlated with the BMI. Factors as the frequency of parents' alarm of fiction TV program contents ( β=3.01, 95% CI: 0.03 - 6.00, P<0.05), the survey time was 2015 ( β=4.83, 95% CI: 1.96 - 7.69, P<0.05) were correlated with BMI. Conclusions:Environmental factors could indirectly influence the change of BMI of children and adolescents to different degrees and various aspects. Urbanization index and rural per capita income had a slight protective effect on increasing BMI of children and adolescents. At the community level, attention should be paid to the setting of activity places around the living environment of children and adolescents. Family members should also guide their children and adolescents to develop nice behavior in watching TV.

At present, the clinical research of Huanglian-Ejiao Decoction for anti-anxiety mainly focuses on the treatment of western medicine combined with the addition and subtraction of Huanglian-Ejiao Decoction. By observing the generalized anxiety patients with heart kidney disharmony or secondary anxiety symptoms of yin deficiency and fire hyperactivity type after taking Huanglian-Ejiao Decoction, all the studies show that this prescription can effectively improve the anxiety state of patients, and has long-term effect, low incidence of adverse reactions and low recurrence rate. However, there are also some deficiencies in the study, such as in the study of generalized anxiety, most clinical observation of TCM syndrome differentiation has no authoritative standard, some of the inclusion criteria for generalized anxiety and panic disorder are not clear, and the course of generalized anxiety is persistent, the observation of long-term efficacy and recurrence rate of diseases is obviously insufficient; in the study of anxiety syndrome, for anxiety disorder The diagnostic criteria of the disease are often not clear, the evaluation criteria of anxiety improvement are not unified, and there lacks the evaluation of safety. At the same time, the mechanism research on Huanglian-Ejiao Decoction is not perfect.

Objective:To discuss the feasibility, safety and efficacy of kissing cover stents technique in the management of pseudoaneurysm near the bifurcation of innominate artery (the distance <1 cm).Methods:A retrospective study of 10 patients with pseudoaneurysm near the bifurcation of innominate artery were performed in the Affiliated Wuxi People’s Hospital of Nanjing Medical University from May 2013 to August 2018. There were 6 males and 4 females, aged from 25.0 to 77.0 years old, with a median age of 50.5 years old. All patients were treated with Viabahn stents combined with kissing stents. The adverse reactions were observed during the perioperative period, and the patients were followed up to evaluate the stents position and patency. Results:Among 10 patients, 2 were in the distal of innominate artery, 5 were in the bifurcation of innominate artery, 2 were in the root of right common carotid artery and 1 was in the origin of right subclavian artery. The distance from the injury site to the bifurcation of innominate artery was less than 5 mm in 4 cases and 8 mm in 1 case. All of them were successfully treated with Viabahn stents combined with kissing stents. Operation time ranged from 100.0 to 150.0 (122.0±14.9) min. The postoperative hospitalization time was (6.3±1.5) d, ranged from 4.0 to 9.0 d. During the operation, 8 mm×100 mm Viabahn stents were implanted in the right subclavian artery and 10 mm×100 mm Viabahn stents were implanted in the right common carotid artery. There were no severe adverse reactions during the perioperative period. Follow-up time ranged from 12 to 24 months. During the follow-up, color Doppler ultrasound and carotid CT angiography showed that the stents were in appropriate position, the blood flow was unobstructed, and there was no occlusion and displacement of stents. Viabahn stents remained at the level of proximal end of the innominate artery.Conclusion:Viabahn stents combined with kissing stents is a safe and effective treatment for pseudoaneurysm near the bifurcation of innominate artery.