Background: Gestational diabetes mellitus (GDM) is a metabolic disorder posing significant risks to maternal and infant health, with a lack of effective early screening markers. Therefore, identifying early screening biomarkers for GDM with higher sensitivity and specificity is urgently needed. Methods: High-throughput sequencing was employed to screen for key circular RNAs (circRNAs), which were then evaluated using reverse transcription quantitative polymerase chain reaction. Logistic regression analysis was conducted to examine the relationship between clinical characteristics, circRNA expression, and adverse pregnancy outcomes. The diagnostic accuracy of circRNAs for early and mid-pregnancy GDM was assessed using receiver operating characteristic curves. Pearson correlation analysis was utilized to explore the relationship between circRNA levels and oral glucose tolerance test results. A predictive model for early GDM was established using logistic regression. Results: Significant alterations in circRNA expression profiles were detected in GDM patients, with hsa_circ_0031560 and hsa_ circ_0000793 notably upregulated during the first and second trimesters. These circRNAs were associated with adverse pregnancy outcomes and effectively differentiated GDM patients, with second trimester cohorts achieving an area under the curve (AUC) of 0.836. In first trimester cohorts, these circRNAs identified potential GDM patients with AUCs of 0.832 and 0.765, respectively. The early GDM prediction model achieved an AUC of 0.904, validated in two independent cohorts. Conclusion Hsa_circ_0031560, hsa_circ_0000793, and the developed model serve as biomarkers for early prediction or midterm diagnosis of GDM, offering clinical tools for early GDM screening.

Background: Gestational diabetes mellitus (GDM) is a metabolic disorder posing significant risks to maternal and infant health, with a lack of effective early screening markers. Therefore, identifying early screening biomarkers for GDM with higher sensitivity and specificity is urgently needed. Methods: High-throughput sequencing was employed to screen for key circular RNAs (circRNAs), which were then evaluated using reverse transcription quantitative polymerase chain reaction. Logistic regression analysis was conducted to examine the relationship between clinical characteristics, circRNA expression, and adverse pregnancy outcomes. The diagnostic accuracy of circRNAs for early and mid-pregnancy GDM was assessed using receiver operating characteristic curves. Pearson correlation analysis was utilized to explore the relationship between circRNA levels and oral glucose tolerance test results. A predictive model for early GDM was established using logistic regression. Results: Significant alterations in circRNA expression profiles were detected in GDM patients, with hsa_circ_0031560 and hsa_ circ_0000793 notably upregulated during the first and second trimesters. These circRNAs were associated with adverse pregnancy outcomes and effectively differentiated GDM patients, with second trimester cohorts achieving an area under the curve (AUC) of 0.836. In first trimester cohorts, these circRNAs identified potential GDM patients with AUCs of 0.832 and 0.765, respectively. The early GDM prediction model achieved an AUC of 0.904, validated in two independent cohorts. Conclusion Hsa_circ_0031560, hsa_circ_0000793, and the developed model serve as biomarkers for early prediction or midterm diagnosis of GDM, offering clinical tools for early GDM screening.

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

Background: Gestational diabetes mellitus (GDM) is a metabolic disorder posing significant risks to maternal and infant health, with a lack of effective early screening markers. Therefore, identifying early screening biomarkers for GDM with higher sensitivity and specificity is urgently needed. Methods: High-throughput sequencing was employed to screen for key circular RNAs (circRNAs), which were then evaluated using reverse transcription quantitative polymerase chain reaction. Logistic regression analysis was conducted to examine the relationship between clinical characteristics, circRNA expression, and adverse pregnancy outcomes. The diagnostic accuracy of circRNAs for early and mid-pregnancy GDM was assessed using receiver operating characteristic curves. Pearson correlation analysis was utilized to explore the relationship between circRNA levels and oral glucose tolerance test results. A predictive model for early GDM was established using logistic regression. Results: Significant alterations in circRNA expression profiles were detected in GDM patients, with hsa_circ_0031560 and hsa_ circ_0000793 notably upregulated during the first and second trimesters. These circRNAs were associated with adverse pregnancy outcomes and effectively differentiated GDM patients, with second trimester cohorts achieving an area under the curve (AUC) of 0.836. In first trimester cohorts, these circRNAs identified potential GDM patients with AUCs of 0.832 and 0.765, respectively. The early GDM prediction model achieved an AUC of 0.904, validated in two independent cohorts. Conclusion Hsa_circ_0031560, hsa_circ_0000793, and the developed model serve as biomarkers for early prediction or midterm diagnosis of GDM, offering clinical tools for early GDM screening.

Background: Gestational diabetes mellitus (GDM) is a metabolic disorder posing significant risks to maternal and infant health, with a lack of effective early screening markers. Therefore, identifying early screening biomarkers for GDM with higher sensitivity and specificity is urgently needed. Methods: High-throughput sequencing was employed to screen for key circular RNAs (circRNAs), which were then evaluated using reverse transcription quantitative polymerase chain reaction. Logistic regression analysis was conducted to examine the relationship between clinical characteristics, circRNA expression, and adverse pregnancy outcomes. The diagnostic accuracy of circRNAs for early and mid-pregnancy GDM was assessed using receiver operating characteristic curves. Pearson correlation analysis was utilized to explore the relationship between circRNA levels and oral glucose tolerance test results. A predictive model for early GDM was established using logistic regression. Results: Significant alterations in circRNA expression profiles were detected in GDM patients, with hsa_circ_0031560 and hsa_ circ_0000793 notably upregulated during the first and second trimesters. These circRNAs were associated with adverse pregnancy outcomes and effectively differentiated GDM patients, with second trimester cohorts achieving an area under the curve (AUC) of 0.836. In first trimester cohorts, these circRNAs identified potential GDM patients with AUCs of 0.832 and 0.765, respectively. The early GDM prediction model achieved an AUC of 0.904, validated in two independent cohorts. Conclusion Hsa_circ_0031560, hsa_circ_0000793, and the developed model serve as biomarkers for early prediction or midterm diagnosis of GDM, offering clinical tools for early GDM screening.

Objective Based on the analysis of the results of retesting of blood donors with human immunodeficiency virus(HIV)serological single-reagent reactivity,the rationality and practical effect of the existing retesting strategy were discussed.Methods HIV serological single-reagent reactivity blood donors in Wenzhou from January to December 2023 were selected as the study objects,and were confirmed by Wenzhou Center for Disease Control and Prevention(CDC)and returning test to confirm whether they could be returnee.Differences in return rates were analyzed by the basic data of blood donors and the S/CO value of HIV serological test during screening.Results Among the 374 HIV serological single-reagent reactivity blood donors,55 were confirmed by CDC with uncertain HIV antibodies,319 met the criteria for return,and 84 actively applied for return.78 showed no reactivity through self-test and return test and were allowed to return to the team.Four showed HIV serological reactivity,one showed HIV nucleic acid testing(NAT)test reactivity,permanent shielding.One showed the reactivity of anti-HIV chemiluminescence immunoassay test,and the HIV NAT test was noreactivity,and continued to be screened to participate in the next round of return.There were statistically significant differences in the permissible return rate of blood donors with different ages,blood types and blood donation times(P<0.05).There was no significant difference in the allowed return rate of blood donors with different S/CO values during screening(χ2=1.898,P=0.168).Conclusion Reasonable return procedures can effectively reduce the loss of blood donors and ensure the safety of blood for clinical use.

Objective:To analyze the demographic characteristics of positive syphilis screening test results among unpaid blood donors in Wenzhou and to provide a theoretical basis for recalling donors who have received false positive results in their syphilis screening tests.Methods:A retrospective study was conducted on the demographic characteristics of 746 unpaid blood donors in Wenzhou who tested positive for syphilis from March 2020 to September 2022. Donors with positive single-test results received targeted notifications, health inquiries, and general examinations. With their consent, these donors were allowed to re-enter the blood donation process.Results:A total of 296 898 blood donor samples were tested, resulting in the identification of 746 positive cases of syphilis antibodies, yielding a positivity rate of 0.3%. Among the positive cases, most were males aged between 35 and 45 years, with blood types A and O. They generally had an education level of junior high school or lower and were primarily first-time donors. Specifically, males accounted for 53.6% of the positive cases, while individuals aged 35 to 45 years made up 34.0% of the positive cases. Blood types A and O comprised 30.2% and 36.9% of the positive cases, respectively. Additionally, individuals with an education level of junior high school or below accounted for 43.7% of the positive cases, and first-time donors constituted 81.6%. A total of 14 cases were recalled, of which 11 were successfully contacted. Among the cases that underwent testing with the enzyme-linked immunosorbent assay, 85.7% (12/14) tested negative for syphilis antibodies, resulting in a recall success rate of 78.6% (11/14).Conclusions:To prevent the transmission of syphilis through blood transfusions, blood donation centers should prioritize recruiting donors from low-risk populations and encourage regular blood donation. Furthermore, these centers should implement a comprehensive and effective recall program to reduce the loss of qualified blood donors and enhance blood safety.

Objective Based on the analysis of the results of retesting of blood donors with human immunodeficiency virus(HIV)serological single-reagent reactivity,the rationality and practical effect of the existing retesting strategy were discussed.Methods HIV serological single-reagent reactivity blood donors in Wenzhou from January to December 2023 were selected as the study objects,and were confirmed by Wenzhou Center for Disease Control and Prevention(CDC)and returning test to confirm whether they could be returnee.Differences in return rates were analyzed by the basic data of blood donors and the S/CO value of HIV serological test during screening.Results Among the 374 HIV serological single-reagent reactivity blood donors,55 were confirmed by CDC with uncertain HIV antibodies,319 met the criteria for return,and 84 actively applied for return.78 showed no reactivity through self-test and return test and were allowed to return to the team.Four showed HIV serological reactivity,one showed HIV nucleic acid testing(NAT)test reactivity,permanent shielding.One showed the reactivity of anti-HIV chemiluminescence immunoassay test,and the HIV NAT test was noreactivity,and continued to be screened to participate in the next round of return.There were statistically significant differences in the permissible return rate of blood donors with different ages,blood types and blood donation times(P<0.05).There was no significant difference in the allowed return rate of blood donors with different S/CO values during screening(χ2=1.898,P=0.168).Conclusion Reasonable return procedures can effectively reduce the loss of blood donors and ensure the safety of blood for clinical use.

Objective:To analyze the demographic characteristics of positive syphilis screening test results among unpaid blood donors in Wenzhou and to provide a theoretical basis for recalling donors who have received false positive results in their syphilis screening tests.Methods:A retrospective study was conducted on the demographic characteristics of 746 unpaid blood donors in Wenzhou who tested positive for syphilis from March 2020 to September 2022. Donors with positive single-test results received targeted notifications, health inquiries, and general examinations. With their consent, these donors were allowed to re-enter the blood donation process.Results:A total of 296 898 blood donor samples were tested, resulting in the identification of 746 positive cases of syphilis antibodies, yielding a positivity rate of 0.3%. Among the positive cases, most were males aged between 35 and 45 years, with blood types A and O. They generally had an education level of junior high school or lower and were primarily first-time donors. Specifically, males accounted for 53.6% of the positive cases, while individuals aged 35 to 45 years made up 34.0% of the positive cases. Blood types A and O comprised 30.2% and 36.9% of the positive cases, respectively. Additionally, individuals with an education level of junior high school or below accounted for 43.7% of the positive cases, and first-time donors constituted 81.6%. A total of 14 cases were recalled, of which 11 were successfully contacted. Among the cases that underwent testing with the enzyme-linked immunosorbent assay, 85.7% (12/14) tested negative for syphilis antibodies, resulting in a recall success rate of 78.6% (11/14).Conclusions:To prevent the transmission of syphilis through blood transfusions, blood donation centers should prioritize recruiting donors from low-risk populations and encourage regular blood donation. Furthermore, these centers should implement a comprehensive and effective recall program to reduce the loss of qualified blood donors and enhance blood safety.

Objective Through the detection of treponema pallida antibody in the unpaid blood donors in Wenzhou area,the recall self-test and recall test were carried out on the blood donors who were reactive to enzyme-linked immunosorbent assay(ELISA)test,and the feasibility of the recall plan was evaluated.Methods From January 2021 to May 2023,275 652 blood donors who successfully participated in unpaid blood donation were tested by anti-treponema pallidum(TP)ELISA,the reactivity rate and S/CO value of different reagents were compared,and the reactivity of single reagent was detected by ELISA.In addition,24 blood donors who volunteered to participate in the recall more than six months after the last blood donation screening were informed of the recall by way of interview,targeted health consultation,general examination and preliminary screening test were passed,and blood samples were collected for recall self-test and recall test.Results A total of 275 652 people were tested by anti-TP ELISA,and 627 cases were found to be reactive,with a reactivity rate of 0.23% ,including a double reagent reactivity rate of 0.12% and a single reagent reactivity rate of 0.11% .The ratio of S/CO≥5.00 with double reagent was 73.6% (240/326),and the ratio of S/CC＜5.00 with single reagent was 92.4% (278/301).24 people entered the recall process,20 people were successfully recalled,3 people failed to pass the self-test and 1 person failed to pass the test.The recall success rate was 83.3% (20/24).Conclusion The problem of false reactivity of anti-TP ELISA test single reagent in blood collection and supply institutions is prominent.Through the established recall scheme,the self-test and recall test of blood donors with strong recall intention can not only ensure the safety of blood donors,but also improve the construction of blood collection and supply service system.