1.Comparison of glucose fluctuation between metformin combined with acarbose or sitagliptin in Chinese patients with type 2 diabetes: A multicenter, randomized, active-controlled, open-label, parallel design clinical trial.
Xiaoling CAI ; Suiyuan HU ; Chu LIN ; Jing WU ; Junfen WANG ; Zhufeng WANG ; Xiaomei ZHANG ; Xirui WANG ; Fengmei XU ; Ling CHEN ; Wenjia YANG ; Lin NIE ; Linong JI
Chinese Medical Journal 2025;138(9):1116-1125
BACKGROUND:
Alpha-glucosidase inhibitors or dipeptidyl peptidase-4 inhibitors are both hypoglycemia agents that specifically impact on postprandial hyperglycemia. We compared the effects of acarbose and sitagliptin add on to metformin on time in range (TIR) and glycemic variability (GV) in Chinese patients with type 2 diabetes mellitus through continuous glucose monitoring (CGM).
METHODS:
This study was a randomized, open-label, active-con-trolled, parallel-group trial conducted at 15 centers in China from January 2020 to August 2022. We recruited patients with type 2 diabetes aged 18-65 years with body mass index (BMI) within 19-40 kg/m 2 and hemoglobin A1c (HbA1c) between 6.5% and 9.0%. Eligible patients were randomized to receive either metformin combined with acarbose 100 mg three times daily or metformin combined with sitagliptin 100 mg once daily for 28 days. After the first 14-day treatment period, patients wore CGM and entered another 14-day treatment period. The primary outcome was the level of TIR after treatment between groups. We also performed time series decomposition, dimensionality reduction, and clustering using the CGM data.
RESULTS:
A total of 701 participants received either acarbose or sitagliptin treatment in combination with metformin. There was no statistically significant difference in TIR between the two groups. Time below range (TBR) and coefficient of variation (CV) levels in acarbose users were significantly lower than those in sitagliptin users. Median (25th percentile, 75th percentile) of TBR below target level <3.9 mmol/L (TBR 3.9 ): Acarbose: 0.45% (0, 2.13%) vs . Sitagliptin: 0.78% (0, 3.12%), P = 0.042; Median (25th percentile, 75th percentile) of TBR below target level <3.0 mmol/L (TBR 3.0 ): Acarbose: 0 (0, 0.22%) vs . Sitagliptin: 0 (0, 0.63%), P = 0.033; CV: Acarbose: 22.44 ± 5.08% vs . Sitagliptin: 23.96 ± 5.19%, P <0.001. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV (group with small wave, moderate wave and big wave). No significant difference was found in the complexity of glucose time series index (CGI) between acarbose users and sitagliptin users. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV.
CONCLUSIONS:
Acarbose had slight advantages over sitagliptin in improving GV and reducing the risk of hypoglycemia. Time series analysis of CGM data may predict GV and the risk of hypoglycemia.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR2000039424.
Humans
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Metformin/therapeutic use*
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Sitagliptin Phosphate/therapeutic use*
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Acarbose/therapeutic use*
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Diabetes Mellitus, Type 2/blood*
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Middle Aged
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Male
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Female
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Adult
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Blood Glucose/drug effects*
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Hypoglycemic Agents/therapeutic use*
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Aged
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Glycated Hemoglobin/metabolism*
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Adolescent
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Young Adult
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China
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East Asian People
2.Prediction method of diopter based on sequence of ocular biological parameters
Luebiao XU ; Lan DING ; Chen LIANG ; Yuliang WANG ; Yujia LIU ; Jianmin SHANG ; Jun ZHU ; Huazhong XIANG ; Renyuan CHU ; Cheng WANG ; Xiaomei QU
International Journal of Biomedical Engineering 2024;47(5):417-422
Objective:To establish a prediction method of diopter based on sequence of ocular biological parameters.Methods:A stratified random cluster sampling method was used to extract the dataset. The dataset consisted of data collected from January 2022 to January 2023 by the Eye & ENT Hospital, Fudan University, from children aged 5 to 13 years in 2 key schools and 2 general schools of Yangpu District, Shanghai. Children’s ocular biological parameters, including sex, age, diopter, axial length, corneal curvature, and anterior chamber depth were collected. The slope of the optimally fitted straight line was calculated using the least squares method. The least square-back propagation (BP) neural network model was established by combining baseline data and the pre-processed rate of the change of ocular biological parameters. The dataset was divided into the training set and the validation set according to the ratio of 8:2 for five-fold cross-validation. The model performance was evaluated by using the mean absolute error (MAE), mean squared error (MSE), root mean square error (RMSE), correlation coefficient R, and coefficient of determination R2. Results:The optimal performances of R2, R, RMSE, MAE, and MSE of the least square-BP neural network model were 0.96, 0.981 9, 0.214 2, 0.139 9 D, 0.045 9, respectively. The regression equation between the predicted value and the true value of the diopter was y=0.97 x+ 0.014 8, R2=0.97, with good correlation. In the internal verification, MAE values of the diopter at three, six, nine, and twelve months of follow-up were 0.110 1, 0.136 0, 0.153 7, and 0.184 8 D, respectively, which achieved clinically acceptable performance (less than 0.25 D). In the external validation, the errors were less than 0.25 D at all ages. Conclusions:A prediction method of diopter based on sequence of ocular biological parameters was successfully developed.
3.Serological follow-up of anti-SARS-CoV-2 antibodies in blood donors after COVID-19 vaccine booster dose and breakthrough infections in Fuzhou
Shuhua JI ; Shou LIN ; Shuming HUANG ; Xiaomei LIN ; Yu ZHANG ; Weimei JIANG ; Xiaoling CHU
Chinese Journal of Blood Transfusion 2023;36(12):1089-1094
【Objective】 To analyze the dynamics of specific SARS-CoV-2 IgG antibodies in blood donors in Fuzhou area after receiving booster doses of inactivated COVID-19 vaccine and breakthrough infections, and to provide evidence for the timing of the collection of specific immune plasma or convalescent plasma and the subsequent vaccine doses. 【Methods】 A total of 109 volunteers who received the first booster dose of inactivated COVID-19 vaccine and 102 volunteers who experienced breakthrough infections were recruited at Fujian Blood Center from October to November 2021. Blood samples were collected at eight time points: 14 (11, 20) days before the booster dose (Time0), 14 (10, 23) days after the booster dose (Time1), 53 (45.5, 61) days after the booster dose (Time2), 88 (78, 101.5) days after the booster dose (Time3), 124 (112.5, 138.5) days after the booster dose (Time4), 158 (146, 174) days after the booster dose (Time5), 194 (179.5, 214) days after the booster dose (Time6) and within one month after the breakthrough infection (Time7). Serum SARS-CoV-2 IgG antibodies were detected using a chemiluminescence immunoassay. The dynamics of antibody levels were analyzed and the effects of age, gender, weight, BMI, blood type and smoking on antibody levels were also analyzed. 【Results】 The positive rate of SARS-CoV-2 IgG antibodies was 53.2% (58/109) at Time0, 100% (109/109) at Time1, and 95.4% (104/109) at Time6. The antibody levels were significantly higher at Time1 and Time6 than at Time0 (P<0.001). The highest level was observed at Time1, followed by a gradual decrease until Time2-Time6, which were 89.9% (9.74/10.84), 77.7% (8.42/10.84), 68.3% (7.4/10.84), 59.4% (6.44/10.84), and 53.9% (5.84/10.84) of the peak value at Time1 (P<0.001). There were no significant differences in IgG antibody levels among different gender, weight, BMI, age, blood type and smoker or non-smoker at the same time points (P values all >0.05). The IgG antibody level at Time7 was 2.07 times than that at Time1 (P<0.001). There were no significant differences in IgG antibody levels between asymptomatic groups and symptomatic groups and also between fever-free groups and fever groups (P values all >0.05). The IgG antibody level in breakthrough infection group was significantly higher than that in non-breakthrough infection group (P<0.001). 【Conclusion】 Booster doses of inactivated COVID-19 vaccine and breakthrough infections can stimulate stronger immune responses in the body. It is recommended to collect specific immune plasma or convalescent plasma within one month after breakthrough infections or booster doses of COVID-19 vaccine for special purposes. The timing of subsequent vaccine doses should be based on the dynamics of antibody levels. It is necessary to continuously monitor antibody levels to provide evidence for subsequent vaccine doses.
4.Construction and validation of a nursing early warning model for postoperative delirium in patients with glioma
Chunfeng ZHANG ; Qingsen CHU ; Xiaomei SHI ; Fan YANG ; Ying LI
Chinese Journal of Behavioral Medicine and Brain Science 2022;31(11):996-1001
Objective:To analyze the risk factors for postoperative delirium in patients with glioma, and construct and validate a nomogram prediction model.Methods:A total of 304 glioma surgery patients admitted to the Department of Neurosurgery of Shandong Provincial Hospital from January 2021 to January 2022 were involved in this research. The training set (234 patients) and the validation set (70 patients) were divided according to the leave-out method. Patients in the training set and validation set were divided into delirium and non-delirium groups using the confusion assessment method (CAM) as the criteria.Clinical data of patients in the two study groups in the training set were analyzed.The risk factors for postoperative delirium were clarified by Logistic regression analysis, and an early warning model for postoperative delirium in glioma was established. The calibration curve and ROC curve were used for internal and external validation in the training set and validation set to evaluate the accuracy and discrimination of the prediction model.Results:Multivariate Logistic regression analysis showed that age>60 ( OR=4.089, 95% CI=1.898-9.103, P<0.001), diabetes ( OR=2.825, 95% CI=1.316-6.186, P=0.008), hypertension ( OR=2.176, 95% CI=1.041-4.587, P=0.008), smoking ( OR=2.432, 95% CI=1.063-5.648, P=0.036), history of epileptic seizures ( OR=4.457, 95% CI=1.924-10.689, P=0.001), poor lung function ( OR=2.452, 95% CI=1.132-5.374, P=0.023), visual analog scale (VAS)>7 points ( OR=3.394, 95% CI=1.591-7.456, P=0.002), anxiety or depression ( OR=2.746, 95% CI=1.285-5.976, P=0.010) and operation duration>4 h ( OR=2.731, 95% CI=1.255-6.062, P=0.012) were the independent risk factors of brain glial postoperative delirium.Based on the above risk factors a nomogram nursing early warning model was established.The area under the ROC curve (AUC) of internal verification was 0.852, and AUC of external verification was 0.914. Conclusion:The early-warning model for postoperative delirium in glioma patients can effectively predict the risk of delirium after glioma surgery, and it has certain clinical promotion value.
5.Cardiovascular risk profile and clinical characteristics of diabetic patients: a cross-sectional study in China.
Fang LYU ; Xiaoling CAI ; Chu LIN ; Tianpei HONG ; Xiaomei ZHANG ; Juming LU ; Xiaohui GUO ; Zhufeng WANG ; Huifang XING ; Guizhi ZONG ; Linong JI
Chinese Medical Journal 2021;135(3):295-300
BACKGROUND:
Cardiovascular (CV) disease is the leading cause of morbidity and mortality in adults with type 2 diabetes (T2D). The aim of this study was to determine the CV risk in Chinese patients with T2D based on the 2019 European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD) guidelines on diabetes, pre-diabetes, and CV diseases.
METHODS:
A total of 25,411 patients with T2D, who participated in the study of China Cardiometabolic Registries 3B study, were included in our analysis. We assessed the proportions of patients in each CV risk category according to 2019 ESC/EASD guidelines.
RESULTS:
Based on the 2019 ESC/EASD guidelines, 16,663 (65.6%), 1895 (7.5%), and 152 (0.6%) of patients were included in "very high risk," "high risk," and "moderate risk" categories, respectively. The proportions of patients in each category varied based on age, sex, body mass index, and duration. While 58.7% (9786/16,663) of elderly patients were classified to "very high risk" group, 89.6% (3732/4165) of patients with obesity were divided into "very high risk" group. Almost all patients with a duration of diabetes >10 years had "very high risk" or "high risk." However, 6701 (26.4%) of Chinese T2D patients, who had shorter duration, and one or two risk factors, could not be included in any category (the "unclear risk" category).
CONCLUSIONS
In China, most patients with T2D have "very high" or "high" CV risk based on 2019 ESC/EASD guidelines. However, the risk of patients in "unclear risk" group needs to be further classified.
Adult
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Aged
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Cardiovascular Diseases/epidemiology*
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Cross-Sectional Studies
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Diabetes Mellitus, Type 2
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Heart Disease Risk Factors
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Humans
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Risk Factors
6.Application of abdominal balloon compression combined with four-dimensional computed tomography in three-dimensional radiotherapy for non-small cell lung cancer
Yongliang ZHAO ; Guodong XIE ; Jianhua JIN ; Xiaomei YANG ; Jianting WU ; Haitao LIU ; Kaiyue CHU
Chinese Journal of Radiation Oncology 2018;27(5):509-512
Objective To compare the size of target volume,amplitudes of movements in different directions,movement vector,dose to the diseased lung,whole lung volume,and setup error between free breathing fixation (method A) and four-dimensional computed tomography (4DCT)-guided abdominal balloon compression fixation (method B),and to demonstrate that the 4DCT-guided abdominal balloon compression fixation is effective in the treatment of non-small cell lung cancer (NSCLC).Methods A retrospective analysis was performed among 80 patients with NSCLC in our hospital.In those patients,40 received method A and 40 method B.The GTVfree and GTVpress were delineated on the maximum intensity projection (MIP) images of 10 respiratory phases using method A and method B,respectively.The PTVfree and PTVPress were obtained by expansion of the GTVfree and GTVpress,respectively.The paired t test was used to analyze the differences in the PTV,maximum amplitudes of movements in three dimensions,absolute value of the movement vector (|V|),and volume between method A and method B.The treatment planning system was used to compare the V5,V10,V20,and V30 of the diseased lung and the whole lung volume between method A and method B.All patients underwent cone-beam CT (CBCT) scans after positioning.Setup error was obtained by matching the CBCT images with the MIP images in the XVI system based on bone and grayscale values.Results The PTVfree and PTVpress were (283.2± 12.74) and (201.8± 12.99)cm3,respectively (P=0.002).The maximum amplitudes of movements in the right-left,superior-inferior,and anterior-posterior directions as well as thel V | value were (0.22±0.02),(1.85±0.08),(0.43±0.26),and (1.91±0.27) em,respectively,for method A,and (0.05±0.01),(0.41±0.03),(0.16±0.16),and (0.44±0.16) cm,respectively,for method B (P=0.120,0.001,0.070).The V5,V10,V20,and V30 for the diseased lung and total lung volume were (61.26± 4.27) %,(44.52± 1.70) %,(28.22± 3.13) %,(18.26±5.17)%,and (3556±223.12) cm3,respectively,for method A,and (52.74±4.78)%,(38.76±4.92) %,(23.71 ±4.03) %,(15.54±3.43) %,and (3376±311.65) cm3,respectively,for method B (P =0.001,0.003,0.004,0.021,0.004).There was no significant difference in setup error obtained by the XVI system between the two fixation methods (P>0.05).Conclusions Without increasing setup error,abdominal balloon compression can effectively control the lung movement amplitude,reduce the planning target volume,and reduce the radiation dose to the lung in patients with NSCLC.
7.The mediating effect of resilience between family support and benefit finding in diabetic patients
Xiaomei LIANG ; Yanjie YANG ; Xue TIAN ; Wenbo WANG ; Haiyun CHU ; Lu CHEN ; Hui PAN ; Huijuan ZHU
Chinese Journal of Behavioral Medicine and Brain Science 2017;26(5):445-449
ObjectiveTo investigate the status of benefit finding in diabetic patients,and mediating effect of resilience between family support and benefit finding in diabetic patients.MethodsFive hundred and thirteen diabetic patients from a hospital of Harbin were recruited as investigative subjects from September 2015 to June 2016.The resilience scale,family adaptability,cohesion scale and benefit finding scale were used in the study.ResultsThe scores of benefit finding,resilience and family adaptability and cohesion were 55.67±12.87,70.65±10.39 and 104.25±15.38,separately.The total score of family adaptability and cohesion was positively related to the total score of benefit finding(r=0.389,P<0.05).The total score of resilience was positively related to the total score of benefit finding(r=0.155,P<0.05).The total score of family adaptability and cohesion was positively related to the total score of resilience(r=0.112,P<0.05).Benefit finding as the dependent variable,the results of hierarchical regression analysis indicated that family adaptability and cohesion (β=0.382,P<0.01),resilience(β=0.098,P<0.01)entered the regression equation.There was a partial mediating effect of resilience between family support and benefit finding in diabetic patients.The mediating effect was 0.011,accounted for 2.8% of the total effect.The resilience was the important protective factor for benefit finding.ConclusionFamily support has a direct influence on benefit finding and an indirect effect mediated by resilience on benefit finding.
8.Development of Magnetic Anastomosis Device for Colostomy
Ji MIAO ; Xiaomei LIU ; Xuefeng XIA ; Xiaodong SHAN ; Xuehui CHU ; Qiang LI ; Xitai SUN ; Wenxian GUAN
Chinese Journal of Medical Instrumentation 2017;41(1):26-28
Introduction of a new magnetic anastomosis device for colostomy including its design and operaging principal. The anastomosis device is composed of magnetic base and anastomosis ring. It is convenient for colon and abdominal subcutaneous tissue going together through the magnetic attraction. The colostomy completes with magnetic compression anastomosis. The device has the advantage of making operation easer, reducing the operation steps and can better solve the colostomy ischemic necrosis, colostomy retraction, colostomy joint complications of skin mucous membrane and the skin diease around the colostomy. Patients can real y benefit from this device.
9.Application of the double-center setup in the precise radiotherapy for middle esophageal carcinoma
Kaiyue CHU ; Binbin GE ; Xiaomei YANG ; Yu LIU ; Jianhua JIN ; Haitao LIU ; Jianting WU ; Yongliang ZHAO ; Gufei CAO
Cancer Research and Clinic 2016;28(7):464-467,470
Objective To compare the errors of double-center and single-center setup, and to study the role of both on reducing the rotational setup errors for the patients with esophageal carcinoma depend on rigid registration errors between online kV-cone-beam computed tomography (kV-CBCT) images and plans for CT images. Methods 20 patients with middle esophageal carcinoma received image scanning before treatment every week by using double-center setup and CBCT, and single-center setup images of 20 patients were taken from the X volume image (XVI) system. Then the images of both setup types, registration errors of CT image and rotational setup errors were compared respectively. Every patient received kV-CBCT scanning analysis before treatment every week, and 6 times in total. 240 group of kV-CBCT images from all of the patients were off-line matched with plans for CT images to calculate the errors of X-axis, Y-axis, Z-axis. Then the data of linear errors and rotational setup errors from patients were collected, aiming at putting the error data into the patients treatment program and analyzing the significances. Results The standard registration of double-center setup was as follows: T (X) (0.28 ±0.19) cm, T (Y) (0.27 ±0.19) cm, T (Z) (0.33 ±0.12) cm, R (X) (0.40 ±0.19)° , R (Y) (0.30 ±0.18)° , R (Z) (0.30 ±0.19)° . The standard registration of single-center setup was as follows:T(X) (0.32±0.20) cm, T(Y) (0.29±0.25)cm, T(Z) (0.31±0.16) cm, R(X) (2.2±0.68)°, R(Y) (0.5±0.32)°, R(Z) (2.10±0.60)°. There were statistical differences between linear errors in T(X) and rotational setup errors in R(X), R(Y) or R(Z) (P< 0.05). Conclusion Double-center position can reduce the rotational setup errors, especially in X-axis, Y-axis errors, and may provide more help for the radiation oncology departments without on-board CBCT.
10.Quantitative research on barriers of acceptance of psychological interventions in cancer patients with chemotherapy and depression or anxiety
Yangyang CHEN ; Xiaomei YANG ; Qian CHU
Chinese Journal of Modern Nursing 2016;22(29):4226-4228,4229
Objective To explore the barriers of acceptance of psychological intervention in cancer patients with chemotherapy and depression or anxiety, and provide references for The implement method of psychological intervention services.Methods Phenomenological methods in the qualitative research and semi-structured open questions were used to investigate 15 cancer patients with depression or anxiety who were receiving the chemotherapy in oncology ward. Material analysis was used to analyze the interview data. Results Barriers of acceptance of psychological intervention in cancer patients with chemotherapy and depression or anxiety were mainly from two aspects, one was from patients′ themselves which includes somatic symptom, lack of acknowledgement in mental health, stigma, disease-avoiding and economic pressure, and the other one was from medical system which includes lack of mental health resource and the separation of psycho-intervention and cancer treatment. Conclusions Nursing staff should actively control the symptoms and pain related to chemotherapy; provide appropriate psychoeducation and encourage patients to get the best way of intervention;recognize the stigma and choose appropriate method and timing for patients; combine the mental health management into clinical treatment of tumor, and optimize the diagnosis and treatment process of psychological distress in cancer patients.

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