1.Establishment and validation of a double antibody sandwich ELISA for the quantification of Coxsackievirus A10 antigen in multivalent hand, foot and mouth disease vaccines
Chinese Journal of Biologicals 2026;39(06):694-703
Objective To establish and validate a double antibody sandwich ELISA method suitable for the detection of Coxsackievirus A10(CV-A10) antigen content in multivalent hand,foot and mouth disease(HFMD) vaccines in China,in order to apply it to the detection of CV-A10 antigen in multivalent HFMD vaccines.Methods According to the general chapter 9307 of the Chinese Pharmacopoeia(Volume Ⅳ,2025 edition),a conformational monoclonal antibody mAb5 with broad-spectrum binding and neutralizing activity targeting the receptor-binding domain was used as the detection antibody.A method for the detection of CV-A10 antigen content was established through analytical target profile(ATP) setting,risk identification,and Design of Experiments(DoE).The specificity,linearity,relative accuracy,and intermediate precision of the method were validated.The applicability of the method for CV-A10 vaccine bulks from six manufacturers was evaluated in combination with national antigen standards.Results Using the signal-to-noise ratio(S/N) as the response indicator,the optimal coating antibody concentration was determined to be 0.25 μg/mL,the detection antibody concentration 2 μg/mL,and the dilution factor of the enzyme-labeled antibody 1∶5 000.The method operable design region(MODR) for the incubation time of the antigen,detection antibody,and enzyme-labeled antibody was obtained using DoE,all ranging from 60 to 90 min,with a chromogenic time of 10 to 15 min.The optimal calculation model was the double logarithmic model.After validation,the established method demonstrated good specificity,a linear R~2 > 0.98,a relative accuracy with average relative bias ranging from-7.21% to 6.55%,and an intermediate precision with geometric coefficient of variation(GCV) ≤ 7.07%,all meeting the predefined ATP acceptance criteria.The applicability study results demonstrated good linearity and parallelism between the national antigen standard and the vaccine bulks from different manufacturers,suggesting that the established method was well applicable to CV-A10 vaccines from various virus strains and manufacturing processes.Conclusion A double antibody sandwich ELISA method for the detection of CV-A10 antigen content in HFMD vaccines was successfully established,which exhibits good specificity,rela-tive accuracy,and intermediate precision,making it suitable for the quantitative detection of CV-A10 antigen content in multivalent HFMD vaccines currently under development,thus providing an effective tool for vaccine quality control.
2.Clinical application value of nutritional control status score combined with prognostic nutritional index in evaluating the risk of anemia in elderly colorectal cancer patients
Cuicui WANG ; Wantong QIAO ; Junying YAO ; Qian LI ; Weige GAO ; Min FAN
The Journal of Practical Medicine 2025;41(17):2696-2704
Objective This study aimed to assess the clinical utility of combining the Controlling Nutri-tional Status(CONUT)score with the Prognostic Nutritional Index(PNI)for evaluating anemia risk in elderly colorectal cancer patients and to establish a risk prediction model.Methods A total of 661 elderly colorectal cancer patients treated at Xinjiang Uygur Autonomous Region People's Hospital from July 2018 to March 2025 were included in this retrospective study.Patients were categorized into anemic and non-anemic groups and randomly assigned to a training set and validation set at a 7:3 ratio.The XGBoost algorithm was applied to develop a predictive model for anemia risk,and its performance was assessed using the receiver operating characteristic(ROC)curve.SHAP value visualization,and other methods.Results Among the 661 patients,257(38.9%)were diagnosed with anemia.Compared with the non-anemic group,patients in the anemic group had significantly lower levels of PNI and albumin,but higher CONUT scores and blood urea nitrogen levels.Additionally,the anemic group had higher proportions of tumor diameter≥5 cm,poorly differentiated tumors,and stage Ⅲ-Ⅳ disease(all P<0.05).The XGBoost model demonstrated good discriminatory ability,with an AUC of 0.897(95%CI:0.868~0.925).SHAP value analysis identified PNI,CONUT score,albumin,blood urea nitrogen,TNM stage,tumor differentiation,and tumor size as major contributing variables.PNI and albumin were protective factors,whereas CONUT score,blood urea nitrogen,and tumor-related features were risk factors.Conclusion Nutritional indicators such as PNI and CONUT score,along with tumor characteristics,can effectively predict the risk of anemia in elderly patients with colorectal cancer.The XGBoost-based predictive model demonstrates high discriminatory power and good inter-pretability,providing valuable support for early screening of high-risk patients and guiding individualized nutri-tional interventions and anemia management.
3.The incidence and mortality trend of breast cancer among women with registered residence in Xiaoshan District of Hangzhou City in Zhejiang Province from 2014 to 2023
Junying LIN ; Yuanyuan GAO ; Dongfei WANG ; Yurong LI
Shanghai Journal of Preventive Medicine 2025;37(12):998-1002
ObjectiveTo analyze the trend of incidence, mortality rate and survival rate of breast cancer among women with registered residence in Xiaoshan District of Hangzhou City in Zhejiang Province from 2014 to 2023, and to provide a basis for improving breast cancer prevention and control strategies. MethodsData on the incidence and mortality of breast cancer among women with registered residence in Xiaoshan District from 2014 to 2023 were collected through Zhejiang Chronic Disease Monitoring and Management System. The crude incidence and mortality rate, as well as the age-standardized incidence and mortality rate using both the 2000 Chinese standard population (abbreviated as “Chinese ASR”) and Segi’s 1960 world standard population (“world ASR”) were calculated. Joinpoint model was employed to analyze the trends in incidence and mortality rate, while R software (version 4.1.1) was used to analyze the 5-year relative survival rate to assess the survival status of breast cancer patients. ResultsFrom 2014 to 2023, the crude incidence rate, the Chinese age-standardized incidence rate (ASIRC) and the world age-standardized incidence rate (ASIRW) of breast cancer among women with registered residence in Xiaoshan District were from 70.00/100 000 to 128.35/100 000, from 52.92/100 000 to 94.29/100 000, and from 40.82/100 000 to 72.07/100 000, respectively, with the corresponding average annual percentage changes (AAPC) of 5.80%, 4.63% and 4.71%, respectively, showing a significant increasing trend over the decade (all P<0.05). The incidence rate of breast cancer among people aged 30‒<40 years old or 50‒<75 years old exhibited a significant increase trend from 2014 to 2023 (all P<0.05). The crude mortality rate of breast cancer in female was from 7.75/100 000 to 12.34/100 000, the ASMRC of breast cancer in female was from 4.62/100 000 to 7.53/100 000, and the ASMRW of breast cancer in female was from 3.58/100 000 to 5.71/100 000, and the AAPC had no statistically significance. However, the mortality rate of breast cancer was increased with age (P<0.001). The 5-year age-standardized relative survival rate of breast cancer in female in Xiaoshan District was significantly higher in the 2016‒2018 period (94.46%) compared to the 2013‒2015 period (91.02%) (P<0.05). ConclusionFrom 2014 to 2023, the annual incidence of breast cancer among women with registered residence in Xiaoshan District of Hangzhou City in Zhejiang Province showed an increasing trend, while the change in mortality rate was not statistically significant. The 5-year survival rate of breast cancer in female was at a high level, indicating notable achievements in comprehensive prevention and control efforts. It is essential to continue to strengthen public awareness campaigns for breast cancer prevention and control, control breast cancer risk factors, actively carry out early diagnosis and treatment of breast cancer among target groups, and improve the quality of life for breast cancer patients.
4.Based on the Theory of Treating Different Diseases with the Same Therapy,This Paper Analyzes the Modern Scientific Connotations of Liuwei Dihuang Pills in the Prevention and Treatment of Alzheimer's Disease and Diabetes
Yilin LYU ; Weiping GAO ; Xixi CHANG ; Pan WANG ; Yunfang SU ; Zhenqiang ZHANG ; Junying SONG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(10):3040-3051
An increasing number of studies have shown that there is a close relationship between Alzheimer's disease(AD)and diabetes mellitus(DM).Traditional Chinese medicine holds that"kidney yin deficiency"is the common pathogenesis of these two diseases,while modern medicine believes that their pathogenesis involves abnormal aggregation of amyloid proteins,insulin deficiency and resistance,inflammatory response,oxidative stress,and autophagy,among others.The well-known traditional Chinese medicine formula Liuwei Dihuang Pills plays a significant role in the treatment of these two diseases with the same therapeutic approach.Therefore,this article will explore the connection between Liuwei Dihuang Pills and the treatment of AD and DM from different aspects;analyze the common etiology and pathogenesis of AD and DM,and explain the mechanism of prevention and treatment of Liuwei Dihuang Pills,with the aim of providing new ideas and methods for the integrated traditional and Western medicine prevention and treatment of AD and DM in the future.
5.Based on the Theory of Treating Different Diseases with the Same Therapy,This Paper Analyzes the Modern Scientific Connotations of Liuwei Dihuang Pills in the Prevention and Treatment of Alzheimer's Disease and Diabetes
Yilin LYU ; Weiping GAO ; Xixi CHANG ; Pan WANG ; Yunfang SU ; Zhenqiang ZHANG ; Junying SONG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(10):3040-3051
An increasing number of studies have shown that there is a close relationship between Alzheimer's disease(AD)and diabetes mellitus(DM).Traditional Chinese medicine holds that"kidney yin deficiency"is the common pathogenesis of these two diseases,while modern medicine believes that their pathogenesis involves abnormal aggregation of amyloid proteins,insulin deficiency and resistance,inflammatory response,oxidative stress,and autophagy,among others.The well-known traditional Chinese medicine formula Liuwei Dihuang Pills plays a significant role in the treatment of these two diseases with the same therapeutic approach.Therefore,this article will explore the connection between Liuwei Dihuang Pills and the treatment of AD and DM from different aspects;analyze the common etiology and pathogenesis of AD and DM,and explain the mechanism of prevention and treatment of Liuwei Dihuang Pills,with the aim of providing new ideas and methods for the integrated traditional and Western medicine prevention and treatment of AD and DM in the future.
6.Trend in incidence of colorectal cancer in Xiaoshan District from 2010 to 2024
LI Yurong ; WANG Dongfei ; GAO Yuanyuan ; JIANG Yuanyuan ; LIN Junying ; XIAO Duanduan
Journal of Preventive Medicine 2025;37(9):927-931,936
Objective:
To analyze the incidence trend of colorectal cancer in Xiaoshan District, Hangzhou City from 2010 to 2024, and predict the incidence of colorectal cancer from 2025 to 2027, so as to provide the evidence for improving the prevention and control strategies of colorectal cancer.
Methods:
Colorectal cancer incidence data from 2010 to 2024 in Xiaoshan District were collected through the Hangzhou Municipal Chronic Disease Monitoring Management System. The crude incidence of colorectal cancer was calculated, and standardized using the data from the Sixth National Population Census in 2010 (Chinese standardized rate) and the Segi's world standard population (world standardized rate). The trend of colorectal cancer incidence from 2010 to 2024 was analyzed using the average annual percent change (AAPC). An exponential smoothing state space model with trigonometric seasonality, box-cox transformation, ARMA errors, trend and seasonal components (TBATS) was established to forecast the crude incidence of colorectal cancer from 2025 to 2027.
Results:
There were 10 726 new cases of colorectal cancer in Xiaoshan District from 2010 to 2024. The crude incidence, Chinese standardized rate, and world standardized rate of colorectal cancer were 59.25/100 000, 38.62/100 000 and 29.50/100 000, respectively. The crude incidence, Chinese standardized rate, and world standardized rate of colorectal cancer in males were 70.56/100 000, 44.44/100 000and 35.58/100 000, respectively, while those in females were 48.37/100 000, 32.69/100 000 and 23.70/100 000, respectively. The Chinese standardized rate of colorectal cancer was significantly higher in males than in females (P<0.05). The crude incidence of colorectal cancer in males, females and the whole population showed upward trends from 2010 to 2024 (AAPC=4.916%, 3.795% and 4.442%, all P<0.05). The crude incidence of colorectal cancer in the groups of 0-<35, 35-<50, 50-<75 and ≥75 years were 1.75/100 000, 19.86/100 000, 112.28/100 000 and 272.99/100 000, respectively, showing an increasing trend with age (P<0.05). From 2010 to 2024, the crude incidence of colorectal cancer in the ≥75 years group showed an increasing trend (AAPC=4.470%, P<0.05), while no significant trend was observed in other age groups (all P>0.05). TBATS model demonstrated good fitting (predictive) performance, indicating a year-by-year increase in the crude incidence of colorectal cancer across the whole population from 2025 to 2027, with an estimated rate reaching 70.45/100 000 in 2027.
Conclusions
The crude incidence of colorectal cancer in Xiaoshan District showed an increasing trend from 2010 to 2024, and it is predicted to continue to increase from 2025 to 2027. Males and the elderly are the key populations for colorectal cancer prevention and control.
7.Trends in incidence and mortality of acute myocardial infarction in Xiaoshan District, Hangzhou City from 2017 to 2023
Yuanyuan GAO ; Fenjuan WANG ; Dongfei WANG ; Yurong LI ; Yuanyuan JIANG ; Fangfang ZHAO ; Duanduan XIAO ; Junying LIN
Shanghai Journal of Preventive Medicine 2025;37(3):249-254
ObjectiveTo analyze the incidence rate and mortality of acute myocardial infarction (AMI) and their changing trends among the registered residents in Xiaoshan District, Hangzhou City from 2017 to 2023, so as to provide references for formulating policies related to AMI prevention. MethodsThe morbidity and mortality data of AMI among the registered residents in Xiaoshan District from 2017 to 2023 were collected through the Hangzhou Chronic Disease and Death Cause Monitoring System. Software such as Excel 2019, SPSS 25.0 and Joinpoint 4.9.1.0 were used to calculate the incidence rate, mortality, and average annual percentage change (AAPC) of AMI. ResultsFrom 2017 to 2023, the average annual crude incidence rate, age-standardized incidence rate using China standard population (ASIRC), and the age-standardized incidence rate using World standard population (ASIRW) of AMI in Xiaoshan District were 48.25/100 000, 29.14/100 000, and 21.64/100 000, respectively, and, from which the AAPCs were 5.495%, 6.010%, and 6.533%, respectively, all showing an upward trend. The average annual crude mortality rate, the age-standardized mortality rate using China standard population (ASMRC), and the age-standardized mortality rate using World standard population (ASMRW) were 11.76/100 000, 6.52/100 000, and 4.71/100 000, respectively, from which the AAPCs were -9.669%, -10.433% and -9.615%, respectively, all showing a downward trend. The average annual crude incidence rate of AMI was higher in males (65.87/100 000) than that in females (31.31/100 000). Moreover, the average annual crude mortality rate of AMI was higher in males (14.08/100 000) than that in females (9.52/100 000), and the difference was statistically significant (all P<0.001) .After age grouping, the crude incidence rate of AMI among the residents aged 35-, 45-, 55-, and 65- years in Xiaoshan District from 2017 to 2023 showed an upward trend over time, with AAPCs of 16.993%, 17.149%, 8.523%, and 5.002%, respectively. While the crude mortality rate in residents aged 35-, 75-, and 85-102 years showed an decreasing trend over time, with AAPCs of -23.977%, -15.467%, and -17.415%, respectively, but there was no statistically significant difference in the trends in incidence rate and mortality of other age groups (all P>0.05). ConclusionThe situation of AMI prevention and control among the registered residents in Xiaoshan District is not optimistic, and targeted measures should be strengthened for the male residents aged ≥35 years old.
8.Clinical application value of nutritional control status score combined with prognostic nutritional index in evaluating the risk of anemia in elderly colorectal cancer patients
Cuicui WANG ; Wantong QIAO ; Junying YAO ; Qian LI ; Weige GAO ; Min FAN
The Journal of Practical Medicine 2025;41(17):2696-2704
Objective This study aimed to assess the clinical utility of combining the Controlling Nutri-tional Status(CONUT)score with the Prognostic Nutritional Index(PNI)for evaluating anemia risk in elderly colorectal cancer patients and to establish a risk prediction model.Methods A total of 661 elderly colorectal cancer patients treated at Xinjiang Uygur Autonomous Region People's Hospital from July 2018 to March 2025 were included in this retrospective study.Patients were categorized into anemic and non-anemic groups and randomly assigned to a training set and validation set at a 7:3 ratio.The XGBoost algorithm was applied to develop a predictive model for anemia risk,and its performance was assessed using the receiver operating characteristic(ROC)curve.SHAP value visualization,and other methods.Results Among the 661 patients,257(38.9%)were diagnosed with anemia.Compared with the non-anemic group,patients in the anemic group had significantly lower levels of PNI and albumin,but higher CONUT scores and blood urea nitrogen levels.Additionally,the anemic group had higher proportions of tumor diameter≥5 cm,poorly differentiated tumors,and stage Ⅲ-Ⅳ disease(all P<0.05).The XGBoost model demonstrated good discriminatory ability,with an AUC of 0.897(95%CI:0.868~0.925).SHAP value analysis identified PNI,CONUT score,albumin,blood urea nitrogen,TNM stage,tumor differentiation,and tumor size as major contributing variables.PNI and albumin were protective factors,whereas CONUT score,blood urea nitrogen,and tumor-related features were risk factors.Conclusion Nutritional indicators such as PNI and CONUT score,along with tumor characteristics,can effectively predict the risk of anemia in elderly patients with colorectal cancer.The XGBoost-based predictive model demonstrates high discriminatory power and good inter-pretability,providing valuable support for early screening of high-risk patients and guiding individualized nutri-tional interventions and anemia management.
9.Effect of breast ultrasound background echotextures on diagnostic efficiency of pregnancy-associated breast cancer
Yue ZHANG ; Yaling CHEN ; Linxiaoxi MA ; Yi GAO ; Junying LIU ; Cai CHANG
Chinese Journal of Ultrasonography 2024;33(3):223-228
Objective:To investigate the diagnostic efficacy of ultrasound in pregnancy associated breast cancer (PABC) under different breast ultrasound background echotextures.Methods:The ultrasonic images of 269 female patients with breast diseases who underwent breast surgery in Fudan University Shanghai Cancer Center from January 2016 to September 2023 and were pregnant or within one year postpartum at the time of onset were retrospectively reviewed. Breast ultrasound background echotextures were classified according to two criteria: the first classification was homogeneous-fat, homogeneous-fibroglandular, and heterogeneous; the other classification was hypoechoic dominated and hyperechoic dominated. The comparison of the diagnostic value of ultrasound in PABC under different backgrounds was conducted by the receiver operating characteristic(ROC) curves.Results:Among 269 patients, 67 patients(24.91%)were during pregnancy and 202 patients(75.09%) were within one year postpartum. Pathologically, 47 patients (17.47%) were confirmed as benign, 222 patients (82.53%) were malignant. According to the first classification, 138 patients were homogeneous-fibroglandular and 131 patients were heterogeneous, with the diagnostic sensitivity of ultrasound in PABC were 88.70% and 59.81% respectively, and the specificity were 91.30% and 83.33% respectively, the areas under the ROC curves were 0.940 and 0.826 respectively ( P=0.022). According to the second classification, 119 were hypoechoic dominated and 150 patients were hyperechoic dominated, the sensitivity were 60.21% and 85.27% respectively, the specificity 84.62% and 90.48% respectively, the areas under the ROC curves were 0.826 and 0.925 ( P=0.042). Conclusions:The heterogeneous background echotextures of the breast may cause decrease of the diagnostic efficiency of ultrasound in PABC, and hypoechoic dominated background was more unfavorable for the diagnosis of PABC compared to the hyperechoic dominated background.
10.Analysis of survival rate among patients with first-ever stroke
LI Yurong ; WANG Dongfei ; GAO Yuanyuan ; WANG Fenjuan ; LIN Junying ; JIANG Yuanyuan ; ZHAO Fangfang ; XIAO Duanduan
Journal of Preventive Medicine 2024;36(10):873-877
Objective:
To understand the survival status and influencing factors of first-ever stroke patients, so as to provide evidence for improving the quality of life and prognosis of stroke patients.
Methods:
Demographic information, medical history, smoking history, and alcohol consumption history of newly diagnosed stroke cases first reported in 2017 in Xiaoshan District were collected through the Hangzhou Chronic Disease Surveillance and Management System. Patients were followed up for 5 years, with stroke death as the outcome event. The survival rate was calculated using the Kaplan-Meier method, and factors affecting survival time of first-ever stroke patients were identified using a multivariable Cox proportional hazard regression model.
Results:
A total of 3 886 patients first-ever stroke patients were included, the cases of cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, and stroke unspecified as to whether it was hemorrhagic or ischemic (unspecified) accounted for 86.93%, 11.45%, 1.06% and 0.57%, respectively. There were 2 047 males (52.68%) and 1 839 females (47.32%), with a mean onset age of (72.01±11.61) years. By the end of the follow-up on December 31, 2022, 906 patients died from stroke, with a median follow-up time of 62.00 (interquartile range, 35.00) months. The 1-year survival rate was 87.35% (95%CI: 86.30%-88.41%), the 3-year survival rate was 82.11% (95%CI: 80.88%-83.34%), and the 5-year survival rate was 76.64% (95%CI: 75.26%-78.02%), respectively. Multivariable Cox proportional hazard regression analysis showed that onset age of ≥75 years (HR=5.543, 95%CI: 3.822-8.039), being treated at township-level hospitals (HR=5.934, 95%CI: 4.027-8.743), history of hypertension (HR=1.566, 95%CI: 1.317-1.863), history of chronic ischemic heart disease (HR=1.611, 95%CI: 1.362-1.906), smoking history (HR=1.455, 95%CI: 1.190-1.778), alcohol consumption history (HR=1.323, 95%CI: 1.067-1.641), stroke subtype of intracerebral hemorrhage (HR=3.442, 95%CI: 2.923-4.053) and unspecified (HR=6.843, 95%CI: 4.353-10.756) were associated with higher mortality risk among first-ever stroke patients.
Conclusion
The 5-year survival rate of first-ever stroke patients was 76.64%, which was influenced by age of onset, hospital level for diagnosis and treatment, stroke subtype, medical history, smoking and alcohol consumption.


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