1.AI-integrated IQPD framework of quality prediction and diagnostics in small-sample multi-unit pharmaceutical manufacturing: Advancing from experience-driven to data-driven manufacturing.
Kaiyi WANG ; Xinhai CHEN ; Nan LI ; Huimin FENG ; Xiaoyi LIU ; Yifei WANG ; Yanfei WU ; Yufeng GUO ; Shuoshuo XU ; Lu YAO ; Zhaohua ZHANG ; Jun JIA ; Zhishu TANG ; Zhisheng WU
Acta Pharmaceutica Sinica B 2025;15(8):4193-4209
The pharmaceutical industry faces challenges in quality digitization for complex multi-stage processes, especially in small-sample systems. Here, an intelligent quality prediction and diagnostic (IQPD) framework was developed and applied to Tong Ren Tang's Niuhuang Qingxin Pills, utilizing four years of data collected from four production units, covering the entire process from raw materials to finished products. In this framework, a novel path-enhanced double ensemble quality prediction model (PeDGAT) is proposed, which combines a graph attention network and path information to encode inter-unit long-range and sequential dependencies. Additionally, the double ensemble strategy enhances model stability in small samples. Compared to global traditional models, PeDGAT achieves state-of-the-art results, with an average improvement of 13.18% and 87.67% in prediction accuracy and stability on three indicators. Additionally, a more in-depth diagnostic model leveraging grey correlation analysis and expert knowledge reduces reliance on large samples, offering a panoramic view of attribute relationships across units and improving process transparency. Finally, the IQPD framework integrates into a Human-Cyber-Physical system, enabling faster decision-making and real-time quality adjustments for Tong Ren Tang's Niuhuang Qingxin Pills, a product with annual sales exceeding 100 million CNY. This facilitates the transition from experience-driven to data-driven manufacturing.
2.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
3.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
4.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
5.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
6.Diagnostic value of serum extra-spindle pole-like protein 1 in the progression of hepatitis B virus-related liver fibrosis
Long HUANG ; Hongqian LIANG ; Aoli REN ; Minghua SU ; Bobin HU ; Qingmei LI ; Tumei SU ; Qianbing YIN ; Yanfei FENG ; Jianning JIANG
Journal of Clinical Hepatology 2024;40(9):1785-1789
Objective To investigate the clinical diagnostic value of extra-spindle pole-like protein 1(ESPL1)in the progression of hepatitis B virus(HBV)-related liver fibrosis.Methods A total of 228 patients with HBV infection who were admitted to The First Affiliated Hospital of Guangxi Medical University from June 2017 to August 2023 were enrolled.The transient elastography system FibroScan was used to determine liver stiffness measurement(LSM)for all patients,and according to the LSM value,they were divided into non-liver fibrosis group with 80 patients,mild liver fibrosis group with 83 patients,advanced liver fibrosis group with 30 patients,and liver cirrhosis group with 35 patients.ELISA was used to measure the serum level of ESPL1.The Kruskal-Wallis H test was used for comparison of the serum level of ESPL1 between the four groups;the Spearman correlation analysis was used to investigate the correlation between ESPL1 and LSM;the receiver operating characteristic(ROC)curve was used to analyze the value of serum ESPL1 in predicting the progression of liver fibrosis.Results The liver cirrhosis group had a significantly higher serum level of ESPL1 than the non-liver fibrosis group and the mild liver fibrosis group(both P<0.05),and the advanced liver fibrosis group and the mild liver fibrosis group had a significantly higher serum level of ESPL1 than the non-liver fibrosis group(both P<0.05).The correlation analysis showed that there was a positive correlation between serum ESPL1 and LSM in the patients with HBV infection and varying degrees of liver fibrosis(r=0.515,P<0.001).Serum ESPL1 had an area under the ROC curve(AUC)of 0.809 in predicting liver cirrhosis and an AUC of 0.638 in predicting advanced liver fibrosis,with a sensitivity of 87.5%and 100%,respectively,and a specificity of 59.7%and 31.3%,respectively.Conclusion There is a certain correlation between serum ESPL1 and HBV-related liver fibrosis,and higher serum ESPL1 may indicate a higher degree of liver fibrosis.Serum ESPL1 is expected to become one of the serum markers for assisting in the diagnosis of liver cirrhosis and an important clinical method for dynamically monitoring the progression of liver fibrosis in patients with HBV infection.
7.Willingness to preventive treatments and related factors among college freshmen with latent tuberculosis infection in Changzhou
Chinese Journal of School Health 2024;45(12):1802-1806
Objective:
To investigate the willingness to accept preventive treatments and its related factors among college freshmen with latent tuberculosis infection (LTBI), so as to provide the evidence for preventive treatment intervention measures for students with LTBI.
Methods:
Cluster sampling method was used to select 368 LTBI freshmen from 8 colleges and universities in Changzhou in September 2023, who conducted a questionnaire survey on the willingness to receive preventive treatment. General demographic data were collected and relevant data were collected using tuberculosis knowledge scale, General Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Adaptation, Partnership, Growth, Affection and Resolve (APGAR), and a self developed Stigma Scale. A binary Logistic regression model was constructed with the willingness to accept preventive treatment as the dependent variable to analyze the willingness to accept preventive treatment and the influencing factors.
Results:
A total of 253 LTBI college freshmen were willing to take preventive treatment, the acceptance rate was 68.75%. The rate of willingness to accept preventive treatment for LTBI was higher among students whose fathers had an education level of high school, compared to those whose fathers had an education level of junior high school or below ( OR =2.16, P <0.05). LTBI students whose per capita family income was >5 000-10 000 yuan and >10 000 yuan were more willing to accept LTBI preventive treatment than those whose per capita family income was <3 000 yuan ( OR =2.72, 4.46, P <0.05). LTBI students who engaged in physical exercise for more than 2 hours per week were more willing to accept than those who exercised less than 0.5 hours per week ( OR =1.91, P <0.05). LTBI students with high levels of tuberculosis knowledge and stigma were more likely to receive preventive treatment ( OR =1.18, 1.11, P < 0.05). LTBI students with high PHQ-9 ( OR =0.85) and GAD-7 ( OR =0.92) scores were more likely to refuse preventive treatment ( P <0.05).
Conclusion
The present study revealed a moderate level of willingness of LTBI students to preventive treatment in Changzhou City, and the acceptance is affected by family factors, healthy lifestyles, tuberculosis knowledge and psychological status.
8.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
9.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.
10.Effect of Different Endometrial Implantation Window Detection Methods on Pregnancy Outcome in Patients with Repeated Implantation Failure
Yanfei WANG ; Guangmei XIE ; Yuankun SANG ; Li WANG ; Ruoxin ZHU ; Jialing WANG ; Liyuan ZHANG ; Fan FENG
Journal of Practical Obstetrics and Gynecology 2024;40(5):381-385
Objective:To evaluate the endometrial implantation window in patients with recurrent implantation failure using endometrial receptive array(ERA)sequencing or endometrial histological detection methods,and to explore the effectiveness and cost-effectiveness analysis of two technologies for improving clinical outcomes in such patients.Methods:A retrospective cohort study was conducted on clinical data of 125 patients diagnosed with repeated implantation failure in Gansu Maternal and Child Health Hospital from January 2018 to December 2022.According to whether endometrial receptivity testing was accepted and different detection techniques were used,they were divided into a control group(n=36),a genomic group(n=35),and a histological group(n=54).The clinical data and pregnancy outcomes of the three groups were compared.Results:①The results of one-way ANOVA showed that the embryo implantation rate in the genomic group and histological group was significantly higher than that in the control group,and the difference was statistically significant(P<0.05).There was no sta-tistically significant difference in embryo implantation rate between genomic and histological groups(P=0.48).②There was no statistically significant difference in clinical pregnancy rate and live birth rate among the three groups(P>0.05).③Log rank test showed:The time for 50%of patients to reach live labor was significantly shorter than that of the control group,and the difference was statistically significant(P<0.05);There was no sta-tistically significant difference in the time to live birth in 50%of patients between the genomic and histological groups of 50%of patients(P>0.05).④The average number of embryos transferred in the control group was significantly higher than that in the genomic and histological groups,with statistical significance(P<0.05).The cost of genomic patients was significantly higher than that of histology group,and the difference was statistically significant(P<0.05).Conclusions:①Endometrial implantation window detection is feasible for patients with re-peated implantation failure,which can effectively shorten the time to live birth and reduce the number of transplan-ted embryos;②Both ERA sequencing and endometrial histology detection have limitations as methods to evaluate endometrial implantation window,and it is not clear which detection method has more advantages in accuracy and practicability.


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