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.Efficacy observation of carilizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer
Cancer Research and Clinic 2025;37(7):525-529
Objective:To explore the therapeutic effect of carilizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.Methods:A retrospective case-control study was conducted. The clinical data of 70 patients with locally advanced cervical cancer admitted to Shanxi Province Cancer Hospital from July 2020 to July 2021 were collected. According to the treatment method, all patients were divided into the control group (chemoradiotherapy alone group, 36 cases) and the observation group (carilizumab combined with concurrent chemoradiotherapy group, 34 cases). The short-term efficacy, serum tumor markers level, T cell subsets, adverse reactions, and progression-free survival (PFS) of the 2 groups were compared.Results:The disease control rate in the observation group was higher than that in the control group [94.12% (32/34) vs. 75.00% (27/36)], and the difference was statistically significant ( χ2 = 4.83, P < 0.05). The levels of serum carcinoma embryonic antigen (CEA), carbohydrate antigen 125 (CA125), squamous cell carcinoma antigen(SCC-Ag), human epididymis protein 4 (HE4), vascular endothelial growth factor A (VEGF-A), and vascular endothelial growth factor receptor 2 (VEGFR2) of the both groups after treatment for 180 d were lower than those of the same corresponding group the day before treatment (all P < 0.05). The levels of serum CEA, CA125, SCC-Ag, HE4, VEGF-A and VEGFR2 after treatment for 180 d in the observation group were lower than those in the control group (all P < 0.05). The proportions of serum CD3 + T cells, CD4 + T cells of the both groups after treatment for 180 d were higher than those of the same corresponding group the day before treatment, and the proportion of CD8 + T cells after treatment for 180 d was lower than that the day before treatment (all P < 0.05). The proportions of serum CD3 + T cells and CD4 + T cells after treatment for 180 d in the observation group were higher than those in the control group, and the proportion of CD8 + T cells in the observation group was lower than that in the control group (all P < 0.05). There were no statistically significant differences in the incidence of bone marrow suppression, gastrointestinal reactions, radiation cystitis and radiation proctitis between the observation group and the control group (all P > 0.05). The median follow-up time was 17 (2-24) months. The 1-year PFS rates of the observation group and the control group were 100.00%, 79.17%, respectively, and the difference in the PFS was statistically significant ( P < 0.001). Conclusions:The combination of carilizumab and concurrent chemoradiotherapy is effective in the treatment of locally advanced cervical cancer. It can decrease serum tumor marker levels, regulate T cell subsets. No serious adverse reactions are found.
3.Establishment and validation of urine AD7c-NTP reference intervals for healthy adults in Mianyang area using the indirect method
Yurong ZHANG ; Yifei HE ; Ping YANG ; Zixi XU ; Zhilong CAI ; Yang LIU ; Dan WANG ; Liang HUANG ; Bing HOU ; Jia YANG ; Xuemei JIANG ; Kun FANG
Chinese Journal of Clinical Laboratory Science 2025;43(5):378-381
Objective To establish the reference interval of urine Alzheimer-associated neuronal thread protein(AD7c-NTP)for healthy adults in Mianyang area using the indirect method.Methods The detection results of urine AD7c-NTP from 5 093 healthy in-dividuals were collected from the information management database of Medical Laboratory Department of Sichuan Science City Hospital from March 2017 to March 2022.Skewness-kurtosis and Kolmogorov-Smirnov tests were used to determine whether the data followed a normal distribution.After removing outliers using the Box Plots method,the enrolled subjects were grouped by gender and age.The Mann-Whitney U or Kruska-Wallis H tests were used to analyze the between-group differences of urine AD7c-NTP in healthy individu-als with different genders and ages.The adjacent age groups without statistically significant difference(P>0.05)were combined,and the indirect method(non-parametric test method)was used to calculate the reference intervals for different gender and age groups.Results Skewness-kurtosis and Kolmogorov-Smirnov tests showed that the data followed a non-normal distribution.After removing 293 outliers using the Box Plots method,a total of 4 800 subjects,including 3 199 males and 1 601 females,were enrolled.The enrolled subjects were grouped by gender and age,and the non-parametric test method were used to establish the reference intervals of urine AD7c-NTP in healthy populations with different genders.The Mann-Whitney U test confirmed that urine AD7c-NTP levels existed gen-der differences(Z=14.09,P<0.01),and the reference intervals for males and females were≤1.10 ng/mL and≤1.40 ng/mL,re-spectively.There were also statistical differences in urine AD7c-NTP levels among different age groups of the same gender.After combi-ning adjacent age groups without statistically significant difference(P>0.05),the reference intervals of urine AD7c-NTP in healthy populations with different genders and ages were established by the non-parametric test method,which were≤1.00 ng/mL for male 20-39 years old group,≤1.10 ng/mL for male 40-79 years old group,≤1.60 ng/mL for male≥80 years old group,≤1.30 ng/mL for female 20-69 years old group,and≤1.60 ng/mL for female≥70 years old group,respectively.The established reference intervals of urine AD7c-NTP were further verified by healthy individuals,and the results met the standards.Conclusion The reference intervals of urine AD7c-NTP in healthy populations with different genders and ages in Mianyang area are established successfully using the indi-rect method,which may help to predict the risk of Alzheimer's disease in clinical practice and provide support for the diagnosis and treatment of the disease.
4.Urban-rural difference in adverse outcomes of pulmonary tuberculosis in patients with pulmonary tuberculosis-diabetes mellitus comorbidity
FANG Zijian ; LI Qingchun ; XIE Li ; SONG Xu ; DAI Ruoqi ; WU Yifei ; JIA Qingjun ; CHENG Qinglin
Journal of Preventive Medicine 2025;37(1):7-11
Objective:
To investigate the urban and rural differences in adverse outcomes of pulmonary tuberculosis (PTB) in patients with pulmonary tuberculosis-diabetes mellitus comorbidity (PTB-DM), so as to provide insights into improving the prevention and treatment measures for PTB-DM.
Methods:
Patients with PTB-DM who were admitted and discharged from 14 designated tuberculosis hospitals in Hangzhou City from 2018 to 2022 were selected. Basic information, and history of diagnosis and treatment were collected through hospital information systems. The adverse outcomes of PTB were defined as endpoints, and the proportions of adverse outcomes of PTB in urban and rural patients with PTB-DM were analyzed. Factors affecting the adverse outcomes of PTB were identified using a multivariable Cox proportional hazards regression model.
Results:
A total of 823 patients with PTB-DM were enrolled, including 354 (43.01%) urban and 469 (56.99%) rural patients. There were 112 (13.61%) patients with adverse outcomes of PTB. The proportions of adverse outcomes of PTB in urban and rural patients were 14.41% and 13.01%, respectively, with no statistically significant difference (P>0.05). Multivariable Cox proportional hazards regression analysis identified first diagnosed in county-level hospitals or above (HR=2.107, 95%CI: 1.181-3.758) and drug resistance (HR=3.303, 95%CI: 1.653-6.600) as the risk factors for adverse outcomes of PTB in urban patients with PTB-DM, while the treatment/observed management throughout the process (HR=0.470, 95%CI: 0.274-0.803) and fixed-dose combinations throughout the process (HR=0.331, 95%CI: 0.151-0.729) as the protective factors for adverse outcomes in rural patients with PTB-DM.
Conclusions
There are differences in influencing factors for adverse outcomes of PTB in urban and rural patients with PTB-DM. The adverse outcomes of PTB are associated with first diagnosed hospitals and drug resistance in urban patients, and are associated with the treatment/observed management and fixed-dose combinations throughout the process in rural patients.
5.Teaching practice of oncology internship for eight-year clinical medicine program students
Zhiyang ZHANG ; Yifei YAN ; Yingyi WANG ; Nan JIA
Basic & Clinical Medicine 2025;45(10):1396-1400
Objective To investigate the needs and gains of eight-year clinical medicine program students during their oncology internships,and provide reference for the reform of clinical teaching in oncology.Methods A ques-tionnaire survey was conducted among 52 students from Peking Union Medical College,Tsinghua University School of Medicine,and Peking Union Medical College"4+4"medical doctor program who underwent internships in the Department of Oncology at Peking Union Medical College from July 2023 to June 2024 in order to examine their basic knowledge of oncology,the courses they are interested in,their preference for teaching methods and the gains from the internships.The exam was conducted before and after the internship.Results All 52 students participated in the survey and examination.Most students were interested in clinical diagnosis and treatment,new drug develop-ment and progress in basic research.All students acknowledged that their ability to solve actual clinical problems had been improved after the internship in oncology,51(98.08%)recognized that their capacity of literature searching and reviewing,integrating the information and reasoning had improved,while 50(96.15%)believed that their capacity to read Computed Tomography(CT)images or perform imaging diagnosis had improved.The number of students who were interested in oncology increased from 41(78.85%)before the internship and up to 47(90.38%)after the training.The average score of the students before internship was 63.88±8.90,and then signif-icantly increased up to 82.94±9.12 afterwards.Conclusions Eight-year program students of clinical medicine are quite interested in oncology,their learning and training outcomes have been further improved through the clinical training during internship.
6.Relationship between physical activity and sarcopenia among elderly people in ten provinces (autonomous regions) of China, 2022—2023
Yuchen WANG ; Huijun WANG ; Yuna HE ; Chang SU ; Jiguo ZHANG ; Wenwen DU ; Xiaofang JIA ; Feifei HUANG ; Li LI ; Jing BAI ; Yanli WEI ; Xiaofan ZHANG ; Fangxu GUAN ; Yifei OUYANG
Journal of Environmental and Occupational Medicine 2025;42(6):661-667
Background The decline of physical activity in the elderly due to aging may increase the risk of sarcopenia. Currently, there is a lack of evidence from large natural populations on the relationship between PA and sarcopenia. Objective To explore the relationship between PA and sarcopenia in the elderly aged 60 years and above in 10 provinces (autonomous regions) of China. Methods Data were retrieved from the 2022—2023 round of the China Development and Nutrition Health Impact Cohort. Personal basic information and PA data were collected by questionnaire survey. Skeletal muscle mass was measured by bio-electrical impedance analysis, muscle strength was measured using a grip dynamometer, and physical performance was reflected by 6-meter walk speed. The Asian Working Group for Sarcopenia (AWGS) 2019 criteria were used to diagnose sarcopenia. Light physical activity (LPA) duration, moderate-to-vigorous physical activity (MVPA) duration, and total physical activity volume were calculated. A total of
7.Clinical characteristics and outcomes of elderly patients with stage Ⅰ diffuse large B-cell lymphoma: a study by the Jiangsu Cooperative Lymphoma Group (JCLG)
Yi XIA ; Jing HE ; Weiying GU ; Tao JIA ; Tingxun LU ; Yongle LI ; Jiahao ZHOU ; Bingzong LI ; Haiying HUA ; Ping LIU ; Yuqing MIAO ; Yuexin CHENG ; Xiaoyan XIE ; Yunping ZHANG ; Wenzhong WU ; Zhuxia JIA ; Xuzhang LU ; Chunling WANG ; Liang YU ; Min XU ; Jinning SHI ; Weifeng CHEN ; Wanchuan ZHUANG ; Zhen QIAN ; Jun QIAN ; Haiwen NI ; Yifei CHEN ; Qiudan SHEN ; Jianyong LI ; Wenyu SHI
Chinese Journal of Internal Medicine 2025;64(6):504-513
Objective:To summarize the clinical characteristics of elderly patients with stage Ⅰ diffuse large B-cell lymphoma (DLBCL) and analyze the factors associated with prognosis.Methods:A case series study was conducted by retrospectively collecting clinical data from patients aged over 60 years with newly diagnosed stage Ⅰ DLBCL across 20 medical centers in Jiangsu Province, China, between June 2010 and April 2023. The involved site, classification and treatment plan were summarized. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Statistical analyses were performed using the Kaplan-Meier method, and Cox regression model.Results:The study included 255 patients with a median age of 69 years, of whom 130 (51.0%) were male, 66 (25.9%) were aged ≥75 years and 26 (10.1%) had a high Charlson Comorbidity Index (CCI) score of ≥2. Extranodal involvement was observed in 163 (63.9%) patients, with the stomach (37.4%, 61/163), intestine (19.0%, 31/163), testes (11.0%, 18/163), and breast (7.4%, 12/163) being the most frequently affected sites. The non-germinal center B-cell (non-GCB) subtype was prevalent in 63.7% of patients (142/223), with no significant difference between the nodal and extranodal groups ( P=0.681). Furthermore, 73.9% (184/249) and 11.7% (29/249) of patients received the R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and R-miniCHOP regimen, respectively. The overall 3-year PFS rate was 81.5%, and the 3-year OS rate was 85.6%. Patients aged ≥75 years ( HR=2.910, 95% CI 1.565-5.408, P=0.001) and/or with a CCI score ≥2 ( HR=2.324, 95% CI 1.141-4.732, P=0.020) had a significantly poorer PFS. Incorporating age ≥75 years and CCI score ≥2 into the stage-modified international prognostic index (sm-IPI) can better stratify the prognosis of elderly patients with stage Ⅰ DLBCL. The 3-year PFS rate was 48.7% in the high-risk group versus 85.7% in the low-risk group ( P<0.001). Conclusions:Our findings show that the elderly patients with stage Ⅰ DLBCL were predominantly characterized by extranodal involvement (particularly in the stomach and intestinal tract) and non-GCB subtype. Age ≥75 years and CCI ≥2 were identified as independent prognostic factors. The newly established sm-IPI-75-CCI incorporating these factors demonstrated superior prognostic discrimination compared to conventional risk assessment systems.
8.Summary of best evidence for postoperative exercise rehabilitation of hip fractures in elderly frail patients
Xuyan HE ; Shoumei JIA ; Liting ZHAO ; Liping SUN ; Yifei JIN ; Rongjing XU ; Yan WANG
Chinese Journal of Practical Nursing 2025;41(19):1494-1503
Objective:To retrieve, evaluate and integrate the evidence related to postoperative exercise rehabilitation for hip fracture in elderly frail patients, and provide reference for clinical rehabilitation nursing.Methods:Evidence on postoperative exercise rehabilitation of hip fractures in elderly frail patients was systemically retrieved in the guideline websites, professional association websites and databases, such as BMJ Best Practice, UpToDate, PubMed, Web of Science, CINAHL, Cochrane Library, Embase, Chinese Biomedical Database, China National Knowledge Infrastructure, Wanfang and VIP, including Best practices, guidelines, clinical decisions, evidence summaries, systematic reviews, and expert consensus. The retrieval time was from the establishment of the database to March 31, 2024.Results:A total of 33 articles were involved, including 12 guidelines, 2 clinical decisions, 7 systematic reviews, 7 expert consensuses, 5 evidence summaries. Forty pieces of evidence were summarized in 7 aspects: the role of exercise, exercise assessment, exercise planning, exercise content, exercise intensity, exercise adherence, exercise nursing, exercise guidance.Conclusions:Healthcare professionals should combine patients' tolerance, rehabilitation goals, and specific clinical situations to target and guide patients in exercise rehabilitation to promote the recovery of postoperative limb function, mitigate frailty, and improve the quality of life.
9.Current status and influencing factors of oral frailty in elderly diabetic patients
Xiaohui SHANG ; Yifei DU ; Baoli WEN ; Qiming JIA ; Yan ZHENG ; Yu'na HU ; Liming LI
Chinese Journal of Modern Nursing 2025;31(14):1925-1930
Objective:To understand the current status of oral frailty in elderly diabetic patients and analyze its influencing factors.Methods:A convenience sampling method was used to select elderly diabetic patients hospitalized at Henan Cancer Hospital and Henan Provincial People's Hospital from October 2023 to May 2024. The general information questionnaire, Oral Frailty Index-8 (OFI-8) , Short Form of Health Literacy Dental Scale (HeLD-14) , Nutritional Risk Screening 2002 (NRS 2002) , and the Diabetes Distress Scale (DDS) were used to collect data. Binary Logistic regression analysis was used to examine the influencing factors of oral frailty in elderly diabetic patients.Results:A total of 235 questionnaires were distributed, and 220 valid questionnaires were returned, with an effective response rate of 93.62% (220/235) . The incidence of oral frailty in elderly diabetic patients was 46.82% (103/220) . The binary Logistic regression analysis showed that glycated hemoglobin, dry mouth, remaining teeth, nutritional risk, oral health literacy, and diabetes distress were significant influencing factors for the occurrence of oral frailty in elderly diabetic patients ( P<0.05) . Conclusions:The current status of oral frailty in elderly diabetic patients is concerning. Healthcare providers should pay attention to the oral health status of elderly diabetic patients and provide targeted nursing interventions and recommendations based on the influencing factors of oral frailty, in order to reduce its occurrence.
10.Establishment and validation of urine AD7c-NTP reference intervals for healthy adults in Mianyang area using the indirect method
Yurong ZHANG ; Yifei HE ; Ping YANG ; Zixi XU ; Zhilong CAI ; Yang LIU ; Dan WANG ; Liang HUANG ; Bing HOU ; Jia YANG ; Xuemei JIANG ; Kun FANG
Chinese Journal of Clinical Laboratory Science 2025;43(5):378-381
Objective To establish the reference interval of urine Alzheimer-associated neuronal thread protein(AD7c-NTP)for healthy adults in Mianyang area using the indirect method.Methods The detection results of urine AD7c-NTP from 5 093 healthy in-dividuals were collected from the information management database of Medical Laboratory Department of Sichuan Science City Hospital from March 2017 to March 2022.Skewness-kurtosis and Kolmogorov-Smirnov tests were used to determine whether the data followed a normal distribution.After removing outliers using the Box Plots method,the enrolled subjects were grouped by gender and age.The Mann-Whitney U or Kruska-Wallis H tests were used to analyze the between-group differences of urine AD7c-NTP in healthy individu-als with different genders and ages.The adjacent age groups without statistically significant difference(P>0.05)were combined,and the indirect method(non-parametric test method)was used to calculate the reference intervals for different gender and age groups.Results Skewness-kurtosis and Kolmogorov-Smirnov tests showed that the data followed a non-normal distribution.After removing 293 outliers using the Box Plots method,a total of 4 800 subjects,including 3 199 males and 1 601 females,were enrolled.The enrolled subjects were grouped by gender and age,and the non-parametric test method were used to establish the reference intervals of urine AD7c-NTP in healthy populations with different genders.The Mann-Whitney U test confirmed that urine AD7c-NTP levels existed gen-der differences(Z=14.09,P<0.01),and the reference intervals for males and females were≤1.10 ng/mL and≤1.40 ng/mL,re-spectively.There were also statistical differences in urine AD7c-NTP levels among different age groups of the same gender.After combi-ning adjacent age groups without statistically significant difference(P>0.05),the reference intervals of urine AD7c-NTP in healthy populations with different genders and ages were established by the non-parametric test method,which were≤1.00 ng/mL for male 20-39 years old group,≤1.10 ng/mL for male 40-79 years old group,≤1.60 ng/mL for male≥80 years old group,≤1.30 ng/mL for female 20-69 years old group,and≤1.60 ng/mL for female≥70 years old group,respectively.The established reference intervals of urine AD7c-NTP were further verified by healthy individuals,and the results met the standards.Conclusion The reference intervals of urine AD7c-NTP in healthy populations with different genders and ages in Mianyang area are established successfully using the indi-rect method,which may help to predict the risk of Alzheimer's disease in clinical practice and provide support for the diagnosis and treatment of the disease.


Result Analysis
Print
Save
E-mail