1.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
2.Research Advancements of Antibody-Drug Conjugates in Breast Cancer at 2024 ASCO Annual Meeting
Hunan YE ; Yulan SHEN ; Jiaying LI ; Huanhuan ZHOU ; Fanrong ZHANG ; Xiaojia WANG
Cancer Research on Prevention and Treatment 2025;52(3):185-192
The 2024 American Society of Clinical Oncology(ASCO)Annual Meeting was held in Chicago,the United States,from May 31 to June 4 in 2024.In recent years,antibody-drug conjugates(ADCs)have become one of the most popular targeted therapies because of their high specificity,efficacy,and low toxicity,making them a focal point in this ASCO meeting.Currently,over 100 ADCs are under investigation,demonstrating the considerable development potential of ADCs in the field of targeted cancer therapy.The aforementioned conference reported several recent research advancements regarding ADCs for the treatment of breast cancer(BC).This review summarizes the latest progress of ADCs in BC treatment discussed at the confer-ence.
3.Construction of tumor-specific mortality risk prediction model for advanced endometrial carcinoma patients
Xiaojia YU ; Xinyan WANG ; Jinyan FANG ; Lexing ZHANG ; Wanglei QU
China Modern Doctor 2025;63(32):28-32
Objective To analyze the influencing factors of tumor-specific mortality in patients with advanced endometrial carcinoma and construct a risk prediction model.Methods A total of 150 patients with advanced endometrial carcinoma admitted to the Fourth Clinical College of Zhejiang Chinese Medical University,Hangzhou First People's Hospital from January 2020 to January 2023 were selected as subjects.Cox regression was employed to analyze factors influencing mortality in advanced endometrial carcinoma.A Logistic regression model was constructed,with receiver operating characteristic(ROC)curve used to evaluate model discrimination,calibration curve for precision assessment,and decision curve for net benefit evaluation.Results Overall 2-year survival rate of 150 patients was 58.67%.The univariate analysis demonstrated that histological grade,lymph node metastasis,tumor maximum diameter,and preoperative carcinoembryonic antigen 125(CA125)levels were all significant risk factors for mortality in advanced endometrial carcinoma(P<0.05).Multivariate analysis confirmed these parameters as independent prognostic indicators(P<0.05).A Logistic regression model established using multivariate Cox regression yielded a C index of 0.873(95%CI:0.792-0.951).ROC curve analysis revealed the model's area under the curve for predicting mortality risk factors in advanced endometrial carcinoma was 0.916(95%CI:0.872-0.960).Conclusion The linear chart prediction model constructed based on histological grading,lymph node metastasis,maximum tumor diameter and preoperative CA125 level in this study can effectively predict the death of advanced endometrial carcinoma.
4.Spring and summer-autumn pollen grading and forecasting model based on daily visits of allergic rhinitis patients
Yuhui OUYANG ; Zhaoyin YIN ; Yun YAN ; Jingguo CHEN ; Wenxuan FEI ; Lili GONG ; Weiwei LIU ; Xiaojia LIU ; Daoliang SONG ; Zhendong XU ; Ying ZHANG ; Yuan ZHANG ; Luo ZHANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):313-320
Objective:To establish graded forecast models of pollen concentration in spring and summer-autumn in northern China, based on long-term data of pollen and allergic rhinitis (AR) medical visits in 8 cities of northern China.Methods:Pollen concentration and the characteristics of AR patients from 8 cities of northern China, including Beijing, Baotou, Hohhot, Xi′an, Xining, Cangzhou, Liaocheng and Zibo, were analyzed. Spearman′s correlation was used to examine the relationship between pollen concentration and daily AR patient visits. A pollen concentration grading was establish, and a pollen forecast model was created using the eXtreme gradient boosting (XGBoost) algorithm. The model incorporated meteorological factors and the 3-day moving average of pollen concentrations.Results:The spring pollen period started early and lasted long in Beijing and Xi ′an, while the summer-autumn pollen period started earlier and persisted longer in Xining, Baotou and Hohhot. During summer-autumn pollen period, and the spring period in most cities (except Baotou and Cangzhou), average daily patient visits were significantly higher than those in non-pollen periods. A strong correlation was observed between daily AR patient visits and the 3-day moving average of pollen concentrations in both the spring and summer-autumn periods across all cities. Based on the correlation, a pollen concentration grading standard of northern China was established. The accuracy evaluation of pollen concentration prediction model showed that the percentage of forecasts with either completely accurate or within one level difference exceeded 91% in spring and 95% in summer-autumn. The most important predictive variable in the model was the pollen level from previous day, followed by the temperature and humidity.Conclusion:The grading prediction model for pollen concentration provides guidance for AR patients in term of travel, early defense and treatment, as well as the determining medication schedules for clinical drug research and specific immunotherapy.
5.Structure, content and data standardization of rehabilitation medical records
Yaru YANG ; Zhuoying QIU ; Di CHEN ; Zhongyan WANG ; Meng ZHANG ; Shiyong WU ; Yaoguang ZHANG ; Xiaoxie LIU ; Yanyan YANG ; Bin ZENG ; Mouwang ZHOU ; Yuxiao XIE ; Guangxu XU ; Jiejiao ZHENG ; Mingsheng ZHANG ; Xiangming YE ; Jian YANG ; Na AN ; Yuanjun DONG ; Xiaojia XIN ; Xiangxia REN ; Ye LIU ; Yifan TIAN
Chinese Journal of Rehabilitation Theory and Practice 2025;31(1):21-32
ObjectiveTo elucidate the critical role of rehabilitation medical records (including electronic records) in rehabilitation medicine's clinical practice and management, comprehensively analyzed the structure, core content and data standards of rehabilitation medical records, to develop a standardized medical record data architecture and core dataset suitable for rehabilitation medicine and to explore the application of rehabilitation data in performance evaluation and payment. MethodsBased on the regulatory documents Basic Specifications for Medical Record Writing and Basic Specifications for Electronic Medical Records (Trial) issued by National Health Commission of China, and referencing the World Health Organization (WHO) Family of International Classifications (WHO-FICs) classifications, International Classification of Diseases (ICD-10/ICD-11), International Classification of Functioning, Disability and Health (ICF), and International Classification of Health Interventions (ICHI Beta-3), this study constructed the data architecture, core content and data standards for rehabilitation medical records. Furthermore, it explored the application of rehabilitation record summary sheets (home page) data in rehabilitation medical statistics and payment methods, including Diagnosis-related Groups (DRG), Diagnosis-Intervention Packet (DIP) and Case Mix Index. ResultsThis study proposed a systematic standard framework for rehabilitation medical records, covering key components such as patient demographics, rehabilitation diagnosis, functional assessment, rehabilitation treatment prescriptions, progress evaluations and discharge summaries. The research analyzed the systematic application methods and data standards of ICD-10/ICD-11, ICF and ICHI Beta-3 in the fields of medical record terminology, coding and assessment. Constructing a standardized data structure and data standards for rehabilitation medical records can significantly improve the quality of data reporting based on the medical record summary sheet, thereby enhancing the quality control of rehabilitation services, effectively supporting the optimization of rehabilitation medical insurance payment mechanisms, and contributing to the establishment of rehabilitation medical performance evaluation and payment based on DRG and DIP. ConclusionStructured rehabilitation records and data standardization are crucial tools for quality control in rehabilitation. Systematically applying the three reference classifications of the WHO-FICs, and aligning with national medical record and electronic health record specifications, facilitate the development of a standardized rehabilitation record architecture and core dataset. Standardizing rehabilitation care pathways based on the ICF methodology, and developing ICF- and ICD-11-based rehabilitation assessment tools, auxiliary diagnostic and therapeutic systems, and supporting terminology and coding systems, can effectively enhance the quality of rehabilitation records and enable interoperability and sharing of rehabilitation data with other medical data, ultimately improving the quality and safety of rehabilitation services.
6.Telpegfilgrastim for chemotherapy-induced neutropenia in breast cancer: A multicenter, randomized, phase 3 study.
Yuankai SHI ; Qingyuan ZHANG ; Junsheng WANG ; Zhong OUYANG ; Tienan YI ; Jiazhuan MEI ; Xinshuai WANG ; Zhidong PEI ; Tao SUN ; Junheng BAI ; Shundong CANG ; Yarong LI ; Guohong FU ; Tianjiang MA ; Huaqiu SHI ; Jinping LIU ; Xiaojia WANG ; Hongrui NIU ; Yanzhen GUO ; Shengyu ZHOU ; Li SUN
Chinese Medical Journal 2025;138(4):496-498
7.Study on the role of coatomer protein Ⅰ in apolipoprotein A-1-mediated cholesterol efflux from foam cells
Weitao HONG ; Feilong ZHANG ; Jie HUANG ; Yumin LIANG ; Gengji CHEN ; Xiaojia CHEN ; Weilie MA ; Hang DING ; Zhizhen ZHANG
Chongqing Medicine 2025;54(3):580-587
Objective To establish a human monocytic THP-1 macrophage-derived foam cell model and analyze the role of the α subunit of coatomer protein Ⅰ(α-COP)in apolipoprotein A-1(apoA-1)-mediated cholesterol efflux from foam cells.Methods THP-1 cells were induced to adhere using PMA(PMA group),followed by treatment with acetylated low-density lipoprotein(Ac-LDL)to generate macrophage-derived foam cells(Ac-LDL group).Subsequent incubation with apoA-1 formed the apoA-1 group.Cholesterol efflux rates mediated by apoA-1 and intracellular lipid accumulation were quantified through liquid scintillation counting and oil red O staining.The expression patterns of α-COP were systematically analyzed using quantitative real-time PCR(qPCR),Western blotting,and laser scanning confocal microscopy.THP-1 macrophage-derived foam cells mediated by apoA-1 were transduced with scrambled shRNA(Scr group)or α-COP-specific shRNA lentivirus(α-COP shRNA group)to assess the effects of α-COP knockdown on cholesterol efflux efficiency and total cellular cholesterol content.Subcellular localization of adipopoilin(ADFP)and cholesterol probe Fil-ipin Ⅲ staining patterns were visualized via laser scanning confocal microscopy.Bioinformatics analysis of α-COP expression profiles in carotid atherosclerotic plaques was performed using datasets from the GEO data-base.Results Compared with the Ac-LDL group,the cholesterol efflux rate in the apoA-1 group was signifi-cantly increased[(9.77±0.79)%vs.(2.74±0.37)%,P<0.001].Oil red O staining demonstrated reduced lipid accumulation in foam cells of the apoA-1 group compared with the Ac-LDL group.The relative mRNA expression level of α-COP in the apoA-1 group was significantly higher than that in the Ac-LDL group(P<0.001),with corresponding elevation in protein expression(P<0.001).Fluorescence intensity analysis re-vealed increased mean fluorescence intensity of α-COP in the apoA-1 group compared with the Ac-LDL group.Following α-COP knockdown by shRNA,the apoA-1-mediated cholesterol efflux rate was significantly de-creased(P<0.05)and total intracellular cholesterol levels were increased(P<0.001)in the α-COP shRNA group compared with the Scr group.The α-COP shRNA group exhibited enhanced red fluorescence intensity of ADFP(P<0.05)and increased blue fluorescence intensity of Filipin Ⅲ(P<0.01)compared with the Scr group.Database analysis indicated that α-COP mRNA expression was lower in carotid atherosclerotic plaques than in normal arterial tissues,with reduced expression in advanced-stage plaques compared with early-stage plaques(P<0.05).Conclusion α-COP participates in apoA-1-mediated cholesterol efflux from foam cells,and interference with α-COP expression results in reduced cholesterol efflux and increased intracellular lipid accumulation.
8.Construction and accuracy analysis of a malnutrition prediction model for patients after proximal femoral nail anti rotation internal fixation
Lin SHEN ; Xiaojia BAI ; Gang WANG ; Lijuan XUE ; Chunhua ZHANG ; Xia LI
Journal of Army Medical University 2025;47(10):1092-1101
Objective To explore the related factors of postoperative nutritional risk in elderly patients with proximal femoral nail anti rotation(PFNA)internal fixation and establish a prediction model of malnutrition.Methods A total of 574 elderly patients who underwent PFNA internal fixation in the First Medical Center of Chinese PLA General Hospital from January 2021 to June 2024 were included and divided into malnutrition group(n=389)and good nutrition group(n=185).The differences in 39 indicators in aspects of physiological,psychological,social,economic,environmental and medical fields were compared between the 2 groups.Logistic analysis was used to screen the nutritional risk factors,and then a nomogram model was constructed based on these factors.Results Advanced age,lower BMI,higher postoperative Self-Rating Anxiety Scale(SAS)score,less exercise before fracture,being farmers,higher economic pressure,lower preoperative albumin,preprotein and hemoglobin,and lower Barthel index before fracture were independent risk factors for nutritional risk in patients undergoing PFNA internal fixation(P<0.05).The nomogram prediction model based on the above factors had an AUC value of 0.995(95%CI:0.987~1.000)in predicting the risk of malnutrition in these patients.When the threshold probability>0.02,this model could be clinically beneficial in predicting the risk of postoperative malnutrition in patients after PFNA internal fixation.Conclusion Our nutritional risk prediction model based on age,BMI,economic pressure,pre-fracture exercise and preoperative albumin and other indicators is constructed for the elderly patients after PFNA internal fixation,and the model has high accuracy and clinical application value.
9.Construction of the training and assessment index system for professional nurse engaged in lung puncture
Zheng ZHANG ; Yanjun MAO ; Yijun LU ; Xiaojia TANG ; Yun XIE
Journal of Interventional Radiology 2025;34(5):531-537
Objective To construct a standardized training and evaluation index system for professional nurse engaged in lung puncture so as to enrich the training theory system and provide the basis for carrying out relevant work.Methods Using literature analysis method and expert interview way,the first draft of standardized training and evaluation index system for nurses working in lung puncture room was formulated.Two rounds of expert consultation were conducted in 17 experts.The obtained consultation opinions were summarized and revised,and the final version of index system was determined.Results The constructed standardized training and assessment index system for nurses working in lung puncture room included 4 level-Ⅰ indicators(training content,training methods,teaching staff,and assessment and evaluation),and 12 level-Ⅱindicators and 58 level-Ⅲ indicators.The positive coefficient was 100%in both rounds of consultation with experts.Of the two rounds of expert consultation,the expert judgment coefficients were 0.965 and 0.977 respectively,the familiarity coefficients were 0.859 and 0.859 respectively,and the authority coefficients were 0.912 and 0.918 respectively.After two rounds of expert consultation,the variation coefficients of indicators at all levels were 0-0.43 and 0-0.20 respectively.The Kendall's Coordination coefficients of the two rounds of expert consultation were 0.363(P<0.001)and 0.554(P<0.001)respectively.Conclusion The constructed standardized training and evaluation index system for nurses working in lung puncture room is scientific,practical,and operable,it can provide scientific standards for relevant assessment and training.
10.Interactions among risk factors of diabetic retinopathy
Xiaojia SUN ; Guoheng ZHANG ; Ziyi ZHOU ; Yali NIU ; Hua FENG ; Ling WANG ; Guorui DOU
Chinese Journal of Experimental Ophthalmology 2025;43(1):38-46
Objective:To investigate the interaction of risk factors for diabetic retinopathy (DR) occurrence.Methods:A cross-sectional study was performed.A total of 6 783 diabetic patients with complete survey data from 2005 to 2018 in the National Health and Nutrition Survey database were enrolled, among which 4 426 patients were included according to inclusion criteria and were divided into non-DR diabetes group of 3 491 cases and DR group of 935 cases.The related risk factors were collected, including age, gender, race, residential status, education, annual household income, body mass index (BMI), fasting glucose, glycosylated hemoglobin, duration of diabetes, family history of diabetes, comorbidities, smoke, alcohol use, sleep, physical activity.Patient Health Questionnaire (PHQ-9) was used to assess the psychological status.After the categorization of all variables, risk factors of DR were analyzed by logistic regression, and the interaction between factors was further analyzed.Results:Multivariate analysis showed that female[odds ratio ( OR)=1.33, 95% confidence interval ( CI): 1.02-1.72], duration of diabetes ≥10 years ( OR=1.03, 95% CI: 1.02-1.04), insulin therapy ( OR=2.38, 95% CI: 1.87-3.05), urinary albumin creatinine ratio (UACR) ≥30 mg/g ( OR=1.55, 95% CI: 1.22-1.96) and depression ( OR=1.44, 95% CI: 1.13-1.83) were risk factors for DR, and BMI≤28 kg/m 2 ( OR=0.70, 95% CI: 0.55-0.89) was a protective factor for DR.Furthermore, interaction analysis revealed additive interaction between UACR ≥30 mg/g and insulin therapy [relative excess risk due to interaction ( RERI)=2.46, 95% CI: 0.84-4.09, attributable proportion due to interaction ( AP)=0.44, 95% CI: 0.26-0.63, synergy index ( S)=2.16, 95% CI: 1.37-3.41).The UACR ≥30 mg/g and longer diabetic duration ≥10 years had both multiplicative ( OR=1.67, 95% CI: 1.00-2.76) and additive interactions ( RERI=2.02, 95% CI: 0.79-3.25, AP=0.47, 95% CI: 0.27-0.66, S=2.53, 95% CI: 1.37-4.68). Conclusions:Patients with diabetes treated with insulin, with a duration of diabetes ≥10 years and accompanied by UACR ≥30 mg/g are at higher risk of developing DR than those with a single risk factor.

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