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.Party building leads the"four-in-one"model to empower the brand construction of medical volunteer services
Yingyuan PAN ; Xiaojia YANG ; Yuan WANG
Modern Hospital 2025;25(6):851-855
This article focuses on the leadership of Party building and the collaborative innovation of volunteer service,based on the advantages of Party building leading medical volunteer service,discusses the dilemma faced by the brand construc-tion of medical volunteer service,and constructs the four-in-one construction path model of"value leadership-organizational em-powerment-brand building-guarantee system"through the case study of the excellent youth volunteer service project in the national health system,and takes the First Affiliated Hospital of Guangdong Pharmaceutical University as an example to illustrate the im-plementation effect of the four-in-one model.The in-depth integration of Party building leadership and volunteer service highlights the governance efficiency of the integration and transformation of the advantages of Party building and the kinetic energy of medical volunteer service,and helps the sustainable and high-quality development of volunteer service.
3.Isolation,identification and whole genome sequencing analysis of a bovine-derived type A Pasteurella multocida strain
Yaping WANG ; Shixing WANG ; Xiwen FAN ; Xiaojia KONG ; Zhen WANG
Chinese Journal of Veterinary Science 2025;45(4):668-677
This study aims to isolate and identify the Pasteurella multocida(Pm)that caused re-spiratory infections in cattle at a farm in Beijing,and to clarify the biological characteristics of the pathogen,including its serotype,drug resistance,pathogenicity,and genomic features.For this pur-pose,nasopharyngeal swabs and tissue samples were collected from an infected cow for bacterial i-solation and purification,16S rRNA gene amplification,capsular serotyping,virulence gene detec-tion,and whole-genome sequencing of the isolated strain.The results showed that after bacterial i-solation and purification,biochemical tests,and PCR identification,a type A P.multocida strain named"Pm WZ01"was identified.The virulence gene amplification revealed that the Pm WZ01 ge-nome contained the tadD,nanH,ompA,exbB,exbD,and fur genes.Whole-genome sequencing determined that the Pm WZ01 strain had a genome size of 2 383 021 bp with a GC content of 40.28%,containing 56 tRNAs,19 rRNAs,155 pseudogenes,three genomic islands,five prophages,and 55 carbohydrate-active enzyme genes.CARD annotation analysis found one PBP3 resistance gene and two EF-Tu resistance genes.VFDB and PHI-base annotation analysis identified 582 viru-lence factor-related genes and 888 phenotypic mutation genes,etc.Phylogenetic tree analysis revealed that the Pm WZ01 strain is most closely related to the Pm-3 strain(CP014618.1)from Changchun,China,the P1933 strain(CP132898.1)from the UK,and the HB01 strain(CP006976.1)from Hubei,China,belonging to the same clade.This study completed the isolation and identifica-tion of a type A P.multocida strain as well as the analysis of its biological characteristics and whole-genome sequencing,providing a theoretical basis for the prevention and control research of bovine type A P.multocida disease.
4.Artificial intelligence iterative reconstruction for preoperative low-dose CT of ovarian tumor
Xiaojia CAI ; Jintao HAN ; Jing LIU ; Fan YANG ; Qi WANG ; Ruxun LI
Chinese Journal of Medical Imaging Technology 2025;41(4):539-542
Objective To investigate the value of artificial intelligence iterative reconstruction(AIIR)in preoperative low-dose CT of ovarian tumor.Methods Seventy patients with ovarian tumor were prospectively enrolled.Routine-dose(120 kVp,200 mAs)and low-dose(120 kVp,40 mAs)contrast-enhanced abdominopelvic CT scanning at portal venous phase were sequentially performed.The routine-dose images were reconstructed with hybrid iterative reconstruction(HIR)(group A),while low-dose images were reconstructed with HIR(group B)and AIIR(group C),respectively.Subjective and objective evaluation of image quality were compared among groups,and the diagnostic accuracy of peripheral organ invasion and peritoneal metastasis based on group A,B and C,as well as radiation dose of routine-and low-dose scanning were recorded.Results In group B,A and C,the subjective scoring of definition of tumor margin and septation,boundary between tumor and surrounding organ,as well as the signal-to-noise ratio and contrast-to-noise ratio of ovarian tumor and psoas muscles,increased successively(all P<0.017).No significant difference of subjective scoring of tumor feeding vessel clarity was found between group A and C(P=0.435),which were both higher than that in group B(P<0.017).The accuracy for diagnosing peripheral organ invasion based on group A,B and C was 83.87% (52/62),72.58% (45/62)and 83.87% (52/62),for diagnosing peritoneal metastasis was 85.71% (60/70),78.57% (55/70)and 84.29% (59/70),respectively.Compared to routine-dose CT,the effective dose of low-dose CT was reduced by 79.70% (2.60 mSv vs.12.81 mSv,P<0.001).Conclusion AIIR could improve image quality and metastasis diagnostic efficacy in low-dose CT of ovarian tumors.
5.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.
6.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.
7.Research of the effect of para-tumoral micro-metastasis on the outcome after radical resection for intrahepatic cholangiocarcinoma
Chaoqun WANG ; Haoting SUN ; Xiaojia LIU ; Bolun ZHU ; Jintong LUO ; Lu LU ; Baobing YIN
Chinese Journal of Surgery 2025;63(6):523-528
Objective:To investigate the impact of para-tumoral micro-metastasis(PTMM) and other clinicopathological characteristics on the prognosis of patients with intrahepatic cholangiocarcinoma (ICC).Methods:This is a retrospective cohort study. Clinical data from 137 ICC patients who underwent radical resection at the Hepatobiliary Surgery Center, Department of General Surgery, Huashan Hospital, Fudan University, between January 2017 and December 2022 were analyzed retrospectively. The cohort included 91 males and 46 females, with age ( M(IQR)) of 63 (13) years (range: 32 to 82 years). Kaplan-Meier curves were used to estimate median survival times, while Log-rank tests assessed differences in overall survival (OS) and recurrence-free survival (RFS). Univariate and multivariate Cox regression models were employed to identify factors associated with OS and RFS. Results:The median OS for all 137 ICC patients was 34 months, with 1-, 2-, and 3-year OS rates of 90.7%, 69.4%, and 39.5%, respectively. The results of univariate and multivariate Cox analysis showed that Child-Pugh grade, CA19-9, carcinoembryonic antigen, and PTMM were independent prognostic factors for OS in ICC patients after radical resection (all P<0.05), Child-Pugh grade, maximum tumor diameter, whether lymph node metastasis, and PTMM were independent prognostic factors for RFS in radical resection in ICC patients (all P<0.05). PTMM-positive patients had a median OS of 21 months and median RFS of 12 months, whereas PTMM-negative patients exhibited a median OS exceeding 60 months and median RFS of 36 months. Log-rank tests demonstrated statistically significant differences in OS and RFS between PTMM-positive and PTMM-negative patients ( P<0.01 and P=0.001, respectively). Conclusion:Preliminary findings suggest that PTMM holds significant prognostic value in evaluating outcomes for ICC patients undergoing curative resection.
8.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.
9.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
10.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.

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