1.Development and exploration of a closed-loop management model for externally dispensed intravenous prescriptions
Xuhua XIE ; Yun WU ; Songqing HUANG ; Yukun HUANG ; Siyan CHEN ; Zheng ZENG ; Weiyan TANG ; Zuolong HE ; Chunxia ZHOU ; Hongliang ZHANG
China Pharmacy 2026;37(10):1246-1250
OBJECTIVE To construct a closed-loop management model for externally dispensed intravenous prescriptions, and to provide reference for standardized management of externally dispensed intravenous prescriptions. METHODS Based on the Expert Consensus on Closed-loop Management of Externally Dispensed Intravenous Prescriptions in Guangxi Zhuang Autonomous Region previously formulated by our hospital, risk points during the entire process were systematically identified through multidisciplinary team brainstorming and a fishbone diagram. A series of strategies were subsequently formulated and implemented, including qualifying designated external dispensing pharmacies and the drug catalogs, operating and maintaining the hospital information system and the Pharmacy Intravenous Admixture Service (PIVAS) intelligent management platform, and strengthening differentiated training for staff in the whole workflow. A whole-process closed-loop management system was constructed with PIVAS as the co re hub and the daytime chemotherapy center as the safety terminal. RESULTS A total of 3 cooperating pharmacies and an initial drug list comprising 35 product specifications were selected. A closed‑loop management process encompassing hospital outpatient prescribing, patient drug purchase in designated pharmacies, PIVAS drug dispensing, and medication use in daytime chemotherapy center was successfully established. This system enabled the mandatory grouping and association of externally dispensed intravenous prescriptions with in-hospital diluents, full-process verification based on drug traceability codes, intelligent monitoring of infusion parameters, and whole-process data traceability. CONCLUSIONS The constructed model effectively resolves the coordination and safety oversight during the use of externally dispensed intravenous drugs from out-of-hospital circulation to in-hospital use, and has preliminarily enabled procedural standardization, whole-process information traceability, and proactive control of medication risks.
2.Analysis of Labeling Situation of Drug Instructions for Drug Dose Adjustment in Hemodialysis Patients with End-Stage Renal Disease
Siyan LI ; Jianghua SHEN ; Yan ZENG ; Yujie QIU ; Chen SHAO ; Suying YAN
Herald of Medicine 2025;44(3):491-496
Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and im-provement of drug instructions.Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodi-alysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with mo-lecular weight≥5 000,or binding rate of plasma protein ≥ 60%,or drug distribution volume>360L were classified as"non-dialysis group",and other drugs were classified as"dialysis group",compared the labeling rate of corresponding information of drugs in"dialysis group"and"non-dialysis group";and compared the labeling rate and content with relevant information in Lexicomp and Micromedex.Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and ex-plicit drug adjustment plan were 16.67%,25.16%,and 24.52%.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the"dialyzable group"and the"non-dialyzable group"(P<0.01).The differ-ence in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P<0.01).Conclusion Attention should be paid to the lack of informa-tion and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.
3.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(9):research report standards and results visualization
Jingru CHENG ; Ruina CHEN ; Jiarui LI ; Shaowen TANG ; Feng SUN ; Siyan ZHAN
Chinese Journal of Pharmacoepidemiology 2025;34(9):1004-1016
Standardized research reporting is crucial for the translation of pharmacoepidemiology research findings,and visual reporting can significantly enhance the clarity,understandability,and transparency of research results.Based on the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition),this article systematically explains the key points for writing each component of a research report(including title,abstract,introduction,research methods,research results,discussion and conclusions,acknowledgments,conflict of interest statement,and references).This article also summarizes recognized international and domestic standards for pharmacoepidemiology research reporting,providing a reference for researchers.Furthermore,real-world cases will be used to demonstrate common forms of visualized reports and their interpretation methods.Finally,it further explores strategies for communicating research results.This study aims to provide pharmacoepidemiology researchers with detailed guidance on visually presenting research results and writing high-quality research reports,thereby enhancing the integrity and impact of their research.
4.Study of application of Common Data Model of Observational Medical Outcomes Partnership in China
Meng ZHANG ; Peng SHEN ; Zhike LIU ; Van Zandt MUI ; Jing LI ; Chao LI ; Yexiang SUN ; Junqing XIE ; Hripcsak GEORGE ; Yong CHEN ; Hongbo LIN ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2025;46(5):907-913
Objective:To comprehensively evaluate the application of Common Data Model (CDM) of Observational Medical Outcomes Partnership (OMOP) in China, and provide reference for the implementation of data standardization and evidence sharing in China.Methods:PubMed, Embase, Web of Science, CNKI, VIP, WanFang and SinoMed databases were used for literature retrieval to collect the research papers of OMOP CDM application for data standardization in China until March 15, 2023. The information about institutions, types and numbers of patients were extracted.Results:A total of 14 research papers, including 9 in English and 5 in Chinese, were selected. The research papers published since 2018 were collected, which focused on patients with hypertension, diabetes, and depression. A total of 12 institutions or platforms transformed data into OMOP CDM. Jiangsu Provincial People's Hospital was the first one to apply the CDM and demonstrated its feasibility in China. Additionally, the regional information system in Yinzhou District of Ningbo, Zhejiang Province, standardized the multi-dimensional data of patients with diabetes and hypertension. Based on this platform, a series of prediction models for complications in patients with diabetes were constructed. Another major database in Beijing Anding Hospital applied OMOP CDM to analyze the characteristics of patients with late-life depression and dementia.Conclusions:This study analyzed the application of OMOP CDM in China. Through in-depth analysis of specific cases, the study provided guidance for the future cross-regional evidence sharing and collaboration.
5.Progress in method development and application of distributed learning for estimation of epidemiological effect
Junting YANG ; Xin GAO ; Xiaoxuan WANG ; Mengdi ZHANG ; Xin CHEN ; Yulin WANG ; Zhike LIU ; Siyan ZHAN
Chinese Journal of Epidemiology 2025;46(5):895-906
Objective:To systematically review the progress in the method development and application of distributed learning in the estimation of epidemiological effect and provide methodological reference for multi-center studies.Methods:We conducted a literature retrieval for English papers published up to December 31, 2023 by using keywords of "health/medical big data" and "distributed/federated learning". After consulting experts, we set criteria of paper inclusion and exclusion and created a framework for data extraction. We collected information about basic study details, including method, application, and evaluation. Two researchers independently screened the papers and extracted information. We used EndNote 20 for the management of literatures and EpiData for the management of data.Results:A total of 3 444 papers were collected, and 29 papers were included in the final analysis. Most of the papers (25, 86.2%) were published in or after 2019, and the papers were mainly from the United States (21/29, 72.4%). For the estimation of epidemiological effects, 22 distributed learning methods had been developed, including methods for logistic regression (8), Cox regression (8), Poisson regression (2), and generalized linear mixed model (GLMM) (4), as well as three platforms for distributed analysis (VLP, Vantage6, AusCAT). The 29 papers described 45 applications, with 20 (44.4%) focusing on the establishment of prediction model and 25 (55.6%) on association analysis. Importantly, except for GLMM, current distributed learning methods can estimate effects with little bias in 1-3 rounds of communication. These methods show less bias compared with meta-analysis, especially in the address of data heterogeneity and rare outcomes. However, less studies examined how differences in data structure and sparse data affect results, an area that requires further research.Conclusion:While distributed learning shows promise in epidemiological effect estimation, it is still in early development, requiring further research on data heterogeneity handling and communication efficiency improvement.
6.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(9):research report standards and results visualization
Jingru CHENG ; Ruina CHEN ; Jiarui LI ; Shaowen TANG ; Feng SUN ; Siyan ZHAN
Chinese Journal of Pharmacoepidemiology 2025;34(9):1004-1016
Standardized research reporting is crucial for the translation of pharmacoepidemiology research findings,and visual reporting can significantly enhance the clarity,understandability,and transparency of research results.Based on the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition),this article systematically explains the key points for writing each component of a research report(including title,abstract,introduction,research methods,research results,discussion and conclusions,acknowledgments,conflict of interest statement,and references).This article also summarizes recognized international and domestic standards for pharmacoepidemiology research reporting,providing a reference for researchers.Furthermore,real-world cases will be used to demonstrate common forms of visualized reports and their interpretation methods.Finally,it further explores strategies for communicating research results.This study aims to provide pharmacoepidemiology researchers with detailed guidance on visually presenting research results and writing high-quality research reports,thereby enhancing the integrity and impact of their research.
7.Prevalence characteristics of autoimmune thyroid disease in women aged 10-59 years in Qingdao City from 2022 to 2024
Xin CHEN ; Junting YANG ; Jinxin GUO ; Shuya LI ; Zhike LIU ; Yingliang ZHU ; Fengjuan LI ; Siyan ZHAN ; Juanjuan GUO
Journal of Peking University(Health Sciences) 2025;57(3):507-513
Objective:To analyze the characteristics of Hashimoto thyroiditis(HT)and Graves disease(GD),two autoimmune thyroid diseases aged 10-59 in Qingdao City from 2022 to 2024,and to provide scientific basis for making targeted prevention and treatment measures.Methods:A cross-sectional study design was adopted,based on the data of the Regional Health Information Platform in Qingdao,the con-firmed cases of HT and GD from 2022 to 2024 were included,and combined with the data of the seventh population census,the three-year and annual prevalence rates of HT and GD were calculated,and the time trend of annual prevalence was analyzed by Cochran-Armitage trend test.The distribution characte-ristics of HT and GD prevalence in different age groups and regions were analyzed,and Chi-square test was used to compare the differences between the groups.Results:The total number of HT patients among women aged 10-59 in Qingdao City from 2022 to 2024 was 40 362.The proportion of HT patients in 30-34 years old was the highest(19.83%).The proportion of HT patients in Huangdao District was the highest(17.72%).The three-year prevalence of HT was 1 206.53/100 000.In 2022-2024,the annual prevalence of HT increased significantly(P<0.001),from 385.32/100 000 in 2022 to 1 206.32/100 000 in 2024.The three-year prevalence of HT was significantly different in age distribution(P<0.001).The three-year prevalence of HT in 25-29 years(2 354.44/100 000)and 35-39 years(2 022.20/100 000)was higher than that in other age groups,showing a bimodal distribution.There were significant differences in the three-year prevalence of HT in different regions(P<0.001),among which the three-year prevalence of HT in Shinan District was the highest(2 392.90/100 000),followed by Licang Dis-trict(1 492.41/100 000),and Laixi City was the lowest(659.940/100 000).The total number of GD patients was 2 095,among which the proportion of GD patients in the 35-39 age group was the highest(15.42%),and the proportion of GD patients from Jimo District was the highest(12.27%).From 2022 to 2024,the three-year prevalence rate of GD was 62.63/100 000,and the annual prevalence rate of GD showed an increasing trend(P<0.001),from 20.33/100 000 in 2022 to 62.63/100 000 in 2024.There were significant differences in the prevalence of GD by age(P<0.001).The three-year prevalence of GD reached the highest value in the 25-29 age group(98.90/100 000),followed by the 35-39 age group(85.21/100 000),and the lowest in the 10-14 age group(14.43/100 000).In the regional distribution,there were significant differences in the 3-year prevalence of GD(P<0.001).Laoshan District had the highest three-year prevalence of GD(107.58/100 000),followed by Shinan District(97.83/100 000)and Huangdao District(28.92/100 000).Conclusion:The three-year pre-valence of HT and GD in females aged 10-59 years in Qingdao City from 2022 to 2024 is low,but the annual prevalence is on the rise,and the three-year prevalence of HT and GD in females aged 25-39 years is higher than that in other age groups,so it is necessary to strengthen the screening and monitoring of this population.
8.Detection of lung cancer driver genes by next-generation sequencing: a comparative analysis of plasma and histological/cytological samples
Siyan LIN ; Kunhe ZHANG ; Yongcong ZHANG ; Chunyang SU ; Yifeng CHEN
Chinese Journal of Pathology 2025;54(7):755-761
Objective:To compare the results of plasma samples and histological/cytological samples for detection of lung cancer driver gene by next-generation sequencing (NGS), to provide reference for sampling selection of clinical patients.Methods:A retrospective analysis was performed on 220 patients with lung cancer who were admitted to Quanzhou First Hospital in Fujian Province from May 2017 to May 2024, and NGS detection of lung cancer driver gene was performed on both plasma samples and histological/cytological samples. Histological specimens included biopsy or surgical resection of lung cancer, cervical lymph nodes and pleural metastases; the cytological specimen was pleural fluid cell wax block. Specimens were divided into plasma group (experimental group) and matched histological and cytological group (control group). Eight gene variants recommended by the guidelines were EGFR mutation, ALK rearrangement, ROS1 rearrangement, BRAF V600 mutation, RET rearrangement, MET exon 14 jump mutation, KRAS mutation, and NTRK1/2/3 rearrangement. The detection results of the two groups of specimens were compared and analyzed.Results:Among the 220 cases, 183 were adenocarcinoma, 23 were squamous cell carcinoma and 14 were non-small cell lung cancer. There were 4 cases in stage Ⅰ, 3 cases in stage Ⅱ, 24 cases in stage Ⅲ, and 189 cases in stage Ⅳ. In the plasma group, 120 cases were positive, the detection rate was 54.5%; There were 152 positive cases in the control group, the detection rate was 69.1%; the detection rate in the plasma group was lower than that in the control group ( χ2=6.12, P<0.05). The detection rate of plasma in patients with stage Ⅰ/Ⅱ/Ⅲ was 12.9% (4/31), which was significantly lower than that in stage Ⅳ (61.4%; χ2=22.10, P<0.05). In the early clinical stage (stage Ⅰ/Ⅱ) of 7 cases, 3 cases were positive in the control group, while all were negative in the plasma group. There were 24 stage Ⅲ cases, 8 were positive in the control group and 4 were positive in the plasma group. Among the positive cases in the control group, 34 were negative and 4 were not detected in the matched plasma group. In the plasma positive cases, there were 2 negative cases and 4 partial mutations were not detected in the matched control group. Among these 6 cases, 5 were treated patients, and the mean mutation abundance of corresponding plasma positive genes was 1.5%. There were 110 cases with the same positive result (the same mutation site) and 66 cases with the same negative result, with agreement rate of 80.0% (176/220). The sensitivity and specificity of the plasma group were 75.0% (114/152) and 91.7% (110/120), respectively. Conclusions:When NGS is used for lung cancer driver gene detection, the positive rate of plasma samples is lower than that of tissue/cytology samples, but the consistency rate with the latter can reach 80%, and the sensitivity is higher than 70%, which has a good clinical detection efficiency, especially for patients with non-small cell lung cancer stage Ⅳ.
9.Uterine myoma combined with breast cancer metastasis: a case report
Siyan ZHU ; Qing CHEN ; Buze CHEN
Chinese Journal of Clinical Medicine 2025;32(5):880-884
A 61-year-old patient was admitted in November 2024 with the chief complaint of “marked enlargement of uterine myoma for 2 months after menopause”. This patient was diagnosed with uterine myoma 8 years ago and underwent modified radical mastectomy for right breast cancer in April 2023. Postoperative pathology revealed invasive carcinoma (SBR grade Ⅲ). Upon admission, examination results showed a cystic-solid mass in the posterior wall of the uterus and an elevated CA153 level of 273 U/mL. Transabdominal total hysterectomy and bilateral adnexectomy were performed. HE staining postoperatively indicated uterine myoma with involvement of invasive lobular carcinoma. Immunohistochemistry showed positivity for pan-cytokeratin (CKpan, +), GATA3 (+), desmin (muscle+), and estrogen receptor (ER, 90%+ + +), confirming the diagnosis of breast cancer metastasis to the uterine myometrium. CDK4/6 inhibitor, anastrozole, and zoledronic acid were used after surgery. Metastasis of invasive lobular carcinoma to the uterine myometrium is rare. Rapid enlargement of uterine myoma in breast cancer patients should alert clinicians to consider the possibility of metastasis, which must be confirmed by pathological examination.
10.Nanoengineered cargo with targeted in vivo Foxo3 gene editing modulated mitophagy of chondrocytes to alleviate osteoarthritis.
Manyu CHEN ; Yuan LIU ; Quanying LIU ; Siyan DENG ; Yuhan LIU ; Jiehao CHEN ; Yaojia ZHOU ; Xiaolin CUI ; Jie LIANG ; Xingdong ZHANG ; Yujiang FAN ; Qiguang WANG ; Bin SHEN
Acta Pharmaceutica Sinica B 2025;15(1):571-591
Mitochondrial dysfunction in chondrocytes is a key pathogenic factor in osteoarthritis (OA), but directly modulating mitochondria in vivo remains a significant challenge. This study is the first to verify a correlation between mitochondrial dysfunction and the downregulation of the FOXO3 gene in the cartilage of OA patients, highlighting the potential for regulating mitophagy via FOXO3 gene modulation to alleviate OA. Consequently, we developed a chondrocyte-targeting CRISPR/Cas9-based FOXO3 gene-editing tool (FoxO3) and integrated it within a nanoengineered 'truck' (NETT, FoxO3-NETT). This was further encapsulated in injectable hydrogel microspheres (FoxO3-NETT@SMs) to harness the antioxidant properties of sodium alginate and the enhanced lubrication of hybrid exosomes. Collectively, these FoxO3-NETT@SMs successfully activate mitophagy and rebalance mitochondrial function in OA chondrocytes through the Foxo3 gene-modulated PINK1/Parkin pathway. As a result, FoxO3-NETT@SMs stimulate chondrocytes proliferation, migration, and ECM production in vitro, and effectively alleviate OA progression in vivo, demonstrating significant potential for clinical applications.

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