1.Chinese medical and pharmaceutical expert consensus on the clinical application of romosozumab
Liqian MO ; Zefu CHEN ; Huiyi WU ; Ping ZHENG ; Zhongmin ZHANG ; Yilei LI
China Pharmacy 2026;37(20):2640-2646
OBJECTIVE To standardize the rational clinical use of romosozumab in China, define suitable patient populations, optimize full-course treatment strategies, and strengthen medication risk management.METHODS This consensus was initiated by the Pharmacy Administration Committee of Guangdong Province Hospital Association and registered on the International Practice Guidelines Registry Platform. Twenty-five experts in pharmacy and orthopedics were organized to identify 7 core clinical questions through 2 rounds of questionnaires and seminars. Chinese and English databases were systematically retrieved, and the Grading of Recommendations Assessment, Development and Evaluation approach was used to assess evidence quality and recommendation strength and to formulate consensus recommendations, which were refined based on expert review.RESULTS Seven recommendations were developed, covering the applicable populations of romosozumab, sequential and switching therapy, and management of fractures and cardiovascular risk during treatment. The pharmaceutical characteristics of romosozumab, as well as other key points for clinical application, including efficacy monitoring, management of missed doses, contraindications, major adverse reactions, and medication adherence, were also summarized.CONCLUSIONS This consensus provides evidence-based guidance and practical reference for the safe, effective, and standardized use of romosozumab in Chinese patients, which may facilitate individualized treatment of patients with osteoporosis at high fracture risk and reduce fracture risk.
2.Overview of Chinese Pharmacopoeia 2025 Edition Volume Ⅲ
CAO Yan ; ZHAO Xiong ; WANG Xiaojuan ; CHEN Huiyi ; LI Huiyi
Drug Standards of China 2025;26(1):028-033
“Chinese Pharmacopoeia” is the legal basis for drug development, production, operation, use and management in China, and the Chinese Pharmacopoeia 2025 Edition is going to be issued and implemented. This article introduces the revision and amendment situations, analyzes the characteristics of the new edition of the Pharmacopoeia and the future development direction of national standards for better understanding and implementation of the latest edition of pharmacopoeia.
3.Research progress of lacrimal gland organoids
Yaxin MO ; Xinyu LIU ; Huiyi GUO ; Xin CHEN ; Qiang CHEN
International Eye Science 2025;25(3):395-399
The lacrimal gland organoids are innovative in vitro cultured tissue model that mimics the lacrimal gland, retaining its original histological and molecular biological properties. This model can more accurately reproduce the physiological environment of the lacrimal gland, including its ductal system and tear film protein secretion. It offers a new platform for studying the physiopathological basis of the lacrimal gland, establishing disease models, conducting regenerative medicine applications, and performing drug screening. Currently, organoids technology is continuously evolving, with ongoing updates to the methods for in vitro culturing of the lacrimal gland. These advancements gradually address challenges related to cultivation complexity, cost, and time, demonstrating a wide range of application potential. In this paper, we summarize the latest progress in lacrimal gland organoids research both domestically and internationally, exploring the development of lacrimal gland organoids, 3D construction technologies, and their potential for clinical applications, in order to provide new insights for clinical research on lacrimal gland-related diseases and to promote broader application of lacrimal gland organoids in drug development and personalized diagnosis and treatment.
4.Research progress of lacrimal gland organoids
Yaxin MO ; Xinyu LIU ; Huiyi GUO ; Xin CHEN ; Qiang CHEN
International Eye Science 2025;25(3):395-399
The lacrimal gland organoids are innovative in vitro cultured tissue model that mimics the lacrimal gland, retaining its original histological and molecular biological properties. This model can more accurately reproduce the physiological environment of the lacrimal gland, including its ductal system and tear film protein secretion. It offers a new platform for studying the physiopathological basis of the lacrimal gland, establishing disease models, conducting regenerative medicine applications, and performing drug screening. Currently, organoids technology is continuously evolving, with ongoing updates to the methods for in vitro culturing of the lacrimal gland. These advancements gradually address challenges related to cultivation complexity, cost, and time, demonstrating a wide range of application potential. In this paper, we summarize the latest progress in lacrimal gland organoids research both domestically and internationally, exploring the development of lacrimal gland organoids, 3D construction technologies, and their potential for clinical applications, in order to provide new insights for clinical research on lacrimal gland-related diseases and to promote broader application of lacrimal gland organoids in drug development and personalized diagnosis and treatment.
5.Overview of Chinese Pharmacopoeia 2025 Edition Volume Ⅲ
Yan CAO ; Xiong ZHAO ; Xiaojuan WANG ; Huiyi CHEN ; Huiyi LI
Drug Standards of China 2025;26(1):28-33
"Chinese Pharmacopoeia"is the legal basis for drug development,production,operation,use and man-agement in China,and the Chinese Pharmacopoeia 2025 Edition is going to be issued and implemented.This article introduces the revision and amendment situations,analyzes the characteristics of the new edition of the Pharmaco-poeia and the future development direction of national standards for better understanding and implementation of the latest edition of pharmacopoeia.
6.Biparametric MRI-based peritumoral radiomics for preoperative prediction of extracapsular extension in prostate cancer
Honghao XU ; Qicong DU ; Yuanhao MA ; Xueyi NING ; Baichuan LIU ; Xu BAI ; Di CHEN ; Yun ZHANG ; Zhe DONG ; Chuang JIA ; Xiaojing ZHANG ; Xiaohui DING ; Baojun WANG ; Aitao GUO ; Jian XUE ; Xuetao MU ; Huiyi YE ; Haiyi WANG
Chinese Journal of Radiology 2025;59(9):1055-1062
Objective:To investigate the value of biparametric-MRI (bpMRI) based peritumoral radiomics for preoperative prediction of extraprostatic extension (EPE) in prostate cancer (PCa).Methods:In this cross-sectional study, consecutive bpMRI of patients undergoing prostatectomy for PCa were retrospectively collected from the First Medical Center (center 1) and the Third Medical Center (center 2) of Chinese PLA General Hospital. A total of 274 patients were finally enrolled. Patients at center 1 from January 2020 to December 2022 were randomly divided into a training set (149 cases) and an internal validation set (63 cases) by stratified random sampling. Patients at center 2 from January 2023 to March 2024 were assigned to the external test set (62 cases). Patients were categorized into EPE-positive group and EPE-negative group according to pathological assessment postoperatively. In the training set, there were 49 cases in EPE-positive group and 100 cases in EPE-negative group. In the internal validation set, there were 26 cases in EPE-positive group and 37 cases in EPE-negative group. In the external test set, there were 22 cases in EPE-positive group and 40 cases in EPE-negative group. Axial T 2WI and apparent diffusion coefficient (ADC) images were manually annotated to obtain index lesion regions of interest (ROIs), with the peritumoral ROIs subsequently delineated by semi-automatic segmentation technique. Radiomics features were extracted from intra-tumoral, peri-tumoral, and intra-tumoral plus peri-tumoral ROIs. The training set data was employed to select and optimize features to build the radiomics models. The logistic regression analysis was used to develop radiomics, clinical, and integrated models. The predictive performance was assessed by the area under the receiver operating characteristic curve (AUC) in the external test set, and compared by the DeLong test. The sensitivity and specificity were compared by the exact McNemar test. Results:In the external test set, the peri-tumoral radiomics model based on bpMRI showed the highest performance in evaluating EPE, with an AUC of 0.739 (95% CI 0.611-0.842), which was identified as the optimal radiomics model. EPE grade ( OR=6.151, 95% CI 3.371-11.226, P<0.001) was incorporated into the clinical model, with an AUC of 0.780 (95% CI 0.657-0.875) in the external test set. The integrated model had an AUC of 0.817 (95% CI 0.698-0.904) in the external test set. There was no statistically significant difference in comparisons of AUCs among the three models (all P>0.05). The sensitivity of the integrated model (68.2%) showed no significant difference from those of the clinical model and the optimal radiomics model (77.3% and 86.4%, respectively; P=0.500 and P=0.289). However, the specificity of the integrated model (85.0%) was significantly higher than those of the clinical model (67.5%, P=0.016) and the optimal radiomics model (50.0%, P<0.001). Conclusion:A bpMRI-based peritumoral radiomics integrating clinical model demonstrates high performance for preoperative prediction of EPE in PCa.
7.Research progress of glycoprotein non-metastatic melanoma protein B in lung diseases
Yufeng CHEN ; Huiyi SHEN ; Qing QIN ; Qianyu WANG
Chinese Journal of Clinical Medicine 2025;32(4):692-702
Glycoprotein non-metastatic melanoma protein B (GPNMB) is a transmembrane glycoprotein that plays an important role in various physiological and pathological processes. In recent years, its role in lung diseases has gradually attracted attention. Studies have found that GPNMB is abnormally expressed in lung diseases and is involved in regulating pathological processes such as inflammatory responses, fibrosis, and tumorigenesis. This article systematically reviews the research progress of GPNMB in common lung diseases such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and lung cancer, and explores its potential as a therapeutic target, providing new insights for the diagnosis and treatment of lung diseases in the future.
8.Investigation of reference values for high-sensitivity cardiac troponin T in middle-aged and elderly populations by GAMLSS: A cross-sectional study
Qian ZHANG ; Weiyan ZHOU ; Huiyi CHEN ; Meng WANG ; Wensong LIU ; Lijuan WANG ; Jiaqi ZHANG ; Chuanbao LI
Chinese Journal of Geriatrics 2025;44(2):156-161
Objective:to investigate age-related changes in high-sensitivity cardiac troponin T(hs-cTnT)levels among middle-aged and elderly individuals, and to establish reference values for the 99th percentile upper reference limit(99th URL)of hs-cTnT within this demographic.Methods:This research is designed as a cross-sectional study.Hs-cTnT test results were collected from outpatients at Beijing Hospital between January 2018 and December 2023.The final sample included 5, 677 outpatients aged 45 to 85 years(65±10), all of whom were free from cardiovascular diseases and other chronic heart-related conditions.Multiple linear regression was utilized to assess the impact of gender and age group on hs-cTnT concentrations within the middle-aged and elderly populations.Furthermore, a generalized additive model for location, scale, and shape(GAMLSS)was employed to generate percentile curves of hs-cTnT by gender in this cohort, with the aim of determining the 99th URLs for both middle-aged and elderly individuals.Results:Multiple linear regression analyses indicated that both gender and age significantly influenced hs-cTnT levels in middle-aged and elderly populations( β60-69 years=1.399, β≥70 years=5.306, βgender=-2.650, all Pvalues<0.001).The hs-cTnT data for both males and females conformed to Box-Cox-Cole-Green(BCCG)distributions, with percentile curves fitted at the 25th, 50th, 75th, and 99th percentiles according to gender.The percentile values of hs-cTnT in both males and females demonstrated a progressive increase with advancing age.Notably, males exhibited higher 99th percentile values than females across all age groups. Conclusions:The GAMLSS approach is employed to establish continuous reference intervals for hs-cTnT in the middle-aged and elderly population.This effort aims to provide a theoretical foundation for reference values specific to this demographic in China and to offer guidance for clinical diagnosis and treatment.
9.Long-chain acylcarnitine deficiency promotes hepatocarcinogenesis.
Kaifeng WANG ; Zhixian LAN ; Heqi ZHOU ; Rong FAN ; Huiyi CHEN ; Hongyan LIANG ; Qiuhong YOU ; Xieer LIANG ; Ge ZENG ; Rui DENG ; Yu LAN ; Sheng SHEN ; Peng CHEN ; Jinlin HOU ; Pengcheng BU ; Jian SUN
Acta Pharmaceutica Sinica B 2025;15(3):1383-1396
Despite therapy with potent antiviral agents, chronic hepatitis B (CHB) patients remain at high risk of hepatocellular carcinoma (HCC). While metabolites have been rediscovered as active drivers of biological processes including carcinogenesis, the specific metabolites modulating HCC risk in CHB patients are largely unknown. Here, we demonstrate that baseline plasma from CHB patients who later developed HCC during follow-up exhibits growth-promoting properties in a case-control design nested within a large-scale, prospective cohort. Metabolomics analysis reveals a reduction in long-chain acylcarnitines (LCACs) in the baseline plasma of patients with HCC development. LCACs preferentially inhibit the proliferation of HCC cells in vitro at a physiological concentration and prevent the occurrence of HCC in vivo without hepatorenal toxicity. Uptake and metabolism of circulating LCACs increase the intracellular level of acetyl coenzyme A, which upregulates histone H3 Lys14 acetylation at the promoter region of KLF6 gene and thereby activates KLF6/p21 pathway. Indeed, blocking LCAC metabolism attenuates the difference in KLF6/p21 expression induced by baseline plasma of HCC/non-HCC patients. The deficiency of circulating LCACs represents a driver of HCC in CHB patients with viral control. These insights provide a promising direction for developing therapeutic strategies to reduce HCC risk further in the antiviral era.
10.Qianggu Kangshu Formula attenuates osteoclast differentiation in rheumatoid arthritis by inhibiting the HIF-1α/BNIP3 autophagy signaling pathway.
Weiyi LI ; Lu JIANG ; Zongxing ZHANG ; Dan CHEN ; Zhuoma BAO ; Li HUANG ; Lin YUAN
Journal of Southern Medical University 2025;45(7):1389-1396
OBJECTIVES:
To investigate the effect of Qianggu Kangshu Formula (QGKSF) for alleviating osteoclast differentiation in rheumatoid arthritis and the underlying mechanism.
METHODS:
RAW264.7 cells cultured under hypoxic conditions were treated with RANKL to induce osteoclast differentiation and incubated with normal rat serum or sera from rats medicated with methotrexate (MTX) or QGKSF at low and high doses. Cell viability, TRAP-positive multinucleated cells and F-actin ring formation in the treated cells were assessed with CCK-8 assay, TRAP staining and Phalloidin staining, respectively. Autophagy and autophagosomes in the cells were observed with MDC staining and transmission electron microscopy. ELISA was used to measure IL-6 and TNF-α levels in the culture supernatant, and the expressions of HIF-1α, BNIP3, Bcl-2, Beclin1, LC3-I, LC3-II, P62 and TRAP mRNAs and proteins were analyzed using RT-qPCR and Western blotting.
RESULTS:
In hypoxia- and RANKL-induced RAW264.7 cells treated with normal rat serum, significant increments of TRAP-positive cells and F-actin ring formation were observed with an enhanced autophagic fluorescence intensity and increased autophagosomes. Treatment of the induced cells with rat sera medicated with MTX and low- and high-dose QGKSF obviously reduced the TRAP-positive cells, F-actin rings and autophagosomes as well as the autophagic fluorescence intensity. RANKL treatment significantly increased IL-6 and TNF-α levels in RAW264.7 cells, which were obviously decreased by treatment with MTX- and QGKSF-medicated sera. RANKL also significantly increased the mRNA and protein expression levels of HIF-1α, BNIP3, Bcl-2, Beclin1, LC3 and TRAP and lowered P62 expressions, and these changes were effectively reversed by treatment with MTX- and QGKSF-medicated sera.
CONCLUSIONS
QGKSF attenuates RANKL-induced osteoclast differentiation in hypoxic RAW264.7 cells by inhibiting the HIF-1α/BNIP3 autophagy signaling pathway, suggesting its potential for treatment of bone destruction in rheumatoid arthritis.
Animals
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Drugs, Chinese Herbal/pharmacology*
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Osteoclasts/drug effects*
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Autophagy/drug effects*
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Mice
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Signal Transduction/drug effects*
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Rats
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Cell Differentiation/drug effects*
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Arthritis, Rheumatoid/pathology*
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Hypoxia-Inducible Factor 1, alpha Subunit/metabolism*
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RAW 264.7 Cells
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Membrane Proteins/metabolism*
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Mitochondrial Proteins

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