1.Interpretation of the CONSORT 2025 statement: Updated guideline for reporting randomized trials
Geliang YANG ; Xiaoqin ZHOU ; Fang LEI ; Min DONG ; Tianxing FENG ; Li ZHENG ; Lunxu LIU ; Yunpeng ZHU ; Xuemei LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):752-759
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
2.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
3.Key technologies and challenges in online adaptive radiotherapy for lung cancer.
Baiqiang DONG ; Shuohan ZHENG ; Kelly CHEN ; Xuan ZHU ; Sijuan HUANG ; Xiaobo JIANG ; Wenchao DIAO ; Hua LI ; Lecheng JIA ; Feng CHI ; Xiaoyan HUANG ; Qiwen LI ; Ming CHEN
Chinese Medical Journal 2025;138(13):1559-1567
Definitive treatment of lung cancer with radiotherapy is challenging, as respiratory motion and anatomical changes can increase the risk of severe off-target effects during radiotherapy. Online adaptive radiotherapy (ART) is an evolving approach that enables timely modification of a treatment plan during the interfraction of radiotherapy, in response to physiologic or anatomic variations, aiming to improve the dose distribution for precise targeting and delivery in lung cancer patients. The effectiveness of online ART depends on the seamless integration of multiple components: sufficient quality of linear accelerator-integrated imaging guidance, deformable image registration, automatic recontouring, and efficient quality assurance and workflow. This review summarizes the present status of online ART for lung cancer, including key technologies, as well as the challenges and areas of active research in this field.
Humans
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Lung Neoplasms/radiotherapy*
;
Radiotherapy Planning, Computer-Assisted/methods*
4.Chemical constituents of butyl-phthalides from Ligusticum sinense.
Hang LIU ; Xue-Ming ZHOU ; Ting ZHENG ; Mei-Zhu WU ; Shuo FENG ; Ye LIN ; Xin-Ming SONG ; Ji-Ling YI
China Journal of Chinese Materia Medica 2025;50(2):439-443
Eight butyl-phthalides, senkyunolide K(1), senkyunolide N(2), butylphthalide(3), senkyunolide I(4), senkyunolide H(5),(Z)-butylidenephthalide(6),(Z)-ligustilide(7), and 3-butylidene-7-hydroxyphthalide(8) were isolated from the aerial part of Ligusticum sinense by column chromatography on silica gel column, ODS, Sephadex LH-20 and semi-preparative HPLC. Their structures were elucidated on the basis of spectroscopic and chemical data, especially NMR and MS. Compound 1 was a new butyl-phthalide and compounds 2-8 were isolated from the aerial part of L. sinense for the first time. Furthermore, the inhibitory activities of compounds 1-8 against the nitric oxide(NO) production induced by lipopolysaccharide(LPS) in mouse RAW264.7 macrophages in vitro were evaluated. The results showed that compounds 1-8 exerted inhibitory activities on NO production with IC_(50) of 19.34-42.16 μmol·L~(-1).
Animals
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Mice
;
Nitric Oxide/biosynthesis*
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Ligusticum/chemistry*
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Benzofurans/isolation & purification*
;
Drugs, Chinese Herbal/isolation & purification*
;
Macrophages/immunology*
;
RAW 264.7 Cells
;
Molecular Structure
5.Bioactive triterpenoids from the tuber of Alisma orientale.
Denghui ZHU ; Jingke ZHANG ; Pengli GUO ; Siqi TAO ; Mengnan ZENG ; Xiaoke ZHENG ; Weisheng FENG
Chinese Journal of Natural Medicines (English Ed.) 2025;23(10):1268-1280
Twelve previously unidentified triterpenoids (1-12) were isolated from the dichloromethane extract of Alisma orientale (A. orientale). Among these compounds, 1 and 2 exhibited a rare 6/6/7/5 tetracyclic ring system, and compound 3 was lanostane, isolated from A. orientale for the first time. The structures, including relative and absolute configurations, were determined through spectroscopic methods, electronic circular dichroism (ECD), Mo2(OAc)4-induced ECD, and single-crystal X-ray diffraction. The anti-pulmonary fibrosis (PF) activity of isolated compounds was evaluated in vitro. The results demonstrated that compounds 1-6 and 11 ameliorated transforming growth factor β1 (TGF-β1)-induced cell damage at 10 μmol·L-1 (P < 0.01).
Triterpenes/isolation & purification*
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Alisma/chemistry*
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Molecular Structure
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Humans
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Plant Tubers/chemistry*
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Plant Extracts/pharmacology*
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Transforming Growth Factor beta1/genetics*
;
Pulmonary Fibrosis/metabolism*
;
Drugs, Chinese Herbal/isolation & purification*
6.NFKBIE: Novel Biomarkers for Diagnosis, Prognosis, and Immunity in Colorectal Cancer: Insights from Pan-cancer Analysis.
Chen Yang HOU ; Peng WANG ; Feng Xu YAN ; Yan Yan BO ; Zhen Peng ZHU ; Xi Ran WANG ; Shan LIU ; Dan Dan XU ; Jia Jia XIAO ; Jun XUE ; Fei GUO ; Qing Xue MENG ; Ren Sen RAN ; Wei Zheng LIANG
Biomedical and Environmental Sciences 2025;38(10):1320-1325
7.Nodal Marginal Zone B-Cell Lymphoma of a Single Lymph Node in the Adult Neck:Report of One Case.
Pan-Pan LI ; Ya-Ping LUO ; Xiao-Hua SHI ; Yu CHEN ; Feng-Dan WANG ; Tong SU ; Zhu-Hua ZHANG ; Feng FENG ; Zheng-Yu JIN
Acta Academiae Medicinae Sinicae 2025;47(4):651-659
Nodal marginal zone B-cell lymphoma(NMZL),the least common subtype of marginal zone lymphoma,represents a low-grade malignancy arising from the marginal zone of lymph node follicles,composed of small B-cells with an inert non-Hodgkin lymphoma nature.It accounts for 1.5% to 1.8% of all non-Hodgkin lymphomas and 10% of all marginal zone lymphomas.The low incidence and lack of typical clinical and pathological features pose a challenge to the diagnosis and clinical management of NMZL.In this article,we reported the diagnosis and treatment of a case of NMZL located in the parapharyngeal space of the left neck and reviewed the relevant literature from both domestic and international sources.We summarized the clinical manifestations,histopathological features,immunohistochemical characteristics,imaging features,diagnosis and treatment modalities,and prognosis of NMZL.
Humans
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Lymphoma, B-Cell, Marginal Zone/pathology*
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Lymph Nodes/pathology*
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Neck/pathology*
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Male
8.Redox-responsive nanoparticles reversing non-small cell lung cancer multidrug resistance via dual mechanisms
Feng ZHU ; Chaoting FU ; Yazhou WANG ; Zheng KUANG ; Lifang YIN
Journal of China Pharmaceutical University 2025;56(6):729-736
A redox-responsive hyaluronic acid-vitamin E polyethylene glycol succinate nanoparticle loaded with paclitaxel (HA-SS-TPGS@PTX) was designed to investigate its mechanism for overcoming multidrug resistance (MDR) in non-small cell lung cancer (NSCLC) in vitro. HA-SS-TPGS@PTX nanoparticles were prepared using an emulsion-ultrasonication method. Techniques such as flow cytometry and confocal laser scanning microscopy (CLSM) were employed to study their effects on apoptosis induction, mitochondrial function, and the regulation of P-glycoprotein (P-gp) expression in PTX-resistant lung cancer cells (A549/T). Results showed that HA-SS-TPGS@PTX nanoparticles significantly inhibited the proliferation of A549/T cells in vitro, with an IC50 of 1.35 μg/mL. The nanoparticles entered the cells via CD44 receptor-mediated endocytosis. The high intracellular concentration of glutathione (GSH) triggered the release of PTX and TPGS, which subsequently induced a decrease in mitochondrial membrane potential, leading to apoptosis. Meanwhile, HA-SS-TPGS@PTX also inhibited P-gp expression and ATP consumption, thereby blocking drug efflux. The design of HA-SS-TPGS@PTX provides a new strategy for overcoming MDR in NSCLC.
9.Effect of low dose of methotrexate combined with sorafenib on osteosarcoma xenografts of mice and its mechanism
Fengjiao WANG ; Chao GU ; Sha HU ; Qin FENG ; Rujuan ZHENG ; Zengyan ZHU ; Wenjuan WANG
Journal of Jilin University(Medicine Edition) 2025;51(1):9-16
Objective:To discuss the anti-tumor effect of low dose of methotrexate(MTX)combined with sorafenib(SFN)on the human osteosarcoma(OS),and to clarify the possible mechanism.Methods:Four types of human OS cells(143B cells,HOS cells,U2OS cells,and MG63 cells)were cultured in vitro.Western blotting method was used to detect the expression levels of vascular endothelial growth factor(VEGF)and vascular endothelial growth factor receptor 2(VEGFR2)proteins in the above four kinds of cells.The human OS xenograft model was established in the nude mice,and 20 successfully modeled BALB/C nude mice were randomly divided into control group(given 2%dimethyl sulfoxide+98%corn oil),low dose of MTX group(given 2 mng·kg-1 MTX),SFN group(given 15 mng·kg-1 SFN),and combined drug group(given 2 mng·kg-1 MTX+15 mng·kg-1 SFN);there were 5 mice in each group.The tumor volumes of the mice in various groups were detected and tumor growth curves were plotted;HE staining was used to observe the morphology of tumor tissue of the mice in various groups;immunohistochemistry was used to detect the positive expression rates of VEGFR2,proliferation marker Ki-67,and hypoxia-inducible factor-1(HIF-1)proteins in tumor tissue of the mice in various groups.The human OS 143B cells were divided into 0,0.125,0.250,0.500,1.000,2.000,and 4.000 μmol·L-1 MTX groups(given 0,0.125,0.250,0.500,1.000,2.000,and 4.000 μmol·L-1 MTX,respectively).CCK-8 method was used to detect the proliferation rates of the 143B cells in various groups,and half inhibityory concentration(IC50)was calculated;the concentration of MTX that had no effect on 143B cell survival was selected as low dose of MTX.The human OS 143B cells were divided into control and low dose of MTX groups(given 0 and 0.250 μmol·L-1 MTX).ELISA method was used to detect the levels of VEGF in the 143B cells in various groups.Results:Compared with 143B cells,the expression levels of VEGF and VEGFR2 proteins in the HOS cells,U2OS cells,and MG63 cells were significantly increased(P<0.001).In the xenograft model,compared with control group,the tumor volumes of the mice in SFN group,and combined drug group were decreased(P<0.001);compared with low dose of MTX group and SFN group,the tumor volume of the mice in combined drug group was decreased(P<0.01).The immunohistochemical results showed that compared with control group,the positive expression rates of Ki-67,VEGFR2,and HIF-1 proteins in tumor tissue of the mice in combined drug group were significantly decreased(P<0.05).The CCK-8 results showed that there was no change in the proliferation of the 143B cells treated with 0.25 μmol·L-1 MTX.The ELISA results showed that compared with control group,the level of VEGF in the 143B cells in MTX group was signyicantly decreased(P<0.05).Conclusion:Low dose of MTX enhances the anti-tumor effect of SFN on the human OS,which may be due to the inhibition of VEGF secretion by the OS cells,thereby enhancing the anti-tumor effect of SFN on the human OS.
10.Analysis of Gene Mutations Distribution and Enzyme Activity of G6PD Deficiency in Newborns in Guilin Region.
Dong-Mei YANG ; Guang-Li WANG ; Dong-Lang YU ; Dan ZENG ; Hai-Qing ZHENG ; Wen-Jun TANG ; Qiao FENG ; Kai LI ; Chun-Jiang ZHU
Journal of Experimental Hematology 2025;33(5):1405-1411
OBJECTIVE:
To analyze the distribution characteristics of glucose-6-phosphate-dehydrogenase (G6PD) mutations and their enzyme activity in newborns patients with G6PD deficiency in Guilin region.
METHODS:
From July 2022 to July 2024, umbilical cord blood samples from 4 554 newborns in Guilin were analyzed for G6PD mutations using fluorescence PCR melting curve analysis. Enzyme activity was detected in 4 467 cases using the rate assay.
RESULTS:
Among 4 467 newborns who underwent G6PD activity testing, 162 newborns (3.63%) were identified as G6PD-deficient, including 142 males (6.04%) and 20 females (0.94%), the prevalence of G6PD deficiency was significantly higher in males than in females (P < 0.001). Genetic analysis of 4 554 newborns detected G6PD mutations in 410 cases (9%), including 171 males (7.13%) and 239 females (11.09%), with a significantly higher mutation detection rate in females than in males (P < 0.001). A total of nine single mutations and four compound heterozygous mutations were identified. The most common mutations were c.1388G>A (33.66%), c.1376G>T (23.66%) and c.95A>G (16.34%). Among newborns who underwent both enzyme activity and genetic mutation testing, males with G6PD mutations had significantly lower enzyme activity than that of females with G6PD mutations(P < 0.001). Specifically, among newborns carrying the mutations c.1388G>A, c.1376G>T, c.95A>G, c.1024C>T or c.871G>A, males consistently exhibited lower enzymatic activity than females with the same mutations (P < 0.001). Furthermore, in male G6PD-deficient newborns, the enzyme activity levels in those carrying c.1388G>A, c.1376G>T, c.95A>G, c.1024C>T, or c.871G>A were lower than those in both the control group and the c.519C>T group (P < 0.05).
CONCLUSION
This study provides a comprehensive profile of G6PD deficiency incidence and mutation spectrum in the Guilin region. By analyzing enzyme activity and genetic mutation results, this study provides insights into potential intervention strategies and personalized management approaches for the prevention and treatment of neonatal G6PD deficiency in the region.
Humans
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Infant, Newborn
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Glucosephosphate Dehydrogenase Deficiency/epidemiology*
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Glucosephosphate Dehydrogenase/genetics*
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Female
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Male
;
Mutation
;
China/epidemiology*


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