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.

This study investigates the mechanism by which Xintong Granules improve myocardial ischemia-reperfusion injury(MIRI) through the regulation of gut microbiota and their metabolites, specifically short-chain fatty acids(SCFAs). Rats were randomly divided based on body weight into the sham operation group, model group, low-dose Xintong Granules group(1.43 g·kg~(-1)·d~(-1)), medium-dose Xintong Granules group(2.86 g·kg~(-1)·d~(-1)), high-dose Xintong Granules group(5.72 g·kg~(-1)·d~(-1)), and metoprolol group(10 mg·kg~(-1)·d~(-1)). After 14 days of pre-administration, the MIRI rat model was established by ligating the left anterior descending coronary artery. The myocardial infarction area was assessed using the 2,3,5-triphenyltetrazolium chloride(TTC) staining method. Apoptosis in tissue cells was detected by the terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling(TUNEL) assay. Pathological changes in myocardial cells and colonic tissue were observed using hematoxylin-eosin(HE) staining. The levels of tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β), interleukin-6(IL-6), creatine kinase MB isoenzyme(CK-MB), and cardiac troponin T(cTnT) in rat serum were quantitatively measured using enzyme-linked immunosorbent assay(ELISA) kits. The activities of lactate dehydrogenase(LDH), creatine kinase(CK), and superoxide dismutase(SOD) in myocardial tissue, as well as the level of malondialdehyde(MDA), were determined using colorimetric assays. Gut microbiota composition was analyzed by 16S rDNA sequencing, and fecal SCFAs were quantified using gas chromatography-mass spectrometry(GC-MS). The results show that Xintong Granules significantly reduced the myocardial infarction area, suppressed cardiomyocyte apoptosis, and decreased serum levels of pro-inflammatory cytokines(TNF-α, IL-1β, and IL-6), myocardial injury markers(CK-MB, cTnT, LDH, and CK), and oxidative stress marker MDA. Additionally, Xintong Granules significantly improved intestinal inflammation in MIRI rats, regulated gut microbiota composition and diversity, and increased the levels of SCFAs(acetate, propionate, isobutyrate, etc.). In summary, Xintong Granules effectively alleviate MIRI symptoms. This study preliminarily confirms that Xintong Granules exert their inhibitory effects on MIRI by regulating gut microbiota imbalance and increasing SCFA levels.
Animals ; Gastrointestinal Microbiome/drug effects* ; Rats ; Male ; Myocardial Reperfusion Injury/genetics* ; Drugs, Chinese Herbal/administration & dosage* ; Rats, Sprague-Dawley ; Apoptosis/drug effects* ; Humans ; Tumor Necrosis Factor-alpha/metabolism* ; Interleukin-6/genetics* ; Malondialdehyde/metabolism*

To improve the quality evaluation system of Hibisci Mutabilis Folium, this study established high performance liquid chromatography(HPLC) fingerprints of Hibisci Mutabilis Folium and evaluated the quality differences of medicinal materials from different places of production by chemometrics. Furthermore, a content measurement method of differential components was established based on quantitative analysis of multi-components by single-marker(QAMS). The fingerprints of 17 batches of Hibisci Mutabilis Folium from different places of production were constructed, with a total of 19 common peaks marked and seven components confirmed. The similarity between the sample fingerprints and the reference fingerprints ranged from 0.890 to 0.974. By utilizing principal component analysis(PCA), hierarchical cluster analysis(HCA), and orthogonal partial least squares-discriminant analysis(OPLS-DA), the chemical patterns of fingerprints were identified. Five components that could be used to evaluate the quality differences of Hibisci Mutabilis Folium were screened, namely peak 6(quercetin 3-O-β-robinobioside), peak 7(rutin), peak 9(kaempferol-3-O-β-robinobioside), peak 10(kaempferol-3-O-rutinoside), and peak 14(tiliroside). The relative correction factors of isoquercitrin, kaempferol-3-O-β-robinobioside, kaempferol-3-O-rutinoside, kaempferol-3-O-β-D-glucoside, and tiliroside were measured with rutin as the internal reference. The QAMS method was established for the content measurement of six flavonoids, and the results showed there was no significant difference compared to the results obtained by an external standard method. In summary, the HPLC fingerprints and QAMS method established in the study, demonstrating stability and accuracy, can provide a reference for the overall quality evaluation of Hibisci Mutabilis Folium.
Chromatography, High Pressure Liquid/methods* ; Drugs, Chinese Herbal/chemistry* ; Quality Control ; Principal Component Analysis

Compounds isolated from Epimedium include the total flavonoids of Epimedium , icariin, and its metabolites (icaritin, icariside I, and icariside II), which have similar molecular structures. Modern pharmacological research and clinical practice have proved that Epimedium and its active components have a wide range of pharmacological effects, especially in improving sexual function, hormone regulation, anti-osteoporosis, immune function regulation, anti-oxidation, and anti-tumor activity. To date, we still need a comprehensive source of knowledge about the pharmacological effects of Epimedium and its bioactive compounds on the male reproductive system. However, their actions in other tissues have been reviewed in recent years. This review critically focuses on the Epimedium , its bioactive compounds, and the biochemical and molecular mechanisms that modulate vital pathways associated with the male reproductive system. Such intrinsic knowledge will significantly further studies on the Epimedium and its bioactive compounds that protect the male reproductive system and provide some guidances for clinical treatment of related male reproductive disorders.
Male ; Epimedium/chemistry* ; Humans ; Genitalia, Male/drug effects* ; Flavonoids/therapeutic use* ; Animals

OBJECTIVE: To investigate the predictive value of morphology, immunology, and cytogenetics for isocitrate dehydrogenase 1 and 2 (IDH1/2) gene mutation in newly diagnosed acute myeloid leukemia (AML) patients. METHODS: The clinical data of 186 newly diagnosed AML patients (except M3 subtype) in the First People's Hospital of Changzhou were retrospectively analyzed, and the variables associated with IDH1/2 mutation in patients were screened using LASSO regression to construct a multivariate logistic regression analysis model. The Bootstrap method was used for internal validation of the model and nomograms were used to visualize the model, and receiver operating characteristic (ROC) curve was used to evaluate the predictive performance of the model. RESULTS: A total of 60 AML patients had IDH1/2 mutation at initial diagnosis. LASSO regression screened 9 predictive variables associated with IDH1/2 mutation, including CD7, CD56, CD11b, CD15, CD64, HLA-DR, platelet count≥50×10⁹/L, isolated +8 and normal karyotype. The nomogram and ROC curve were plotted based on the above 9 variables. The area under the ROC curve (AUC) of the training set and the validation set were 0.871 and 0.806, respectively. Internal validation showed that the nomogram had good predictive ability. CONCLUSION The prediction model based on MIC typing constructed in this study has a good predictive ability for the presence of IDH1/2 mutations in newly diagnosed AML patients and has important clinical application value when the gene mutation detection results are unavailable.
Humans ; Isocitrate Dehydrogenase/genetics* ; Leukemia, Myeloid, Acute/genetics* ; Mutation ; Retrospective Studies ; Nomograms ; Female ; Male ; ROC Curve ; Middle Aged

Digital technologies have become an integral part of complete denture restoration. With advancement in computer-aided design and computer-aided manufacturing (CAD/CAM), tools such as intraoral scanning, facial scanning, 3D printing, and numerical control machining are reshaping the workflow of complete denture restoration. Unlike conventional methods that rely heavily on clinical experience and manual techniques, digital technologies offer greater precision, predictability, and efficacy. They also streamline the process by reducing the number of patient visits and improving overall comfort. Despite these improvements, the clinical application of digital complete denture restoration still faces challenges that require further standardization. The major issues include appropriate case selection, establishing consistent digital workflows, and evaluating long-term outcomes. To address these challenges and provide clinical guidance for practitioners, this expert consensus outlines the principles, advantages, and limitations of digital complete denture technology. The aim of this review was to offer practical recommendations on indications, clinical procedures and precautions, evaluation metrics, and outcome assessment to support digital restoration of complete denture in clinical practice.
Humans ; Denture, Complete ; Computer-Aided Design ; Denture Design/methods* ; Consensus ; Printing, Three-Dimensional

OBJECTIVE: To systematically summarize and analyze the project applications and funding in the field of Emergency and Critical Care Medicine by the Medical Science Department of the National Natural Science Foundation of China (NSFC) from 2010 to 2024, and to identify research hotspots and developmental trends, providing scientific references for the high-quality development of the Emergency and Critical Care Medicine in China. METHODS: Data on all project applications and funding in the field of Emergency and Critical Care Medicine (application code H16) from 2010 to 2024 were collected from the NSFC Grants System, including project application numbers, funding numbers and amounts, project categories, regional and affiliated institutions distributions. Keyword co-occurrence analysis was conducted using VOSviewer software to identify research hotspots, and results were presented using bar charts, pie charts, and Sankey diagrams. RESULTS: Over the past 15 years, the Emergency and Critical Care Medicine field of NSFC received 13 747 project applications and funded 1 781 projects, with a cumulative funding amount of 8.064 99 billion RMB. The annual number of applications increased from 296 in 2010 to 1 971 in 2024, representing an average annual growth rate of 40.42%. Similarly, the number of funded projects grew from 45 in 2010 to 175 in 2024, with an average annual growth rate of 20.63%, while annual funding rose from 20.01 million RMB in 2010 to 74.20 million RMB in 2024, reflecting an average annual growth rate of 19.34%. The majority of funded projects belonged to the General Program (774 projects), Young Scientists Fund (754 projects), and Regional Science Fund (163 projects), collectively accounting for 94.95% of total funded projects (1 691/1 781). Funding was concentrated in two primary research areas: Organ Dysfunction and Support (H1602, 751 projects) and Sepsis (H1601, 612 projects), together comprising 76.53% of total funded projects (1 363/1 781). The total number of funded projects (1 781 projects) in Emergency and Critical Care Medicine was fewer than the average across the subfields of Medical Science Department (4 181 projects). Shanghai (305 projects, 17.1%), Guangdong (222 projects, 12.5%), Jiangsu (154 projects, 8.6%), Zhejiang (149 projects, 8.4%), and Beijing (134 projects, 7.5%) ranked as the top five regions in terms of funded projects. Keyword co-occurrence analysis revealed that sepsis, organ injury, pulmonary injury and poisoning, and cardiopulmonary resuscitation were the main research hotspots in the field of Emergency and Critical Care Medicine over the past 15 years. CONCLUSION From 2010 to 2024, the NSFC funding for the field of Emergency and Critical Care Medicine has shown a significant upward trajectory, providing vital support for the rapid advancement of basic and applied research. This growth has played a crucial role in facilitating the high-quality development of Emergency and Critical Care Medicine in China.
China ; Critical Care/economics* ; Emergency Medicine/economics* ; Humans ; Foundations

Lyme disease is a natural zoonotic infectious disease transmitted by ticks infected by different genotypes of Borre-lia burgdorferi sensu lato,which was discovered in the 1970s.This pathogen is prevalent primarily in temperate and subtropi-cal areas.Dogs,cats,horses,cattle,deer,and other animals are susceptible,and humans are also susceptible hosts.The main symptoms of Lyme disease in humans are erythema migrans,arthritis,and other neurological symptoms,and the common symptoms in infected animals include joint diseases,coat shedding,fever,laminitis,and lameness.Lyme disease is wide-spread,but diagnosis is difficult,and this disease is easily misdiagnosed and missed.Awareness of Lyme disease must be in-creased to avoid its toll on livestock and the pet industry.Therefore,this article reviews research progress in diagnosis and con-trol technology for animal Lyme disease and Borrelia burgdorferi,to provide a reference for accurate,rapid diagnosis and con-trol of Lyme disease.

Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.

Objective To investigate the safety of regular plasma donors aged 55 to 60,so as to provide reference for retention and recruitment of elderly plasma donors in China.Methods Plasma donors from 9 blood products manufacturing enterprises from 2018 to 2020 and the local general population were selected as the research objects.The total protein level,albumin and globulin ratio(ALB/GLB,A/G)and adverse reactions of plasma donation of regular plasma donors and local general population were retrospectively analyzed.Results The total protein level(g/L)and A/G of plasma donors aged 56 to 60 and the general population were 61.21±5.62 vs 60.04±6.93 and 1.610±0.299 vs 1.635±0.330,respectively,and the differences were statistically significant.The total protein level of regular plasma donors was higher than that of general popu-lation,but A/G was slightly lower than that of general population.From 2018 to 2020,there were a total of 23 056 302 plas-ma donations in 108 plasma stations,and adverse reactions occurred in 20 932 donations,with a total incidence of 0.09%,with no serious adverse reactions.Conclusion It is safe for regular plasma donors aged 55 to 60 to donate plasma,and the retention of them can alleviate the pressure of plasma supply.