Frontiers in Medicine最新文献

{"title":"Association between compound dietary antioxidant index and all-cause and cancer mortality in patients with chronic obstructive pulmonary disease: results from NHANES 1999-2018.","authors":"Wenqiang Li, Jingshan Bai, Yanlei Ge, Yuting Fan, Qian Huang, Zhiping Deng","doi":"10.3389/fmed.2025.1544841","DOIUrl":"10.3389/fmed.2025.1544841","url":null,"abstract":"<p><strong>Objective: </strong>Chronic obstructive pulmonary disease (COPD) is one of the most important causes of death in the world, and its core is chronic inflammation. Antioxidants play a positive role in the onset and prognosis of chronic respiratory diseases. In maintaining human health, the composite dietary antioxidant index (CDAI) plays an important function. Therefore, the purpose of the current study was to investigate the relationship between CDAI and all-cause and cancer mortality in individuals with COPD.</p><p><strong>Methods: </strong>A prospective cohort study was conducted by investigating NHANES data between 1999-2018. The study included people who satisfied the inclusion and exclusion criteria. In this study, the association between CDAI and all-cause and cancer mortality was investigated using weighted Cox regression. The relationship between them is illustrated by drawing constrained cubic spline curves (RCS). Finally, subgroup analysis is used to further verify.</p><p><strong>Results: </strong>The study included 1,534 participants. CDAI was associated with COPD patients mortality, and after adjusting for multiple factors, we observed a 5% reduction in the risk of all-cause mortality (HR = 0.95, 95% CI: 0.92-0.97) was associated with a 9% lower risk of cancer mortality for each one-unit increase in CDAI (HR = 0.91, 95% CI: 0.85-0.98). After adjusting for multiple factors, high CDAI was associated with a reduced risk of mortality, with patients in the high CDAI group having 35% lower all-cause mortality than those in the low CDAI group (<i>HR</i> = 0.65, 95% <i>CI</i>: 0.50-0.85), the high CDAI group had a 61% lower risk of cancer mortality (<i>HR</i> = 0.39,95% <i>CI</i>: 0.23-0.68). Subgroup analysis and sensitivity analysis showed a consistent association between CDAI and COPD mortality.</p><p><strong>Conclusion: </strong>Our study highlights the inverse association between CDAI and all-cause and cancer mortality in patients with COPD. Further prospective studies are needed to confirm the role of CDAI in mortality risk in patients with COPD.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1544841"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11968349/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of deep vein thrombosis prophylaxis use in a Northwest Ethiopian medical ward: an observational follow-up study.","authors":"Samuel Berihun Dagnew, Tilaye Arega Moges, Fisseha Nigussie Dagnew, Abraham Nigussie Assefa, Sisay Sitotaw Anberbr, Adane Tsegaw Geremew, Getu Tesfaw Addis","doi":"10.3389/fmed.2025.1468190","DOIUrl":"10.3389/fmed.2025.1468190","url":null,"abstract":"<p><strong>Background: </strong>During hospitalization, a significant number of patients at risk of thromboembolism do not receive prophylaxis, despite established standards and viable procedures for preventing deep vein thrombosis (DVT). This study aimed to assess the appropriateness of vein thrombosis prophylaxis use among patients admitted to the medical ward of Debre Tabor Comprehensive Specialized Hospital (DTCSH) in Northwest Ethiopia.</p><p><strong>Methods: </strong>An observational follow-up study was conducted in the medical wards of Debre Tabor Comprehensive Specialized Hospital in Northwest Ethiopia to determine whether thromboprophylaxis was appropriately used, based on the Padua risk assessment tool. To identify factors associated with the occurrence of inappropriate thromboprophylaxis use, a binary logistic regression model was used. Statistical significance was considered when the <i>p</i>-value was <0.05, with a 95% confidence interval.</p><p><strong>Results: </strong>Among the 365 patients in the study, 21.37% received inappropriate thromboprophylaxis, while 78.63% received it correctly. Patients admitted to the ICU [AOR = 4.276, 95% CI: 1.878-16.134; <i>p</i> = 0.000], those who stayed for more than 6 days [AOR =6.192, 95% CI: 2.085-14.391; <i>p</i> = 0.000], and general practitioners [AOR = 1.816, 95% CI: 1.007-3.207; <i>p</i> = 0.048] were more likely to receive inappropriate thrombophylaxis.</p><p><strong>Conclusion: </strong>The appropriateness of DVT prophylaxis use was suboptimal, especially among the patients treated by general practitioners, those hospitalized in the intensive care unit, and those who stayed for more than a few days in the ward. Using an integrated risk stratification checklist is an effective way to promote the more rational use of DVT prophylaxis.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1468190"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11968744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical efficacy of etonogestrel implants on relieving dysmenorrhea in endometriosis and adenomyosis women for up to 3 years.","authors":"Yinghua Li, Dingheng Li, Ting Feng, Chunfen Wang","doi":"10.3389/fmed.2025.1460578","DOIUrl":"10.3389/fmed.2025.1460578","url":null,"abstract":"<p><strong>Background: </strong>Dysmenorrhea and menstrual disorders caused by endometriosis (EM) and adenomyosis (AM) have significantly affected the quality of life of a large number of women. As a highly effective clinical contraceptive measure, etonogestrel implants have been previously reported to relieve dysmenorrhea. However, the dysmenorrhea treatment and menstrual regulation effects of etonogestrel implants in AM and EM patients have not been systematically studied.</p><p><strong>Methods: </strong>This retrospective study followed up 100 patients with etonogestrel implants from May 2015 to October 2016, including 44 patients with EM and 56 patients with AM. The VAS scores of dysmenorrhea, menstrual volume, and related adverse events were measured at 12, 24, and 36 months after etonogestrel implantation in these patients.</p><p><strong>Results: </strong>In 100 EM and AM patients, dysmenorrhea significantly improved, with moderate and severe cases decreasing from 50 to 16 and 0% at 36 months. Amenorrhea increased over time, and frequent bleeding declined. Adverse reactions included weight gain (21%), acne (13%), and decreased sexual desire (10%). Serum CA125 levels dropped, confirming therapeutic efficacy.</p><p><strong>Conclusion: </strong>Etonogestrel implantation significantly alleviated dysmenorrhea symptoms in AM and EM patients.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1460578"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11968362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial: Rehabilitation and alternative medicine in the healthcare for chronic rheumatic pain disorders.","authors":"Tieh-Cheng Fu, Nancy E Lane, Si-Huei Lee, Juei-Chao Chen, Sheng-Feng Hsu, Ching-Mao Chang","doi":"10.3389/fmed.2025.1586105","DOIUrl":"10.3389/fmed.2025.1586105","url":null,"abstract":"","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1586105"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11968693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hand-to-surface bacterial transfer and healthcare-associated infections prevention: a pilot study on skin microbiome in a molecular biology laboratory.","authors":"Arianna Delicati, Beatrice Marcante, Dolores Catelan, Annibale Biggeri, Luciana Caenazzo, Pamela Tozzo","doi":"10.3389/fmed.2025.1546298","DOIUrl":"10.3389/fmed.2025.1546298","url":null,"abstract":"<p><strong>Background: </strong>Healthcare-associated infections (HAIs) are a major global public health problem, contributing significantly to patient morbidity and mortality. This study analyses differences in type and amounts of bacteria transferred from volunteers' dominant palm to two healthcare-relevant surfaces (glass and laminate table), both before and after hand washing with water and antibacterial soap. The aim was to understand hand-to-surface microbial contamination and support the development of HAI prevention strategies.</p><p><strong>Methods: </strong>Microbial DNA was extracted and sequenced to identify bacteria species. Taxonomic and statistical analyses were performed to evaluate bacterial diversity and abundance across the experimental groups.</p><p><strong>Results: </strong>The results confirmed greater bacteria abundance and species richness on palm compared to surfaces, with a significant reduction after hand washing, especially on glass. Taxa analysis highlighted the increased persistence of Gram-negative HAIs-related bacteria on laminate surface, while Gram-positive opportunistic bacteria were more abundant on palms and glass surface. Beta diversity confirmed significant differences in microbial composition between the groups, highlighting the importance of bacteria-surface characteristics in designing preventive measures.</p><p><strong>Conclusion: </strong>Despite some limitations, our study emphasizes the importance of microbiological surveillance for all opportunistic bacteria with pathogenic potential. These findings can contribute to more effective guidelines for surface disinfection and hand washing, key elements in preventing HAIs.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1546298"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correlation between orbital imaging features of thyroid-associated ophthalmopathy and pupillary light reflex measurement.","authors":"Yongran Li, Ziao Zhu, Yanling Lu, Qihui Lin, Miaozhi Liu, Zeyi Li","doi":"10.3389/fmed.2025.1552729","DOIUrl":"10.3389/fmed.2025.1552729","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to assess the factors associated with quantitative pupillary light reflex analysis and orbital magnetic resonance imaging (MRI) indicators in thyroid-associated ophthalmopathy (TAO) patients with different TAO severities, and their diagnostic significance of dysthyroid optic neuropathy (DON).</p><p><strong>Methods: </strong>A retrospective cross-sectional analysis was conducted on 57 patients with TAO, involving 109 orbits. Using the EUGOGO severity grading system, patients were categorized into three groups: Mild TAO (45 orbits), Moderate-to-Severe TAO (48 orbits), and DON (16 orbits). All participants underwent comprehensive ophthalmological assessments, pupillary light reflex analysis using the RAPDx device (Konan Medical), and MRI imaging (GE 3.0 Signa Creator, GE Medical Systems). MRI measurements included orbital bone wall area, extraocular muscle area, and proptosis. Differences in clinical characteristics, pupillary function indicators, and MRI-derived indicators were analyzed using Generalized Estimating Equations (GEE). Correlations and trends between Latency Onset of Constriction (LOC) and MRI indicators were assessed through Pearson multivariate analysis and linear regression models. The diagnostic value of LOC and the Volume of the Medial Orbital Wall (VMW) for diagnosing DON was further evaluated using Receiver Operating Characteristic (ROC) curve analysis.</p><p><strong>Results: </strong>The results revealed that LOC was significantly prolonged in the DON group compared to both the Mild TAO and Moderate-to-Severe TAO groups (<i>p</i> < 0.05 for both). LOC demonstrated strong positive correlations with Inferior Orbital Nerve Signal Loss (IONSL) (<i>r</i> = 0.494, <i>p</i> < 0.001), Proptosis (<i>r</i> = 0.448, p < 0.001), and Medial Rectus Area (MRA) (<i>r</i> = 0.428, <i>p</i> < 0.001). Multivariate binary logistic regression analysis identified LOC and VMW as independent predictors of DON. A predictive model combining LOC and VMW showed excellent diagnostic performance, with an Area Under the Curve (AUC) of 0.886 (<i>p</i> < 0.001), sensitivity of 90.5%, and specificity of 82.4%.</p><p><strong>Conclusion: </strong>These findings underscore the critical roles of pupillary light reflex analysis and MRI in diagnosing and evaluating TAO. The significant correlations of LOC with IONSL, Proptosis, and MRA, along with its strong predictive value alongside VMW, highlight their utility as reliable diagnostic markers for DON.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1552729"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11968689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a predictive model for acute exacerbation in chronic obstructive pulmonary disease patients with comorbid insomnia.","authors":"Qianqian Gao, Hongbin Zhu","doi":"10.3389/fmed.2025.1511874","DOIUrl":"10.3389/fmed.2025.1511874","url":null,"abstract":"<p><strong>Aim: </strong>To develop and validate a risk prediction model for estimating the likelihood of insomnia in patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD).</p><p><strong>Methods: </strong>This prospective study enrolled 253 patients with AECOPD treated at the Department of Respiratory and Critical Care Medicine, Chaohu Hospital Affiliated with Anhui Medical University, between September 2022 and April 2024. Patients were randomly assigned to a training set and a testing set in a 7:3 ratio. Least Absolute Shrinkage and Selection Operator (LASSO) regression analysis was conducted in the training set to identify factors associated with insomnia in patients with AECOPD. A nomogram was constructed based on four identified variables to visualize the prediction model. Model validation involved the Hosmer-Lemeshow test, and its performance was assessed through receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA). Model interpretability was further enhanced using SHapley Additive exPlanations (SHAP).</p><p><strong>Results: </strong>PSQI grade, marital status (widowed), white blood cell (WBC) count, and eosinophil percentage (EOS%) were identified as significant predictors of insomnia in patients with AECOPD. The nomogram based on these predictors exhibited excellent predictive performance, with areas under the ROC curve (AUCs) of 0.987 and 0.933 for the training and testing sets, respectively. The calibration curves and Hosmer-Lemeshow test demonstrated strong agreement between predicted and observed outcomes, while DCA confirmed the model's superior clinical utility.</p><p><strong>Conclusion: </strong>This study established a risk prediction model based on four variables to estimate the probability of insomnia in patients with AECOPD. The model exhibited excellent predictive accuracy and clinical applicability, offering valuable guidance for early identification and management of insomnia in this population.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1511874"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11968377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of premature luteinizing hormone surge on pregnancy outcomes in intracytoplasmic sperm injection or <i>in vitro</i> fertilization cycles.","authors":"Maram Aldarsooni, Mohammad Alfarah, Fatimah Albohammod, Dania Al-Jaroudi","doi":"10.3389/fmed.2024.1429033","DOIUrl":"10.3389/fmed.2024.1429033","url":null,"abstract":"<p><strong>Background: </strong>A premature surge in luteinizing hormone (LH) during ovarian stimulation cycles between 12 and 25% has been commonly reported. However, there is still a lack of consensus on whether premature LH surge affects pregnancy outcomes.</p><p><strong>Objective: </strong>This study aimed to evaluate the effect of premature LH surge on pregnancy rates in women with and without premature LH surge during intracytoplasmic sperm injection or stimulation of <i>in vitro</i> fertilization cycles at a tertiary hospital in Riyadh, Saudi Arabia.</p><p><strong>Materials and methods: </strong>A cross-sectional study was conducted. Information related to 771 women who had IVF/ICSI cycles between January 2022 and December 2022 was reviewed. Patients were divided into two groups based on premature LH surge.</p><p><strong>Results: </strong>There was no significant difference in patients' characteristics. The live birth rates were significantly higher in women without premature LH surge than in women with LH surge (12.9% vs. 5.6%) (<i>p</i> = 0.010). With regard to the number of oocytes collected, M2, and fertilization rate, these were significantly higher in women without premature LH surge, with <i>p-</i>values of 0.001, 0.002, and 0.004, respectively.</p><p><strong>Conclusion: </strong>The study demonstrates significantly higher live birth rates in women without premature LH surge.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1429033"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969798/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic performance of [⁶⁸Ga]Ga-FAPI-04 PET vs. [¹⁸F]FDG PET in detecting lymph node metastasis in digestive system cancers: a head-to-head comparative meta-analysis.","authors":"Huo Li, Zhognzhuan Li, Jing Qin, Shijiang Huang, Shufen Qin, Zhixin Chen, Rong Ouyang","doi":"10.3389/fmed.2025.1541461","DOIUrl":"10.3389/fmed.2025.1541461","url":null,"abstract":"<p><strong>Purpose: </strong>This meta-analysis aimed to compare the diagnostic effectiveness of [⁶⁸Ga]Ga-FAPI-04 PET and [¹⁸F]FDG PET for detecting lymph node metastasis in digestive system cancer patients.</p><p><strong>Methods: </strong>A comprehensive search of PubMed, Web of Science, and Embase databases was conducted to identify relevant articles up to June 2024. Studies were included if they evaluated the diagnostic performance of [⁶⁸Ga]Ga-FAPI-04 PET and [¹⁸F]FDG PET in detecting lymph node metastasis in digestive system cancer patients. Sensitivity and specificity were assessed using the DerSimonian and Laird method and were transformed using the Freeman-Tukey double arcsine transformation.</p><p><strong>Results: </strong>Fifteen articles, encompassing a total of 617 patients, were included in this study. The overall sensitivity of [⁶⁸Ga]Ga-FAPI-04 PET for diagnosing lymph node metastasis in digestive system cancers was 0.82 (95% CI: 0.67-0.93), and the specificity was 0.91 (95% CI: 0.84-0.97). In comparison, the sensitivity of [¹⁸F]FDG PET was 0.51 (95% CI: 0.38-0.63), with a specificity of 0.81 (95% CI: 0.64-0.94). These results suggest that [⁶⁸Ga]Ga-FAPI-04 PET has a significantly higher sensitivity (<i>P</i> < 0.01) and similar specificity (<i>P</i> = 0.20) compared to [¹⁸F]FDG PET in detecting lymph node metastasis in digestive system cancers.</p><p><strong>Conclusion: </strong>Our meta-analysis indicates that [⁶⁸Ga]Ga-FAPI-04 PET has higher sensitivity and similar specificity compared to [¹⁸F]FDG PET in diagnosing lymph node metastasis in digestive system cancers. However, the high heterogeneity among the studies may impact the robustness of the current evidence. Therefore, future research should prioritize larger prospective studies with more diverse populations and specific cancer subtypes to draw more definitive conclusions.</p><p><strong>Systematic review registration: </strong>https://www.crd.york.ac.uk/PROSPERO/view/CRD42024572412, Unique Identifier: CRD42024572412.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1541461"},"PeriodicalIF":3.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11968752/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143795175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sijunzi decoction granules for the treatment of advanced refractory colorectal cancer: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.","authors":"Shuchang Nie, Yingyu Su, Lu Lu, Yanhua Jing, Zenghua Jiang, Yangxian Xu, Tingting Wu, Yi Zhong, Hao Wu, Junming Chen, Ming Ruan, Lan Zheng, Liyu Wang, Yabin Gong, Guang Ji, Hanchen Xu","doi":"10.3389/fmed.2025.1523913","DOIUrl":"10.3389/fmed.2025.1523913","url":null,"abstract":"<p><strong>Background: </strong>Colorectal cancer (CRC) ranks among the most common gastrointestinal cancers globally, with both its incidence and mortality rates showing an upward trend. In particular, the 5-year survival rate for stage IV CRC patients is only 14%. Conventional treatments such as chemotherapy and immunotherapy can lead to drug resistance, exacerbate gastrointestinal function damage, and induce immunosuppression. Sijunzi decoction (SJZD), as a fundamental formula of Traditional Chinese medicine (TCM), has been demonstrated to confer distinct advantages in treatment of CRC. Therefore, we designed this trial to explore the efficacy of SJZD for the treatment of advanced refractory CRC.</p><p><strong>Methods: </strong>A multicenter, randomized, double-blind, placebo-controlled trial is being conducted to assess the effectiveness of SJZD combined with standard therapy for treating advanced refractory CRC. Patients with advanced CRC will be recruited and randomly allocated to either the SJZD treatment group or the placebo group in a 1:1 ratio. Both groups will receive standard treatment. The intervention period will last for 6 months, with follow-up assessments every 8 to 10 weeks. Progression-free survival (PFS) is the main outcome measure. And the secondary outcomes contain duration of disease control (DDC), overall survival (OS), completion rate of chemotherapy, incidence of treatment-related adverse events, quality of survival scale score for tumor patients and changes in spleen deficiency patient-reported outcome (PRO) scores following the intervention.</p><p><strong>Expected outcomes: </strong>To the best of our knowledge, this trial marks the first clinical investigation into the therapeutic potential of SJZD for managing advanced refractory CRC. The primary aim of this study is to provide robust clinical evidence to support the integration of TCM with Western medicine in the treatment of advanced refractory CRC.</p><p><strong>Trial registration: </strong>The trial was registered at Chinese Clinical Trial Registry, http://www.chictr.org.cn (Registration No: ChiCTR2200065434); Date: 2022-11-04.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1523913"},"PeriodicalIF":3.1,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11965362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}