{"title":"Effects of the Paediatric Regulation funding on the development of off-patent medicines in children.","authors":"Lucia Ruggieri, Silvia Torretta, Viviana Giannuzzi, Alessandra Natale, Mariagrazia Felisi, Adriana Ceci, Fedele Bonifazi","doi":"10.3389/fmed.2024.1473862","DOIUrl":"https://doi.org/10.3389/fmed.2024.1473862","url":null,"abstract":"<p><strong>Introduction: </strong>In paediatrics, medicines repurposing is a particularly advantageous approach, offering a route to address unmet medical needs and turn off-label use into evidence-based treatments for paediatric populations. This study analysed the effects of funds provided under the Seventh Framework Programme for Research (FP7-FRP), issued by the European Commission from 2007 to 2013 according to the European Paediatric Regulation, in terms of new paediatric marketing authorisations (MAs) including paediatric Use Marketing Authorisations (PUMAs). Additionally, we investigated which funded projects included repurposing initiatives.</p><p><strong>Methods: </strong>Data was collected on paediatric Investigation Plans (PIPs), new MAs, and MAs variations from the EMA website, national medicine registers, and final project reports. A survey to project coordinators was also conducted to explore the challenges faced during paediatric drug development plans.</p><p><strong>Results: </strong>The 20 FP7-funded projects studied 24 off-patent active substances. Eighteen substances had agreed PIPs with the European Medicines Agency paediatric Committee (PDCO). Positive compliance checks were granted for three PIPs, resulting in three new PUMAs. According to the adopted definition, 22 out of 24 (91.6%) paediatric development plans could be classified as repurposing. New conditions were proposed for eight substances, while 16 aimed to extend existing indications to broader paediatric populations. Additionally, 18 development plans included new age-appropriate formulations. The survey revealed that primary challenges in paediatric development plans included budgeting, lengthy regulatory processes, and recruitment.</p><p><strong>Discussion: </strong>Taken together, these results highlighted on one hand that the FP7 programme had a positive impact, as three new PUMAs were effectively obtained, representing one third of the nine PUMAs obtained since the paediatric Regulation entered into force, and three out of 18 agreed PIPs were successfully completed within 3-10 years. In addition, repurposing existing drugs for paediatric use significantly contributed to addressing unmet medical needs in paediatrics. On the other hand, the gap between the number of agreed PIPs and those that have led to PUMAs is still considerable, due to regulatory barriers and financial constraints. This underscores the need for continued support and further initiatives to streamline public-private partnerships for paediatric drug development, ensuring that off-patent medicines can be safely and effectively repurposed for paediatric use.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1473862"},"PeriodicalIF":3.1,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11823639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143412744","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}
Frontiers in MedicinePub Date : 2025-01-30eCollection Date: 2025-01-01DOI: 10.3389/fmed.2025.1557035
Georgios Filippou, Nicola Dalbeth, Sara K Tedeschi
{"title":"Editorial: Calcium pyrophosphate deposition disease.","authors":"Georgios Filippou, Nicola Dalbeth, Sara K Tedeschi","doi":"10.3389/fmed.2025.1557035","DOIUrl":"https://doi.org/10.3389/fmed.2025.1557035","url":null,"abstract":"","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1557035"},"PeriodicalIF":3.1,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11821655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413531","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}
Frontiers in MedicinePub Date : 2025-01-29eCollection Date: 2025-01-01DOI: 10.3389/fmed.2025.1503472
Zhuo-Ma Dawa, Ting Zhai, Chuan-Chuan Liu, Hai-Ning Fan
{"title":"Efficacy and safety of pseudolaric acid B against <i>Echinococcus multilocularis in vitro</i> and in a murine infection model.","authors":"Zhuo-Ma Dawa, Ting Zhai, Chuan-Chuan Liu, Hai-Ning Fan","doi":"10.3389/fmed.2025.1503472","DOIUrl":"10.3389/fmed.2025.1503472","url":null,"abstract":"<p><strong>Introduction: </strong>Alveolar echinococcosis (AE) is a chronic zoonotic disease caused by the larvae of the <i>Echinococcus multilocularis</i> (<i>E. multilocularis</i>). The current chemotherapy for AE relies on albendazole and mebendazole, which exhibit only parasitostatic rather than parasiticidal effects. Therefore, there is a need to find new anti-Echinococcosis drugs. Pseudolaric acid B (PAB) has been described to have strong antiparasitic effects. However, the in-depth mechanism by which PAB acts against <i>E. multilocularis</i> remains unclear.</p><p><strong>Methods: </strong>To evaluate the effect of a PAB intervention on protoscoleces, metacestode vesicles and germinal cells in <i>E. multilocularis in vitro</i>. In addition, the effects of PAB on T lymphocyte and collagen synthesis were evaluated after PAB administration in a mouse model.</p><p><strong>Results: </strong>Metacestode vesicles and germinal cells were successfully cultured, and specific genes were amplified via RT-PCR to identify the protoscoleces, vesicles, and germinal cells as the sources of <i>E. multilocularis</i>. <i>In vitro</i> studies have demonstrated that PAB exhibits dose- and concentration-dependent cytotoxicity against <i>E. multilocularis</i> protoscoleces. Scanning electron microscopy revealed that the microvilli structure of the protoscolex was destroyed and the rostellar hooks had fallen off. PAB induced. The release of PGI from the metacestode vesicles, leading to the structural destruction of the inner surfaces. PAB suppressed the proliferation of germinal cells. After PAB treatment, the serum and the host tissue surrounding the metacestodes IFN-<i>γ</i> levels were upregulated and the IL-4 and IL-10 levels was downregulated. After PAB treatment, the levels of CD4<sup>+</sup> T lymphocytes increased and the levels of CD8<sup>+</sup> T lymphocytes decreased in the host tissue surrounding the metacestodes and the spleen. The proportions of the Th1 and Th17 cell subpopulations were increased and the proportion of Th2 cell and Treg cell subpopulations was decreased in the host tissue surrounding the metacestodes. Additionally, collagen deposition was increased after PAB treatment. PAB suppressed the expression of matrix metalloproteinases (MMPs 1, 2, 3, 9, 13) and the activation of the PI3K/AKT signaling pathway in the host tissue surrounding the metacestodes.</p><p><strong>Conclusion: </strong>PAB has a significant killing effect on <i>E. multilocularis</i>, suggesting that it is a potential candidate for the treatment of AE.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1503472"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11813755/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406696","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}
Frontiers in MedicinePub Date : 2025-01-29eCollection Date: 2024-01-01DOI: 10.3389/fmed.2024.1503678
Shu-Jane Wang, Tien-Pei Fang, Daniel D Rowley, Nan-Wei Liu, Jui-O Chen, Jui-Fang Liu, Hui-Ling Lin
{"title":"Inspiratory muscle training facilitates liberation from mechanical ventilation in subacute critically ill patients-a randomized controlled trial.","authors":"Shu-Jane Wang, Tien-Pei Fang, Daniel D Rowley, Nan-Wei Liu, Jui-O Chen, Jui-Fang Liu, Hui-Ling Lin","doi":"10.3389/fmed.2024.1503678","DOIUrl":"10.3389/fmed.2024.1503678","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing mechanical ventilation often develop rapid diaphragmatic atrophy, respiratory muscle weakness, and dysfunction, which are associated with prolonged duration of ventilation. This study aimed to evaluate whether Inspiratory Muscle Training (IMT) facilitates weaning from mechanical ventilation and enhances muscle strength in critically ill, subacute adult patients, while examining the relationship between IMT and relevant clinical laboratory values.</p><p><strong>Methods: </strong>In this randomized clinical trial, patients admitted to the intensive care unit requiring mechanical ventilation for more than 2 days, with stable hemodynamics and resolved acute conditions, were enrolled. Participants were randomly assigned to the IMT or no-IMT group. The IMT group received training twice daily, 5 days a week, for three consecutive weeks. The primary outcome was ventilator duration. The primary outcome measure was the number of days until liberation from mechanical ventilation. The secondary outcomes of interest were respiratory muscle strength and biomarker levels.</p><p><strong>Results: </strong>Thirty-three subjects (17 in the IMT group, 16 in the no-IMT group) were included in the final analysis. The IMT group had significantly shorter ventilator days (12.6 ± 5.2 vs. 18.1 ± 8.8, <i>p</i> = 0.04). IMT intervention significantly reduced rapid shallow breathing index and improved respiratory muscle strength, with greater maximum inspiratory pressure (<i>p</i> < 0.01), maximum expiratory pressure (<i>p</i> = 0.03), and peak expiratory flow (<i>p</i> = 0.01). A moderate positive correlation was observed between IMT and increased creatinine levels (rs = 0.54, <i>p</i> = 0.01), whereas the no-IMT group showed a reduction.</p><p><strong>Conclusion: </strong>IMT significantly shortened ventilator duration and improved respiratory muscle strength. A moderate correlation between increased creatinine levels and respiratory muscle strength was observed, suggesting that creatinine may be a potential biomarker for muscle recovery during IMT.</p><p><strong>Clinical trial registration: </strong>This study was registered at ClinicalTrials.gov (NCT06611683).</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1503678"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11815589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406930","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}
Frontiers in MedicinePub Date : 2025-01-29eCollection Date: 2025-01-01DOI: 10.3389/fmed.2025.1510742
Haiyu Wang, Yumin Ding, Min Zhuang, Kaixu Li, Shujing Zhao, Dehong Li
{"title":"Application and progress of nomograms in gastric cancer.","authors":"Haiyu Wang, Yumin Ding, Min Zhuang, Kaixu Li, Shujing Zhao, Dehong Li","doi":"10.3389/fmed.2025.1510742","DOIUrl":"10.3389/fmed.2025.1510742","url":null,"abstract":"<p><p>Gastric cancer, as one of the malignant tumors with a significant disease burden globally, emphasizes the importance of early diagnosis and personalized treatment for improving patient prognosis. In recent years, clinical prediction models (CPMs) have played a crucial role in predicting disease risks, assisting medical decision-making, and evaluating clinical prognosis and benefits as tools for risk-benefit assessment. Nomograms, as an important visualization form of clinical prediction models, have been increasingly applied in tumor-related research. Numerous studies have constructed multiple nomogram models by integrating clinical, pathological, laboratory, imaging data, and genetic characteristics, providing an accurate and effective tool for predicting the risk of gastric cancer, early diagnosis, treatment response assessment, and prognosis analysis. This article aims to review the current clinical applications and research progress of nomograms in gastric cancer, with the goal of providing robust references and theoretical support for clinical practice.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1510742"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11813919/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406724","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":"Handgrip strength as a potential indicator of aging: insights from its association with aging-related laboratory parameters.","authors":"Nina Kemala Sari, Stepvia Stepvia, Muhana Fawwazy Ilyas, Siti Setiati, Kuntjoro Harimurti, Ika Fitriana","doi":"10.3389/fmed.2025.1491584","DOIUrl":"10.3389/fmed.2025.1491584","url":null,"abstract":"<p><strong>Introduction: </strong>The aging process is frequently associated with a decline in functional capacity, endurance, muscle quality, and overall quality of life. Examining aging-related biomarkers often requires significant time and financial resources, underscoring the need for a straightforward and practical indicator. This study aims to investigate the association between handgrip strength and aging-related laboratory parameters in the elderly population of Indonesia.</p><p><strong>Methods: </strong>A cross-sectional study was conducted involving 109 participants aged 60-82 years. Handgrip strength was measured using a Jamar hydraulic hand dynamometer and Jamar PLUS+ digital dynamometer. Aging-related laboratory biomarkers were defined as those indicating physiological aging processes.</p><p><strong>Results: </strong>The study revealed a significant association between handgrip strength and several aging-related laboratory parameters, including leukocyte count, absolute neutrophil count, absolute lymphocyte count, neutrophil/lymphocyte ratio, and erythrocyte sedimentation rate.</p><p><strong>Discussion: </strong>These findings suggest that handgrip strength could serve as a cost-effective, non-invasive predictor of aging-related health status in older adults. Its practical utility highlights its potential for guiding health interventions targeting the elderly population.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1491584"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11814436/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406762","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}
Frontiers in MedicinePub Date : 2025-01-29eCollection Date: 2024-01-01DOI: 10.3389/fmed.2024.1497780
Daniel Bundó-Luque, Oriol Cunillera-Puértolas, Sílvia Cobo-Guerrero, José Romano, Ariadna Arbiol-Roca, José Alberto Domínguez-Alonso, Josep Maria Cruzado, Betlem Salvador-González
{"title":"Recalibrating the kidney failure risk equation for a Mediterranean European population: reducing age and sex inequality.","authors":"Daniel Bundó-Luque, Oriol Cunillera-Puértolas, Sílvia Cobo-Guerrero, José Romano, Ariadna Arbiol-Roca, José Alberto Domínguez-Alonso, Josep Maria Cruzado, Betlem Salvador-González","doi":"10.3389/fmed.2024.1497780","DOIUrl":"10.3389/fmed.2024.1497780","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic kidney disease (CKD) patients may develop kidney failure (KF), receiving renal replacement therapy (RRT) in some cases. The Kidney Failure Risk Equation (KFRE-4), predicting RRT risk, is widely validated but not in a primary care Mediterranean European population. We aim to recalibrate KFRE-4 accordingly, considering death as a competing risk, to improve performance. Additionally, we recalibrate KFRE-4 for predicting KF, including all patients reaching CKD stage 5, not just those on RRT.</p><p><strong>Methods: </strong>Retrospective cohort study including individuals aged ≥50 years with confirmed glomerular filtration rate (eGFR) <60 mL/min/1.73m<sup>2</sup> and measured albumin-to-creatinine ratio (ACR). Dataset was split into training and test sets. New KFRE-4 models were developed in the training set and performance was evaluated in the test set: Base hazard adapted-KFRE (Basic-RRT), Cox reestimation (Cox- RRT), Fine and Gray RRT reestimation (FG-RRT), and Fine and Gray KF reestimation (FG-KF).</p><p><strong>Results: </strong>Among 165,371 primary care patients (58.1% female; mean age 78.1 years; mean eGFR 47.3 mL/min/1.73m<sup>2</sup>, median ACR 10.1 mg/g), original KFRE-4 showed good discrimination but poor calibration, overestimating RRT risk. Basic-RRT showed poorer performance. Cox-RRT and FG-RRT, enhancing the influence of old age and female sex, diminished overprediction. FG-RRT, considering death as a competing risk, resulted the best RRT model. Age and sex had less impact on KF prediction.</p><p><strong>Conclusion: </strong>A fully tailored recalibration model diminished RRT overprediction. Considering death as a competing event optimizes performance. Recalibrating for KF prediction offers a more inclusive approach in primary care, addressing the needs of women and elderly.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1497780"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11813909/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406572","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}
Frontiers in MedicinePub Date : 2025-01-29eCollection Date: 2025-01-01DOI: 10.3389/fmed.2025.1446695
Daniel Fleischmann, Benedicta Binder, Muriel Huss, Tanja Elger, Claudia Wolf, Johanna Loibl, Hauke Christian Tews, Arne Kandulski, Stephan Schmid, Martina Müller, Alexander Kratzer
{"title":"Interprofessional approach to personalized medication management and therapy optimization in IBD care.","authors":"Daniel Fleischmann, Benedicta Binder, Muriel Huss, Tanja Elger, Claudia Wolf, Johanna Loibl, Hauke Christian Tews, Arne Kandulski, Stephan Schmid, Martina Müller, Alexander Kratzer","doi":"10.3389/fmed.2025.1446695","DOIUrl":"10.3389/fmed.2025.1446695","url":null,"abstract":"<p><p>A considerable number of patients with chronic inflammatory bowel diseases (IBD) are required to manage extensive polypharmaceutical regimes, which significantly elevates the risk of drug-drug interactions. Also, the disease's impact often leads to the consumption of additional self-medication by the patients such as naturopathic remedies to alleviate disease-induced suffering and nutritional supplements to compensate for malabsorption syndromes inherent to the condition. There is a well-established consensus that polymedication coupled with unregulated supplementary intake can jeopardize the safety of drug therapy. Despite this, pharmaceutical co-supervision-proven to mitigate adverse drug events and enhance patient adherence to treatment-is generally lacking in routine clinical settings. Furthermore, the assessment of individual therapy adherence, a crucial predictive factor for therapeutic outcomes, is frequently suboptimal. In response to these issues, this study implemented an interdisciplinary approach wherein a team comprising medical and pharmaceutical professionals conducted a comprehensive survey coupled with a medication review for patients attending an IBD outpatient clinic. Employing an IBD-specific questionnaire alongside the patients' documented medication regimens enabled the identification and subsequent discussion of current therapeutic concerns and potential medication-related risks during follow-up consultations. This intervention aimed to bolster individual patient satisfaction and enhance medication safety, ultimately fostering sustained success in IBD management.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1446695"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11814462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406844","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":"Meta-analysis of the efficiency and safety of neoadjuvant therapy with immune checkpoint inhibitors in resectable hepatocellular carcinoma.","authors":"Adili Tuersun, Yadikaer Yasen, Munire Mohetaer, Guanxin Hou, Gang Cheng, Xin Zhao","doi":"10.3389/fmed.2024.1511511","DOIUrl":"10.3389/fmed.2024.1511511","url":null,"abstract":"<p><strong>Purpose: </strong>Immunotherapy as a neoadjuvant treatment approach has achieved certain therapeutic effects in various types of cancer. However, in the specific cancer type of hepatocellular carcinoma (HCC), standardized protocols for neoadjuvant immunotherapy remain to be defined. This systematic review and meta-analysis focus on evaluating the efficacy and safety of neoadjuvant immunotherapy in the treatment of HCC, aiming to provide a robust basis for clinical decision-making.</p><p><strong>Methods: </strong>This study systematically searched databases such as PubMed, EMBASE, the Cochrane Library, and conference proceedings to identify clinical trials focusing on patients with HCC undergoing neoadjuvant immunotherapy. The Review Manager 5.4 software was applied to estimate the odds ratio (OR) of effect sizes and their corresponding 95% confidence intervals (CI).</p><p><strong>Results: </strong>Immune checkpoint inhibitors (ICIs) demonstrate significant efficacy in improving pathological outcomes and safety profiles in patients with resectable hepatocellular carcinoma (HCC). Specifically, ICIs significantly increase the pathological complete response (pCR) rate (OR = 0.23, 95% CI [0.14, 0.37], <i>p</i> < 0.00001) and major pathological response (MPR) rate (OR = 0.47, 95% CI [0.32, 0.70], <i>p</i> = 0.0002). They also markedly enhance the objective response rate (ORR) (OR = 0.42, 95% CI [0.28, 0.63], <i>p</i> < 0.0001). Furthermore, ICIs potentially improve the surgical resection rate (OR = 3.91, 95% CI [2.05, 7.45], <i>p</i> < 0.0001) and reduce the incidence of grade 3-4 treatment-related adverse events (TRAEs) (OR = 0.27, 95% CI [0.17, 0.44], <i>p</i> < 0.00001), indicating both therapeutic benefits and acceptable toxicity profiles.</p><p><strong>Conclusion: </strong>Neoadjuvant immunotherapy shows promise in the treatment of resectable HCC. Nonetheless, to further validate its efficacy, more large-scale, well-designed clinical trials are necessary to provide conclusive evidence.</p><p><strong>Systematic review registration: </strong>This comprehensive review adheres to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) standards and has been carried out as per a preregistered protocol (PROSPERO registration number: CRD42024560660).</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1511511"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11814204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143405660","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}
Frontiers in MedicinePub Date : 2025-01-29eCollection Date: 2025-01-01DOI: 10.3389/fmed.2025.1523139
Kai Liu, Shu Liu, Ting-Ting Xu, Hong Qiao
{"title":"The clinical features and outcomes of diabetes patients infected with COVID-19: a systematic review and meta-analysis comprising 192,693 patients.","authors":"Kai Liu, Shu Liu, Ting-Ting Xu, Hong Qiao","doi":"10.3389/fmed.2025.1523139","DOIUrl":"10.3389/fmed.2025.1523139","url":null,"abstract":"<p><strong>Objectives: </strong>We sought to explore the relevance of analyses that include critical laboratory parameters and drug treatment, clinical characteristics of diabetic patients who are infected with COVID-19, to the development of individualized treatment strategies for diabetic patients infected with COVID-19.</p><p><strong>Methods: </strong>We searched Cochrane, Embase, FMRS, Pubmed, Springer, Web of Science databases for systematic reviews and meta-analyses to estimate the clinical characteristics and prognosis of confirmed covid-19 infections in patients with and without diabetes.</p><p><strong>Results: </strong>Our meta-analysis included a total of 32 studies with 192,693 COVID-19 patients. Common comorbidities in the diabetic group were hypertension, cerebrovascular disease, chronic kidney disease and cardiovascular disease. We discovered that white blood cell count, neutrophil count, inflammatory marker levels, D-dimer, urea, precursor of the brain natriuretic peptide (Pro-BNP) increased and lymphocyte count, estimated glomerular filtration rate (eGFR), albumin decreased significantly in the diabetic group in laboratory test results. Compared with the non-diabetic group, the diabetic group had a higher incidence of complications in acute respiratory distress syndrome (ARDS), shock, acute heart injury, acute kidney injury and more regularly used oxygen therapy, invasive ventilation, non-invasive ventilation, continuous renal replacement therapy (CRRT), extracorporeal membrane oxygenation (ECMO) treatment. Mortality and intensive care unit (ICU) hospitalization rates were highest in the diabetic group than in the non-diabetic group (<i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>Diabetic patients hospitalized with COVID-19 have an increased risk of death, lower discharge rates, and higher ICU admission rates. Their presence of hypertension, cerebrovascular disease, chronic kidney disease (CKD), higher levels of inflammatory markers. Multiple complications are all predictors of poor outcomes in people with diabetes. Our findings will help identify elevated risk factors in diabetics, which will benefit early prediction.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1523139"},"PeriodicalIF":3.1,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11813781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406915","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}