Therapeutics and Clinical Risk Management最新文献

{"title":"Novel Obstetric Air Cushion for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section: A Randomized Controlled Clinical Trial.","authors":"Yang Dong, Wei-Wei Cao, Hao Weng, Rong Liu, Ding-Ding Huang","doi":"10.2147/TCRM.S499475","DOIUrl":"10.2147/TCRM.S499475","url":null,"abstract":"<p><strong>Purpose: </strong>Intravenous administration of large doses of vasopressors to treat hypotension due to spinal anesthesia can adversely affect the fetus and the mother. We assessed the effect of a novel obstetric air cushion pretreatment on the incidence of hypotension after spinal anesthesia.</p><p><strong>Patients and methods: </strong>Eighty parturients were randomly assigned to the air cushion or blank control group (Group A or B, respectively). The air cushion was placed in the lumbar area between the lower border of the costal arch and the iliac crest. The primary endpoint was the incidence of hypotension, while the secondary endpoints included norepinephrine dosage, success rate of maternal hypotension management, and adverse reactions like bradycardia.</p><p><strong>Results: </strong>Hypotension occurred in 50% of the participants in Group A and 75% of those in Group B(<i>P</i>=0.035). Group A (median 4μg, range 0-8μg) required a lower norepinephrine dose than Group B (median 4μg, range 0-12μg; <i>P</i>=0.015). The success rate of hypotension management was significantly higher for Group A at 97.4% than for Group B at 83.3% (<i>P</i>=0.035). Bradycardia was less frequent for Group A than for Group B (10.5% vs 30.6%, <i>P</i>=0.032). Group A also showed a higher umbilical artery blood pH than Group B(<i>P</i>=0.026).</p><p><strong>Conclusion: </strong>The novel air cushion pretreatment reduces the incidence of hypotension after spinal anesthesia in pregnant women, reduces the dose of single intravenous norepinephrine, improves the success rate of hypotension management, and increases the pH of fetal umbilical artery blood.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"321-330"},"PeriodicalIF":2.8,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11911231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143650915","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 Manifestations and Risk Factors of Liver Injury Induced by PD-1 Inhibitors in Patients with Malignancies: A Case-Control Study.","authors":"Pengfei Zhao, Lihong Yu, Wenming Ma, Ting Zhao","doi":"10.2147/TCRM.S510973","DOIUrl":"https://doi.org/10.2147/TCRM.S510973","url":null,"abstract":"<p><strong>Background: </strong>Hepatic injury induced by immune checkpoint inhibitors (ICPIs) is an inevitable challenge in the era of innovative anti-tumor therapies. However, studies on immune-related liver injury are relatively insufficient, and the associated risk factors are still lacking. The purpose of this study was to explore the incidence and clinical manifestations of immunotherapy-related liver injury.</p><p><strong>Methods: </strong>A retrospective case-control study was conducted involving patients treated with PD-1 inhibitors at Weifang People's Hospital, a tertiary general hospital in China, from January 1, 2021 and July 31, 2024. Univariate and multivariate logistic regression analyses were employed to identify the potential risk factors. Then, the predictive value of these risk factors was evaluated using receiver operating characteristic (ROC) curve analysis.</p><p><strong>Results: </strong>In total, 300 patients were included. Among these patients, 52 patients experienced liver injury. The mean time from the initiation of immunotherapy to the onset of liver injury was 28.4 days, with a range from 2 to 219 days. 71.15% of patients developed liver injury within the first 30 days. 82.69% presented with mild cases (grade 1), 13.46% with moderate cases (grade 2), and 3.84% with severe cases (grades 3-4). The overall incidence of PD-1 inhibitors-related liver injury was 0.34%. Specifically, nivolumab exhibited the highest incidence at 2.86%, followed by sintilimab at 0.41%. Both toripalimab and camrelizumab exhibited an incidence of 0.34%, while tislelizumab had the lowest at 0.28%. Multivariate logistic regression analysis showed that GGT and AST were independent risk factors for liver injury. ROC curve analysis revealed that patients with baseline ALT≥19.5 U/L, AST≥19.5 U/L, and GGT≥28.5 U/L were at increased risk of developing liver injury.</p><p><strong>Conclusion: </strong>In clinical therapy, close monitoring of liver function is recommended, especially for patients with baseline ALT≥19.5 U/L, AST≥19.5 U/L, and GGT≥28.5 U/L during immunotherapy with PD-1 inhibitors.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"309-320"},"PeriodicalIF":2.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11910050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143650904","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 Machine Learning Models for Outcome Prediction in Patients with Poor-Grade Aneurysmal Subarachnoid Hemorrhage Following Endovascular Treatment.","authors":"Senlin Du, Yanze Wu, Jiarong Tao, Lei Shu, Tengfeng Yan, Bing Xiao, Shigang Lv, Minhua Ye, Yanyan Gong, Xingen Zhu, Ping Hu, Miaojing Wu","doi":"10.2147/TCRM.S504745","DOIUrl":"10.2147/TCRM.S504745","url":null,"abstract":"<p><strong>Background: </strong>Endovascular treatment (EVT) has been recommended as a superior modality for the treatment of intracranial aneurysm. However, there still exists a worse percentage of poor functional outcome in patients with poor-grade aneurysmal subarachnoid hemorrhage (aSAH) undergoing EVT. Therefore, it is urgently needed to investigate the risk factors and develop a critical decision model in the subtype of such patients.</p><p><strong>Methods: </strong>We extracted the target variables from an ongoing registry cohort study, PROSAH-MPC, which was conducted in multiple centers in China. We randomly assigned these patients to training and validation cohorts with a ratio of 7:3. Univariate and multivariate logistic regressions were performed to find the potential factors, and then nine machine learning models and a stack ensemble model were developed with optimized variables. The performance of these models was evaluated through several indicators, including area under the receiver operating characteristic curve (AUC-ROC). We further use Shapley Additive Explanations (SHAP) methods for the distribution of feature visualization based on the optimal models.</p><p><strong>Results: </strong>A total of 226 eligible patients with poor-grade aSAH undergoing EVT were enrolled, while 89 (39.4%) has a poor 12-month outcome. Age (Adjusted OR [aOR], 1.08; 95% CI: 1.03-1.13; p = 0.002), subarachnoid hemorrhage volume (aOR, 1.02; 95% CI: 1.00-1.05; p = 0.033), World Federation of Neurosurgical Societies grade (WFNS) (aOR, 2.03; 95% CI: 1.05-3.93; p = 0.035), and Hunt-Hess grade (aOR, 2.36; 95% CI: 1.13-4.93; p = 0.022) were identified as the independent risk factors of the poor outcome. Then, the prediction models developed have revealed that LightGBM algorithm has a superior performance with an AUC-ROC value of 0.842 in the validation cohort, while the SHAP results showed that age is the most important risk factor affecting functional outcomes.</p><p><strong>Conclusion: </strong>The LightGBM model holds immense potential in facilitating risk stratification for poor-grade aSAH patients undergoing endovascular treatment who are at risk of adverse outcomes, thereby enhancing clinical decision-making processes.</p><p><strong>Trial registration: </strong>PROSAH-MPC. NCT05738083. Registered 16 November 2022 - Retrospectively registered, https://clinicaltrials.gov/study/NCT05738083.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"293-307"},"PeriodicalIF":2.8,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606395","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":"A Nomogram Based on S100A7 and Clinicopathological Characteristics to Predict the Efficacy of Neoadjuvant Chemotherapy in Breast Cancer: A Retrospective Study.","authors":"Tianqi Zhang, Xin Yu, Xiaolu Yang, Yilun Li, Xiaolong Li, Li Ma","doi":"10.2147/TCRM.S508507","DOIUrl":"10.2147/TCRM.S508507","url":null,"abstract":"<p><strong>Background: </strong>We have previously found that S100 calcium-binding protein A7 (S100A7) is strongly associated with chemoresistance in breast cancer (BC). In this study, we investigated whether S100A7 can be used to predict the efficacy of neoadjuvant chemotherapy (NAC) and assessed its relationship with clinicopathological characteristics in BC.</p><p><strong>Methods: </strong>We retrospectively analyzed the clinicopathological data of patients with BC who underwent NAC at the Fourth Hospital of Hebei Medical University between January 2021 and December 2021. The <i>t</i>-test, Wilcoxon test, and chi-square test were used to compare clinicopathological characteristics between the NAC-sensitive and NAC-insensitive groups and assess the relationship between S100A7 expression and clinicopathological characteristics. Binomial logistic regression analysis was used to identify the predictors of NAC efficacy. A prediction model was constructed and visualized using a nomogram for clinical prediction of NAC efficacy.</p><p><strong>Results: </strong>A total of 76 patients with BC who underwent NAC were included in this study; of these patients, 49 were sensitive to NAC, whereas 27 were insensitive to NAC. Statistically significant differences were observed in age, menstrual status, histological grade, T stage, Ki67, and S100A7 expression between the NAC-sensitive and NAC-insensitive groups. Regression analysis showed that age, histological grade, Ki67, subtype, menstrual status, TILs and S100A7 expression were predictors of NAC efficacy. However, only histological grade III (OR, 25.613; 95% CI, 1.254-523.077; <i>P</i> = 0.035), Ki67 (OR, 9.781; 95% CI, 2.022-47.317; <i>P</i> = 0.005), TILs (OR, 1.227; 95% CI, 1.064-1.415; <i>P</i> = 0.005), and S100A7 expression (OR, 0.042; 95% CI, 0.010-0.174; <i>P</i><0.001) were independent predictors. Therefore, we constructed a model incorporating these four characteristics and visualised the model in a nomogram to predict NAC efficacy in clinical settings, with a model prediction accuracy of 0.927.</p><p><strong>Conclusion: </strong>S100A7 may serve as a predictor of NAC efficacy in patients with BC.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"283-292"},"PeriodicalIF":2.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11892500/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143597811","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":"Risk of Serious Immune-Related Adverse Events with Various PD1 and PD-L1 Inhibitors: A Single-Institution, Real-Life, Comparative Study.","authors":"Tiphaine Boucheron, Laurent Chiche, Guillaume Penaranda, Maxime Souquet, Hervé Pegliasco, Julien Deturmeny, Véronique Brunel, Nicolas Barrière, Chloé Arbault-Bitton, Emilie Coquet, Laetitia Diaz, Thomas Escoda","doi":"10.2147/TCRM.S479686","DOIUrl":"10.2147/TCRM.S479686","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) are responsible for causing immune-related adverse events (irAEs). The frequency and severity of irAEs depend on various factors, but the role of the molecule used remains unclear. Our aim was to assess the comparative safety profile of different programmed cell death-1 inhibitors (anti-PD1) and programmed cell death ligand-1 inhibitors (anti-PD-L1) in a real-life setting.</p><p><strong>Methods: </strong>The occurrence of severe irAEs (grade ≥3) and their characteristics were recorded for all patients treated with anti-PD1 or anti-PD-L1, alone or in combination, at our center. Potential predictive factors for the occurrence of irAEs, particularly concerning the type of molecule, were identified by statistical analysis. Factors related to overall survival were also analyzed.</p><p><strong>Results: </strong>A total of 406 patients who received at least one dose of anti-PD1 (68.5%) or anti-PD-L1 (31.5%) were included, among which 60% had lung cancer. The overall frequency of the different ICIs was 51%, 17.5%, 14.3%, 12.8%, and 4.4% for pembrolizumab, nivolumab, atezolizumab, durvalumab, and avelumab, respectively. Fifty-three (13%) patients experienced severe irAEs (grade 3 or 4). While there were no significant differences with regard to ICI categories (13.7% for anti-PD1 vs 11.7% for anti-PD-L1; p = 0.5878), the rates of severe irAEs were significantly different between ICIs (29.6% for nivolumab, 22.2% for avelumab, 13.8% for atezolizumab, 8.2% for pembrolizumab, and 5.8% for durvalumab; p < 0.0001). Multivariate analyses showed that treatments with nivolumab and low polymorphonuclear neutrophil level were significant risk factors for severe irAEs. The risk of early death was lower in patients who reported severe irAEs and the risk of cancer progression was greater with one of the least toxic molecules (atezolizumab).</p><p><strong>Discussion: </strong>This study highlights the differences in toxicity profile of various ICIs targeting the PD1/PD-L1 axis in real-life use, as well as the identification of possible predictive biomarkers.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"273-282"},"PeriodicalIF":2.8,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11890422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587059","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":"Health and Economic Advantages Associated With the Use of TachoSil: An Update of Systematic Review.","authors":"Giorgio Lorenzo Colombo, Andrea Droghetti, Sergio Di Matteo, Henrike Ottenjann, Giacomo Matteo Bruno","doi":"10.2147/TCRM.S476650","DOIUrl":"10.2147/TCRM.S476650","url":null,"abstract":"<p><strong>Background: </strong>The international scientific literature is systematically analyzed in this review over a period of nearly 10 years with respect to the use of the active hemostat and surgical sealant patch TachoSil, considering its economic effects. It`s an update of the first review published in 2014.</p><p><strong>Methods: </strong>A PubMed systematic literature review was done from Nov 2013 up to December 2022. Based on the criteria used to select, the papers were grouped in terms of study design, surgery type, reduction in the time to hemostasis, shorter hospital stay, fewer number of post-operative complications, and the impact of TachoSil to operative procedures.</p><p><strong>Results: </strong>Medical evidence of TachoSil is well documented, in different clinical studies and for several indications. In this second review 18 scientific papers were screened. In total data from 3.375 patients were analyzed, of whom 1.748 were treated with TachoSil. Nine of the 18 papers (50%) were classified as randomized clinical trials (RCTs). The time required for hemostasis following the administration of TachoSil was significantly shorter than that observed with other surgical treatment techniques, with a median time of up to four minutes. The reduction in post-operative complications was evaluated in 15 studies that were conducted on patients in a variety of surgical specialties. When using TachoSil the hospitalization duration was briefer, as observed in the past review.</p><p><strong>Conclusion: </strong>The second analysis of scientific papers demonstrates that TachoSil plays a supporting role in surgical procedures, enhancing hemostasis and facilitating tissue sealing when conventional techniques are inadequate.This approach has been linked to a reduction in post-operative complications, length of hospital stay, and consequently, hospital cost.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"257-271"},"PeriodicalIF":2.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11881641/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568190","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":"Chinese Expert Consensus on Preventing and Managing Chyle Fistula in Cervical Lymph Node Dissection for Thyroid Cancer (2024).","authors":"Qingqing He, Wen Tian, Jingqiang Zhu, Ping Wang, Hao Zhang","doi":"10.2147/TCRM.S493007","DOIUrl":"10.2147/TCRM.S493007","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of thyroid carcinoma is on the rise, with cervical lymph node metastasis being a frequent occurrence necessitating surgical intervention. Chyle fistula, a significant postoperative complication, can have a substantial impact on recovery.</p><p><strong>Objective: </strong>To reduce the incidence of chyle fistula, enhance the effectiveness of postoperative treatment, and assist thyroid surgeons in performing cervical lymph node dissection, the consensus was compiled in a standardized and secure manner.</p><p><strong>Methods: </strong>Drawing from the expertise of Chinese specialists in managing chyle fistula and the latest international advancements in this field following cervical lymph node dissection, the thyroid tumor experts group of Chinese Thyroid Association, Chinese College of Surgeons, Chinese Medical Doctor Association and Thyroid Disease Professional Committee of Chinese Research Association have developed innovative approaches to address this issue. An evidence-based approach was employed, integrating the knowledge and practical experience of the panelists.</p><p><strong>Results: </strong>We developed twelve expert consensus recommendations, addressing the prevention, diagnosis, and treatment of postoperative chyle fistula. These recommendations included the dietary management and nutritional support, continuous negative pressure suction, local adhesive treatment, application of local compression methods, the use of somatostatin and its analogs, and surgery treatment.</p><p><strong>Conclusion: </strong>This evidence-based consensus would be valuable to assist front-line surgeons and medical specialists in the management of chyle fistula.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"229-237"},"PeriodicalIF":2.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568186","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":"Nomogram-Based Prediction of 3-Month Unfavorable Outcome and Early Neurological Deterioration After Endovascular Thrombectomy in Acute Ischemic Stroke.","authors":"Yixuan Wu, Jiaxin Han, Yawen Cheng, Meng Wei, Fude Liu, Chen Chen, Ying Tan, Wenlong Ma, Jia Yu, Jianfeng Han, Guogang Luo, Kang Huo","doi":"10.2147/TCRM.S505897","DOIUrl":"10.2147/TCRM.S505897","url":null,"abstract":"<p><strong>Background: </strong>Some acute ischemic stroke (AIS) patients due to large-vessel occlusion, who underwent endovascular thrombectomy (EVT), continue to experience unfavorable outcomes. Furthermore, the impact of internal carotid artery (ICA) tortuosity remains uncertain. This study aimed to determine the value of ICA tortuosity and clinical features in predicting 3-month unfavorable outcome and early neurological deterioration (END) after EVT in AIS patients through nomograms.</p><p><strong>Methods: </strong>A total of 313 AIS patients treated with EVT at the First Affiliated Hospital of Xi'an Jiaotong University were retrospectively analyzed and randomized into two cohorts: training cohort (n=219) and validation cohort (n=94). After the selection of relevant features, nomograms for predicting the 3-month unfavorable outcome (mRS > 2) and END (an increase in NIHSS score of ≥4 within 24 hours) were established. The predictive accuracy of the nomograms was evaluated using ROC curves, calibration plots, and decision curve analysis (DCA).</p><p><strong>Results: </strong>Among 313 patients, ICA tortuosity was observed in 19.50% (extracranial) and 21.10% (cavernous) of patients. Furthermore, 53.30% of patients experienced a 3-month unfavorable outcome, while END occurred in 15.70%. The independent predictors for the 3-month unfavorable outcome included age, NIHSS score, puncture-to-recanalization time, eTICI score, and blood glucose. The addition of two tortuosity features (extracranial and cavernous ICA tortuosity) resulted in a significant improvement in model differentiation. The nomogram that included ICA tortuosity achieved an AUC of 0.826 and 0.803 in the training and validation cohorts. ASPECT score, occlusion site, number of retriever passes, and blood glucose were identified as factors associated with END. The AUC was 0.770 and 0.772 in the training and validation cohorts. However, the incorporation of ICA tortuosity did not significantly enhance the model for predicting END.</p><p><strong>Conclusion: </strong>ICA tortuosity characteristics significantly improve the discrimination of the nomogram model in predicting the 3-month unfavorable outcome. This can be used as guidance in clinical decision-making.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"239-256"},"PeriodicalIF":2.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543620","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":"Advancing Heart Valve Replacement: Risk Mitigation of Decellularized Pulmonary Valve Preparation for Its Implementation in Public Tissue Banks.","authors":"Jose Ignacio Rodríguez Martínez, Cristina Castells-Sala, Ana Rita Baptista Piteira, Giulia Montagner, Diletta Trojan, Pablo Martinez-Legazpi, Alejandra Acosta Ocampo, Maria Eugenia Fernández-Santos, Javier Bermejo, Ramadan Jashari, Maria Luisa Pérez, Elba Agustí, Jaime Tabera, Anna Vilarrodona","doi":"10.2147/TCRM.S486508","DOIUrl":"10.2147/TCRM.S486508","url":null,"abstract":"<p><strong>Purpose: </strong>Cryopreserved homografts for valve replacement surgeries face a major problem regarding their durability after implantation and decellularized pulmonary heart valves have raised as potential new generation substitute for these surgeries. The present study aims to document the work performed for the safe implementation in public tissue banks of a new decellularization method for human pulmonary heart valves, based on previous risk evaluation.</p><p><strong>Methods: </strong>After assessing new preparation method associated risks, using EuroGTP-II methodologies, an extensive array of in vitro <i>studies</i> were defined to validate the new technique, mitigate the risks and provide quality and safety data.</p><p><strong>Results: </strong>Initial evaluation of risks using EuroGTP II tool, showed Final Risk Score of 23 (high risk), and four studies were devised to mitigate identified risks: (i) tissue structure integrity; (ii) cell content; (iii) microbiological safety; and (iv) cytotoxicity evaluation in final tissue preparation. Protein quantification, mechanical properties, and histological evaluation indicated no tissue damage, reducing implant failure probability, while cellular content removal demonstrated a 99% DNA removal and microbiological control ensured contamination absence. Moreover, in vitro results showed no cytotoxicity. Risk re-evaluation indicated a risk reduction to moderate risk (Final Risk Score = 10), suggesting that further evidence for safe clinical use would be needed at pre-clinical in vivo evaluation to mitigate remaining risks.</p><p><strong>Conclusions: </strong>The studies performed and reviewed bibliography were able to significantly reduce the original level of risk associated with the clinical application of this homograft's preparation. However, additional in vivo studies and tissue stability tests are still necessary to address the remaining risks associated with reagents' effect on extracellular matrix and storage conditions, which could influence implant failure, before the clinical evaluation procedures can be implemented to determine the efficacy and safety of the new decellularized heart valves.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"209-228"},"PeriodicalIF":2.8,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11873323/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543464","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":"Outperforming Traditional Staging: A Novel Nomogram for HR-Positive Breast Cancer.","authors":"Chaoxing Liu, Jiabin Ding, Jinbiao Xu, Chen Fang, GuoHua Zhang, Chao Shi, Feng Qiu","doi":"10.2147/TCRM.S485685","DOIUrl":"https://doi.org/10.2147/TCRM.S485685","url":null,"abstract":"<p><strong>Background: </strong>Hormone receptor-positive breast cancer (HR-positive BC), the most prevalent subtype, typically has a favorable prognosis. However, treatment decision-making and survival prediction remain challenging due to the limitations of traditional staging systems like AJCC. Improved prognostic tools are needed to enhance individualized risk stratification.</p><p><strong>Materials and methods: </strong>Clinical information from the Surveillance, Epidemiology, and End Results (SEER) database and the First Affiliated Hospital of Nanchang University were analyzed to evaluate outcomes across HR-positive BC subtypes. Patients were divided into training and validation cohorts. A prognostic nomogram was developed using factors identified by univariate and multivariate Cox regression analyses and evaluated through C-index, Receiver Operating Characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA).</p><p><strong>Results: </strong>The study included 156,378 patients (training) and 67,016 (validation) for breast cancer-specific survival (BCSS) and 165,047 (training) and 70,732 (validation) for overall survival (OS), along with 232 external validation cases. Multivariate Cox regression analysis revealed that the ER-positive/PR-negative (HR=2.317 (2.219-2.419)) and ER-negative/PR-positive (HR=3.498 (3.143-3.894)) subtypes had worse prognosis than ER-positive/PR-positive patients. The prognosis of ER-negative/PR-positive subtype (HR=1.511 (1.686-1.351)) was also worse than that of ER-positive/PR-negative subtype. A nomogram integrating age, race, tumor size, grade, histology, bone, brain, lung, and liver metastases, tumor stage, HER2, marital status, positive lymph node numbers, and radiation therapy. The nomogram had a good C-index values and area under curve values for predicting OS and BCSS in both the training and validation set. Moreover, the DCA revealed that the nomogram performed better than the AJCC (TNM) staging system in predicting the three- and five-year OS and BCSS in both the groups.</p><p><strong>Conclusion: </strong>This study introduces and validates a novel prognostic nomogram for HR-positive BC, providing enhanced risk stratification, particularly in regions with limited access to comprehensive genetic testing. Further validation through multicenter clinical studies is recommended to confirm its clinical utility.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"191-208"},"PeriodicalIF":2.8,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11871874/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543624","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}