Therapeutics and Clinical Risk Management最新文献

{"title":"The Role of Intravenous Selexipag in Managing PAH and Bridging Gaps in Oral Treatment: A Narrative Review.","authors":"Sienna Goren, Nermeen Kidwai, Wilbert S Aronow, Gregg M Lanier","doi":"10.2147/TCRM.S332358","DOIUrl":"10.2147/TCRM.S332358","url":null,"abstract":"<p><p>Pulmonary arterial hypertension (PAH) is a rare and potentially fatal condition characterized by progressive increases in blood pressure in the arteries of the lungs. Oral selexipag, approved by the Food and Drug Administration (FDA) in 2015 for the treatment of PAH, targets prostacyclin receptors on pulmonary arterial vascular smooth muscle and endothelial cells to improve blood flow through the lungs and reduce pulmonary vascular resistance. Oral selexipag is effective, but may be discontinued due to factors like side effects, emergency conditions, or inability to take oral medication, potentially leading to severe adverse events, such as rebound pulmonary hypertension and right heart failure. To address treatment interruptions, intravenous (IV) selexipag was introduced as an alternative for patients who are temporarily unable to take oral medications. IV selexipag bypasses hepatic metabolism, requiring a 12.5% higher dose compared to the oral form to achieve similar therapeutic effects. It is administered via IV infusion twice daily over 80 minutes, typically for short-term use. However, caution is needed when prescribing selexipag to patients with hepatic or renal issues, and it is contraindicated with strong CYP2C8 inhibitors. A Phase III clinical trial confirmed that switching between oral and IV selexipag was safe, with comparable efficacy and tolerability, though it was limited by small sample size and short duration. Given the risks of treatment interruption and the complexity of managing PAH, this review provides essential insights into the practical use of IV selexipag as a bridging therapy. Furthermore, it calls for larger clinical trials to refine dosing strategies, explore long-term outcomes, and identify patient populations most likely to benefit from IV selexipag.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"55-60"},"PeriodicalIF":2.8,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11733194/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012170","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":"Chronic Rhinosinusitis with Nasal Polyps and Biologics: A Call for Better Data Standardisation and Presentation in Clinical Studies.","authors":"Harsha Hemantha Kariyawasam, Dean Langan, Joanne Rimmer","doi":"10.2147/TCRM.S467250","DOIUrl":"10.2147/TCRM.S467250","url":null,"abstract":"<p><p>Chronic rhinosinusitis with nasal polyps (CRSwNP) is often severe, debilitating and difficult to treat. Recent randomised control trials (RCTs) of biologics that target key inflammatory pathways have demonstrated clinical efficacy in treating CRSwNP. Such RCTs must facilitate meta-analysis. Here we report the need for urgent improvement in double-blind randomised controlled trials of biologics in CRSwNP, having previously undertaken a systematic review and meta-analysis of such studies. The RCTs included in that systematic review did not conform to a standard study design. Patient selection criteria was not consistent in studies with several heterogeneous disease subgroups of CRSwNP patients present in each study. Different durations of treatment and variable outcome measures also made the comparative assessment of efficacy between different biologics difficult. Data presentation to allow extraction for meta-analysis was not always clear, such that on occasion selected data sets or even an entire RCT had to be excluded from further evaluation. As such, the high heterogeneity between studies made the overall interpretation of the findings difficult. We make an urgent call to design and conduct future RCTS of biologics in CRSwNP in a more standardised manner, and to present data in a clear way that is easily extractable. This will facilitate more inclusive and thus robust evaluation and interpretation via meta-analysis, which will in turn enable clearer insight into which CRSwNP patient subgroups might benefit from specific biologics and thus achieve better clinical outcomes.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"27-34"},"PeriodicalIF":2.8,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972246","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":"Thyroid Dysfunction After Intensity-Modulated Radiotherapy and PD⁃1 Inhibitor Treatment for Locally Advanced Nasopharyngeal Carcinoma.","authors":"Kai Shang, Qianyong He, Xinyu Xu, Xunyan Luo, Chaofen Zhao, Lina Liu, Zhuoling Li, Yuanyuan Li, Feng Jin","doi":"10.2147/TCRM.S489899","DOIUrl":"10.2147/TCRM.S489899","url":null,"abstract":"<p><strong>Purpose: </strong>Analyze the incidence and risk factors of thyroid dysfunction in patients with advanced nasopharyngeal carcinoma (LA-NPC) after intensity-modulated radiotherapy (IMRT) and PD⁃1 inhibitor treatment and their relationship with treatment efficacy and prognosis.</p><p><strong>Methods: </strong>Eighty-five LA-NPC patients treated with IMRT and PD-1 inhibitors were retrospectively collected from March 1, 2019, to May 30, 2022. The incidence of thyroid dysfunction after combination therapy was analyzed. The Kaplan-Meier method was used to analyze the relationship between thyroid dysfunction and patient prognosis. Logistic regression analysis was used to screen independent risk factors for thyroid dysfunction.</p><p><strong>Results: </strong>As of data cutoff (May 31, 2024), the median follow-up time was 27.8 months (range: 25.6 to 32.0 months). The median time of onset of thyroid dysfunction was 8.26 months. The incidence of thyroid dysfunction is 47.06% (40/85), with clinical hypothyroidism being the main cause at an incidence rate of 28.24% (24/85) and clinical hyperthyroidism at an incidence rate of 3.53% (3/85). The incidence of grade 1 thyroid immune-related adverse events (irAEs) was 29.41% (25/85), and the incidence of grade 2 thyroid irAEs was 17.65% (15/85). Patients with thyroid dysfunction had longer overall survival, progression-free survival, and distant metastasis-free survival at both one and two years compared to patients with normal thyroid function, but the difference was not statistically significant (p > 0.05). Multivariate logistic regression analysis showed that pretreatment lactate dehydrogenase (LDH) (p = 0.079) is an independent predictor of thyroid dysfunction after radiotherapy in combination with immunotherapy for LA-NPC.</p><p><strong>Conclusion: </strong>The study found that the addition of immunotherapy increases the risk and shortens the onset time of thyroid dysfunction in LA-NPC patients treated with chemoradiotherapy. Pretreatment LDH may serve as an independent risk factor for thyroid dysfunction for LA-NPC patients.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"15-25"},"PeriodicalIF":2.8,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972248","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 Prognostic Molecular Phenotype and Clinical Characterization in Grade III Diffuse Gliomas Treatment with Radio-Chemotherapy.","authors":"Weiguo Gu, Jiaming Tang, Penghui Liu, Jinyu Gan, Jianfei Lai, Jinbiao Xu, Jianxiong Deng, Chaoxing Liu, Yuhua Wang, Guohua Zhang, Feng Yu, Chao Shi, Ke Fang, Feng Qiu","doi":"10.2147/TCRM.S478905","DOIUrl":"10.2147/TCRM.S478905","url":null,"abstract":"<p><strong>Background: </strong>The relationship between molecular phenotype and prognosis in high-grade gliomas (WHO III and IV, HGG) treated with radiotherapy and chemotherapy is not fully understood and needs further exploration.</p><p><strong>Methods: </strong>The HGG patients following surgery and treatment with radiotherapy and chemotherapy. Univariate and multivariate Cox analyses were used to assess the independent prognostic factors. The nomogram model was established, and its accuracy was determined via the calibration plots.</p><p><strong>Results: </strong>A total of 215 and 88 patients had grade III glioma and grade IV glioma, respectively. Grade III oligodendroglioma (OG-G3) patients had the longest mPFS and mOS than other grade III pathology, while grade III astrocytoma (AA-G3) patients were close to IDH-1 wildtype glioblastoma (GBM) and had a poor prognosis. The IDH-1 mutant group had a better mPFS and mOS than the IDH-1 wildtype group in all grade III patients, OG-G3 and AA-G3 patients. Furthermore, 1p/19q co-deletion group had a longer mPFS and mOS than 1p/19q non-deletion group in all grade III patients. IDH-1 mutation and 1p/19q co-deletion patients had the best prognosis than other molecular types. Also, the MGMT methylation and IDH-1 mutation or 1p/19q co-deletion group had a longer mPFS and mOS than the MGMT unmethylation and IDH-1 wildtype or 1p/19q non-codeletion of grade III patients. In addition, the low Ki-67 expression group had a better prognosis than high Ki-67 expression group in grade III patients. Univariate and multivariate COX showed that 1p/19q co-deletion and MGMT methylation were the independent prognostic factors for mPFS and mOS. The calibration curve showed that the established nomogram could well predict the survival based on these covariates.</p><p><strong>Conclusion: </strong>The AA-G3 with IDH-1 wildtype, MGMT unmethylation or 1p/19q non-codeletion patients was resistant to radiotherapy and chemotherapy, has a poor prognosis and needs a more active treatment.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"35-53"},"PeriodicalIF":2.8,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11721490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972247","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":"Environmental PM_2.5 Exposure: An Ignored Factor Associated with Blood Cadmium Level in Hemodialysis Patients.","authors":"Ching-Wei Hsu, Ming-Jen Chan, Cheng-Hao Weng, Tsung-Yu Tsai, Tzung-Hai Yen, Wen-Hung Huang","doi":"10.2147/TCRM.S496491","DOIUrl":"https://doi.org/10.2147/TCRM.S496491","url":null,"abstract":"<p><strong>Background: </strong>The negative impacts of particulate matter with an aerodynamic diameter of 2.5 μm or less (PM_2.5) are well known. Patients undergoing maintenance hemodialysis (HD) have significantly higher blood cadmium levels (BCLs) than healthy individuals. As elemental cadmium can be found in the PM_2.5 particle fraction, we conducted this study to assess the effect of environmental PM_2.5 exposure and other clinical variables on BCLs in maintenance HD patients.</p><p><strong>Patient and methods: </strong> This cross-sectional study included 754 hD patients who had previously participated in a BCL study. Demographic, hematological, biochemical and dialysis-related data were collected for analysis. For each patient, the mean PM_2.5 concentrations in the living environment during the previous 12 and 24 months were recorded and analyzed.</p><p><strong>Results: </strong>Of all patients, the median BCL of was 0.36 µg/L (range: 0.21, 0.79 µg/L). The mean PM_2.5 concentration was 28.45 ± 3.57 μg/m³ during the 12 months and 29.81 ± 3.47 μg/m³ during the 24 months, respectively. From a multivariate linear regression analysis, log BCL was positively associated with the mean PM_2.5 concentration during the previous 12 and 24 months. In addition, log BCL was positively associated with the number of days with PM_2.5 concentrations above the standard level during the previous 12 and 24 months. Moreover, according to the tertiles of days with a daily mean PM_2.5 concentration above the normal limit in the previous 24 months, patients with the highest exposure days exhibited a significantly higher BCL than those in the other two patient groups.</p><p><strong>Conclusion: </strong>Chronic environmental exposure to PM_2.5 is significantly associated with BCLs in maintenance HD patients, and exposure to PM_2.5-bound cadmium may contribute to the harmful effects on health in this population. Further studies are needed to confirm these observations and to explore the underlying mechanisms.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"21 ","pages":"1-13"},"PeriodicalIF":2.8,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11706018/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955459","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":"Factors Associated with Recurrent Emergency Department Visits for Epistaxis in Adults, Cross Sectional Study in Two Tertiary Care Hospitals in Riyadh, Saudi Arabia.","authors":"Mohammed Alghofili, Bader Alwhaibi, Abdullah Mohammed Alassaf, Omar Wahaf Aldhasee, Nawfal Aljerian, Nawaf Alsubaie, Ahmed Alhussien, Saad Alsaleh","doi":"10.2147/TCRM.S480084","DOIUrl":"10.2147/TCRM.S480084","url":null,"abstract":"<p><strong>Introduction and objectives: </strong>This study aimed to investigate the prevalence of recurrent and active epistaxis in adult patients presenting to the Emergency Department (ED) and explored the association of recurrent epistaxis with demographic characteristics, comorbidities and medications, and types of emergency interventions in adult epistaxis patients.</p><p><strong>Methods: </strong>A retrospective cross-sectional study was conducted with data from Eds of two tertiary hospitals over three years, from January 2019 to January 2022. All adult patients aged ≥18 years with active epistaxis not resolved by pressure on the nose or head positioning were included. Demographic data, details of clinical presentation and clinical management were collected from the patient's electronic medical records.</p><p><strong>Results: </strong>Of 404 patients, 73 (18.1%) revisited the ED with recurrence of epistaxis within 28 days. There was a male predilection in the study, with an average age of 55.4 ± 18.03. Most patients had unilateral (n = 328, 81.2%) and anterior (n = 376, 93.1%) nasal bleeding. Heart failure as a comorbidity was associated with a significantly increased risk of recurrent epistaxis (p = 0.001). The most common treatments included expandable polyvinyl acetate packs (EPAP) (n = 198, 49%); topical xylometazoline (n = 108, 26.7%); and chemical cautery (n = 57, 14.1%). EPAP for controlling initial bleeding was significantly associated with ED revisits due to epistaxis (p = 0.033).</p><p><strong>Conclusion: </strong>The prevalence of recurrent epistaxis mostly occurs in older-aged males. Congestive heart failure may be an under-recognised risk factor for recurrent epistaxis. In patients with a high risk of epistaxis recurrence, other treatment modalities should be sought aside from expandable polyvinyl acetate packs as they can increase the risk of rebleeding.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"20 ","pages":"955-962"},"PeriodicalIF":2.8,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11694024/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142923203","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":"Intra-Articular Platelet-Rich Plasma versus Hyaluronic Acid in the Treatment of Hip Osteoarthritis: A Cross-Sectional Analysis of the Overlapping Systematic Reviews.","authors":"Shi Yin, Xiyan Zhao, Tian Li, Xingxuan Li, Zongjun Xie, Hao Tang, Yi Wang, Zhiwei Jia, Tianlin Wen, Yaohong Wu","doi":"10.2147/TCRM.S487948","DOIUrl":"10.2147/TCRM.S487948","url":null,"abstract":"<p><strong>Purpose: </strong>The debate over the effectiveness of platelet-rich plasma (PRP) versus hyaluronic acid (HA) in treating hip osteoarthritis (HOA) continues. This cross-sectional analysis of overlapping systematic reviews aims to evaluate the efficacy of intra-articular PRP compared to HA for HOA treatment. The goal is to guide decision-makers in selecting the most reliable systematic reviews and to provide treatment recommendations based on the best available evidence.</p><p><strong>Methods: </strong>We conducted comprehensive searches of PubMed, EMBASE, and Cochrane Library databases to identify systematic reviews comparing intra-articular PRP and HA for HOA treatment. The methodological quality of these reviews was assessed, and relevant data were extracted. The Jadad algorithm was applied to determine which reviews provided the most robust evidence.</p><p><strong>Results: </strong>Five systematic reviews were included, all categorized as Level-II evidence. The Assessment of Multiple Systematic Reviews scores ranged from 4 to 9, with a median score of 8. A high-quality systematic review was chosen according to the Jadad algorithm. It is suggested that there were no significant differences observed in the improvement of any short-term outcome scores (mean follow-up of 12.2 months for PRP, 11.9 months for HA), including the Western Ontario and McMaster Universities Osteoarthritis Index, the Visual Analog Scale for pain, and the Harris Hip Score, from pre-injection to post-injection between the groups.</p><p><strong>Conclusion: </strong>There is inconsistency among the conclusions of the overlapping systematic reviews comparing intra-articular PRP and HA for HOA treatment. The best evidence indicates that PRP and HA injections yield similar short-term clinical benefits for patients with HOA. Further studies with larger sample sizes and longer follow-up periods are needed to provide more definitive conclusions.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"20 ","pages":"919-927"},"PeriodicalIF":2.8,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11687311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915594","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":"Adoption of Digital Therapeutics in Europe.","authors":"Amelie Fassbender, Shaantanu Donde, Mitchell Silva, Adriano Friganovic, Alessandro Stievano, Elisio Costa, Tonya Winders, Joris van Vugt","doi":"10.2147/TCRM.S489873","DOIUrl":"10.2147/TCRM.S489873","url":null,"abstract":"<p><p>Digital therapeutics (DTx) are an emerging medical therapy comprising evidence-based interventions that are regulatory approved for patient use, or are under development, for a variety of medical conditions, including hypertension, cancer, substance use disorders and mental disorders. DTx have significant potential to reduce the overall burden on healthcare systems and offer potential economic benefits. There is currently no specific legal regulation on DTx in the EU. Although European countries have similar approaches to digital health solutions, the adoption of DTx varies across the continent. The aim of this narrative review is to discuss the levels of adoption of DTx in Europe, and to explore possible strategies to improve adoption, with the goal of higher rates of adoption, and more consistent use of DTx across the continent. The article discusses the regulatory and reimbursement landscape across Europe; validation requirements for DTx, and the importance of co-design and an ecosystem-centric approach in the development of DTx. Also considered are drivers of adoption and prescription practices for DTx, as well as patient perspectives on these therapeutics. The article explores potential factors that may contribute to low rates of DTx adoption in Europe, including lack of harmonisation in regulatory requirements and reimbursement; sociodemographic factors; health status; ethical concerns; challenges surrounding the use and validation of AI; knowledge and awareness among healthcare professionals (HCPs) and patients, and data standards and interoperability. Efforts to improve rates of access to DTx and adoption of these therapeutics across Europe are described. Finally, a framework for improved uptake of DTx in Europe is proposed.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"20 ","pages":"939-954"},"PeriodicalIF":2.8,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11687304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915592","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 Factors for Digital Replantation Failure: A Nomogram Prediction Model.","authors":"Tianhao Guo, Tao Ma, Ruijiao Gao, Kunlun Yu, Jiangbo Bai","doi":"10.2147/TCRM.S498528","DOIUrl":"10.2147/TCRM.S498528","url":null,"abstract":"<p><strong>Study design: </strong>A Retrospective study.</p><p><strong>Objective: </strong>Digital necrosis (DN) after replantation can cause some serious complication. Few articles focused on the risk factors of DN; therefore, we aim to investigate the risk factors of necrosis after multiple digital replantation.</p><p><strong>Methods: </strong>We collected the data of patients receiving multiple digital replantation in our hospital between Jan. 2017 and Jan. 2024. Based on the necrosis or not after replantation, patients with DN were as necrosis group (NG), and patients without DN were as success group (SG). The demographics, comorbidities, and admission laboratory examinations of patients were computed by univariate analysis, logistic regression analysis, and receiver operating characteristic (ROC) curve analysis. We then construct a nomogram prediction model, plot ROC curves, calibration curves, and DCA decision curves using R language software.</p><p><strong>Results: </strong>The survival rate in our study was 83.7% (278 of 332). Univariate analysis indicated that there were significant differences in the level of D-dimer, white blood cell, neutrophil, monocyte, monocyte-to-lymphocyte ratio, systemic immune-inflammation index, system inflammation response index, C-reactive protein (CRP), neutrophils/high density lipoprotein (HDL), monocytes/HDL were significantly higher in NG than in SG. However, logistic regression analysis showed that D-dimer and CRP were independent risk factors of DN, and we identified their cut-off values. Then, we constructed a nomogram prediction model with 0.7538 in AUC of the prediction model with good consistency in the correction curve and good clinical practicality by decision curve analysis.</p><p><strong>Conclusion: </strong>The level of D-dimer and CRP was found to be closely related to DN. We constructed a nomogram prediction model that can effectively predict DN in patients with multiple digital replantation.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"20 ","pages":"929-937"},"PeriodicalIF":2.8,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11687301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142915595","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":"Efficacy and Safety of Tranexamic Acid on Hidden Blood Loss in Osteoporotic Vertebral Compression Fractures Patients Treated with Percutaneous Kyphoplasty: A Prospective Randomized Controlled Trial.","authors":"Zhenqi Lou, Kanling Jiang, Sanqiang Xia, Sihui Chen, Yi Jiang, Jinyu Zhu, Jieyang Zhu","doi":"10.2147/TCRM.S494728","DOIUrl":"10.2147/TCRM.S494728","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the efficacy and safety of intravenous tranexamic acid (TXA) in patients undergoing percutaneous kyphoplasty (PKP), and identify the factors influencing hidden blood loss (HBL).</p><p><strong>Methods: </strong>This randomized, placebo-controlled trial included 146 patients undergoing PKP surgery from September 2023 to July 2024. Patients were randomly assigned into the TXA group (75 patients received 1.0 g/100mL TXA intravenously) and the placebo group (71 patients received 100mL of normal saline intravenously). Demographic and clinical characteristics were comparable between groups. HBL was calculated and compared on postoperative days 1 (POD1) and 3 (POD3). Visual analog scale (VAS) scores were also recorded preoperatively and during the follow-up. Multivariate logical regression analysis identified independent risk factors for HBL.</p><p><strong>Results: </strong>The HBL in the TXA group was 183.78±115.48mL on POD 1 and 240.65±114.73mL on POD 3, which was significantly lower than the placebo group at 251.30±235.58mL on POD1 (<i>P</i>=0.032) and 384.94±223.18mL on POD3 (<i>P</i><0.001). The drop in hemoglobin in the TXA group was generally lower than that of the placebo group on POD1 (4.72±3.54 vs 7.62±8.38 g/L, <i>P</i>=0.007), but showed no significant difference on POD 3. The drop in hematocrit in the TXA group was significantly lower than that in the placebo group on POD1 (1.91±1.21% vs 2.65±2.42%, <i>P</i>=0.023) and POD3 (2.49±1.23% vs 3.92±2.09%, <i>P</i><0.001). Additionally, the VAS scores on POD1 (2.28±0.88 vs 2.82±0.98, <i>P</i><0.001) and POD3 (1.95±0.75 vs 2.25±0.69, <i>P</i>=0.011) were lower in the TXA group than in the placebo group. Multivariate logical regression analysis revealed that the use of TXA (<i>P</i><0.001), injury time (<i>P</i><0.001), number of punctures (<i>P</i>=0.004), cement leakage (<i>P</i>=0.001), and restoration of vertebral height (<i>P</i>=0.002) were significantly correlated with HBL.</p><p><strong>Conclusion: </strong>A single of 1g dose of intravenous TXA reduces HBL and early postoperative pain in PKP patients without increasing the complication rate. The use of TXA, injury time, number of punctures, cement leakage, and restoration of vertebral height were risk factors for HBL in PKP surgery. (ChiCTR2300075428).</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"20 ","pages":"907-917"},"PeriodicalIF":2.8,"publicationDate":"2024-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11683199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142907715","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}