European Journal of Clinical Pharmacology最新文献

{"title":"Drug safety during pregnancy: a challenging and ever moving field.","authors":"M Conijn, B Cuppers-Maarschalkerweerd, F O'Shaughnessy, M Berlin, U Nörby, M H M van Tuyl","doi":"10.1007/s00228-024-03793-4","DOIUrl":"10.1007/s00228-024-03793-4","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"463-464"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-drug interaction of phenytoin sodium and methylprednisolone on voriconazole: a population pharmacokinetic model in children with thalassemia undergoing allogeneic hematopoietic stem cell transplantation.","authors":"Yun Wu, Lu-Lu Niu, Ya-Yun Ling, Si-Ru Zhou, Tian-Min Huang, Jian-Ying Qi, Dong-Ni Wu, Rong-da Cai, Ting-Qing Wu, Yang Xiao, Taotao Liu","doi":"10.1007/s00228-024-03795-2","DOIUrl":"10.1007/s00228-024-03795-2","url":null,"abstract":"<p><strong>Purpose: </strong>Voriconazole (VRC) is recommended for the prevention and treatment of invasive fungal infections in children undergoing hematopoietic stem cell transplantation (HSCT). It demonstrates nonlinear pharmacokinetics (PK) and exhibits substantial inter- and intraindividual variability. Phenytoin sodium (PHT) and methylprednisolone (MP) are commonly used in the early stages of HSCT to prevent epilepsy and graft-versus-host disease. Drug-drug interactions between VRC and these medications represent a significant concern in HSCT recipients. This study aims to investigate the effects of coadministration with PHT, MP, and other covariates on VRC metabolism in children with thalassemia (TM) undergoing allogeneic HSCT (Allo-HSCT) using population pharmacokinetics (PPK) and to recommend the optimal dosage regimen for this unique group.</p><p><strong>Methods: </strong>A total of 237 samples from 57 children with TM undergoing Allo-HSCT were collected. Non-linear mixed effects modeling and Monte Carlo simulation (MCS) were applied for PPK analysis and for optimizing VRC dosing, respectively.</p><p><strong>Results: </strong>The VRC data were characterized by a two-compartment model with linear elimination and first-order absorption. All parameters were incorporated in allometric scaling form, with PHT and MP significantly influencing VRC clearance. The MCS revealed a negative correlation between the children's body weight (ranging from 10 to 40 kg) and the required dose. When PHT was co-administered, approximately three times the regular dose of VRC was required. In contrast, when MP was administered together, the dose needed to be increased by 12.5-50%.</p><p><strong>Conclusion: </strong>The proposed regimen improved the probability of target attainment for VRC and may serve as a reference for the individualized administration of VRC in clinical practice.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"365-374"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Features and results availability of non-commercial Spanish COVID-19 trials: a systematic review of clinical trial registers and corresponding literature.","authors":"Rafael Dal-Ré, Elena García-Méndez, Ignacio Mahillo-Fernández","doi":"10.1007/s00228-024-03791-6","DOIUrl":"10.1007/s00228-024-03791-6","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to characterize non-commercial Spanish COVID-19 trials and to determine the availability of results. Differences in outcomes according to the interventions assessed (medicines, non-medicines) will also be determined.</p><p><strong>Methods: </strong>This systematic review was conducted in March 2024 by searching non-commercial Spanish COVID-19 trials on four registers (EUCTR, Clinical.</p><p><strong>Trials: </strong>gov, ISRCTN, DRKS) and the WHO ICTRP. Phase-1 medicines trials were excluded. Several variables were retrieved from registers. Publication of main trial results were searched on PubMed, Cochrane COVID-19 Study Register, and Google Scholar. Journals' impact factor and articles' citations on Google Scholar were also registered. Results from medicines and non-medicines trials extracted from registers and articles were compared.</p><p><strong>Results: </strong>A total of 170 trials (57.1% medicines trials) were identified. These 170 trials were randomized (87.1%), masked (41.8%), or multicenter (39.4%); a total of 15,555 participants were enrolled, mostly in small trials (median, n = 88). Only 8.8% (15/170) of trials posted results on the registers; only 47.6% (81/170) of trials had either published results or posted them on registers. Publications accounted for 92.6% (75/81) of these. Articles were published in 56 different journals, had a median impact factor of 4.4 and a median of 10 citations. Most (58.7%, 44/75) described negative results. There were statistically significant differences (p < 0.001) between medicines and non-medicines trials on timely registration and on being multicenter. This was also the case among published trials with respect to negative results of the primary endpoint.</p><p><strong>Conclusion: </strong>Although most trials were randomized, a minority were multicenter, large, or masked. Trial results should be posted on the registers to make them accessible to everyone.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"429-439"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Population pharmacokinetic model of tranexamic acid in patients who undergo cardiac surgery with cardiopulmonary bypass.","authors":"Tsuyoshi Nakai, Takahiro Tamura, Yasuhiro Miyagawa, Takayuki Inagaki, Masato Mutsuga, Shigeki Yamada, Kiyofumi Yamada, Kimitoshi Nishiwaki, Hiroyuki Mizoguchi","doi":"10.1007/s00228-025-03802-0","DOIUrl":"10.1007/s00228-025-03802-0","url":null,"abstract":"<p><strong>Purpose: </strong>Tranexamic acid (TXA) is widely used as an antifibrinolytic drug. However, studies to determine the optimal blood concentration of TXA have produced inconsistent results. During cardiac surgery, cardiopulmonary bypass (CPB) has serious effects on drug distribution, elimination, and plasma concentration. Therefore, we aimed to establish a population pharmacokinetics model of TXA in patients undergoing cardiac surgery with CPB that considers renal function as a covariate, thereby facilitating personalized treatment.</p><p><strong>Methods: </strong>In total, 453 TXA plasma samples were prospectively collected from 77 patients who underwent cardiac surgery with CPB. Plasma concentrations were determined by ultra-performance liquid chromatography-tandem mass spectrometry. The population pharmacokinetic model of TXA was analyzed using nonlinear mixed-effects modeling.</p><p><strong>Results: </strong>The two-compartment-based model with combined errors was determined as the best. The final model included the effect of bodyweight and CL_cr may be summarized as V₁ (L) = 12.77 × (bodyweight / 61.4)^0.911, V₂ (L) = 6.857, CL₁ (L/h) = 3.263 × [CL_cr (L/h) / 61.0]^0.752, CL₂ (L/h) = 2.859.</p><p><strong>Conclusion: </strong>Patients who undergo cardiac surgery with CPB may require an adjusted dose of TXA tailored to CPB due to lower CL₁ and increased V₁. Our TXA population pharmacokinetic model may be useful for developing individualized dosing designs for TXA in patients who undergo cardiac surgery with CPB.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"441-449"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11825552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002533","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":"Estimated equipotent conversion ratios of morphine, sufentanil and fentanyl as continuous infusion in neonatal intensive care units: a pharmacoepidemiologic cohort study.","authors":"Manon Tauzin, Inès Cavalier, Matthieu Ortala, Camille Jung, Béatrice Gouyon, Xavier Durrmeyer","doi":"10.1007/s00228-024-03796-1","DOIUrl":"10.1007/s00228-024-03796-1","url":null,"abstract":"<p><strong>Purpose: </strong>Opioids are frequently used to treat pain in neonatal intensive care units (NICU) with fentanyl, morphine and sufentanil being mainly used agents. Equianalgesic potency between opioids is not clearly described in the neonatal population. The aim of this study was to compare theoretical and actual equipotent conversion ratios between morphine, sufentanil and fentanyl based on prescriptions.</p><p><strong>Methods: </strong>In this observational, multicentric, pharmacoepidemiologic study, prescriptions' data (doses, duration of use, patients' characteristics) were collected and analyzed for all neonates hospitalized in one of the 30 Level III French NICUs using the same prescription software (Logipren®) and who received at least one prescription of morphine, sufentanil or fentanyl as continuous infusion during a 6-year period (2014-2020).</p><p><strong>Results: </strong>Among 65,555 neonates, 8361 (12.8%) received a prescription of continuous opioid infusion in one of the 30 French NICUs: 5054 (60.4%) received sufentanil, 2413 (28.9%) morphine and 894 (10.7%) fentanyl. After conversion to equipotent morphine doses using theoretical conversions ratios of 50:1 for morphine/fentanyl ratio and 500:1 for morphine/sufentanil ratio, prescribed mean maintenance doses of fentanyl and sufentanil were two times and five times higher than morphine doses, respectively. In this cohort, potency conversion ratios between the different opioids were 20:1 for morphine/fentanyl ratio and 100:1 for morphine/sufentanil ratio, and 4:1 for fentanyl/sufentanil ratio (theoretical conversion ratio of 7: 1).</p><p><strong>Conclusion: </strong>In a large cohort of neonates treated with continuous opioids in NICU, fentanyl and sufentanil doses used were significantly higher than morphine doses when using theoretical conversion ratios.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"375-381"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of obesity with ropivacaine and sufentanil EC50 in labor analgesia: a single-center prospective study.","authors":"Zunyi Liu, Xuelan Zhou, Jiang Zhu","doi":"10.1007/s00228-024-03800-8","DOIUrl":"10.1007/s00228-024-03800-8","url":null,"abstract":"<p><strong>Objective: </strong>In part I, measure the EC50 of sufentanil in obese and non-obese parturients combined with 0.1% ropivacaine and compare the differences. Similarly, in part II, measure the EC50 of ropivacaine in obese and non-obese parturients combined with 0.5 µg/ml sufentanil and compare the differences.</p><p><strong>Methods: </strong>This study comprises two parts, with an initial intention to enroll 120 full-term primiparous women who underwent vaginal delivery and sought epidural analgesia. Each part includes an obese group (OA group, Obese Adults, defined as prepartum BMI≥29 kg/m²) and a non-obese group (CON group, Control group, defined as 18.5<prepartum BMI<28 kg/m²), with 30 participants in each. Both parts, for both obese and non-obese women, utilized an initial concentration of 0.1% ropivacaine with 0.5 µg /ml sufentanil. The initial concentration of sufentanil is 0.5 µg/ml. When the NRS score is ≤3 within 30min after analgesia, it is considered effective analgesia, and the concentration of sufentanil in the next parturients decreases by 0.05 µg/ml. Otherwise, the concentration of sufentanil in the next parturient will increase by 0.05 µg/ml. The second part uses the same method to measure the EC50 of ropivacaine (increase or decrease by 0.01%) in the OA group and CON group combined with 0.5 µg/ml sufentanil, with 30 participants in each group. EC50 measurements were performed through up-and-down sequential allocation, with effective analgesia defined as an NRS score ≤3, 30 min post-analgesia.</p><p><strong>Results: </strong>In part I, the EC50 of epidural sufentanil in the OA group was 0.090 µg/ml (95% CI, 0.061~0.115µg/ml), and in the CON group, it was 0.170µg/ml (95% CI, 0.117~0.219µg/ml). In part II, the EC50 of epidural ropivacaine in the OA group was 0.048% (95% CI, 0.041~0.053%), and in the CON group, it was 0.070% (95% CI, 0.064~0.075%). The secondary outcomes in both parts of the study showed no statistically significant differences.</p><p><strong>Conclusion: </strong>Obese parturients exhibited significantly lower EC50 values for ropivacaine and sufentanil compared to non-obese parturients. Lower concentrations of both agents can be considered for labor analgesia in obese parturients.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"419-428"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validating the accuracy of mathematical model-based pharmacogenomics dose prediction with real-world data.","authors":"Yolande Saab, Zahi Nakad","doi":"10.1007/s00228-025-03805-x","DOIUrl":"10.1007/s00228-025-03805-x","url":null,"abstract":"<p><strong>Objective: </strong>The study aims to verify the usage of mathematical modeling in predicting patients' medication doses in association with their genotypes versus real-world data.</p><p><strong>Methods: </strong>The work relied on collecting, extracting, and using real-world data on dosing and patients' genotypes. Drug metabolizing enzymes, i.e., cytochrome CYP 450, were the focus. A total number of 1914 subjects from 26 studies were considered, and CYP2D6 and CYP2C19 gene polymorphisms were used for the verification.</p><p><strong>Results: </strong>Results show that the mathematical model was able to predict the reported optimal dosing of the values provided in the considered studies. Predicting patients' optimal doses circumvents trial and error in patients' treatments.</p><p><strong>Discussion: </strong>The authors discussed the advantages of using a mathematical model in patients' dosing and identified multiple issues that would hinder the usability of raw data in the future, especially in the era of artificial intelligence (AI). The authors recommend that researchers and healthcare professionals use simple descriptive metabolic activity terms for patients and use allele activity scores for drug dosing rather than phenotype/genotype classifications.</p><p><strong>Conclusion: </strong>The authors verified that a mathematical model could assist in providing data for better-informed decision-making in clinical settings and drug research and development.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"451-462"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacogenetics of opioid medications for relief of labor pain and post-cesarean pain: a systematic review and meta-analysis.","authors":"Martina Giacon, Sarah Cargnin, Maria Talmon, Salvatore Terrazzino","doi":"10.1007/s00228-024-03798-z","DOIUrl":"10.1007/s00228-024-03798-z","url":null,"abstract":"<p><strong>Objective: </strong>Several studies have attempted to identify genetic determinants of clinical response to opioids administered during labor or after cesarean section. However, their results were often contrasting. A systematic review and meta-analysis was conducted to quantitatively assess the association between gene polymorphisms and clinical outcomes of opioid administration in the treatment of labor pain and post-cesarean pain.</p><p><strong>Methods: </strong>A comprehensive search was performed up to December 2023 using PubMed, Web of Knowledge, Cochrane Library, and OpenGrey databases. The clinical endpoints of interest were pain score after opioid treatment, total opioid consumption, patient's analgesic satisfaction, and incidence of opioid side effects. Random-effects meta-analyses were conducted when data were available in at least three studies.</p><p><strong>Results: </strong>Twenty-six studies enrolling 7765 patients were included in the systematic review. Overall, a total of 12 candidate polymorphic genes (OPRM1, COMT, CYP2D6, CYP3A4, ABCB1, ABCC3, UGT2B7, CGRP, OPRK1, OPRD1, KCNJ6, KCNJ9) were considered by the included studies, among which the most investigated variant was OPRM1 rs1799971. Overall pooled results indicated that individuals carrying the G allele of OPRM1 rs1799971 required higher opioid doses for pain management in comparison to rs1799971 AA subjects (standardized mean difference: 0.26; 95% CI: 0.09-0.44; P = 0.003). Such an association was confirmed in the subgroups of patients with labor pain and post-cesarean pain.</p><p><strong>Conclusion: </strong>The present meta-analysis provides strong evidence of an association between OPRM1 rs1799971 and opioid dose requirement for relief of labor pain or post-cesarean pain. However, given the insufficient evidence for other polymorphic gene variants, large studies are still needed to investigate the impact of genetic variability on the efficacy and safety of opioid medications for relief of labor pain and post-cesarean pain (INPLASY Registration No. 202410040).</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"403-417"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11825576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946737","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":"Is nivolumab alone or in combination with ipilimumab more effective for treating lung cancer? a meta-analysis.","authors":"Qasi Najah, Nereen A Almosilhy, Thoria Ibrahim Essa Ghanm","doi":"10.1007/s00228-024-03789-0","DOIUrl":"10.1007/s00228-024-03789-0","url":null,"abstract":"<p><strong>Background: </strong>Nivolumab and ipilimumab combination immunotherapy has become a standard treatment option for certain cancers. However, the benefits of combination therapy compared to nivolumab monotherapy in lung cancer patients are not entirely clear. We aimed to evaluate whether nivolumab plus ipilimumab improves clinical outcomes in lung cancer patients compared to nivolumab monotherapy.</p><p><strong>Methods: </strong>A literature search was performed on PubMed, Web of Science, and Scopus from inception until November 2024 to identify relevant randomized controlled trials. The Cochrane risk of bias tool was used to assess the risk of bias, the hazard ratio (HR) was calculated for survival, risk ratios (RRs) were calculated for response rate and safety outcomes, and a random effects model meta-analysis was performed to estimate the safety and efficacy of the treatments.</p><p><strong>Results: </strong>Seven trials comprising 2134 patients were included. Compared with patients receiving nivolumab monotherapy, non-small cell lung cancer patients who received combination therapy had better progression-free survival (HR = 0.82, 95% CI 0.71; 0.93, P < 0.01, low certainty), and there were no significant differences in overall survival (HR = 0.95, 95% CI 0.86; 1.0, P = 0.31, moderate certainty), or objective response rate (RR = 1.36, 95% CI 0.91; 2.02, P = 0.14 very low certainty). The combination group had a significantly greater risk of grade 3-4 adverse events (RR = 2.77, 95% CI 1.38; 5.56, P < 0.01, low certainty).</p><p><strong>Conclusion: </strong>Although combination treatment significantly improved progression-free survival in NSCLC patients, it was also associated with a greater risk of adverse events and treatment-related mortality than nivolumab monotherapy. The current evidence is insufficient for choosing combination treatment over nivolumab monotherapy.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"269-278"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advances in the study of nebulized tranexamic acid for pulmonary hemorrhage.","authors":"Ping Zhang, Jiaoni Zheng, Xuefeng Shan, Bo Zhou","doi":"10.1007/s00228-024-03784-5","DOIUrl":"10.1007/s00228-024-03784-5","url":null,"abstract":"<p><strong>Purpose: </strong>Pulmonary hemorrhage is a life-threatening condition characterized by blood leakage into lung tissues, leading to severe respiratory distress. Nebulized tranexamic acid (TXA) has emerged as a promising treatment option for pulmonary hemorrhage due to its localized hemostatic effects and minimal systemic side effects. This review aims to summarize the research progress on the effectiveness and safety of nebulized TXA in pulmonary hemorrhage.</p><p><strong>Methods: </strong>A comprehensive search of the Embase, PubMed, and Scopus databases was conducted to identify relevant studies published between the date of inception of each database and November 2023. A comprehensive search was conducted in the PubMed, Embase, Scopus, and Google Scholar databases using the following keywords: \"hemoptysis,\" \"haemoptysis,\" \"pulmonary hemorrhage,\" \"tranexamic acid,\" \"antifibrinolytic,\" \"nebulize,\" and \"inhale.\" Additional articles were identified by reviewing the references of the retrieved studies. Studies were selected based on their focus on the application of nebulized TXA for pulmonary hemorrhage. The authors and dates of publication, study type, patients, diseases, intervention and main outcomes of these papers are tabulated. This consisted of two randomized controlled trials (RCTs), six case series, and nine case reports.</p><p><strong>Results: </strong>The commonly used dosage of nebulized TXA in the studies reviewed was 500 mg/5 ml, administered 3-4 times daily. Evidence suggests that nebulized TXA effectively controls bleeding in pulmonary hemorrhage with a hemostatic efficacy comparable to systemic administration, but with a lower risk of venous thrombosis. Safety data indicates that nebulized TXA is generally well-tolerated, with no significant systemic adverse reactions reported. Local reactions, such as bronchospasm, were rare and resolved with short-term bronchodilator treatment.</p><p><strong>Conclusion: </strong>Nebulized TXA appears to be an innovative and minimally invasive therapy for pulmonary hemorrhage, providing targeted hemostatic effects with a favorable safety profile. However, the predominance of small-scale studies and case reports highlights the need for large-scale, high-quality research to establish standardized guidelines.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"237-246"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11717782/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754896","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}