European Journal of Clinical Pharmacology最新文献

{"title":"Correction to: Effects of an intraoperative intravenous Bolus Dose of Dexmedetomidine on postoperative catheter-related bladder discomfort in male patients undergoing transurethral resection of bladder tumors: a randomized, double-blind, controlled trial.","authors":"Tianhua Zhang, Huiting Li, Chunnan Lin, Rui An, Wenqian Lin, Hongying Tan, Longhui Cao","doi":"10.1007/s00228-024-03768-5","DOIUrl":"10.1007/s00228-024-03768-5","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"181"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460943","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":"Olaparib-associated toxicity in cancer patients: a systematic review and meta-analysis.","authors":"Wenfang Jin, Qing Yang, Zhifeng Zhang, Jing Li","doi":"10.1007/s00228-024-03771-w","DOIUrl":"10.1007/s00228-024-03771-w","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the characteristics of olaparib-associated adverse events (AEs) in cancer patients.</p><p><strong>Methods: </strong>Databases were searched for phase II and III randomized controlled trials (RCTs) involving olaparib treatment up to March 2024. A systematic assessment was performed.</p><p><strong>Results: </strong>Twenty-seven RCTs involving 9542 patients were included. This meta-analysis indicates that olaparib could significantly increase the risk of developing any all-grade (RR, 1.08; 95% CI, 1.03-1.13; p = 0.001) and high-grade (RR, 1.45; 95% CI, 1.19-1.77; p = 0.0003) AEs in cancer patients. Olaparib could increase the risk of dose reduction (RR, 3.00; 95% CI, 1.59-5.70; p = 0.0007) and treatment discontinuation (RR, 2.00; 95% CI, 1.28-3.14; p = 0.002). Hematologic toxicities and gastrointestinal toxicities commonly occur in patients receiving olaparib. Anemia, nausea, and fatigue were the most frequent AEs, with olaparib increasing the risk of both all-grade and high-grade occurrences of these events. Patients with longer treatment durations tend to have a higher risk of anemia. Patients with urinary system tumors tend to have a higher risk of nausea, while those with breast cancer tend to have a higher risk of fatigue. Olaparib maintenance therapy may be associated with a higher risk of fatigue. Olaparib could increase other AEs such as diarrhea, vomiting, decreased appetite, dyspepsia, dysgeusia, dizziness, headache, back pain, urinary tract infection, dyspnea, and cough.</p><p><strong>Conclusion: </strong>Olaparib-containing therapy could increase the occurrence of specific AEs in patients with cancer. Clinicians should be aware of these risks and conduct regular monitoring.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"65-81"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582088","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":"Assessment of severity and avoidability of adverse drug reactions in neonates: a reproducibility study of the Hartwig tool and LAAT.","authors":"Ramon Weyler Leopoldino, Luan Carvalho Assunção Rocha, Flávia Evelyn Medeiros Fernandes, Haline Tereza Matias de Lima Costa, Letícia Martins Pereira Vale, Antonio Gouveia Oliveira, Rand Randall Martins","doi":"10.1007/s00228-024-03765-8","DOIUrl":"10.1007/s00228-024-03765-8","url":null,"abstract":"<p><strong>Objective: </strong>Tools for classifying adverse drug reactions (ADRs) have not yet been validated in the context of the neonatal intensive care unit (NICU). The study aims to investigate the inter-rater reliability of the Hartwig tool and the Liverpool avoidability assessment tool (LAAT) in assessing the severity and avoidability of ADR cases in hospitalized neonates.</p><p><strong>Methods: </strong>An observational and prospective study was conducted in the NICU of a maternity hospital in Natal, Brazil. The Hartwig tool and LAAT were employed to assess the severity and avoidability of ADRs, respectively. Three experienced clinical pharmacists independently assessed all ADR cases. Inter-rater reliability was measured using Cohen's kappa coefficient (k) with corresponding 95% confidence intervals (CI).</p><p><strong>Results: </strong>Among 79 ADR cases, the mean gestational age was 29.7 ± 4.4 weeks, and the birth weight averaged 1446.0 ± 1179.3 g. The assessment of ADR severity using the Hartwig tool revealed a significant overall correlation (overall k = 0.573; 95% CI 0.395 to 0.753) with exact agreement (EA) and extreme disagreement (ED) rates between evaluators of 86.5% and 2.5%, respectively. However, no statistically significant correlation was observed for determining avoidability using the LAAT (overall k = 0.017; 95% CI - 0.048 to 0.082), with an EA rate of 83.6% and ED rate of 10.1%.</p><p><strong>Conclusion: </strong>The Hartwig tool demonstrates good reproducibility among different evaluators in determining the severity of ADRs, unlike the LAAT for assessing avoidability.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"123-127"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460942","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":"Use of dipyrone during pregnancy and risk of congenital anomalies: a systematic review.","authors":"Karine Duarte Curvello, Helana Ortiz Garcia, Tatiana da Silva Sempé, Raimunda Alyne Maciel Feitosa da Silva, Luana Giongo Pedrotti, Fernanda Sales Luiz Vianna, Tatiane da Silva Dal Pizzol","doi":"10.1007/s00228-024-03769-4","DOIUrl":"10.1007/s00228-024-03769-4","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to summarize the evidence on the teratogenic effects of dipyrone used during pregnancy.</p><p><strong>Methods: </strong>Databases (MEDLINE, EMBASE, Cochrane Library, CINAHL, Web of Science, Lilacs, SciELO, SCOPUS, OasisBR, and OpenGray) were reviewed until September 2023. We included studies that compared pregnant women who used dipyrone during any gestational period with those who used other analgesics or did not use any analgesics during the same gestational period. The outcome assessed was the presence of any congenital anomaly. Two reviewers independently conducted the review process, and a third reviewer resolved any disagreements. The risk of bias was assessed using the Joanna Briggs Institute tool for observational studies. The reviewed data synthesis is presented in narrative form.</p><p><strong>Results: </strong>The search retrieved 2045 results, of which seven studies were included in the review, four were case‒control studies, and three were cohort studies involving 153,562 participants. The congenital anomalies evaluated varied across studies, with unspecified congenital anomalies predominating. Five of seven studies found no association between dipyrone and congenital anomalies. In a case‒control study, a positive association was found between dipyrone use and isolated congenital cataracts compared to two control groups; in another study, a positive association for unspecified congenital anomalies was observed in only one of the two control groups analyzed. In all studies, a high risk of bias was identified, especially regarding measuring the exposure, outcome, and assessment of confounding factors.</p><p><strong>Conclusion: </strong>There is not enough evidence to define the risk of congenital anomalies associated with dipyrone use during pregnancy.</p><p><strong>Registration: </strong>CRD 42022333041.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"35-44"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497380","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":"A meta-analysis and systematic review based on perioperative management of elderly patients: is ciprofol an alternative to propofol?","authors":"Wei Chen, YuGuang Xu, YaFei Zeng, GuiPing Xing","doi":"10.1007/s00228-024-03782-7","DOIUrl":"10.1007/s00228-024-03782-7","url":null,"abstract":"<p><strong>Purpose: </strong>With the rising number of elderly surgical patients, selecting an appropriate anesthetic tailored to their specific needs is essential. Ciprofol, a novel intravenous anesthetic, has garnered attention due to its low injection pain rate and minimal impact on the circulatory system. This meta-analysis aims to examine the efficacy and safety profile of ciprofol during perioperative management of elderly patients.</p><p><strong>Methods: </strong>Comprehensive searches of PubMed, Embase, Cochrane, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang, and VIP databases from inception to March 23, 2024, were conducted. Eligible studies were included, data extracted, quality assessed using the ROB2 tool, and analyses performed with Stata 17.0.</p><p><strong>Results: </strong>Analysis of eleven randomized controlled trials (RCTs) comprising 1715 patients demonstrated that ciprofol outperformed propofol regarding injection pain (RR: 0.13, 95% CI: 0.09-0.20, p < 0.001), hypotension (RR: 0.72; 95% CI: 0.56-0.94; p = 0.014), bradycardia (RR: 0.64, 95% CI: 0.48-0.85, p = 0.002), respiratory depression (RR: 0.29, 95% CI: 0.19-0.43, p < 0.001), hypoxemia (RR: 0.38, 95% CI: 0.26-0.55, p < 0.001), and body movement (RR: 0.73, 95% CI: 0.56-0.96, p = 0.022). No significant differences were observed in induction time(SMD: 0.11,95% CI: -0.39-0.61, p = 0.655), sedative success rate(RR:1.01,,:95% CI:0.97-1.06, p = 0.669)), time of leaving the operating room(SMD-0.21,95% CI: -0.83-0.40, p = 0.497), bucking(RR:0.56,:95% CI:0.27-1.17, p = 0.134)), nausea and vomiting(RR:0.69,95% CI:0.43-1.11, p = 0.143)).</p><p><strong>Conclusion: </strong>Ciprofol demonstrates comparable efficacy to propofol in general anesthesia for elderly patients, with an enhanced safety profile, making it a viable clinical alternative. Further well-designed large RCTs are required to substantiate its safety profile.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"111-121"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675342","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":"Evaluation of the predictive performance of an online voriconazole dose calculator in children.","authors":"Abdullah Alsultan, Razan Almofada, Sufyan Alomair, Eric F Egelund, Ahmed A Albassam, Mohammed Ali, Charles A Peloquin, Khalid W Taher","doi":"10.1007/s00228-024-03762-x","DOIUrl":"10.1007/s00228-024-03762-x","url":null,"abstract":"<p><strong>Background: </strong>The dosing of voriconazole is challenging in pediatrics. One approach to improve the dosing is through the use of Bayesian concentration-guided dosing software. Our study assessed the predictive performance of a freely available online voriconazole dose calculator in pediatric patients \"NextDose\" ( https://www.nextdose.org/ ).</p><p><strong>Methods: </strong>Per each dose calculator, we predicted voriconazole concentrations. We did both a priori and a posteriori Bayesian predictions.</p><p><strong>Results: </strong>A total of 51 patients were included in this study. For a priori predictions, bias was + 26% while imprecision was 70%. For a posteriori predictions, bias and imprecision were 0.01% and 46%.</p><p><strong>Discussion: </strong>In conclusion, the available online dose calculator was overpredicting the concentrations before voriconazole observations were available. However, with just one measured concentration, the predictions improved with minimal bias and an acceptable level of imprecision. There is a need for more prospective studies evaluating the use of voriconazole dosing calculators in the pediatric population to assess if they can improve the achievement of therapeutic target concentrations compared to standard of care.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1989-1993"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343999","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":"GLP 1 receptor agonists and obesity-associated cancers: a disproportionality analysis in Vigibase®.","authors":"Jean-Louis Montastruc","doi":"10.1007/s00228-024-03761-y","DOIUrl":"10.1007/s00228-024-03761-y","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1999-2001"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344000","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":"Comment on \"Use of statins and risks of ovarian, uterine, and cervical diseases: a cohort study in the UK Biobank\".","authors":"Pei-Ying Chung, Kuan-Fu Liao, Shih-Wei Lai","doi":"10.1007/s00228-024-03760-z","DOIUrl":"10.1007/s00228-024-03760-z","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1997-1998"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282329","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":"Approaches for posaconazole therapeutic drug monitoring and their clinical benefits.","authors":"Silu Wang, Changkun Li, Yalin Dong, Weihua Dong","doi":"10.1007/s00228-024-03756-9","DOIUrl":"10.1007/s00228-024-03756-9","url":null,"abstract":"<p><strong>Objective: </strong>This review examines the progress of research on posaconazole therapeutic drug monitoring (TDM) that has focused on differences in the TDM of posaconazole after clinical application in different formulations and in different populations, the factors that affect posaconazole concentrations, the advantages of posaconazole TDM in terms of clinical efficacy and cost savings, and measurement methods.</p><p><strong>Methods: </strong>A literature search (2006 to 2024) was performed in PubMed and Embase with the following search terms: noxafil, posaconazole hydrate, posaconazole, drug monitoring, therapeutic drug monitoring, and TDM. Abstracts of review articles, prospective studies, and retrospective studies were reviewed.</p><p><strong>Results: </strong>TDM should be implemented earlier for posaconazole tablets and injections than for oral posaconazole suspensions. Posaconazole TDM is beneficial for improving clinical efficacy, and the incidence of breakthrough invasive fungal infections (IFIs) can be significantly reduced by gradually adjusting the posaconazole dose in response to TDM in patients with inadequate trough concentrations. Early TDM allows more patients to achieve target therapeutic posaconazole concentrations. TDM can also facilitate dose adjustments, which reduce the cost of this expensive drug. Different assay techniques, including chromatography, microbiological detection, chemofluorimetry, paper spray mass spectrometry, and capillary electrophoresis, can be used for posaconazole TDM.</p><p><strong>Conclusions: </strong>Posaconazole TDM has potential clinical utility and cost-saving benefits and could improve the outcomes of IFI treatment.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1845-1855"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153408","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":"A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward.","authors":"Mahendra Chougule, Sivacharan Kollipara, Smritilekha Mondal, Tausif Ahmed","doi":"10.1007/s00228-024-03763-w","DOIUrl":"10.1007/s00228-024-03763-w","url":null,"abstract":"<p><strong>Purpose: </strong>In silico modeling and simulation techniques such as physiologically based pharmacokinetic (PBPK) and physiologically based biopharmaceutics modeling (PBBM) have demonstrated various applications in drug discovery and development. Virtual bioequivalence leverages these computation tools to predict bioequivalence between reference and test formulations thereby demonstrating possibilities to reduce human studies. A pre-requisite for virtual bioequivalence is development of validated virtual population that depicts the same variability as that of observed in clinic. This development, validation and optimization of virtual population is a key attribute of virtual bioequivalence based on which conclusion of bioequivalence is made.</p><p><strong>Methods: </strong>Various strategies for optimization of virtual population based on appropriate considerations of physicochemical, physiological and disposition aspects are demonstrated with the help of six diverse case studies of immediate and modified release formulations. Once the virtual population is optimized to match in vivo variability, it can be used for various applications such as biowaivers, dissolution specification justification, f2 mismatch, establishing dissolution safe space, etc. In this review article, we attempted to describe various methodologies and approaches for optimization of virtual population using Gastroplus.</p><p><strong>Results: </strong>Strategies based on optimization of virtual population with emphasis on specific and sensitive parameters were portrayed. We have further elucidated considerations related to study design, in vivo variability, sample size for optimization of virtual population from Gastroplus perspective.</p><p><strong>Conclusion: </strong>We believe that this review article provides a step-by-step process for virtual population optimization for interest of biopharmaceutics modeling scientists in order to ensure reliable and credible physiological models.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1903-1922"},"PeriodicalIF":2.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142389013","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}