Acta Clinica Belgica最新文献

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Graves' hyperthyroidism following COVID-19 vaccination: a multicenter case series and literature review. COVID-19疫苗接种后Graves甲亢:多中心病例系列和文献综述
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-09-27 DOI: 10.1080/17843286.2026.2730184
Fllënza Aliju, Lucrezia De Marchi, Dragos Barglazan, Evelyne Maillart, David Unuane, Corina Andreescu, Kris Poppe, Laura Iconaru, Jeroen de Filette
{"title":"Graves' hyperthyroidism following COVID-19 vaccination: a multicenter case series and literature review.","authors":"Fllënza Aliju, Lucrezia De Marchi, Dragos Barglazan, Evelyne Maillart, David Unuane, Corina Andreescu, Kris Poppe, Laura Iconaru, Jeroen de Filette","doi":"10.1080/17843286.2026.2730184","DOIUrl":"https://doi.org/10.1080/17843286.2026.2730184","url":null,"abstract":"<p><strong>Objectives: </strong>Since the introduction of COVID-19 vaccination, cases of Graves' disease (GD) occurring shortly after immunization have been reported. This study compared the clinical, biochemical and imaging features of GD diagnosed after vaccination with those of other newly diagnosed GD cases.</p><p><strong>Methods: </strong>A multicenter retrospective case series was conducted in three university hospitals in Brussels, Belgium. Adults diagnosed with de novo GD between 1 January 2021 and 31 October 2022 were included. Patients were categorized into three groups according to vaccination status and timing of disease onset: early-onset GD (≤30 days) after COVID-19 vaccination, later-onset GD (>30 days), and GD in unvaccinated individuals. A literature review of peer-reviewed case reports and case series of de novo GD following COVID-19 vaccination was also performed.</p><p><strong>Results: </strong>A total of 160 patients were included: 17 with early-onset post-vaccination GD, 57 with later-onset disease, and 86 unvaccinated at GD diagnosis. No significant differences were observed between the three groups with respect to biochemical, imaging or initial treatment characteristics. Age differed significantly between groups, with patients in the later-onset group being older (<i>p</i> = 0.002). The literature review identified 51 published cases of de novo GD following COVID-19 vaccination, most occurring within the first weeks after vaccination.</p><p><strong>Conclusion: </strong>In this multicenter retrospective series, GD diagnosed after COVID-19 vaccination did not demonstrate a distinct clinical, biochemical or imaging phenotype compared with GD in unvaccinated individuals. Standard diagnostic and therapeutic strategies for GD therefore remain appropriate, irrespective of COVID-19 vaccination status or timing.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-14"},"PeriodicalIF":1.4,"publicationDate":"2026-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149070331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
GATA2: a small gene with big impact - a case report and literature review. GATA2:影响大的小基因——一例报告及文献综述。
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-09-07 DOI: 10.1080/17843286.2026.2724538
Elias Iturrospe, Eva De Backer, Marie-Berthe Maes, Kathleen Deiteren, Reinoud Flies, Alessandro Toscano, Marie Le Mercier, Katleen Janssens, Catharina van der Heijden
{"title":"GATA2: a small gene with big impact - a case report and literature review.","authors":"Elias Iturrospe, Eva De Backer, Marie-Berthe Maes, Kathleen Deiteren, Reinoud Flies, Alessandro Toscano, Marie Le Mercier, Katleen Janssens, Catharina van der Heijden","doi":"10.1080/17843286.2026.2724538","DOIUrl":"https://doi.org/10.1080/17843286.2026.2724538","url":null,"abstract":"<p><strong>Objectives: </strong>We present a case of GATA2 deficiency in a young adult with recurrent infections, highlighting uncommon clinical manifestations including persistent eosinophilia and primary sclerosing cholangitis, to raise awareness of this underdiagnosed condition and emphasize the importance of early diagnosis.</p><p><strong>Methods: </strong>We describe the clinical presentation, immunological and hematological work-up, molecular genetic testing and clinical course of a 21-year-old patient referred for immunological consultation due to recurrent infections, complemented by a narrative review of the literature on GATA2 deficiency.</p><p><strong>Results: </strong>The patient presented with three episodes of pneumonia, persistent diffuse warts and molluscum contagiosum. Hematological evaluation revealed profound monocytopenia, mild eosinophilia, an inverted CD4/CD8 ratio, and B- and NK-lymphopenia. Bone marrow examination showed hypercellularity with mild dysplastic features in the myeloid and megakaryocytic series. On molecular testing, a pathogenic GATA2 variant was found alongside two additional STAG2 variants. Germline analysis confirmed a de novo heterozygous GATA2 variant, consistent with GATA2 deficiency. Notably, beyond the characteristic immunological features, persistent eosinophilia and hepatobiliary abnormalities compatible with primary sclerosing cholangitis were also present, representing uncommon features in the context of GATA2 deficiency. The patient subsequently underwent allogeneic hematopoietic stem cell transplantation, currently the sole curative treatment.</p><p><strong>Conclusion: </strong>GATA2 deficiency is a complex disorder with a broad clinical spectrum, including immunodeficiency and increased risk of hematological malignancies. Early recognition, as illustrated in this case, is essential to improve prognosis and facilitate genetic counselling. Clinicians should maintain a high index of suspicion in young adults presenting with recurrent infections, persistent warts and cytopenia.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-11"},"PeriodicalIF":1.4,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148901298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Urinary false-positive ecstasy screening by Mebeverine Metabolite: a confirmatory study and controlled administration. 通过Mebeverine代谢物筛选尿假阳性摇头丸:一项确证性研究和对照用药。
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-09-07 DOI: 10.1080/17843286.2026.2724290
Bounab Moncef, Mechalikh Rahima Tassadit, Boussebt Cheima, Ettaieb Errahmani Salima, Kaddour Salma
{"title":"Urinary false-positive ecstasy screening by Mebeverine Metabolite: a confirmatory study and controlled administration.","authors":"Bounab Moncef, Mechalikh Rahima Tassadit, Boussebt Cheima, Ettaieb Errahmani Salima, Kaddour Salma","doi":"10.1080/17843286.2026.2724290","DOIUrl":"https://doi.org/10.1080/17843286.2026.2724290","url":null,"abstract":"<p><p>Urinary immunochromatographic tests (ICTs) are first-line tools for psychoactive substance screening in clinical and forensic settings. Their limited specificity, however, predisposes them to cross-reactive interferences generating false-positive results.We report three consecutive cases of false-positive 3,4-methylenedioxymethamphetamine (MDMA) results on rapid urinary ICT screening attributable to therapeutic mebeverine use, all confirmed by gas chromatography-mass spectrometry (GC-MS). Three patients admitted to emergency and intensive care units were all receiving mebeverine therapeutically.A 12-panel ICT (MDMA cut-off: 500 ng/mL) returned presumptive positive MDMA results in all three specimens. GC-MS confirmatory analysis detected neither MDMA nor its primary metabolite, 3,4-methylenedioxyamphetamine (MDA). Mebeverine O-desmethyl-butanol was consistently identified in all three specimens. A spiking experiment with certified mebeverine hydrochloride at 3000 ng/mL yielded a negative ICT result, excluding the parent compound as the causative agent. A controlled single-dose administration experiment (200 mg oral mebeverine) produced positive MDMA ICT results in all four urine specimens collected between 4 and 13 hours post-ingestion; GC-MS confirmed mebeverine O-desmethyl-butanol as the sole mebeverine-derived compound identified, strongly implicating this metabolite in the observed cross-reactivity.Any positive MDMA immunochromatographic result in a patient receiving mebeverine must be confirmed by GC-MS or LC-MS/MS. Mebeverine and its metabolites should be incorporated into cross-reactivity documentation by ICT manufacturers.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-9"},"PeriodicalIF":1.4,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148901348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Paliperidone-induced diabetes mellitus presenting with hyperosmolar hyperglycemic state: a case report. 以高渗性高血糖状态为表现的帕利哌酮所致糖尿病1例报告。
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-08-28 DOI: 10.1080/17843286.2026.2719654
Michiel Reunes, Lise Haems, Aurelie Vanthuyne, Marijn Speeckaert
{"title":"Paliperidone-induced diabetes mellitus presenting with hyperosmolar hyperglycemic state: a case report.","authors":"Michiel Reunes, Lise Haems, Aurelie Vanthuyne, Marijn Speeckaert","doi":"10.1080/17843286.2026.2719654","DOIUrl":"https://doi.org/10.1080/17843286.2026.2719654","url":null,"abstract":"<p><strong>Background: </strong>Second-generation antipsychotics (SGA) have been associated with adverse metabolic effects, including the development of diabetes mellitus (DM) and, in rare cases, life-threatening hyperglycemic emergencies such as diabetic ketoacidosis and hyperosmolar hyperglycemic state (HHS). Paliperidone, a more recently developed SGA, is generally considered to have a more favourable metabolic profile compared with older SGAs.</p><p><strong>Objective: </strong>We report new-onset diabetes mellitus presenting as HHS, with paliperidone as a major precipitating factor besides an underlying infection.</p><p><strong>Materials and methods: </strong>We present a case detailing the patient's presenting symptoms, clinical findings, laboratory investigations and clinical course.</p><p><strong>Results: </strong>We present a case of de novo diabetes mellitus presenting with HHS, with clinical suspicion that paliperidone acted as a major precipitating factor, in addition to transient infection-related insulin resistance. After adequate antibiotic treatment and discontinuation of paliperidone, the patient's insulin requirements declined rapidly, allowing discharge on metformin monotherapy. To our knowledge, this is the first case of HHS linked to paliperidone usage, although a limited number of case reports have described diabetic ketoacidosis in patients treated with paliperidone. Conclusion: This case highlights the need for vigilant metabolic monitoring following the initiation of SGAs, even those considered more favourable metabolically.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-6"},"PeriodicalIF":1.4,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mpox vaccination in Belgium: clinical guidance for implementation readiness. 比利时的麻疹疫苗接种:实施准备的临床指导。
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-08-24 DOI: 10.1080/17843286.2026.2706157
Steven Callens, Koen Blot, Marie-Angélique De Scheerder, Agnès Libois, Laurens Liesenborghs, Florence Rolin, Heidi Theeten, Christophe Van Dijck, Laura Kostov, Veerle Mertens, Yves Van Laethem
{"title":"Mpox vaccination in Belgium: clinical guidance for implementation readiness.","authors":"Steven Callens, Koen Blot, Marie-Angélique De Scheerder, Agnès Libois, Laurens Liesenborghs, Florence Rolin, Heidi Theeten, Christophe Van Dijck, Laura Kostov, Veerle Mertens, Yves Van Laethem","doi":"10.1080/17843286.2026.2706157","DOIUrl":"https://doi.org/10.1080/17843286.2026.2706157","url":null,"abstract":"<p><strong>Background: </strong>Clade Ib monkeypox virus (MPXV) emerged in the Democratic Republic of Congo in 2023 with sustained sexual transmission and has since spread internationally, including to Europe. This review synthesises evidence on MVA-BN vaccine effectiveness, safety and durability to guide Belgian clinical practice.</p><p><strong>Methods: </strong>Narrative review of MVA-BN effectiveness studies, meta-analyses, immunogenicity data and safety surveillance from the 2022-2025 clade IIb outbreak response.</p><p><strong>Results: </strong>Two-dose MVA-BN effectiveness against symptomatic mpox is approximately 82% (95% CI 72-92%), although these 2022 observational estimates may be inflated by concurrent behavioural risk reduction. Pooled single-dose effectiveness is 76%, but is lower in people living with HIV (34.9%) than in HIV-negative individuals (84.1%), underlining the importance of two-dose completion in immunocompromised populations. Neutralising antibodies wane within 5 to 7 months, yet clinical protection persists through memory B-cell and T-cell responses. MVA-BN is safe in HIV infection and atopic dermatitis, with myocarditis risk below 1 per 100,000 doses; pregnancy data are limited and must be weighed against maternal and fetal risk. No direct clade I effectiveness data exist, but cross-protection is expected from epitope conservation, animal data and human evidence of protection after previous smallpox vaccination.</p><p><strong>Conclusions: </strong>Sexual health services should offer prompt vaccination to men who have sex with men with multiple partners, PrEP users, sex workers and people living with HIV, emphasising two-dose completion in immunocompromised individuals. Despite antibody waning, memory responses support durable protection against hospitalisation. Post-exposure prophylaxis is ideally given within four days, though administration up to 14 days may attenuate severity.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-15"},"PeriodicalIF":1.4,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148814589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Left atrial volume index in patients with Rosacea: a retrospective case-control study. 酒渣鼻患者的左心房容积指数:一项回顾性病例对照研究。
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-08-21 DOI: 10.1080/17843286.2026.2720751
Candan Celik, Erdoğan Yasar, Mehmet Semih Celik, Sule Gencoglu, Murat Cap, Abdurrahman Akyüz, Ferhat Isık
{"title":"Left atrial volume index in patients with Rosacea: a retrospective case-control study.","authors":"Candan Celik, Erdoğan Yasar, Mehmet Semih Celik, Sule Gencoglu, Murat Cap, Abdurrahman Akyüz, Ferhat Isık","doi":"10.1080/17843286.2026.2720751","DOIUrl":"https://doi.org/10.1080/17843286.2026.2720751","url":null,"abstract":"<p><strong>Objectiv: </strong>Rosacea is a chronic inflammatory skin disease that may have systemic and cardiovascular effects. The left atrial volume index (LAVI) reflects left atrial remodeling and diastolic function. This study evaluated LAVI and diastolic echocardiographic parameters in patients with rosacea.</p><p><strong>Materials and methods: </strong>This cross-sectional case-control study included patients with rosacea and age- and sex-matched healthy controls. All participants underwent transthoracic echocardiography. Left atrial diameter, left ventricular dimensions, ejection fraction (EF), transmitral Doppler parameters (E, A), tissue Doppler-derived early diastolic velocity (E'), E/E' ratio, and LAVI were recorded. Data distribution was assessed using the Shapiro-Wilk test. Intergroup comparisons were performed using appropriate statistical tests, and correlations between LAVI and echocardiographic parameters were assessed using Spearman correlation analysis.</p><p><strong>Results: </strong>A total of 150 participants were included, comprising 75 patients with rosacea (56 females and 19 males; mean age, 33.2 ± 10.7 years) and 75 age- and sex-matched healthy controls (53 females and 22 males; mean age, 33.5 ± 11.4 years). Compared with controls, patients with rosacea had significantly higher LAVI values (<i>p</i> < 0.001). In addition, significant differences were observed in E' velocity, E/E' ratio, and left atrial diameter (all <i>p</i> < 0.001), whereas ejection fraction was similar between the groups (<i>p</i> = 0.062). Correlation analysis demonstrated a moderate positive correlation between LAVI and E/E' (ρ = 0.489, <i>p</i> < 0.001), a weak negative correlation between LAVI and age (ρ = -0.219, <i>p</i> = 0.007), and a weak positive correlation between LAVI and EF (ρ = 0.175, <i>p</i> = 0.032).</p><p><strong>Conclusion: </strong>Patients with rosacea had higher LAVI values and altered diastolic echocardiographic parameters than healthy controls, suggesting subclinical alterations in cardiac filling dynamics. However, causality cannot be established from these observational findings. Larger prospective studies are needed for confirmation.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-8"},"PeriodicalIF":1.4,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148800270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From polypharmacy to precision prescribing: the future of medication review in nursing homes. 从综合用药到精确处方:养老院药物审查的未来。
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-08-18 DOI: 10.1080/17843286.2026.2719662
Mirko Petrovic
{"title":"From polypharmacy to precision prescribing: the future of medication review in nursing homes.","authors":"Mirko Petrovic","doi":"10.1080/17843286.2026.2719662","DOIUrl":"https://doi.org/10.1080/17843286.2026.2719662","url":null,"abstract":"","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-3"},"PeriodicalIF":1.4,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148800247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of pioglitazone versus dipeptidyl peptidase-4 inhibitor use with incident gout in type 2 diabetes: a real-world cohort study. 吡格列酮与二肽基肽酶-4抑制剂与2型糖尿病患者痛风事件的关联:一项现实世界队列研究
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-08-10 DOI: 10.1080/17843286.2026.2716102
Shih-Wei Lai, Kuan-Fu Liao, Chau-Ren Jung, Bing-Fang Hwang, Hui-Fen Chiang
{"title":"Association of pioglitazone versus dipeptidyl peptidase-4 inhibitor use with incident gout in type 2 diabetes: a real-world cohort study.","authors":"Shih-Wei Lai, Kuan-Fu Liao, Chau-Ren Jung, Bing-Fang Hwang, Hui-Fen Chiang","doi":"10.1080/17843286.2026.2716102","DOIUrl":"10.1080/17843286.2026.2716102","url":null,"abstract":"<p><strong>Objective: </strong>Pioglitazone and dipeptidyl peptidase-4 inhibitors (DPP-4is) are used to treat type 2 diabetes mellitus (T2DM), yet their influence on gout risk remains unclear. This study aimed to examine whether the incidence of newly diagnosed gout differed between pioglitazone users and DPP-4i users among patients with T2DM.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using data from the TriNetX. Patients with T2DM aged 20-84 years were selected. The pioglitazone and DPP-4i cohorts were matched 1:1 using propensity score matching based on demographic and clinical characteristics. The primary endpoint was incident gout. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using the 'Compare Outcomes' module within the TriNetX.</p><p><strong>Results: </strong>After propensity score matching and using post-matching 6-month lag exclusion, 120,095 patients in the pioglitazone group and 120,211 patients in the DPP-4i group were included. During the maximum follow-up period of 5 years, 1,948 cases of gout occurred in the pioglitazone group and 1,877 in the DPP-4i group, corresponding to cumulative incidence of 1.622% and 1.561%, respectively. The Cox proportional hazards analysis indicated a modestly higher incidence of gout among pioglitazone users compared with DPP-4i users (HR, 1.085; 95% CI, 1.018-1.156).</p><p><strong>Conclusion: </strong>Pioglitazone use is associated with a modestly higher incidence of gout compared with DPP-4i use in patients with T2DM; however, the small absolute risk difference and observational design warrant cautious interpretation.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"1-8"},"PeriodicalIF":1.4,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148701913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Unveiling unexpected adverse events and haemorrhagic safety: post-marketing safety surveillance of ramucirumab from the FAERS database. 揭示意外不良事件和出血安全性:来自FAERS数据库的ramucirumab上市后安全性监测。
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-08-01 Epub Date: 2026-04-19 DOI: 10.1080/17843286.2026.2655844
Hong Zhou, Tingting Chen, Ting Wei, Jinhua Zhang
{"title":"Unveiling unexpected adverse events and haemorrhagic safety: post-marketing safety surveillance of ramucirumab from the FAERS database.","authors":"Hong Zhou, Tingting Chen, Ting Wei, Jinhua Zhang","doi":"10.1080/17843286.2026.2655844","DOIUrl":"10.1080/17843286.2026.2655844","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to investigate the overall and haemorrhagic safety profile of ramucirumab based on Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>A retrospective disproportionality analysis using reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) was performed to evaluate adverse event reporting associated with ramucirumab.</p><p><strong>Results: </strong>A total of 7901 AEs of ramucirumab and 233 risk signals involving 19 system organ classes (SOCs) were identified. The main AEs associated with ramucirumab including haemorrhage, gastrointestinal perforations, and proteinuria were consistent with the package insert. New potential unexpected AEs including interstitial lung disease, pyogenic granuloma, osteonecrosis of the jaw, and myelodysplastic syndrome should be paid more attention. Subgroup analysis of 490 cases of ramucirumab-associated haemorrhage revealed that positive signals were distributed across 8 SOCs with 32 positive signals, with unexpected signals found in nervous system, renal and urinary, and eye disorders. Additionally, more than half of AE cases occurred within the first month with a median onset time of 27 days.</p><p><strong>Conclusion: </strong>This study outlines the post-marketing safety profile of ramucirumab, identifying unexpected signals that warrant further investigation, including a newly described subgroup of ramucirumab-induced haemorrhage.</p>","PeriodicalId":48865,"journal":{"name":"Acta Clinica Belgica","volume":" ","pages":"303-315"},"PeriodicalIF":1.4,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147724201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
DMARDs and gout therapy in patients with chronic arthritis and end-stage renal disease: a descriptive guide. 慢性关节炎和终末期肾病患者的DMARDs和痛风治疗:描述性指南
IF 1.4 4区 医学
Acta Clinica Belgica Pub Date : 2026-08-01 Epub Date: 2026-04-05 DOI: 10.1080/17843286.2026.2654069
Hebe Stuer, Johan De Meester, Barbara Neerinckx
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