Journal of Clinical Medicine最新文献

{"title":"Comparison of Postoperative Outcomes in 71 Patients Undergoing Cataract Surgery at a Single Center with and Without Preoperative Keratostill Moisturizing Eye Drops.","authors":"Piotr Miklaszewski, Anna Maria Gadamer, Dominika Janiszewska-Bil, Anita Lyssek-Boroń, Dariusz Dobrowolski, Edward Wylęgała, Beniamin Oskar Grabarek, Katarzyna Krysik","doi":"10.3390/jcm14124349","DOIUrl":"10.3390/jcm14124349","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Dry eye disease (DED) is a common condition that can significantly impact cataract surgery outcomes. Preoperative management strategies, including the use of moisturizing eye drops, may improve ocular surface health and postoperative recovery. This study aimed to compare postoperative outcomes in 71 patients undergoing cataract surgery between June 2022 and May 2023 at a single center with and without preoperative keratostill moisturizing eye drops (sterile aqueous 0.3% hydroxypropyl methylcellulose solution) determined using the ocular surface disease index (OSDI), tear break-up time (TBUT), and optical coherence tomography (OCT) at diagnosis, on the day of surgery, and at two weeks postoperatively. <b>Methods</b>: A prospective observational study was conducted on 71 patients undergoing cataract surgery at Saint Barbara Hospital Trauma Center, Sosnowiec, Poland, from June 2022 to May 2023. Patients were randomly assigned to a test group (moisturizing eye drops) or a control group (no preoperative eye drops). The OSDI, TBUT, and OCT were evaluated at the baseline, preoperatively, and postoperatively. <b>Results</b>: The test group showed a significant improvement in OSDI scores (preoperative: 6.34 vs. baseline: 11.81; <i>p</i> < 0.001), which further decreased postoperatively (3.30; <i>p</i> < 0.001). TBUT also significantly increased from baseline to the preoperative visit (6.20 s to 7.97 s; <i>p</i> = 0.002) and remained stable after surgery (7.78 s). In contrast, the control group demonstrated only a minimal postoperative change in OSDI (3.92 to 3.70; <i>p</i> > 0.05) and a significant postoperative decrease in TBUT (5.96 s to 5.69 s; <i>p</i> = 0.864). Only the control group showed a significant postoperative decrease in epithelial thickness in operated eyes (<i>p</i> = 0.021), whereas no significant changes were observed in the test group. <b>Conclusions</b>: The preoperative use of moisturizing eye drops significantly improves the tear film stability, ocular comfort, and epithelial integrity, leading to better postoperative outcomes in cataract surgery patients.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496916","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":"Elevated Immunoglobulin G as a Predictor of Progression to Severe Lung Disease in Cystic Fibrosis: A Longitudinal Cohort Study.","authors":"Ori Goldberg, Siwar Shekh-Yusuf, Miri Dotan, Moshe Heching, Eyal Jacobi, Meir Mei-Zahav, Hannah Blau, Huda Mussaffi, Dario Prais","doi":"10.3390/jcm14124331","DOIUrl":"10.3390/jcm14124331","url":null,"abstract":"<p><p><b>Background:</b> Elevated immunoglobulin G (IgG) levels are associated with worse lung function and disease severity in people with cystic fibrosis (PwCF). This study evaluated whether elevated IgG levels-defined as values above the 97.5th percentile (Z-score ≥ 1.96 standard deviations above the mean)-can predict progression to severe lung disease. <b>Methods:</b> A retrospective cohort study of children and adults with CF at a single-center clinic was performed. Patients with elevated baseline IgG Z-scores were compared to those with normal or low IgG levels. Progression to severe lung disease was defined as % predicted FEV₁ < 40%, referral for lung transplantation, or death. Kaplan-Meier survival curves and Cox models were used to analyze clinical outcomes. A sensitivity analysis was conducted for patients aged 18 years or older. <b>Results:</b> Of 97 patients, 31 (31.9%) had elevated IgG levels. Progression to severe lung disease occurred in 14 (14.4%) patients, 12 (85.7%) of whom had elevated IgG. These patients were significantly older and had a higher prevalence of Pseudomonas aeruginosa colonization. Among adults, those with elevated IgG had lower baseline % predicted FEV1 and greater annual lung function decline. Elevated IgG was independently associated with progression to severe lung disease (adjusted hazard ratio [aHR]: 9.8; 95% CI: 1.9-48.6), even after adjusting for Pseudomonas colonization and annual % predicted FEV1 decline. <b>Conclusions:</b> Elevated IgG was associated with progression to severe lung disease in PwCF and correlated with older age, Pseudomonas colonization, and-in adults-lower baseline lung function and faster decline. These findings highlight elevated serum IgG as a meaningful prognostic biomarker for identifying high-risk PwCF who may benefit from closer monitoring and earlier intervention.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194623/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496955","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":"The Impact of Ureteral Stent Indwelling Duration on Encrustation Degree and Extraction Difficulty: A Retrospective Study.","authors":"Laurian Stefan Maxim, Ruxandra Maria Rotaru, Camelia Cornelia Scarneciu, Marius Alexandru Moga, Raul Dumitru Gherasim, Mihail Alexandru Badea, Alexandru Ghicavîi, Razvan Dragos Multescu, Bogdan Ovidiu Feciche, Ioan Scarneciu","doi":"10.3390/jcm14124334","DOIUrl":"10.3390/jcm14124334","url":null,"abstract":"<p><p><b>Background/Objectives:</b> Ureteral stents are indispensable tools in contemporary urological practice; however, their prolonged indwelling is frequently associated with a spectrum of complications. This study aims to evaluate the correlation between indwelling duration and the extent of stent encrustation, as well as the impact on extraction difficulty. <b>Methods:</b> A retrospective analysis was conducted on 33 patients treated at Clinical County Emergency Hospital of Brașov between December 2023 and December 2024. All patients had polyurethane double-J ureteral stents placed. Parameters assessed included the degree of stent encrustation, discoloration, incidence of urinary tract infections (UTIs), and extraction difficulty. These were analyzed in relation to indwelling time and patient comorbidities. Statistical processing was performed using SPSS 23.0 software, with significance set at <i>p</i> < 0.05. <b>Results:</b> A statistically significant association was observed between longer stent indwelling times and higher grades of encrustation, particularly for the intervals of 45-90 days and over 90 days (<i>p</i> = 0.008 and <i>p</i> = 0.01, respectively). Low encrustation demonstrated correlations with certain comorbidities, whereas no statistically relevant associations were found for moderate and severe encrustation. Black coloration of the stents was strongly associated with UTIs caused by <i>Escherichia coli</i>, <i>Klebsiella</i> spp., and <i>Enterococcus</i> spp. (<i>p</i> < 0.001), as well as with extended indwelling durations (<i>p</i> < 0.001). No significant correlation was identified between the presence of UTIs and the degree of stent encrustation. <b>Conclusions:</b> Indwelling time is a critical determinant of both ureteral stent encrustation and discoloration, with direct implications for clinical decision-making regarding stent management and extraction planning. Timely removal and close monitoring are essential to reduce the risk of complications associated with long-term stent placement.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144497116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Literature Review of the Lubricants Used in Dermatome-Assisted Split-Thickness Skin Graft Harvest.","authors":"William Wright, Marc Ingram, Quentin Frew","doi":"10.3390/jcm14124336","DOIUrl":"10.3390/jcm14124336","url":null,"abstract":"<p><p><b>Background:</b> Split-thickness skin grafts (STSGs) are utilised to close wounds which cannot be closed by primary closure. Dermatome-assisted STSG harvest utilises a lubricant to control friction, which facilitates graft harvest. Many different lubricants are used during graft harvest, although little research has been conducted to identify the optimal lubricant. Furthermore, new techniques such as Meek grafting are incompatible with commonly used oil-based lubricants. <b>Method:</b> A literature search was conducted, following the PRISMA protocol. 173 records were screened with 6 included in this study. We also reviewed the literature on lubricants in other biotribological systems including shaving. <b>Results:</b> We found support for numerous lubricants, including: mineral oil, catheter gel, chlorhexidine, saline and ultrasound gel. Evidence consisted of expert opinions, and one blinded comparative review. There was no consensus on the optimal lubricant, and we did not find evidence that lubricant compatibility with Meek grafting had been assessed. <b>Conclusions:</b> Presently, lubrication choice in STSG harvest lacks a scientific basis, and further research is needed to design a bespoke, Meek-compatible lubricant which considers only four of Engelhardt's characteristics (1. cost-effectiveness; 4. lubrication; 6. no side effects; 8. practicability) to be essential. This should be followed by a blinded trial of lubricants.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194572/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496839","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":"Editorial: Updates and Challenges in Maxillofacial Surgery.","authors":"Andreas M Neff","doi":"10.3390/jcm14124345","DOIUrl":"10.3390/jcm14124345","url":null,"abstract":"<p><p>Oral and maxillofacial surgery (OMFS) is a rapidly evolving specialty that includes a wide variety of subspecialties, all of which are equally innovative in advancing OMFS [...].</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12193999/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Head-to-Head Comparison Between [¹⁸F]Fluorodeoxyglucose ([¹⁸F]FDG) Positron Emission Tomography/Computed Tomography (PET/CT) and ^99mTechnetium-Hexamethylpropylene Amine Oxime (HMPAO)-Labeled Leukocyte Scintigraphy in a Case Series of Patients with Suspected Vascular Prosthesis Infection: To Trust Is Good, but to Check Is Better.","authors":"Marina Scarpuzza, Alice Ambrogio, Andrea Leo, Lorenzo Roberto Suardi, Michele Marconi, Marco Falcone, Raffaella Berchiolli, Elena Lazzeri","doi":"10.3390/jcm14124352","DOIUrl":"10.3390/jcm14124352","url":null,"abstract":"<p><p><b>Background:</b> Prosthetic vascular graft infection (PVGI) is a serious complication associated with vascular prostheses. Nuclear medicine techniques, including [¹⁸F]fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) and ^99mtechnetium-hexamethylpropylene amine oxime (HMPAO)-labeled leukocyte (WBC) scintigraphy, are part of the MAGIC diagnostic criteria for PVGI. <b>Methods:</b> In this retrospective study, we analyzed eight patients with suspected PVGI who underwent both [¹⁸F]FDG PET/CT and WBC scintigraphy within an average of 8 days. <b>Results:</b> Of all eight patients (median age 69 years), three showed concordant positive results with both PET/CT and WBC, and their final diagnosis confirmed the presence of infection; five showed discordant results: in all five of these patients, PET/CT showed false-positive findings, whereas WBC correctly identified five true-negative cases. <b>Conclusions:</b> [¹⁸F]FDG PET/CT is highly sensitive but prone to false positives. WBC scintigraphy, combined with SPECT/CT, particularly in the evaluation of the treatment response, showed greater specificity, and it may warrant consideration as a MAGIC major diagnostic criterion for PVGI.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496838","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":"Changes of Airway Space and Flow in Patients Treated with Rapid Palatal Expander (RPE): An Observational Pilot Study with Comparison with Non-Treated Patients.","authors":"Paolo Faccioni, Alessia Pardo, Giorgia Matteazzi, Erika Zoccatelli, Silvia Bazzanella, Elena Montini, Fabio Lonardi, Benedetta Olivato, Massimo Albanese, Pietro Montagna, Giorgio Lombardo, Miriana Gualtieri, Annarita Signoriello, Giulio Conti, Alessandro Zangani","doi":"10.3390/jcm14124357","DOIUrl":"10.3390/jcm14124357","url":null,"abstract":"<p><p><b>Background/Objectives</b>. With a rapid palatal expander (RPE) is reported to be effective in increasing the volume of nasal cavities, with a restoration of physiological nasal airflow. The purpose of this retrospective clinical study was to evaluate, using Cone Beam Computed Tomography (CBCT), the volumetric changes and airflow velocity changes in the nasal cavities, retro-palatal and retro-glossal airways, resulting from the use of RPE with dental anchorage (group A), also comparing these data with patients non treated with RPE (group B). <b>Methods</b>. Sixteen subjects (aged 9.34 years) with transverse maxillary deficiency and unilateral posterior crossbite were treated with RPE with dental anchorage. Additionally, 8 patients (aged 11.11 years) with juvenile idiopathic arthritis, who did not undergo any orthodontic treatment, were selected as a control group. Expansion was performed until overcorrection was achieved, and the device was left in place for 6 months as fixed retention, followed by another 6 months of night-time removable retention. From the retrospective evaluation, all patients presented two CBCT scans at baseline (T0) and 1-year follow-up (T1). The 3D-Slicer software was used for each CBCT to measure the nasal (VN), retropalatal (VRP), and retroglossal (VRG) volumes, while an iterative Excel spreadsheet allowed for a pilot approximated modeling and calculation of airway flow-related data. <b>Results</b>. Regarding mean age, a statistically significant difference (<i>p</i> = 0.01 *) was found between groups, suggesting that group B is closer to the pubertal growth peak. Analysis between T0 and T1 revealed: (i) a statistically significant increase for volumes VN, VRP and VRG in group A; (ii) a statistically significant increase for VN in group B; (iii) a statistically significant decrease for all variables related to airflow velocity in both groups. Furthermore, comparison between group A and B, regarding variations between T0 and T1, found a statistically significant difference only for VN. <b>Conclusions</b>. Within the limitations of this pilot evaluation, the treatment with RPE revealed promising outcomes for retro-palatal, retro-glossal and nasal volumes, together with clinical changes in airflow velocities.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194650/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Characteristics of Dizzy Patients Showing Discordant Results Between Bithermal Caloric Test and Video Head Impulse Test.","authors":"Hahn Jin Jung, Sangeun Lee, Hyeop Oh, Jee Hye Wee, Chang Gun Cho, Joo Hyun Park","doi":"10.3390/jcm14124350","DOIUrl":"10.3390/jcm14124350","url":null,"abstract":"<p><p><b>Background/Objectives:</b> To evaluate the clinical characteristics and diagnostic significance of dissociation between bithermal caloric test and video head impulse test (vHIT) in patients presenting with dizziness. <b>Methods</b>: We retrospectively reviewed 644 patients who underwent bithermal caloric testing and vHIT at a university-affiliated general hospital. Patients were classified into concordant and discordant groups based on test results. The discordant group was further subdivided into those with abnormal caloric test and normal vHIT, and those with normal caloric test and abnormal vHIT. Demographic data, vestibular function test outcomes, and clinical diagnoses were analyzed. <b>Results</b>: Discordant results were observed in 36.5% of patients. Among these, 31.8% had abnormal caloric responses with normal vHIT, and 4.7% had normal caloric responses with abnormal vHIT. Most patients in both discordant subgroups were diagnosed with peripheral vestibular disorders, such as Ménière's disease and unilateral vestibulopathy. The abnormal caloric/normal vHIT pattern was more common and associated with low-frequency dysfunction. The normal caloric/abnormal vHIT pattern, though less frequent, also involved predominantly peripheral etiologies. <b>Conclusions</b>: Dissociation between caloric and vHIT results is not uncommon and provides important diagnostic insights. Employing both tests in a complementary manner enhances the identification of frequency-specific vestibular deficits and supports more accurate diagnosis and management of vestibular disorders.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194406/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496885","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":"FFA Patient Profile Analysis Based on the Authors' Observations and a Review of the Literature-An Original Survey.","authors":"Michał Owczarek, Magdalena Jałowska, Agnieszka Mariowska, Wiktoria Grochowska, Joanna Szyszkowska, Daria Metelkina, Maciej Marek Spałek","doi":"10.3390/jcm14124346","DOIUrl":"10.3390/jcm14124346","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Frontal fibrosing alopecia (FFA) is a scarring alopecia with an unclear aetiology, primarily affecting postmenopausal women. This study aims to identify potential risk factors contributing to FFA development and progression, as well as provide a clinical profile to aid in the differential diagnosis. <b>Methods</b>: The study included 19 women diagnosed with FFA. The participants completed a 20-question survey based on a literature review of potential risk factors. Statistical analyses were performed to investigate the associations between patient characteristics and FFA. <b>Results</b>: All patients were female and their mean age was 60.58 years (SD = 12.81). In 63.1% of the cases, FFA onset occurred postmenopause, with a mean latency of 8.17 years. In the majority of cases, the diagnostic delay exceeded five years. The average menarche age was 13.68 years (SD = 2.06), whereas late menarche (≥15 years) was found in two subjects. A history of reproductive organ or breast malignancy was reported by 42.1% of the patients, which frequently required surgery. Most subjects did not receive hormone replacement therapy, or hormonal contraception. The most prevalent comorbidity was hypothyroidism (89.47%). Although smoking was rare among the subjects, hair colouring was quite common, yet no participant underwent scalp aesthetic procedures. In 47.4% of cases, scalp itching or pain was present. Sunscreens were frequently used, mostly on a daily or seasonal basis. <b>Conclusions</b>: FFA predominantly affects women in their early 60s, often following the menopause. In our study, a tendency toward an early menopause and an above-average menarche age of the subjects was observed. In the analysed group, only reproductive and breast cancers were reported, which requires further investigation. Frequent β-blocker use, second only to levothyroxine, may suggest that they play a role in FFA pathogenesis. Itching and pain of the scalp may contribute to the correct diagnosis, although these symptoms are not universal. Moreover, sunscreens were indicated as a potential trigger, yet avoiding them should not be routinely recommended due to the risk of carcinogenesis. The variability in the diagnostic delay emphasises the need for increasing clinician awareness and conducting further research.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144496895","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":"Reported Adverse Events in Patients with CF Receiving Treatment with Elexacaftor/Tezacaftor/Ivacaftor: 5 Years Observational Study.","authors":"Francesca Lucca, Ilaria Meneghelli, Gloria Tridello, Francesca Buniotto, Giulia Cucchetto, Sonia Volpi, Emily Pintani, Valentino Bezzerri, Marco Cipolli","doi":"10.3390/jcm14124335","DOIUrl":"10.3390/jcm14124335","url":null,"abstract":"<p><p><b>Background:</b> Elexacaftor/tezacaftor/ivacaftor (ETI) treatment is showing remarkable beneficial effects in people with Cystic Fibrosis (pwCF) harboring the F508del mutation in the Cystic Fibrosis Transmembrane conductance Regulator (<i>CFTR</i>) gene. Although this therapy is generally well tolerated in pwCF, some adverse events (AEs) have been recently described both in controlled studies and in post-marketing observations. <b>Methods</b>: We followed 414 pwCF carrying F508del <i>CFTR</i> that initiated ETI treatment, recording AEs for a period of 5 years. <b>Results</b>: A total of 142 AEs were reported. The most frequent AEs in the whole cohort were liver marker elevation, skin rush, epigastric pain, headache, and depression. Considering pediatric subjects, psychiatric and gastrointestinal disorders were the most frequent AEs. Only one patient reported a severe AE, leading to treatment discontinuation. In case of AEs, different decisions on ETI treatment were made, including temporary interruption and temporary or permanent dosage modification. <b>Conclusions</b>: Throughout the long-term observational period, almost 21% of pwCF experienced at least one AE. Psychiatric disorders, in particular attention deficit, were the most prevalent issue in our pediatric cohort, whereas adult patients mainly reported depression, anxiety and sleep disorders. This study therefore strengthen the recommendation of screening for changes in mental health during ETI treatment. AEs led to the permanent reduction of ETI dosage in 32% of cases, raising the issue of safety in relation to dosage reduction, efficacy, and minimum ETI levels. Eventually, this study highlights the need for a longitudinal monitoring of ETI safety since a significant number of AEs occurred after one year of treatment.</p>","PeriodicalId":15533,"journal":{"name":"Journal of Clinical Medicine","volume":"14 12","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144497097","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}