BMC Pharmacology & Toxicology最新文献

{"title":"Food effects and pharmacokinetic evaluation of oral single-dose prednisone acetate and prednisolone in healthy Chinese subjects.","authors":"Baole Cai, Lingjun Li, Pengcheng Ma, Lei Tao, Jun Wei, Hongyang Li, Zhujun Shao, Yumin Yao, Yindi Zhong, Yibing Li","doi":"10.1186/s40360-025-00865-8","DOIUrl":"10.1186/s40360-025-00865-8","url":null,"abstract":"<p><strong>Background: </strong>To assess the food effects and pharmacokinetic profile of oral prednisone (test preparation,5 mg) and prednisolone tablets (reference preparation,5 mg) using a randomized, two-period, two crossover, single-dose, fast and fed trial in 48 (24 in fast, 24 in fed) healthy Chinese adult subjects.</p><p><strong>Materials and methods: </strong>In the trial, the plasma concentrations were determined at different time points up to 24 h and the pharmacokinetic parameters were analyzed according to the concentration data by non-compartmental analysis using WinNonlin software. All laboratory parameters, vital signs and adverse events (AEs) were monitored and recorded under the supervision of the clinicians throughout the whole process of the study.</p><p><strong>Results: </strong>Prednisone and prednisolone undergo interconversion in liver. On average, the bioavailability of prednisolone after oral prednisone is approximately 80% of that after prednisolone. And about 20% of prednisolone is converted to prednisone after administration of equivalent oral of prednisolone tablet. Food taken with prednisone or prednisolone tablets delays the time reach the peak prednisone or prednisolone concentration (T_max) by approximately 0.5 h but does not affect systemic exposure. Prednisone and prednisolone tablets were well tolerated, and there were no serious adverse events reported in the study.</p><p><strong>Conclusions: </strong>For there was no information about the pharmacokinetic profile and food effects of oral prednisone and prednisolone tablets, the result of this research would be a clinical medication for doctors especially dealing patients with varying degrees of liver diseases.</p><p><strong>Clinical trial registration: </strong>CTR20200093; registered in http://www.chinadrugtrials.org.cn/ at 11 March 2020.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"34"},"PeriodicalIF":2.8,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834215/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143439778","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":"Identification of benzo(a)pyrene-related toxicological targets and their role in chronic obstructive pulmonary disease pathogenesis: a comprehensive bioinformatics and machine learning approach.","authors":"Jiehua Deng, Lixia Wei, Yongyu Chen, Xiaofeng Li, Hui Zhang, Xuan Wei, Xin Feng, Xue Qiu, Bin Liang, Jianquan Zhang","doi":"10.1186/s40360-025-00842-1","DOIUrl":"10.1186/s40360-025-00842-1","url":null,"abstract":"<p><strong>Background: </strong>Chronic obstructive pulmonary disease (COPD) pathogenesis is influenced by environmental factors, including Benzo(a)pyrene (BaP) exposure. This study aims to identify BaP-related toxicological targets and elucidate their roles in COPD development.</p><p><strong>Methods: </strong>A comprehensive bioinformatics approach was employed, including the retrieval of BaP-related targets from the Comparative Toxicogenomics Database (CTD) and Super-PRED database, identification of differentially expressed genes (DEGs) from the GSE76925 dataset, and protein-protein interaction (PPI) network analysis. Functional enrichment and immune infiltration analyses were conducted using GO, KEGG, and ssGSEA algorithms. Feature genes related to BaP exposure were identified using SVM-RFE, Lasso, and RF machine learning methods. A nomogram was constructed and validated for COPD risk prediction. Molecular docking was performed to evaluate the binding affinity of BaP with proteins encoded by the feature genes.</p><p><strong>Results: </strong>We identified 72 differentially expressed BaP-related toxicological targets in COPD. Functional enrichment analysis highlighted pathways related to oxidative stress and inflammation. Immune infiltration analysis revealed significant increases in B cells, DC, iDC, macrophages, T cells, T helper cells, Tcm, and TFH in COPD patients compared to controls. Correlation analysis showed strong links between oxidative stress, inflammation pathway scores, and the infiltration of immune cells, including aDC, macrophages, T cells, Th1 cells, and Th2 cells. Seven feature genes (ACE, APOE, CDK1, CTNNB1, GATA6, IRF1, SLC1A3) were identified across machine learning methods. A nomogram based on these genes showed high diagnostic accuracy and clinical utility. Molecular docking revealed the highest binding affinity of BaP with CDK1, suggestive of its pivotal role in BaP-induced COPD pathogenesis.</p><p><strong>Conclusions: </strong>The study elucidates the molecular mechanisms of BaP-induced COPD, specifically highlighting the role of oxidative stress and inflammation pathways in promoting immune cell infiltration. The identified feature genes may serve as potential biomarkers and therapeutic targets. Additionally, the constructed nomogram demonstrates high accuracy in predicting COPD risk, providing a valuable tool for clinical application in BaP-exposed individuals.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"33"},"PeriodicalIF":2.8,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143439781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of nanospray loaded with ciclopirox for dermal fungus treatment: determination of pro-inflammatory interleukin IL-2 mRNA expression.","authors":"Yasir Mehmood, Hira Shahid, Rabbia Nazir, Mohammad N Uddin, Mohammad Nur-E-Alam, Mohammed Bourhia, Khalid S Almaary, Mohsin Kazi, Ousman B Mahamat","doi":"10.1186/s40360-025-00853-y","DOIUrl":"10.1186/s40360-025-00853-y","url":null,"abstract":"<p><p>The aim of this study was to develop a ciclopirox (CXP) topical nano spray using nanotechnology to enhance drug bioavailability and skin absorption. A precipitation method was employed to incorporate CXP in its nano particulate form, using chitosan as the polymer. Chitosan nanoparticles (CT NPs) possess unique properties that make them highly suitable for biological applications. The study focused on investigating the penetration behavior of chitosan nanoparticles (nano spray) through artificial skin, with the goal of developing them as effective skin delivery systems for medications. The nanoparticles had an average size of 640 nm, with a positive or negative surface potential and a polydispersity index (PDI) of 0.298. A thorough analysis of the nano spray was conducted using several scientific techniques, including X-ray diffractometry, scanning electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimetry (DSC), as well as in vitro release and diffusion studies. Additionally, cell viability was evaluated using the MTT assay, and blood compatibility was tested through a hemolysis test. The study also assessed the levels of the anti-inflammatory cytokine IL-2 in the lungs of mice using RNA extraction, reverse transcription, and polymerase chain reaction (RT-PCR). The drug dissolution and diffusion rates showed a significant improvement compared to the pure reference sample. Therefore, the CXP nano spray appears to be an efficient and practical method to enhance skin penetration, bioavailability, and permeability. Based on the results, the CXP nano spray holds potential as a promising treatment for fungal infections, particularly for skin diseases.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"32"},"PeriodicalIF":2.8,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11827433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424841","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 comparative study of using scorpion antivenom versus scorpion antivenom and prazosin drug for scorpion stings management in Sohag University Hospitals.","authors":"Meray Medhat Shokry Zaghary, Mai Mostafa Abd ElKader","doi":"10.1186/s40360-025-00854-x","DOIUrl":"10.1186/s40360-025-00854-x","url":null,"abstract":"<p><strong>Background: </strong>Scorpion envenomation is a worldwide problem, especially in tropical and subtropical areas like Egypt. Scorpion envenomation is responsible for the high mortality rate all over the world, which makes much research carried out to see the efficacy of other drugs as supportive treatment in addition to antivenom.</p><p><strong>Aim: </strong>To see the efficacy of prazosin drug with scorpion antivenom compared to antivenom alone.</p><p><strong>Methods: </strong>It is a prospective randomized comparative study between two groups from February 2023 to July 2024. Each group is 50 cases to compare the efficacy of prazosin with antivenom (group 1) and the antivenom alone (group 2) in scorpion stings cases.</p><p><strong>Results: </strong>The median age of the 100 cases was 7 years old. 54% of the study population were males. 46% of cases were females. Most of the cases were from rural areas. There was no significant difference in age, sex, and the patients' residence between the two groups. There was no significant difference between the 2 groups regarding the duration of stay in the hospital till mortality or discharge, with a median of 3 days in each group. However, there was a significant difference in the antivenom received in each case between the 2 groups, with a median of 6 vials in group 1 and 9 vials in group 2. Mortality and complications were observed to occur more in group 2 than in group 1 despite the insignificant p values. The study's mortality rate was 14%, 4/50 (8%) in group 1 and 10/50 (20%) in group 2. The number of antivenoms significantly increased with an increase in duration of stay, heart rate, respiratory rate, troponin level, and mortality outcome. While the number of antivenoms significantly decreased with the rise in systolic and diastolic blood pressure.</p><p><strong>Conclusion and recommendations: </strong>The study concluded that prazosin can be added to antivenom to increase its efficacy and decrease the number of needed antivenoms. Prazosin is a safe drug when used with precautions to avoid the first-dose phenomenon. Prazosin decreases complications and mortality when added to antivenom, but not significantly. The study recommends using prazosin with precautions for all manifested scorpion cases with antivenoms to increase the efficacy of the antivenom and treat the adrenergic manifestation.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"31"},"PeriodicalIF":2.8,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11827372/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143424769","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":"Melatonin protect against pregabalin-induced gonadotoxicity via anti-oxidative, anti-inflammatory, anti-apoptotic, enzymatic and hormonal regulatory mechanisms in rats.","authors":"Ayodeji Folorunsho Ajayi, Motolani Susan Borisade, Precious Oyedokun, Oyedayo Phillips Akano, Lydia Oluwatoyin Ajayi, David Tolulope Oluwole, Wale Johnson Adeyemi","doi":"10.1186/s40360-025-00863-w","DOIUrl":"10.1186/s40360-025-00863-w","url":null,"abstract":"<p><strong>Background: </strong>The therapeutic value of pregabalin in managing various pathological states, such as sleep, anxiety, and bipolar disorders, fibromyalgia, epilepsy, and others, cannot be overstated. Nevertheless, the gonadotoxicity of this drug remains a concern. In contrast, melatonin, an endogenous hormone, is known for its beneficial effects on reproductive tissues following various insults. Thus, this study aimed to examine the impact of melatonin on male Wistar rats exposed to pregabalin.</p><p><strong>Methods: </strong>A total of sixty male Wistar rats, weighing between 120 and 140 g, were randomly assigned to six groups, with each group consisting of ten rats. The control group was given 0.5 ml of normal saline orally, whereas melatonin was administered alone at 10 mg/kg/BW, and pregabalin was delivered at low and high doses of 150 and 300 mg/kg/BW orally, respectively. At the specified dosages, rats were also treated simultaneously with low and high doses of pregabalin in combination with melatonin. All treatments lasted for 56 days. Biomarkers were assayed in the testicular and epididymal tissues, while hormones were assayed in the serum.</p><p><strong>Results: </strong>Pregabalin treatment resulted in notable decreases in the percentage body weight change, testicular weight, relative testicular weight, FSH, LH, testosterone, 3β-HSD, 17β-HSD, SOD, catalase, and GSH, as compared to the control group. However, these effects were mitigated in the groups administered melatonin in conjunction with pregabalin. Pregabalin treatment also caused significant elevations in lactate, pyruvate, LDH, GGT, MDA, caspase, IL-1β, NF-κB, and TNF-α, and distorted testicular histoarchitecture, but these effects were blunted in the group co-administered with pregabalin and melatonin. The histological findings paralleled the biochemical assays.</p><p><strong>Conclusion: </strong>Conclusively, melatonin has a protective effect against pregabalin-induced gonadotoxicity through anti-oxidative, anti-inflammatory, anti-apoptotic, enzymatic, and hormonal regulatory mechanisms.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"30"},"PeriodicalIF":2.8,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11818422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143405556","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":"Assessment the real-world safety of intravitreal dexamethasone implant (Ozurdex): novel insights from a comprehensive pharmacovigilance analysis utilizing the FAERS database.","authors":"Chao-Fu Zhao, Lina Lan, Xing-Yu Shi, Jun Li, Shipei Fan","doi":"10.1186/s40360-025-00866-7","DOIUrl":"10.1186/s40360-025-00866-7","url":null,"abstract":"<p><strong>Objective: </strong>The intravitreal dexamethasone implant (Dex) is widely used for various ocular conditions, including diabetic macular edema (DME), retinal vein occlusion (RVO), and non-infectious uveitis. Despite its efficacy, concerns remain regarding its safety profile. This study aims to analyze the adverse events (AEs) associated with Dex reported in the FDA Adverse Event Reporting System (FAERS) database from 2010 to 2024.</p><p><strong>Methods: </strong>Data were extracted from FAERS, focusing on cases where Dex was the primary suspect drug. The dataset was processed to eliminate duplicates and incomplete entries. Disproportionality analysis, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR), was used to detect safety signals. AEs were categorized by system organ class (SOC) and preferred term (PT).</p><p><strong>Results: </strong>A total of 1,588 adverse event reports (AERs) were analyzed, revealing a significant upward trend. The Eye disorders was the most commonly reported SOC, with strong disproportionality signals (ROR: 45.11; PRR: 23.71). Key AEs identified at the PT level included Corneal decompensation, Choroidal hematoma, and Posterior capsule rupture, which were not listed on the drug label. Considering the reported numbers, the Endophthalmitis was the most common AE. Additionally, a significant proportion of AEs were observed within the first seven days post-administration, emphasizing the need for monitoring.</p><p><strong>Conclusion: </strong>While Dex remains an effective treatment option for ocular conditions, its use is associated with significant risks, particularly regarding unexpected and severe complications such as corneal decompensation. Continuous pharmacovigilance and detailed patient monitoring are essential to mitigate these risks. Future studies should focus on prospective designs and comprehensive clinical data to better understand the safety profile of Dex.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"29"},"PeriodicalIF":2.8,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809023/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143389902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of drug-induced pericardial effusion: a disproportionality analysis of the FAERS database.","authors":"Gaocan Ren, Pingping Huang, Yanqiu Ding, Xiaochang Ma","doi":"10.1186/s40360-025-00867-6","DOIUrl":"10.1186/s40360-025-00867-6","url":null,"abstract":"<p><strong>Objective: </strong>By using the FAERS database, we aim to identify and assess risk signals of adverse drug events (ADEs) potentially causing pericardial effusion, to inform clinical drug management and promote rational drug use.</p><p><strong>Methods: </strong>We obtained reports of pericardial effusion events from the FAERS database spanning from the first quarter of 2004 to the second quarter of 2024, and identified the top 50 drugs ranked by report frequency or signal strength. Four algorithms, namely the reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed for signal detection of these drugs. Furthermore, for drugs with positive signals, we conducted sensitivity analyses and employed the Weibull shape parameter test to perform a time to onset (TTO) analysis.</p><p><strong>Results: </strong>We identified 20,057 ADEs related to pericardial effusion, involving 19,693 patients for analysis. The patient population comprised 10,187 males (51.7%) and 7,939 females (40.3%). Adults aged 18-65 years were the largest group (7,798 cases, 39.6%). Regarding clinical outcomes, 9,924 patients (50.4%) experienced hospitalization, and 2,770 cases (14.1%) resulted in death. Ranked by the ROR risk signal strength, the top 3 drugs were hydralazine [ROR (95% CI): 27.11 (22.28-33)], dasatinib [ROR (95% CI): 15.62 (14.07-17.33)], and mesalazine [ROR (95% CI): 8.99 (6.84-11.8)]. We conducted a TTO analysis for the 26 drugs with positive signals. The median TTO and interquartile range (IQR) for the top 3 drugs causing the earliest pericardial effusion were: cytarabine 14 (7.5,38), selexipag 14.5 (4.25, 157.75), dabigatran etexilate 29 (9, 229). Most drugs exhibited an early failure type.</p><p><strong>Conclusion: </strong>This study systematically compiled a list of drugs with potential risks of causing pericardial effusion. There is a significant association between pericardial effusion and the use of hydralazine, dasatinib, and mesalazine. Moreover, pericardial effusion is more common in patient groups receiving treatments with antineoplastic and immunomodulating agents.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"27"},"PeriodicalIF":2.8,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11806542/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370257","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 real-world safety profile of empagliflozin: a disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.","authors":"Huiping Hu, Maochang Liu, Zhiwen Fu, Shijun Li, Kaiping Wang, Zi Huang","doi":"10.1186/s40360-025-00861-y","DOIUrl":"10.1186/s40360-025-00861-y","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate the entire adverse events (AEs) spectrum and to identify some new or rare AEs associated with empagliflozin based on the FAERS database.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on AE reports extracted from the FAERS, spanning from the first quarter of 2004 to that of 2023. Disproportionality analysis methods, including the ROR, PRR, BCPNN, and MGPS, were employed to quantify signals of AEs associated with empagliflozin. Additionally, demographic characteristics and time to onset were further elucidated.</p><p><strong>Results: </strong>The results showed a total of 20,734 AE reports related to empagliflozin, identifying 322 significant preferred terms (PTs) covering 27 System Organ Classes (SOCs). Empagliflozin was significantly associated with pre-specified AEs compared to other novel antidiabetic medications. Beyond common AEs, unexpected significant AEs such as pancreatitis, gastroenteritis, cerebral infarction, and cardiac operations were identified. The median onset time for empagliflozin-related AEs was 28 days (interquartile range (IQR) 4-154 days), with the majority of AE cases (n = 2,112, 10.19%) occurring within the first month following initiation of empagliflozin therapy.</p><p><strong>Conclusion: </strong>The clinically observed AEs, along with potential new AE signals associated with empagliflozin were identified based on the FAERS database, which could provide valuable evidence for clinical monitoring, risk identification, and further safety studies of identification.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"28"},"PeriodicalIF":2.8,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11806693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143370262","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":"Intratympanic N-acetylcysteine in the prevention of cisplatin-induced ototoxicity: a systematic review and meta-analysis of randomized controlled trials.","authors":"Mohamed Tawalbeh, Rewan M Ibrahim, Taif Al-Saraireh, Lubna Khreesha, Baeth Al Rawashdeh","doi":"10.1186/s40360-024-00829-4","DOIUrl":"10.1186/s40360-024-00829-4","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy of the otoprotective transtympanic application of N-acetylcysteine in preventing chemotherapy-induced ototoxicity in patients subjected to platinum-based chemotherapy.</p><p><strong>Data sources: </strong>PubMed, Scopus, Web of Science, Cochrane Central, and ClinicalTrials.gov were searched for the following concepts: ((\"Acetylcysteine\" [Mesh]) AND (\"Ototoxicity\" [Mesh]) AND (\"Cisplatin\" [Objective: To evaluate the efficacy of otoprotective transtympanic application of N-acetylcysteine in the prevention of chemotherapy-induced ototoxicity in patients subjected to platinum-based chemotherapy. [Mesh]).</p><p><strong>Study selection: </strong>Inclusion: randomized controlled trials, Exclusion: (1) case reports or case series; (2) thesis; (3) review articles; (4) conference abstracts; (5) animal studies; (6) non-english studies; (7) studies whose population was other than patients on platinum-based chemotherapy.</p><p><strong>Data extraction: </strong>changes in hearing thresholds measured by pure tone tympanometry, covering high and low frequencies: 250, 500, 1000, 2000, 4000, and 8000 Hz. We used RevMan (Review Manager) version 5.3 to conduct the meta-analysis and GRADE to assess the quality of the evidence.</p><p><strong>Data synthesis: </strong>The literature search yielded 277 unique articles. After reviewing six full-text articles, three RCTs provided data available for meta-analysis. A total of 88 cisplatin-based chemotherapy candidates were included for final analysis. Hearing thresholds showed a significant threshold difference between the ear treated with N-acetylcysteine and the control ear (ear not treated with N-acetylcysteine), especially at high frequencies as high as 8000 Hz (pooled effect size - 10.67, 95% CI [-12.33, -9.02], P < 0.00001). The data favored the Nac group in all frequencies as well, at 4000 Hz (pooled effect size - 2.13, 95% CI [-3.49, -0.77], P = 0.002), at 2000 Hz (pooled effect size - 1.38, 95% CI [-2.69, -0.06], P = 0.04), at 1000 Hz (pooled effect size - 1.58, 95% CI [-2.63, -0.53], P = 0.003), at 500 Hz (pooled effect size - 1.58, 95% CI [-2.62, -0.54], P = 0.003), and at the low frequency of 250 after solving the heterogeneity (pooled effect size - 0.96, 95% CI [-2.88, 0.95], P = 0.32).</p><p><strong>Conclusions: </strong>Current data justifies the transtympanic administration of N-acetylcysteine for otoprotection in chemotherapy patients, minimizing the enduring consequences of cisplatin-induced ototoxicity and auditory impairment. Given the results' emphasis on the Sarafraz et al. (2018) study, more randomized controlled trials are necessary with an expanded sample size and standardization of N-acetylcysteine concentration, study population, and assessed outcomes.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"26"},"PeriodicalIF":2.8,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188125","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":"Drug-related macular edema: a real-world FDA Adverse Event Reporting System database study.","authors":"Xiang Li, Yi-Qing Sun, Qiong-Lian Huang, Zhi-Jie Zhang, Li-Qiang Shi, Jia-Feng Tang, Zhan-Yang Luo","doi":"10.1186/s40360-025-00856-9","DOIUrl":"10.1186/s40360-025-00856-9","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to assess the risks associated with drug-induced macular edema and to examine the epidemiological characteristics of this condition.</p><p><strong>Methods: </strong>This study analyzed data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database from January 2004 to June 2024 to conduct a disproportionality analysis identifying drugs with positive signals of drug-induced ME. Additionally, the onset time of ME associated with these drugs was examined.</p><p><strong>Results: </strong>In the FAERS database, a total of 490 drugs were reported to pose a risk of drug-induced ME. Disproportional analysis and screening further identified 8 drugs that significantly increased this risk. Among these, one is ophthalmic drugs, including Latanoprost (ROR = 5.51), and ten are non-ophthalmic drugs, including Cefuroxime (ROR = 75.93), Fingolimod (ROR = 30.69), and Siponimod (ROR = 20.51).</p><p><strong>Conclusions: </strong>This study utilizes the FAERS database to investigate potential associations between drug use and the occurrence of ME, rapidly identify drugs that may induce the condition, and propose research strategies. These findings hold significant value for guiding clinical medication practices.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"23"},"PeriodicalIF":2.8,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783817/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143062823","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}