Clinical therapeutics最新文献

{"title":"Differences in Drug Poisonings Among Those Who Identify as Transgender Compared to Cisgender: An Analysis of the Toxicology Investigators Consortium (ToxIC) Core Registry, United States 2017-2021.","authors":"Kristine Magnusson, Emily Glidden, Desiree Mustaquim, Laura E Welder, Erin K Stokes, Gillian A Beauchamp, Marna R Greenberg, Kim Aldy, Richard J Mazzaccaro, Beth A Careyva, Judith N Sabino, Derek J Fikse, Katelyn McLain, Alexandra M Amaducci","doi":"10.1016/j.clinthera.2024.08.018","DOIUrl":"10.1016/j.clinthera.2024.08.018","url":null,"abstract":"<p><strong>Purpose: </strong>In this manuscript, the abbreviation TG is defined as persons who identify as transgender, GNC is defined as persons who identify as gender nonconforming, and CG is defined as persons who identify as cisgender. TG and GNC (e.g., nonbinary), are those whose gender identity and sex assigned at birth do not align, as opposed to CG. This study describes drug poisonings among TG, GNC, and CG captured in the Toxicology Investigators Consortium (ToxIC) Core Registry during 2017-2021.</p><p><strong>Methods: </strong>Authors conducted a secondary data analysis of medical toxicology physician consultations involving intentional exposures (i.e., use with the knowledge of the exposed person) within the ToxIC Core Registry from 2017 through 2021. Demographic characteristics, exposure intent, and reported drug classes are reported by gender identity and sex assigned at birth.</p><p><strong>Findings: </strong>From a total of 15,800 medical toxicology consultations, 213 (1.3%) involved both TG (n = 187, 1.2%) and GNC (n = 26, 0.2%), and 15,587 (98.7%) involved CG. Among TG, 128 (68.8%) were transgender men, 58 (31.2%) transgender women. Sixty-two percent of TG/GNC (n = 132) and 34.8% of CG (n = 5,428) were aged ≤18 years. Reported intent for exposure (i.e., self-harm and misuse/harmful use) differed proportionally across both sexes assigned at birth and gender identity among transgender men and cisgender men.</p><p><strong>Implications: </strong>In the ToxIC Core Registry, the consultations varied proportionally by age group across TG/GNC and CG, with more than half of TG/GNC aged ≤18 years. The proportion of consultations also varied by intent across TG/GNC and CG. Further research to delineate differences between TG/GNC and CG could increase knowledge in prevention, assessment, and treatment of drug poisonings in this population.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"953-959"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281581","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}

{"title":"Drug Review and Approval Policies Based on Real-world Evidence in China and the United States: A Comparative Study.","authors":"Munire Mohetaer, Adili Tuersun, Pei Li, Su Wang, Xingyan Zhang, Yuwen Chen","doi":"10.1016/j.clinthera.2024.09.009","DOIUrl":"10.1016/j.clinthera.2024.09.009","url":null,"abstract":"<p><strong>Purpose: </strong>The use of real-world evidence (RWE) in regulatory reviews and approvals is currently experiencing significant changes amid increasingly active discussions, primarily reflected in relevant policies, regulations, and guidance documents. However, disparities persist between China and the United States regarding the acceptance and formulation of policies for incorporating real-world data/evidence (RWD/E) in regulatory evaluation and authorization. Furthermore, the current policies lack specific operational details necessary for effective implementation and widespread adoption.</p><p><strong>Methods: </strong>After conducting a systematic literature review and comparing relevant policies, regulations, and guidelines, as well as the related information published on their official websites, we analyze key aspects of RWE-based drug review and approval policies to highlight similarities and differences in these policies between China and the United States.</p><p><strong>Findings: </strong>This paper reviews the frameworks and existing guidelines in China and the U.S., discussing similarities and differences observed in key policy aspects, including relevant definitions, data sources, data standards, data quality, and connectivity, information requirements, study design, personnel training, and communication, including an example of the application of RWE in drug review and approval processes.</p><p><strong>Implications: </strong>Further develop and refine RWE policies, encourage cooperation, and share best practices and successful examples to enhance the effectiveness of policy implementation and increase its social acceptance.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1059-1068"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142379231","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}

{"title":"Evaluation of Dexmedetomidine Withdrawal and Management After Prolonged Infusion.","authors":"Christine S Kim, Kevin C McLaughlin, Natasha Romero, Kaitlin E Crowley","doi":"10.1016/j.clinthera.2024.09.006","DOIUrl":"10.1016/j.clinthera.2024.09.006","url":null,"abstract":"<p><strong>Purpose: </strong>Dexmedetomidine is often used for longer than its labeled indication of 24 hours, raising concerns for potential withdrawal. Data are limited regarding this syndrome in adult patients. This study aimed to further characterize dexmedetomidine withdrawal in critically ill adult patients after prolonged use.</p><p><strong>Methods: </strong>This was an institutional review board-exempt, single-center, retrospective chart review conducted at a tertiary academic medical center. Adult intensive care unit (ICU) patients on dexmedetomidine for ≥72 hours in 2019 were screened for inclusion. Exclusion criteria were interruption of dexmedetomidine for >6 hours, indications for dexmedetomidine other than sedation, or patients with neurological or burn injury. The major end point was the incidence of dexmedetomidine withdrawal, defined as meeting ≥2 of the following criteria within 24 hours of discontinuation: newly positive Confusion Assessment Method for ICU, Richmond Agitation Sedation Scale score of ≥+2, hypertension, and tachycardia. Minor end points were incidence of individual withdrawal signs as previously described, additional sedatives or antipsychotics required, dose and duration of dexmedetomidine infusion, length of ventilation, ICU and hospital length of stay, and new onset of the following: fever, vomiting, loose stools/diarrhea, diaphoresis, or seizure.</p><p><strong>Findings: </strong>Of the 152 patients included, dexmedetomidine withdrawal occurred in 54 patients (35.5%). Rebound hypertension was the most common withdrawal sign (47 patients [87.0%]). In the withdrawal group, significantly more patients required additional β-blockers (29 [53.7%] vs 10 [10.2%]; P < 0.01), were reinitiated on dexmedetomidine (16 [29.6%] vs 10 [10.2%]; P < 0.01), and required a start or increased dose of clonidine (6 [11.1%] vs 3 [3.1%]; P = 0.04). There was no significant difference in the cumulative dose or duration of dexmedetomidine between the groups. Length of ventilation was longer in the withdrawal group (171 hours [83.7-280.8 hours] vs 159 hours [149.0-335.7 hours]; P < 0.01), but there was no difference in ICU or hospital length of stay.</p><p><strong>Implications: </strong>Prolonged use of dexmedetomidine was associated with withdrawal syndrome in 35.5% of patients in our study. Larger trials are needed to confirm the risk factors for dexmedetomidine withdrawal and identify measures to prevent withdrawal.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1034-1040"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388662","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}

{"title":"Population Pharmacokinetic Model of Intravenous Immunoglobulin in Patients Treated for Various Immune System Disorders.","authors":"Jian Lynn Lee, Noraida Mohamed Shah, Mohd Makmor-Bakry, Farida Islahudin, Hamidah Alias, Shamin Mohd Saffian","doi":"10.1016/j.clinthera.2024.09.018","DOIUrl":"10.1016/j.clinthera.2024.09.018","url":null,"abstract":"<p><strong>Purpose: </strong>Intravenous immunoglobulin (IVIG) is used to treat various immune system disorders, but the factors influencing its disposition are not well understood. This study aimed to estimate the population pharmacokinetic parameters of IVIG and to investigate the effect of genetic polymorphism of the FCGRT gene encoding the neonatal Fc receptor (FcRn) and clinical variability on the pharmacokinetic properties of IVIG in patients with immune system disorders.</p><p><strong>Methods: </strong>Patients were recruited from 4 hospitals in Malaysia. Clinical data were recorded, and blood samples were taken for pharmacokinetic and genetic studies. Population pharmacokinetic parameters were estimated by nonlinear mixed-effects modeling in Monolix. Age, weight, baseline immunoglobulin G concentration, ethnicity, sex, genotype, disease type, and comorbidity were investigated as potential covariates. Models were evaluated using the difference in objective function value, goodness-of-fit plots, visual predictive checks, and bootstrap analysis.</p><p><strong>Findings: </strong>A total of 292 blood samples were analyzed from 79 patients. The IVIG concentrations were best described by a 2-compartment model with linear elimination. Weight was found to be an important covariate for volume of distribution in the central compartment (Vc), volume of distribution in the peripheral compartment (Vp), and clearance in the central compartment, whereas disease type was found to be an important covariate for Vp. Goodness-of-fit plots indicated that the model fit the data adequately. Genetic polymorphism of the FCGRT gene encoding the neonatal Fc receptor did not affect the pharmacokinetic properties of IVIG.</p><p><strong>Implications: </strong>This study supports the use of dosage based on weight as per current practice. The study findings highlight that Vp is significantly influenced by the type of disease being treated with IVIG. This relationship suggests that different disease types, particularly inflammatory and autoimmune conditions, may alter tissue permeability and fluid distribution due to varying degrees of inflammation. Increased inflammation can lead to enhanced permeability and retention of IVIG in peripheral tissues, reflecting higher Vp values.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"e25-e37"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375272","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}

{"title":"Cost-effectiveness Analysis of Prophylaxis Versus On-demand Treatment for Children With Moderate or Severe Hemophilia A in China.","authors":"Yaohan Zhou, Zhengping Li, Guoqing Liu, Zhenping Chen, Wanru Yao, Gang Li, Yingzi Zhen, Xiaoling Cheng, Di Ai, Kun Huang, Wang Cao, Runhui Wu","doi":"10.1016/j.clinthera.2024.09.003","DOIUrl":"10.1016/j.clinthera.2024.09.003","url":null,"abstract":"<p><strong>Background: </strong>It is still being determined if prophylaxis (PR) has superior cost effectiveness compared with on-demand (OD) treatment for moderate or severe hemophilia A (HA) children in China.</p><p><strong>Objective/purpose: </strong>To evaluate the cost-effectiveness of PR and OD treatment for children with moderate or severe HA without inhibitors in China.</p><p><strong>Methods: </strong>A retrospective cost-effectiveness study was conducted on 640 HA children (373 and 267 children were on the PR and OD treatment, respectively) from January 2021 to November 2022. The Markov model was used to estimate the economic and clinical outcomes and would run for 17 yearly cycles with the initial age at 2 years. The transfer probabilities were extracted from the data of \"Hemophilia Home Care Center\" and the literature published. All patients' drug costs were collected from the data of \"Hemophilia Home Care Center\". One-way and probabilistic sensitivity analyses were conducted on the data to evaluate the robustness of the results.</p><p><strong>Results/findings: </strong>PR was consistently associated with higher overall quality-adjusted life years (QALYs) compared with OD treatment (9.59 QALYs vs. 6.85 QALYs). The incremental cost-effectiveness ratio (ICER) of PR compared with the OD treatment was calculated to be approximately US$12,151.35 (RMB¥81,778.55) per QALY gained. This amount was lower than the willingness-to-pay (WTP) threshold of US$38,212.74 (RMB¥257,171.71). One-way sensitivity analysis found that the results were sensitive to the cost of OD and PR treatments.</p><p><strong>Conclusions/implications: </strong>This study indicated that PR is cost-effective compared with OD treatment for children with moderate or severe HA without inhibitors in China.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1010-1015"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459922","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}

{"title":"Systematic Review of Sex-specific High Sensitivity Cardiac Troponin I and T Thresholds.","authors":"Mengchen Cao, Ava E Pierce, Marquita S Norman, Bhaskar Thakur, Kiersten Diercks, Cooper Hale, Yacine Issioui, Deborah B Diercks","doi":"10.1016/j.clinthera.2024.09.025","DOIUrl":"10.1016/j.clinthera.2024.09.025","url":null,"abstract":"<p><strong>Purpose: </strong>High-sensitivity cardiac troponin I (hs-cTnI) and T (hs-cTnT) have been demonstrated to have lower sex-specific 99th percentiles in healthy females. However, these sex-specific thresholds are not widely adopted in clinical practice which could lead to underdiagnosis of acute myocardial infarction in females. We conducted a systematic review to explore sex-specific 99th percentiles for hs-cTnI and hs-cTnT from healthy reference populations.</p><p><strong>Methods: </strong>The principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to complete this systematic review. We used PubMed and OVID EMBASE to search for original studies published between November 2017 and November 2021 that included reference populations used to establish the 99th percentiles of hs-cTnI and hs-cTnT with the following inclusion criteria: adults; English language; samples taken as part of a healthy, reference population; studies using high-sensitivity troponin assay; and sample size > 300. Studies were excluded if the reference population sample size was < 300, if a conventional troponin assay was used, or if they did not include independently derived, sex-specific 99th percentiles. Data was extracted from the studies through Covidence to perform a qualitative data synthesis. Female-specific, male-specific, and overall 99th percentiles for hs-cTn were compared.</p><p><strong>Findings: </strong>We reviewed 131 articles of which 19 met inclusion criteria. These 19 studies derived sex-specific 99th percentiles for 11 different hs-cTnI assays and 9 different hs-cTnT assays. More than 90% (13 of 14 studies) of hs-cTnI assays found lower female 99th percentiles compared to male and to overall 99th percentiles. One study included nine different hs-cTnI assays, of which only one assay resulted in a higher female 99th percentile compared to male and to overall 99th percentiles. Eight of nine hs-cTnT studies (88.9%) found lower female 99th percentiles compared to male and to overall 99th percentiles.</p><p><strong>Implications: </strong>The data shows significantly lower 99th percentiles in females compared to 99th percentiles in males and overall. Incorporating these sex-specific 99th percentile cut-offs into clinical practice could lead to increased diagnosis and potentially better outcomes for females presenting with acute myocardial infarction.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"988-994"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590359","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}

{"title":"Chest Pain in the Setting of Acute Stress: A Tale of Two Women.","authors":"Bryn E Mumma, Joseph M Kim, Jason H Rogers","doi":"10.1016/j.clinthera.2024.10.012","DOIUrl":"10.1016/j.clinthera.2024.10.012","url":null,"abstract":"<p><p>Chest pain is one of the most common reasons for emergency department visits in the United States. Common etiologies of chest pain include both anxiety and myocardial infarction (MI); furthermore, anxiety and stress may contribute to the development of MI, particularly MI with non-obstructed coronary arteries (MINOCA). We present the cases of two women with acute chest pain in the setting of acute life stressors who were found to have MINOCA. We discuss the relationship between acute stress, chest pain, and MINOCA, as well as the importance of considering a broad differential diagnosis in women with acute chest pain.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1005-1009"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692369","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}

{"title":"Machine Learning for Prediction of Postoperative Delirium in Adult Patients: A Systematic Review and Meta-analysis.","authors":"Hao Chen, Dongdong Yu, Jing Zhang, Jianli Li","doi":"10.1016/j.clinthera.2024.09.013","DOIUrl":"10.1016/j.clinthera.2024.09.013","url":null,"abstract":"<p><strong>Purpose: </strong>This meta-analysis aimed to evaluate the performance of machine learning (ML) models in predicting postoperative delirium (POD) and to provide guidance for clinical application.</p><p><strong>Methods: </strong>PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to April 29, 2024. Studies reported ML models for predicting POD in adult patients were included. Data extraction and risk of bias assessment were performed using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis - AI (TRIPOD-AI) and Prediction model Risk Of Bias ASsessment Tool (PROBAST) tools. Meta-analysis with the area under the curve (AUC) was performed using MedCalc software.</p><p><strong>Findings: </strong>A total of 23 studies were included after screening. Age (n = 20, 86.95%) and Random Forest (RF) (n = 24, 17.27%) were the most frequently used feature and ML algorithm, respectively. The meta-analysis showed an overall AUC of 0.792. The ensemble models (AUC = 0.805) showed better predictive performance than single models (AUC = 0.782). Additionally, considerable variations in AUC were found among different ML algorithms, with AdaBoost (AB) demonstrating good performance with AUC of 0.870. Notably, the generalizability of these models was uncertain due to limitations in external validation and bias assessment.</p><p><strong>Implications: </strong>The performance of ensemble models were higher than single models, and the AB algorithms demonstrated better performance, compared with other algorithms. However, further research was needed to enhance the generalizability and transparency of ML models.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1069-1081"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459923","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}

{"title":"Response to Letter Regarding Article, \"Pancreatitis and Pancreatic Cancer Risk Among Patients with Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors: An Updated Meta-Analysis of Randomized Controlled Trials\".","authors":"Adili Tuersun, Munire Mohetaer, Munire Tuerhong, Guanxin Hou, Gang Cheng","doi":"10.1016/j.clinthera.2024.09.002","DOIUrl":"10.1016/j.clinthera.2024.09.002","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1087-1088"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343083","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}

{"title":"Unraveling the Spectrum of Ocular Toxicity with Oxaliplatin: Clinical Feature Analysis of Cases and Pharmacovigilance Assessment of the US Food and Drug Administration Adverse Event Reporting System Database.","authors":"Wensheng Liu, Xuan Ye, Han Shan, Mengmeng Wang, Yingbin Wang, Zihan Guo, Jiyong Liu, Qiong Du","doi":"10.1016/j.clinthera.2024.09.019","DOIUrl":"10.1016/j.clinthera.2024.09.019","url":null,"abstract":"<p><strong>Purpose: </strong>Ocular adverse events (oAEs) are a class of adverse events associated with oxaliplatin that are realistically observed in real-world settings. Herein, we aim to describe the clinical characteristics of oAEs associated with oxaliplatin through a systematic review of case reports and to assess a potential safety signal.</p><p><strong>Methods: </strong>PubMed, Embase, and Cochrane Library databases were used to retrieve case reports. The global disproportionality study was performed leveraging the US Food and Drug Administration Adverse Event Reporting System database from January 2004 to September 2023. Bayesian information component (IC) and reporting odds ratio (ROR) were applied to identify and evaluate potential oAEs associated oxaliplatin.</p><p><strong>Findings: </strong>A total of 20 cases from the systematic case review (of 13 screened articles) were reported on oAEs associated with oxaliplatin, with ages between 26 and 76 years. Therein, 16 (84.2%) cases described loss of vision, and the remaining cases presented with bilateral blepharoptosis, papilledema, and optic disc swelling. Insights from the US Food and Drug Administration Adverse Event Reporting System database showed that oAEs accounted for 4.28% (n = 1194) of the overall oxaliplatin-related adverse event reports, of which 1140 (95.48%) had a serious outcome. The median (interquartile range) onset time of oAEs with oxaliplatin was day 1 (0-25; n = 649). Disproportionality analysis revealed that ocular injuries NEC (n = 28, ROR, 22.72; lower limit of the 95% 2-sided CI for IC, 3.12) was the most significant signals detected. Additionally, unexpected significant oAEs, including eyelid ptosis, eyelid edema, eye movement disorder, blepharospasm, periorbital edema, swelling of eyelid, ophthalmoplegia, retinal vein thrombosis, cataract nuclear, blindness cortical, cataract subcapsular, and lacrimation disorder, were also reported disproportionality.</p><p><strong>Implications: </strong>Our study systematically described the characteristics and outcomes of oxaliplatin-related ocular toxicity and also uncovered potential oAEs that were not disclosed in the package insert. Further prospective epidemiologic studies to validate these findings are warranted.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1049-1058"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459925","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}