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Machine Learning for Prediction of Postoperative Delirium in Adult Patients: A Systematic Review and Meta-analysis 预测成人患者术后谵妄的机器学习:系统回顾与元分析》。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-12-01 DOI: 10.1016/j.clinthera.2024.09.013
Hao Chen MSc , Dongdong Yu MSc , Jing Zhang MSc , Jianli Li PhD

Purpose

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.

Methods

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.

Findings

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.

Implications

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.
目的:本荟萃分析旨在评估机器学习(ML)模型在预测术后谵妄(POD)方面的性能,并为临床应用提供指导:方法:检索了 PubMed、Embase、Cochrane Library 和 Web of Science 数据库中从开始到 2024 年 4 月 29 日的内容。纳入了报告成人患者 POD 预测 ML 模型的研究。数据提取和偏倚风险评估使用 "个人预后或诊断多变量预测模型透明报告-AI(TRIPOD-AI)"和 "预测模型偏倚风险评估工具(PROBAST)"工具进行。使用 MedCalc 软件对曲线下面积(AUC)进行了元分析:经过筛选,共纳入 23 项研究。年龄(n = 20,86.95%)和随机森林(RF)(n = 24,17.27%)分别是最常用的特征和 ML 算法。荟萃分析显示,总体 AUC 为 0.792。集合模型(AUC = 0.805)比单一模型(AUC = 0.782)显示出更好的预测性能。此外,不同 ML 算法的 AUC 也有很大差异,AdaBoost(AB)的 AUC 为 0.870,表现出色。值得注意的是,由于外部验证和偏差评估的局限性,这些模型的普适性并不确定:启示:集合模型的性能高于单一模型,与其他算法相比,AB 算法的性能更好。然而,要提高 ML 模型的普遍性和透明度,还需要进一步研究。
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引用次数: 0
Systematic Review of Sex-specific High Sensitivity Cardiac Troponin I and T Thresholds 性别特异性高敏心肌肌钙蛋白 I 和 T 阈值的系统性回顾。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-12-01 DOI: 10.1016/j.clinthera.2024.09.025
Mengchen Cao MD, Ava E. Pierce MD, Marquita S. Norman MD, MBA, Bhaskar Thakur PhD, Kiersten Diercks BA, Cooper Hale MD, Yacine Issioui MD, Deborah B. Diercks MD, MSc, MBA

Purpose

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.

Methods

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.

Findings

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.

Implications

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.
目的:高敏心肌肌钙蛋白 I(hs-cTnI)和 T(hs-cTnT)在健康女性中的性别特异性第 99 百分位数较低。然而,这些性别特异性阈值在临床实践中并未被广泛采用,这可能会导致女性急性心肌梗死的诊断率偏低。我们进行了一项系统性研究,以探讨健康参考人群中 hs-cTnI 和 hs-cTnT 的性别特异性第 99 百分位数:我们采用系统综述和荟萃分析首选报告项目(PRISMA)指南的原则完成了这项系统综述。我们使用PubMed和OVID EMBASE检索了2017年11月至2021年11月期间发表的原始研究,这些研究包含用于确定hs-cTnI和hs-cTnT第99百分位数的参考人群,纳入标准如下:成人;英语;作为健康参考人群一部分的样本;使用高敏肌钙蛋白测定法的研究;样本量大于300。如果参考人群样本量小于 300 人、使用的是传统肌钙蛋白测定法或未包含独立得出的性别特异性第 99 百分位数,则排除这些研究。通过 Covidence 从研究中提取数据,进行定性数据综合。比较了女性特异性、男性特异性和总体 hs-cTn 第 99 百分位数:我们审查了 131 篇文章,其中 19 篇符合纳入标准。这 19 项研究得出了 11 种不同 hs-cTnI 检测方法和 9 种不同 hs-cTnT 检测方法的性别特异性第 99 百分位数。超过 90% 的 hs-cTnI 检测方法(14 项研究中的 13 项)发现,女性的第 99 百分位数低于男性和总体第 99 百分位数。一项研究包括九种不同的 hs-cTnI 检测方法,其中只有一种检测方法的女性第 99 百分位数高于男性和总体第 99 百分位数。九项 hs-cTnT 研究中有八项(88.9%)发现女性第 99 百分位数低于男性和总体第 99 百分位数:数据显示,女性的第 99 百分位数明显低于男性和总体的第 99 百分位数。将这些性别特异性第 99 百分位数临界值纳入临床实践,可提高对女性急性心肌梗死患者的诊断率,并可能改善其预后。
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引用次数: 0
Chest Pain in the Setting of Acute Stress: A Tale of Two Women 急性应激状态下的胸痛:两个女人的故事
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-12-01 DOI: 10.1016/j.clinthera.2024.10.012
Bryn E. Mumma MD, MAS , Joseph M. Kim MD , Jason H. Rogers MD
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.
在美国,胸痛是急诊科最常见的就诊原因之一。胸痛的常见病因包括焦虑和心肌梗死(MI);此外,焦虑和压力还可能导致心肌梗死的发生,尤其是冠状动脉未阻塞性心肌梗死(MINOCA)。我们介绍了两名在急性生活压力下出现急性胸痛并被发现患有 MINOCA 的女性病例。我们讨论了急性应激、胸痛和 MINOCA 之间的关系,以及考虑对急性胸痛女性进行广泛鉴别诊断的重要性。
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引用次数: 0
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” 关于 "接受二肽基肽酶 4 抑制剂治疗的 2 型糖尿病患者的胰腺炎和胰腺癌风险:随机对照试验的最新 Meta 分析 "一文的回复。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-12-01 DOI: 10.1016/j.clinthera.2024.09.002
Adili Tuersun , Munire Mohetaer , Munire Tuerhong , Guanxin Hou , Gang Cheng
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引用次数: 0
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 揭示奥沙利铂眼部毒性的范围:病例临床特征分析和美国食品药品管理局不良事件报告系统数据库的药物警戒评估。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-12-01 DOI: 10.1016/j.clinthera.2024.09.019
Wensheng Liu , Xuan Ye , Han Shan , Mengmeng Wang , Yingbin Wang , Zihan Guo , Jiyong Liu , Qiong Du

Purpose

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.

Methods

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.

Findings

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.

Implications

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.
目的:眼部不良事件(oAEs)是与奥沙利铂相关的一类不良事件,在现实世界中可以观察到。在此,我们旨在通过对病例报告的系统回顾,描述与奥沙利铂相关的眼部不良事件的临床特征,并评估潜在的安全信号:方法:使用 PubMed、Embase 和 Cochrane Library 数据库检索病例报告。利用 2004 年 1 月至 2023 年 9 月的美国食品和药物管理局不良事件报告系统数据库进行了全球比例失调研究。应用贝叶斯信息成分(IC)和报告几率比(ROR)来识别和评估与奥沙利铂相关的潜在oAE:系统性病例回顾(共筛选出 13 篇文章)共报告了 20 例与奥沙利铂相关的 OAE,患者年龄在 26 岁至 76 岁之间。其中,16 个病例(84.2%)描述了视力丧失,其余病例表现为双侧眼睑下垂、视乳头水肿和视盘肿胀。美国食品和药物管理局不良事件报告系统数据库显示,在所有奥沙利铂相关不良事件报告中,oAE 占 4.28%(n = 1194),其中 1140 例(95.48%)有严重后果。奥沙利铂 oAEs 的中位(四分位数间距)发生时间为第 1 天(0-25;n = 649)。比例失调分析显示,眼部损伤 NEC(n = 28,ROR,22.72;IC 的 95% 双侧 CI 下限为 3.12)是检测到的最重要信号。此外,眼睑下垂、眼睑水肿、眼球运动障碍、眼睑痉挛、眶周水肿、眼睑肿胀、眼肌麻痹、视网膜静脉血栓、核性白内障、皮质性失明、囊下白内障和流泪障碍等意想不到的重要 OAE 也被报告为比例失调:我们的研究系统地描述了奥沙利铂相关眼部毒性的特征和结果,还发现了包装说明书中未披露的潜在眼部毒性反应。有必要进一步开展前瞻性流行病学研究以验证这些发现。
{"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 ,&nbsp;Xuan Ye ,&nbsp;Han Shan ,&nbsp;Mengmeng Wang ,&nbsp;Yingbin Wang ,&nbsp;Zihan Guo ,&nbsp;Jiyong Liu ,&nbsp;Qiong Du","doi":"10.1016/j.clinthera.2024.09.019","DOIUrl":"10.1016/j.clinthera.2024.09.019","url":null,"abstract":"<div><h3>Purpose</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Findings</h3><div>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.</div></div><div><h3>Implications</h3><div>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.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correlation of Triethylamine N-oxide (TMAO), LPS, and TNF-Alpha Levels With Clinical Features of the Disease in Patients With and Without Septic Shock Infected With COVID-19 Virus 感染 COVID-19 病毒的脓毒性休克患者体内三乙胺 N-氧化物 (TMAO)、LPS 和 TNF-Alpha 水平与疾病临床特征的相关性。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-12-01 DOI: 10.1016/j.clinthera.2024.09.021
Kübra Polat , Mehtap Gömleksiz , Kübra Oral , Nevzat Gözel , Gaweł Sołowski , Tugҫe Kaymaz , Mehmet Ferit Gürsu

Background

Inflammation is a response of the immune system to protect the body against various diseases or injuries. Serum trimethylamine N-oxide (TMAO) levels may vary depending on age, gender, habits, comorbidities, and microbiota.

Aims

In this study, we investigated whether TMAO levels have diagnostic significance and their potential as a marker in the early diagnosis of the disease. Another aim of the research was to identify changes in TMAO levels as a reflection of the deterioration in the microflora, and IL-6, IL-10, IL-1β, TNF-alpha, and LPS levels in patient groups. Then, we recognized relationships between these parameters in patients infected with COVID-19 without septic shock and with COVID-19 who were without transmission of COVID-19 in septic shock.

Study Design

A total of 160 patients were investigated, including 40 patients infected with COVID-19 without septic contact, 40 patients with COVID-19 positive septic shock, 40 patients with COVID-19 negative septic shock, and 40 healthy individuals as the control group.

Results

TNF-α and IL-1β levels were significantly lower (P < 0.001) and IL-6 and IL-10 levels were significantly higher (P < 0.001) in patient groups than in control groups. IL-1β showed a significant decrease, especially in the groups infected with COVID-19. Although IL-6, increased even more in the groups infected with COVID-19.

Conclusions

LPS level was remarkably high in the sepsis group infected with COVID-19 compared to the other groups. TMAO level was significantly higher (P < 0.001) in the sepsis group. Therefore, TMAO is a potential biomarker in sepsis and septic shock.
背景:炎症是免疫系统保护机体免受各种疾病或伤害的一种反应。血清中三甲胺 N-氧化物(TMAO)的水平会因年龄、性别、习惯、合并症和微生物群的不同而变化。目的:在这项研究中,我们探讨了 TMAO 水平是否具有诊断意义,以及其作为疾病早期诊断标志物的潜力。研究的另一个目的是确定 TMAO 水平的变化是否反映了微生物群的恶化,以及患者群体中的 IL-6、IL-10、IL-1β、TNF-α 和 LPS 水平。然后,我们确认了感染COVID-19但未发生脓毒性休克的患者和感染COVID-19但未传播COVID-19而发生脓毒性休克的患者的这些参数之间的关系:研究设计:共调查了160名患者,包括40名感染COVID-19但无脓毒症接触的患者、40名COVID-19阳性脓毒症休克患者、40名COVID-19阴性脓毒症休克患者,以及40名健康人作为对照组:结果:患者组的TNF-α和IL-1β水平明显低于对照组(P<0.001),IL-6和IL-10水平明显高于对照组(P<0.001)。IL-1β 明显下降,尤其是在感染 COVID-19 的组别中。结论:COVID-19 感染组的 LPS 水平明显高于对照组:结论:与其他组相比,感染 COVID-19 的败血症组 LPS 水平明显较高。败血症组的 TMAO 水平明显更高(P < 0.001)。因此,TMAO是脓毒症和脓毒性休克的潜在生物标志物。
{"title":"Correlation of Triethylamine N-oxide (TMAO), LPS, and TNF-Alpha Levels With Clinical Features of the Disease in Patients With and Without Septic Shock Infected With COVID-19 Virus","authors":"Kübra Polat ,&nbsp;Mehtap Gömleksiz ,&nbsp;Kübra Oral ,&nbsp;Nevzat Gözel ,&nbsp;Gaweł Sołowski ,&nbsp;Tugҫe Kaymaz ,&nbsp;Mehmet Ferit Gürsu","doi":"10.1016/j.clinthera.2024.09.021","DOIUrl":"10.1016/j.clinthera.2024.09.021","url":null,"abstract":"<div><h3>Background</h3><div>Inflammation is a response of the immune system to protect the body against various diseases or injuries. Serum trimethylamine N-oxide (TMAO) levels may vary depending on age, gender, habits, comorbidities, and microbiota.</div></div><div><h3>Aims</h3><div>In this study, we investigated whether TMAO levels have diagnostic significance and their potential as a marker in the early diagnosis of the disease. Another aim of the research was to identify changes in TMAO levels as a reflection of the deterioration in the microflora, and IL-6, IL-10, IL-1β, TNF-alpha, and LPS levels in patient groups. Then, we recognized relationships between these parameters in patients infected with COVID-19 without septic shock and with COVID-19 who were without transmission of COVID-19 in septic shock.</div></div><div><h3>Study Design</h3><div>A total of 160 patients were investigated, including 40 patients infected with COVID-19 without septic contact, 40 patients with COVID-19 positive septic shock, 40 patients with COVID-19 negative septic shock, and 40 healthy individuals as the control group.</div></div><div><h3>Results</h3><div>TNF-α and IL-1β levels were significantly lower (<em>P</em> &lt; 0.001) and IL-6 and IL-10 levels were significantly higher (<em>P</em> &lt; 0.001) in patient groups than in control groups. IL-1β showed a significant decrease, especially in the groups infected with COVID-19. Although IL-6, increased even more in the groups infected with COVID-19.</div></div><div><h3>Conclusions</h3><div>LPS level was remarkably high in the sepsis group infected with COVID-19 compared to the other groups. TMAO level was significantly higher (<em>P</em> &lt; 0.001) in the sepsis group. Therefore, TMAO is a potential biomarker in sepsis and septic shock.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages e1-e8"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496506","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
Advances in Enrolling Pregnant Persons Into Acute Care Clinical Trials, A Discussion With the Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (ICECAP) Trial Principal Investigators 将孕妇纳入急性护理临床试验的进展——与冷却时间对心脏骤停患者疗效影响的探讨(ICECAP)试验首席研究员。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-12-01 DOI: 10.1016/j.clinthera.2024.11.006
Sarah M. Perman MD, MSCE, William Meurer MD, MS, Robert Silbergleit MD, Angela F. Jarman MD, MPH
{"title":"Advances in Enrolling Pregnant Persons Into Acute Care Clinical Trials, A Discussion With the Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (ICECAP) Trial Principal Investigators","authors":"Sarah M. Perman MD, MSCE,&nbsp;William Meurer MD, MS,&nbsp;Robert Silbergleit MD,&nbsp;Angela F. Jarman MD, MPH","doi":"10.1016/j.clinthera.2024.11.006","DOIUrl":"10.1016/j.clinthera.2024.11.006","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Pages 945-948"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754835","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
Letter to the Editor, Regarding "Optimizing Acute Ischemic Stroke Outcomes: The Role of Tenecteplase Before Mechanical Thrombectomy" Recently Published by Ketabforoush and Colleagues. 致编辑的信,关于“优化急性缺血性卒中结局:Tenecteplase在机械取栓前的作用”,最近由Ketabforoush及其同事发表。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-30 DOI: 10.1016/j.clinthera.2024.11.008
Senta Frol, René Chapot
{"title":"Letter to the Editor, Regarding \"Optimizing Acute Ischemic Stroke Outcomes: The Role of Tenecteplase Before Mechanical Thrombectomy\" Recently Published by Ketabforoush and Colleagues.","authors":"Senta Frol, René Chapot","doi":"10.1016/j.clinthera.2024.11.008","DOIUrl":"https://doi.org/10.1016/j.clinthera.2024.11.008","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767052","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 Between Prior Antiplatelet Therapy and Prognosis in Patients With Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis 脑出血患者既往抗血小板治疗与预后之间的关系:系统回顾与元分析》。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.clinthera.2024.08.010
Hanxu Zhang PhD , Xiaoran Hou MS , Yidan Gou MS , Yanyan Chen MS , Shuo An MD , Yingsheng Wei MD , Rongcai Jiang MD , Ye Tian MD , Hengjie Yuan PhD

Purpose

Approximately 20% to 30% of intracerebral hemorrhage (ICH) patients were reported to be on antiplatelet therapy (APT), and association between prior APT and prognosis was unclear. We aimed to clarify the impact of APT on the prognosis of ICH through an updated systematic review and meta-analysis, and to further compare the risk of single APT (SAPT) or dual APT (DAPT) prior to ICH as well as the risk associated with various antiplatelet drugs.

Methods

EMBASE, MEDLINE via Ovid SP and Web of Science were searched from inception of each database to November 4, 2023. Included studies reported prognosis in both patients with prior APT and those without.

Findings

A total of 433,103 patients from 43 studies were included in the meta-analysis. Both univariate and multivariate analyses demonstrated a significant association between prior-APT and an increased mortality risk (odd ratio [OR] 1.43, 95% confidence interval [CI] 1.28–1.59; OR 1.20, 95%CI 1.10–1.30, respectively). The risk was higher in short term follow-up (Univariate OR 1.73, 95%CI 1.22–2.46; Multivariate OR 1.94, 95%CI 1.48–2.55). A notably increased risk of hematoma expansion was also observed in patients previously treated with APT (Univariate OR 1.47, 95%CI 1.12–1.94; Multivariate OR 1.88, 95%CI 1.30–2.71), which were mainly attributed to events within 24 hours. The impact of prior-APT on poor functional outcome was inconsistent between univariate and multivariate analyses. Both direct and indirect comparisons showed that SAPT significantly reduced the risk of mortality (OR 0.67, 95%CI 0.64–0.70; OR 0.84, 95%CI 0.71–0.99) and poor functional outcome (OR 0.84, 95%CI 0.72–0.98; OR 0.81, 95%CI 0.72–0.91) compared to DAPT.

Implications

Prior-APT increased the risk of mortality and hematoma expansion in patients with ICH. The increased risk of mortality and hematoma expansion was more obvious in the short term follow-up and within 24 hours, respectively. The effect of APT on poor functional outcome exhibited inconsistency between univariate and multivariate analyses, suggesting that further investigation is warranted to clarify this relationship. In comparison with DAPT, SAPT could decrease the risk of mortality and poor functional outcome. Further studies focusing on antiplatelet drug response, racial differences, and specific APT regimens may help verify the influence.
目的:据报道,约 20% 至 30% 的脑内出血 (ICH) 患者接受过抗血小板治疗 (APT),而既往 APT 与预后之间的关系尚不明确。我们旨在通过最新的系统综述和荟萃分析来阐明 APT 对 ICH 预后的影响,并进一步比较 ICH 前单一 APT(SAPT)或双重 APT(DAPT)的风险以及与各种抗血小板药物相关的风险:方法:检索EMBASE、通过Ovid SP检索的MEDLINE和Web of Science,检索时间从各数据库建立之初至2023年11月4日。纳入的研究报告了既往有 APT 患者又无 APT 患者的预后情况:荟萃分析共纳入了 43 项研究中的 433 103 例患者。单变量和多变量分析表明,既往有 APT 患者与死亡风险增加之间存在显著关联(奇异比 [OR] 1.43,95% 置信区间 [CI] 分别为 1.28-1.59;OR 1.20,95%CI 1.10-1.30)。短期随访的风险更高(单变量 OR 1.73,95%CI 1.22-2.46;多变量 OR 1.94,95%CI 1.48-2.55)。在之前接受过 APT 治疗的患者中也观察到血肿扩大的风险明显增加(单变量 OR 1.47,95%CI 1.12-1.94;多变量 OR 1.88,95%CI 1.30-2.71),这主要归因于 24 小时内发生的事件。在单变量和多变量分析中,既往APT对不良功能预后的影响并不一致。直接和间接比较均显示,与DAPT相比,SAPT可显著降低死亡风险(OR 0.67,95%CI 0.64-0.70;OR 0.84,95%CI 0.71-0.99)和不良功能预后(OR 0.84,95%CI 0.72-0.98;OR 0.81,95%CI 0.72-0.91):启示:预先APT会增加ICH患者的死亡率和血肿扩大风险。在短期随访和 24 小时内,死亡率和血肿扩大风险的增加分别更为明显。APT 对不良功能预后的影响在单变量分析和多变量分析中表现出不一致性,这表明需要进一步研究以明确这种关系。与 DAPT 相比,SAPT 可降低死亡率和不良功能预后的风险。针对抗血小板药物反应、种族差异和特定 APT 方案的进一步研究可能有助于验证这种影响。
{"title":"Association Between Prior Antiplatelet Therapy and Prognosis in Patients With Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis","authors":"Hanxu Zhang PhD ,&nbsp;Xiaoran Hou MS ,&nbsp;Yidan Gou MS ,&nbsp;Yanyan Chen MS ,&nbsp;Shuo An MD ,&nbsp;Yingsheng Wei MD ,&nbsp;Rongcai Jiang MD ,&nbsp;Ye Tian MD ,&nbsp;Hengjie Yuan PhD","doi":"10.1016/j.clinthera.2024.08.010","DOIUrl":"10.1016/j.clinthera.2024.08.010","url":null,"abstract":"<div><h3>Purpose</h3><div>Approximately 20% to 30% of intracerebral hemorrhage (ICH) patients were reported to be on antiplatelet therapy (APT), and association between prior APT and prognosis was unclear. We aimed to clarify the impact of APT on the prognosis of ICH through an updated systematic review and meta-analysis, and to further compare the risk of single APT (SAPT) or dual APT (DAPT) prior to ICH as well as the risk associated with various antiplatelet drugs.</div></div><div><h3>Methods</h3><div>EMBASE, MEDLINE via Ovid SP and Web of Science were searched from inception of each database to November 4, 2023. Included studies reported prognosis in both patients with prior APT and those without.</div></div><div><h3>Findings</h3><div>A total of 433,103 patients from 43 studies were included in the meta-analysis. Both univariate and multivariate analyses demonstrated a significant association between prior-APT and an increased mortality risk (odd ratio [OR] 1.43, 95% confidence interval [CI] 1.28–1.59; OR 1.20, 95%CI 1.10–1.30, respectively). The risk was higher in short term follow-up (Univariate OR 1.73, 95%CI 1.22–2.46; Multivariate OR 1.94, 95%CI 1.48–2.55). A notably increased risk of hematoma expansion was also observed in patients previously treated with APT (Univariate OR 1.47, 95%CI 1.12–1.94; Multivariate OR 1.88, 95%CI 1.30–2.71), which were mainly attributed to events within 24 hours. The impact of prior-APT on poor functional outcome was inconsistent between univariate and multivariate analyses. Both direct and indirect comparisons showed that SAPT significantly reduced the risk of mortality (OR 0.67, 95%CI 0.64–0.70; OR 0.84, 95%CI 0.71–0.99) and poor functional outcome (OR 0.84, 95%CI 0.72–0.98; OR 0.81, 95%CI 0.72–0.91) compared to DAPT.</div></div><div><h3>Implications</h3><div>Prior-APT increased the risk of mortality and hematoma expansion in patients with ICH. The increased risk of mortality and hematoma expansion was more obvious in the short term follow-up and within 24 hours, respectively. The effect of APT on poor functional outcome exhibited inconsistency between univariate and multivariate analyses, suggesting that further investigation is warranted to clarify this relationship. In comparison with DAPT, SAPT could decrease the risk of mortality and poor functional outcome. Further studies focusing on antiplatelet drug response, racial differences, and specific APT regimens may help verify the influence.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 11","pages":"Pages 905-915"},"PeriodicalIF":3.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Retrospective Cross-Sectional Analysis of the Humanistic and Economic Burden of Bipolar I Disorder 对双相情感障碍 I 的人文和经济负担的回顾性横断面分析。
IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.clinthera.2024.08.003
Larry Culpepper MD, MPH , Ashley Martin PhD, MS , Amanda Harrington PhD , Sally W. Wade MPH , Mousam Parikh MSc, BSc
<div><h3>Purpose</h3><div>This study quantified the burdens of bipolar I disorder (BP-I) by examining patient characteristics, health-related quality of life (HRQoL), health care resource utilization (HCRU), and costs of patients with versus without BP-I. Additionally, these outcomes were assessed across BP-I severity levels.</div></div><div><h3>Methods</h3><div>A retrospective, cross-sectional analysis of the 2020 National Health and Wellness Survey was conducted. Adults who self-reported a physician diagnosis of BP-I were assigned to the BP-I cohort, with severity-specific subgroups (mild, moderate, severe) created for analysis. A separate cohort of participants without BP-I or MDD was used for comparison. Exclusion criteria included a schizophrenia diagnosis. Bivariate analyses compared demographic and socioeconomic characteristics between cohorts. HRQoL (Short Form-36v2 Health Survey [SF36v2] mental and physical component scores, EuroQol Five-Dimension Visual Analogue Scale [EQ-5D VAS]), HCRU (health care provider visits, emergency department visits, hospitalizations), and annualized costs (direct and indirect) were evaluated for participants with versus without BP-I as well as across BP-I severity subgroups using multivariate analyses adjusted for key baseline differences. Because BP-I is often misdiagnosed as MDD, outcomes were evaluated in a subgroup of participants with MDD who according to the Mood Disorder Questionnaire screened as having probable BP-I (ie, potentially misdiagnosed BP-I) and were compared with the BP-I severity subgroups.</div></div><div><h3>Findings</h3><div>Cohorts included 818 participants with BP-I (mild = 336, moderate = 285, severe = 197) and 53,021 participants without BP-I. Participants with BP-I reported significantly lower HRQoL scores on the SF-36v2 and EQ-5D VAS (all measures, <em>P</em> < 0.001), and increasing BP-I severity was predictive of declining HRQoL. Participants with BP-I had significantly greater HCRU (all measures, <em>P</em> < 0.05) than participants without BP-I and increasing BP-I severity was associated with greater HCRU versus the mild BP-I cohort (all measures, <em>P</em> < 0.05). Participants with BP-I incurred significantly greater total direct (<em>P</em> < 0.01) and indirect (<em>P</em> < 0.001) costs versus participants without BP-I. Direct costs were incrementally higher across BP-I severity, while indirect costs were high across all groups but did not differ significantly. Participants with potentially misdiagnosed BP-I (n = 302) had similar HRQoL to those with mild-to-moderate BP-I and similar HCRU and direct costs to those with mild BP-I.</div></div><div><h3>Implications</h3><div>These results demonstrate the substantial clinical and economic burdens associated with BP-I, and these negative impacts generally increase with BP-I severity. The study also suggests that despite not having the diagnosis of BP-I, burdens of potentially misdiagnosed patients are similar to
目的:本研究通过考察双相情感障碍(BP-I)患者与非双相情感障碍(BP-I)患者的患者特征、健康相关生活质量(HRQoL)、医疗资源利用率(HCRU)和费用,对双相情感障碍(BP-I)造成的负担进行量化。此外,这些结果还根据 BP-I 的严重程度进行了评估:对 2020 年全国健康与保健调查进行了回顾性横断面分析。自我报告经医生诊断为血压Ⅰ的成年人被归入血压Ⅰ队列,并按严重程度(轻度、中度、重度)创建子群进行分析。没有 BP-I 或 MDD 的参与者组成了一个单独的队列进行比较。排除标准包括精神分裂症诊断。双变量分析比较了不同组群的人口统计学和社会经济特征。使用多变量分析评估了患有 BP-I 和未患有 BP-I 的参与者的 HRQoL(短表格-36v2 健康调查 [SF36v2] 精神和身体部分得分、EuroQol 五维视觉模拟量表 [EQ-5D VAS])、HCRU(医疗服务提供者就诊、急诊就诊、住院)和年化成本(直接和间接成本),并对关键基线差异进行了调整。由于 BP-I 经常被误诊为 MDD,因此对根据情绪障碍问卷筛查出可能患有 BP-I 的 MDD 参与者亚组(即可能被误诊为 BP-I 者)的结果进行了评估,并与 BP-I 严重程度亚组进行了比较:组群包括 818 名患有 BP-I 的参与者(轻度 = 336,中度 = 285,重度 = 197)和 53 021 名未患有 BP-I 的参与者。患有 BP-I 的参与者在 SF-36v2 和 EQ-5D VAS 上的 HRQoL 得分明显较低(所有测量指标,P < 0.001),BP-I 严重程度的增加预示着 HRQoL 的下降。患有血压Ⅰ的参与者的 HCRU 明显高于未患有血压Ⅰ的参与者(所有测量指标,P < 0.05),与轻度血压Ⅰ组群相比,血压Ⅰ严重程度的增加与 HCRU 的增加有关(所有测量指标,P < 0.05)。与无 BP-I 的参试者相比,有 BP-I 的参试者产生的直接费用总额(P < 0.01)和间接费用总额(P < 0.001)明显更高。直接费用在 BP-I 严重程度不同时递增,而间接费用在所有组别中都很高,但差异不大。可能被误诊为 BP-I 的参与者(n = 302)的 HRQoL 与轻度至中度 BP-I 者相似,HCRU 和直接费用与轻度 BP-I 者相似:这些结果表明,血压Ⅰ会带来巨大的临床和经济负担,而且这些负面影响通常会随着血压Ⅰ的严重程度而增加。研究还表明,尽管没有确诊为血压Ⅰ,但可能被误诊的患者的负担与轻度至中度血压Ⅰ患者相似。总之,这些结果揭示了患有血压Ⅰ的成人中存在大量不同的未满足需求。
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Clinical therapeutics
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