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The effects between andexanet alpha and four-factor prothrombin complex concentrate on DOACs anticoagulation reversal 安赛蜜α和凝血酶原四因子浓缩物对 DOAC 抗凝逆转的影响
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-19 DOI: 10.1186/s13054-024-05157-x
Tengfei Yang, Bo Zhao
<p>To the Editor,</p><p>The publication by Daniele Orsc et al. [1] in Critical Care, titled "Andexanet alpha versus four-factor prothrombin complex concentrate in DOACs anticoagulation reversal: an updated systematic review and meta-analysis," has significant clinical implications. This present study obtained two key findings that may complement their conclusions.</p><p>The primary outcome of this meta-analysis revealed a higher thromboembolic event risk associated with Andexanet alpha when analyzing controlled (RCT and PSM) studies. However, the authors did not perform trial sequential analysis (TSA), potentially leading to type I and type II errors and premature conclusions. To address this, TSA Viewer version 0.9.5.10 Beta was utilized to determine if published studies provided sufficient evidence for reliable conclusions. The two-sided type I error was set at 5%, and 80% power was selected to calculate the required information size (RIS). The control group incidence was determined through meta-analysis. Results from the TSA showed that the blue Z-curve crossed the conventional boundary but not the TSA boundary (Fig. 1). Moreover, the data failed to meet the required information size (RIS = 1717). Consequently, conventional meta-analysis may yield false-positive results. Additional trials are necessary to confirm the difference in thromboembolic events between the groups.</p><figure><figcaption><b data-test="figure-caption-text">Fig. 1</b></figcaption><picture><source srcset="//media.springernature.com/lw685/springer-static/image/art%3A10.1186%2Fs13054-024-05157-x/MediaObjects/13054_2024_5157_Fig1_HTML.png?as=webp" type="image/webp"/><img alt="figure 1" aria-describedby="Fig1" height="451" loading="lazy" src="//media.springernature.com/lw685/springer-static/image/art%3A10.1186%2Fs13054-024-05157-x/MediaObjects/13054_2024_5157_Fig1_HTML.png" width="685"/></picture><p>Trial sequential analysis (TSA) for the rate of thromboembolic events. Blue Z curve stands for Z-values accumulated from the meta-analysis (combined relative risk). Pink dotted lines are indicative of conventional boundaries, whereas red solid lines stand for TSA boundaries. RIS, required information size</p><span>Full size image</span><svg aria-hidden="true" focusable="false" height="16" role="img" width="16"><use xlink:href="#icon-eds-i-chevron-right-small" xmlns:xlink="http://www.w3.org/1999/xlink"></use></svg></figure><p>In the analysis of all-cause short-term mortality in retrospective studies, the authors included the studies with varying follow-up periods, ranging from 7-day, 28-day, 30-day, and in-hospital mortality. This variability may introduce inaccuracies in meta-analysis results due to factors such as persistent treatment effects and disease deterioration, potentially leading to heterogeneity and compromising result interpretation and conclusion reliability. To address this, a subgroup analysis using Revman5.3 software was conducted on six studies [2,3,4,5,6,7] that r
致编辑:Daniele Orsc 等人[1] 在《重症监护》(Critical Care)杂志上发表的题为 "Andexanet alpha 与凝血酶原复合物四因子浓缩物在 DOACs 抗凝逆转中的比较:最新的系统综述和荟萃分析 "的文章具有重要的临床意义。这项荟萃分析的主要结果显示,在分析对照研究(RCT 和 PSM)时,与 Andexanet alpha 相关的血栓栓塞事件风险较高。然而,作者并没有进行试验序列分析(TSA),这可能会导致I型和II型错误以及过早得出结论。为了解决这个问题,我们使用了 0.9.5.10 Beta 版 TSA 查看器来确定已发表的研究是否提供了足够的证据来得出可靠的结论。双侧 I 型误差设定为 5%,并选择 80% 的功率来计算所需的信息量 (RIS)。对照组的发病率是通过荟萃分析确定的。TSA 结果显示,蓝色 Z 曲线跨越了常规边界,但未跨越 TSA 边界(图 1)。此外,数据未达到所需的信息量(RIS = 1717)。因此,传统的荟萃分析可能会产生假阳性结果。有必要进行更多试验,以确认各组间血栓栓塞事件的差异。蓝色 Z 曲线代表荟萃分析积累的 Z 值(综合相对风险)。粉色虚线表示常规边界,红色实线表示 TSA 边界。RIS,所需信息尺寸全尺寸图片在分析回顾性研究中的全因短期死亡率时,作者纳入了随访期不同的研究,包括 7 天、28 天、30 天和住院死亡率。由于治疗效果持续存在和疾病恶化等因素,这种差异性可能会导致荟萃分析结果不准确,从而可能导致异质性,影响结果解释和结论可靠性。为了解决这个问题,我们使用 Revman5.3 软件对报告了 30 天死亡率的六项研究[2,3,4,5,6,7]进行了亚组分析。采用固定效应模型,与回顾性研究中的四因子凝血酶原复合物相比,Andexanet alpha 组的风险比 (RR) 为 0.62(95% CI 0.47-0.84),如图 2 所示。这一差异具有统计学意义。这些研究结果与原始荟萃分析结果之间的差异凸显了在评估重症患者死亡率时考虑不同时间点的重要性。Orso D, Fonda F, Brussa A, Comisso I, Auci E, Sartori M, et al. Andexanet alpha 与四因子凝血酶原复合物浓缩物在 DOACs 抗凝逆转中的应用:最新系统综述和荟萃分析。Crit Care.2024; 28(1):221.Article PubMed PubMed Central Google Scholar Siepen BM, Polymeris A, Shoamanesh A, Connolly S, Steiner T, Poli S, et al. Andexanet alfa versus non-specific treatments for intracerebral hemorrhage in patients taking factor Xa inhibitors-individual patient data analysis of ANNEXA-4 and TICH-NOAC.Int J Stroke.2024;19(5):506-14.Article PubMed Google Scholar Oh ES, Schulze P, Diaz F, Shah K, Rios J, Silverman ME.在颅内出血中使用安赛蜜α和4因子凝血酶原复合物浓缩物。Am J Emerg Med.2023;64:74-7.Article PubMed Google Scholar Vestal ML, Hodulik K, Mando-Vandrick J, James ML, Ortel TL, Fuller M, et al. Andexanet alfa 和凝血酶原四因子浓缩物用于逆转阿哌沙班和利伐沙班在确诊颅内出血患者中的应用。J Thromb Thrombolysis.2022; 53(1):167-75.Article PubMed Google Scholar Stevens VM, Trujillo TC, Kiser TH, MacLaren R, Reynolds PM, Mueller SW.逆转Xa因子抑制剂相关出血的andexanet alfa和4因子凝血酶原复合物的回顾性比较。Clin Appl Thromb Hemost.2021;27:10760296211039020.Article PubMed PubMed Central Google Scholar Irizarry-Gatell VM, Bacchus MW, De Leo EK, Zhang Y, Lagasse CA, Khanna AY, et al. The use of andexanet alfa vs. 4-factor prothrombin complex concentrates in the setting of life-threatening intraranial hemorrhage.血液凝固纤溶。2024; 35(3):94-100.Article PubMed Google Scholar Huttner HB, Gerner ST, Kuramatsu JB, Connolly SJ, Beyer-Westendorf J, Demchuk AM, et al. Hematoma expansion and clinical outcomes in patients with factor-Xa inhibitor-related atraumatic intracerebral hemorrhage treated within the ANNEXA-4 trial versus real-world usual care.Stroke.2022;53(2):532-43.Article PubMed Google Scholar Download referencesNone.
{"title":"The effects between andexanet alpha and four-factor prothrombin complex concentrate on DOACs anticoagulation reversal","authors":"Tengfei Yang, Bo Zhao","doi":"10.1186/s13054-024-05157-x","DOIUrl":"https://doi.org/10.1186/s13054-024-05157-x","url":null,"abstract":"&lt;p&gt;To the Editor,&lt;/p&gt;&lt;p&gt;The publication by Daniele Orsc et al. [1] in Critical Care, titled \"Andexanet alpha versus four-factor prothrombin complex concentrate in DOACs anticoagulation reversal: an updated systematic review and meta-analysis,\" has significant clinical implications. This present study obtained two key findings that may complement their conclusions.&lt;/p&gt;&lt;p&gt;The primary outcome of this meta-analysis revealed a higher thromboembolic event risk associated with Andexanet alpha when analyzing controlled (RCT and PSM) studies. However, the authors did not perform trial sequential analysis (TSA), potentially leading to type I and type II errors and premature conclusions. To address this, TSA Viewer version 0.9.5.10 Beta was utilized to determine if published studies provided sufficient evidence for reliable conclusions. The two-sided type I error was set at 5%, and 80% power was selected to calculate the required information size (RIS). The control group incidence was determined through meta-analysis. Results from the TSA showed that the blue Z-curve crossed the conventional boundary but not the TSA boundary (Fig. 1). Moreover, the data failed to meet the required information size (RIS = 1717). Consequently, conventional meta-analysis may yield false-positive results. Additional trials are necessary to confirm the difference in thromboembolic events between the groups.&lt;/p&gt;&lt;figure&gt;&lt;figcaption&gt;&lt;b data-test=\"figure-caption-text\"&gt;Fig. 1&lt;/b&gt;&lt;/figcaption&gt;&lt;picture&gt;&lt;source srcset=\"//media.springernature.com/lw685/springer-static/image/art%3A10.1186%2Fs13054-024-05157-x/MediaObjects/13054_2024_5157_Fig1_HTML.png?as=webp\" type=\"image/webp\"/&gt;&lt;img alt=\"figure 1\" aria-describedby=\"Fig1\" height=\"451\" loading=\"lazy\" src=\"//media.springernature.com/lw685/springer-static/image/art%3A10.1186%2Fs13054-024-05157-x/MediaObjects/13054_2024_5157_Fig1_HTML.png\" width=\"685\"/&gt;&lt;/picture&gt;&lt;p&gt;Trial sequential analysis (TSA) for the rate of thromboembolic events. Blue Z curve stands for Z-values accumulated from the meta-analysis (combined relative risk). Pink dotted lines are indicative of conventional boundaries, whereas red solid lines stand for TSA boundaries. RIS, required information size&lt;/p&gt;&lt;span&gt;Full size image&lt;/span&gt;&lt;svg aria-hidden=\"true\" focusable=\"false\" height=\"16\" role=\"img\" width=\"16\"&gt;&lt;use xlink:href=\"#icon-eds-i-chevron-right-small\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"&gt;&lt;/use&gt;&lt;/svg&gt;&lt;/figure&gt;&lt;p&gt;In the analysis of all-cause short-term mortality in retrospective studies, the authors included the studies with varying follow-up periods, ranging from 7-day, 28-day, 30-day, and in-hospital mortality. This variability may introduce inaccuracies in meta-analysis results due to factors such as persistent treatment effects and disease deterioration, potentially leading to heterogeneity and compromising result interpretation and conclusion reliability. To address this, a subgroup analysis using Revman5.3 software was conducted on six studies [2,3,4,5,6,7] that r","PeriodicalId":10811,"journal":{"name":"Critical Care","volume":"1 1","pages":""},"PeriodicalIF":15.1,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142670818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Electrical impedance tomography monitoring in adult ICU patients: state-of-the-art, recommendations for standardized acquisition, processing, and clinical use, and future directions 成人重症监护病房患者的电阻抗断层扫描监测:最新技术、标准化采集、处理和临床使用建议以及未来方向
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-19 DOI: 10.1186/s13054-024-05173-x
Gaetano Scaramuzzo, Bertrand Pavlovsky, Andy Adler, Walter Baccinelli, Dani L. Bodor, L. Felipe Damiani, Guillaume Franchineau, Juliette Francovich, Inéz Frerichs, Juan A. Sánchez Giralt, Bartłomiej Grychtol, Huaiwu He, Bhushan H. Katira, Alette A. Koopman, Steffen Leonhardt, Luca S. Menga, Amne Mousa, Mariangela Pellegrini, Thomas Piraino, Paolo Priani, Peter Somhorst, Elena Spinelli, Claas Händel, Fernando Suárez-Sipmann, Jantine J. Wisse, Tobias Becher, Annemijn H. Jonkman
Electrical impedance tomography (EIT) is an emerging technology for the non-invasive monitoring of regional distribution of ventilation and perfusion, offering real-time and continuous data that can greatly enhance our understanding and management of various respiratory conditions and lung perfusion. Its application may be especially beneficial for critically ill mechanically ventilated patients. Despite its potential, clear evidence of clinical benefits is still lacking, in part due to a lack of standardization and transparent reporting, which is essential for ensuring reproducible research and enhancing the use of EIT for personalized mechanical ventilation. This report is the result of a four-day expert meeting where we aimed to promote the consistent and reliable use of EIT, facilitating its integration into both clinical practice and research, focusing on the adult intensive care patient. We discuss the state-of-the-art regarding EIT acquisition and processing, applications during controlled ventilation and spontaneous breathing, ventilation-perfusion assessment, and novel future directions.
电阻抗断层扫描(EIT)是一种新兴技术,可用于无创监测通气和灌注的区域分布,提供实时和连续的数据,大大提高我们对各种呼吸系统疾病和肺灌注的了解和管理。该技术的应用对重症机械通气患者尤为有益。尽管其潜力巨大,但仍缺乏临床获益的明确证据,部分原因是缺乏标准化和透明的报告,而标准化和透明的报告对于确保研究的可重复性和加强 EIT 在个性化机械通气中的应用至关重要。本报告是为期四天的专家会议的成果,我们在会上以成人重症监护患者为重点,旨在推广 EIT 的一致和可靠使用,促进其与临床实践和研究的结合。我们讨论了有关 EIT 采集和处理、控制通气和自主呼吸期间的应用、通气灌注评估以及未来新方向的最新进展。
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引用次数: 0
Inhalation NO in the HFNC group may result in a meaningless extension of survival time. 在 HFNC 组中吸入 NO 可能会导致生存时间毫无意义地延长。
IF 8.8 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-18 DOI: 10.1186/s13054-024-05154-0
Lin Zhong, Lingtong Huang
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引用次数: 0
Volatile anaesthetics for ICU sedation: beyond hypnosis? 用于重症监护室镇静的挥发性麻醉剂:超越催眠?
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-15 DOI: 10.1186/s13054-024-05163-z
José Manuel Añón, Fernando Suarez-Sipmann, María Paz Escuela, Aris Perez-Lucendo, Andoni García-Muñoz
<p>We read the review by Müller-Wirtz [1] et al., recently published in this journal with interest. It addresses the advantages of using volatile anaesthetics for lung and diaphragm-protective sedation. As the authors point out in their methodology, it is a narrative review based on expert opinion to which we wanted to contribute with some comments we believe are important.</p><p>The authors affirm that volatile anaesthetics reduce tidal volume and simultaneously increase respiratory rate in a dose-dependent fashion, thus potentially contributing to reduce lung stress and strain in spontaneously breathing patients. In addition, volatile anaesthetics better preserve respiratory drive than do common intravenous alternatives. The combination of these two effects lead them to conclude that volatile anaesthetics may contribute to a lung-diaphragmatic protective ventilation. Attributing a lung-diaphragmatic protective effect to the use of one specific type of sedation based mainly on pre-clinical studies [2,3,4,5,6] and small studies on healthy volunteers [7,8,9,10,11] with little data on critically ill patients, is a hypothesis that warrants to be tested and confirmed in well-designed clinical trials. We agree on the importance of adequate sedation and the potential protective benefits of volatile anaesthetics, but the role of factors such as the underlying lung condition, the effective control of respiratory drive and the dosage needed for it, the synergistic effects with opioids and other hypnotics, among others are yet to be established. The best balance between a preserved or excessive respiratory drive is difficult and depends on the individual patient and may vary along the evolution. For instance, in the presence of a high respiratory drive, such as seen in patients with acute respiratory distress syndrome (ARDS), sedation should rather contribute to modulate the intensity of the spontaneous inspiratory effort than to enhance it. Nevertheless, volatile anaesthetics are a welcome new addition to the clinical arsenal to improve sedation strategies in the always complicated transition from controlled to spontaneous mechanical ventilation.</p><p>All reflectors increase dead space ventilation due to their internal volume and partial carbon dioxide reflection. The two devices clinically available for inhaled sedation have made an effort to reduce their instrumental dead space volume, on average from 100 ml in the first-generation devices to around 50 ml of the currently used ones. However, it is important to pay special attention to avoid unnecessary increases in dead space particularly in patients ventilated with lower tidal volumes, where instrumental dead-space can add up to a 15–30% to the dead-space fraction. In this respect, the graphical abstract used to illustrate the clinical setup is rather unfortunate showing a large straight connector adding an additional instrumental dead space volume of at least 50–70 ml something that should be strictl
我们饶有兴趣地阅读了 Müller-Wirtz [1] 等人最近在本杂志上发表的评论。这篇综述探讨了使用挥发性麻醉剂进行肺和膈肌保护镇静的优势。正如作者在其研究方法中所指出的,这是一篇基于专家意见的叙事性综述,我们希望对此发表一些我们认为重要的评论。作者肯定了挥发性麻醉剂可减少潮气量,同时以剂量依赖的方式增加呼吸频率,因此可能有助于减少自主呼吸患者的肺部压力和负荷。此外,与普通静脉注射麻醉剂相比,挥发性麻醉剂能更好地保持呼吸动力。综合这两种作用,他们得出结论:挥发性麻醉剂可能有助于肺-膈保护性通气。将肺膈保护作用归因于使用一种特定类型的镇静剂,主要是基于临床前研究[2,3,4,5,6]和对健康志愿者的小型研究[7,8,9,10,11],而对危重病人的研究数据很少。我们同意充分镇静的重要性以及挥发性麻醉剂的潜在保护作用,但肺部状况、呼吸驱动力的有效控制和所需剂量、与阿片类药物和其他催眠药的协同作用等因素的作用仍有待确定。呼吸驱动力的维持或过度之间的最佳平衡很难把握,这取决于患者的个体情况,并可能随着病情的发展而变化。例如,在急性呼吸窘迫综合征(ARDS)患者等呼吸动力较强的情况下,镇静剂应有助于调节自发吸气的强度,而不是增强吸气的强度。尽管如此,挥发性麻醉剂仍是临床治疗中值得欢迎的新手段,可在从控制机械通气向自发机械通气的复杂转变过程中改善镇静策略。临床上用于吸入镇静的两种设备都在努力减少器械死腔容积,从第一代设备的平均 100 毫升减少到目前使用的约 50 毫升。不过,必须特别注意避免不必要地增加死腔,尤其是在使用较低潮气量通气的患者中,器械死腔可增加高达 15-30% 的死腔分数。在这方面,用于说明临床设置的图表摘要相当不幸,其中显示一个大的直通接头增加了至少 50-70 毫升的额外器械死腔容积,而在使用挥发性麻醉剂时应严格避免这种情况。患者需要通过增加每分钟通气量(潮气量、呼吸频率或两者)来补偿这种影响,所有这些都有可能导致肺损伤,这可能会超过减少肺部机械应力的预期保护效果[12]。总之,在危重病人中使用异氟醚首先要考虑的是权衡其作为催眠药的益处,至少在短期内,这是一种有吸引力的选择。尽管与其他静脉催眠药相比,异氟醚在重症患者中的长期效果和结果仍不明确,但在重症监护室中的使用似乎越来越多。一些科学协会认为异氟醚是需要中度或深度镇静的通气患者的一线镇静剂,因为其作用时间短且安全。但他们的建议强调,必须对 ICU 医护人员进行充分培训,以优化镇静剂的使用并将相关风险降至最低 [13]。其他潜在的益处还有待证实。目前,正在对需要镇静超过 48 小时的患者进行与异丙酚的比较研究,重点关注谵妄或机械通气时间等结果。异氟醚可能会减轻自主呼吸患者的压力和负荷,或对肺部和横膈膜有保护作用,这是一个非常有吸引力的假设,需要在重症监护环境下的临床试验中得到证实。作者声明无利益冲突,本研究未生成或分析数据集。Crit Care.2024; 28:269.Article PubMed PubMed Central Google Scholar Bourgeois T, Ringot M, Ramanantsoa N, Matrot B, Dauger S, Delclaux C, et al. 麻醉状态下的呼吸。麻醉学》。2019;130:995-1006.
{"title":"Volatile anaesthetics for ICU sedation: beyond hypnosis?","authors":"José Manuel Añón, Fernando Suarez-Sipmann, María Paz Escuela, Aris Perez-Lucendo, Andoni García-Muñoz","doi":"10.1186/s13054-024-05163-z","DOIUrl":"https://doi.org/10.1186/s13054-024-05163-z","url":null,"abstract":"&lt;p&gt;We read the review by Müller-Wirtz [1] et al., recently published in this journal with interest. It addresses the advantages of using volatile anaesthetics for lung and diaphragm-protective sedation. As the authors point out in their methodology, it is a narrative review based on expert opinion to which we wanted to contribute with some comments we believe are important.&lt;/p&gt;&lt;p&gt;The authors affirm that volatile anaesthetics reduce tidal volume and simultaneously increase respiratory rate in a dose-dependent fashion, thus potentially contributing to reduce lung stress and strain in spontaneously breathing patients. In addition, volatile anaesthetics better preserve respiratory drive than do common intravenous alternatives. The combination of these two effects lead them to conclude that volatile anaesthetics may contribute to a lung-diaphragmatic protective ventilation. Attributing a lung-diaphragmatic protective effect to the use of one specific type of sedation based mainly on pre-clinical studies [2,3,4,5,6] and small studies on healthy volunteers [7,8,9,10,11] with little data on critically ill patients, is a hypothesis that warrants to be tested and confirmed in well-designed clinical trials. We agree on the importance of adequate sedation and the potential protective benefits of volatile anaesthetics, but the role of factors such as the underlying lung condition, the effective control of respiratory drive and the dosage needed for it, the synergistic effects with opioids and other hypnotics, among others are yet to be established. The best balance between a preserved or excessive respiratory drive is difficult and depends on the individual patient and may vary along the evolution. For instance, in the presence of a high respiratory drive, such as seen in patients with acute respiratory distress syndrome (ARDS), sedation should rather contribute to modulate the intensity of the spontaneous inspiratory effort than to enhance it. Nevertheless, volatile anaesthetics are a welcome new addition to the clinical arsenal to improve sedation strategies in the always complicated transition from controlled to spontaneous mechanical ventilation.&lt;/p&gt;&lt;p&gt;All reflectors increase dead space ventilation due to their internal volume and partial carbon dioxide reflection. The two devices clinically available for inhaled sedation have made an effort to reduce their instrumental dead space volume, on average from 100 ml in the first-generation devices to around 50 ml of the currently used ones. However, it is important to pay special attention to avoid unnecessary increases in dead space particularly in patients ventilated with lower tidal volumes, where instrumental dead-space can add up to a 15–30% to the dead-space fraction. In this respect, the graphical abstract used to illustrate the clinical setup is rather unfortunate showing a large straight connector adding an additional instrumental dead space volume of at least 50–70 ml something that should be strictl","PeriodicalId":10811,"journal":{"name":"Critical Care","volume":"45 1","pages":""},"PeriodicalIF":15.1,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142642702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
The long-term conditional mortality rate in older ICU patients compared to the general population. 与普通人群相比,ICU 老年患者的长期条件死亡率。
IF 8.8 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-14 DOI: 10.1186/s13054-024-05147-z
Anna Aronsson Dannewitz, Bodil Svennblad, Karl Michaëlsson, Miklos Lipcsey, Rolf Gedeborg

Background: Understanding how preexisting comorbidities may interact with a critical illness is important for the assessment of long-term survival probability of older patients admitted to the ICU.

Material and methods: The mortality after a first ICU admission in patients ≥ 55 years old registered in the Swedish Intensive Care Registry was compared to age- and sex-matched individuals from the general population with a landmark after 1 year. The comparison was adjusted for age, sex, and baseline comorbidity using Cox regression.

Results: The 7-year study period included 140 008 patients, of whom 23% were 80 years or older. Patients surviving the first year remained at an increased risk compared to the general population, but much of this difference was attenuated after adjustment for baseline comorbidity (HR, 1.03; 95% CI 1.02-1.04). Excluding cardio-thoracic ICU admissions, the increased risk remained slightly elevated (adjusted HR, 1.15; 95% CI 1.13-1.16). Also, the subgroup ≥ 75 years old surviving the first year returned to a mortality rate comparable to the general population (HR, 0.98; 95% CI 0.96-0.99). Stratified by admission diagnosis an increased mortality rate remained beyond the first year for acute-on-chronic respiratory failure (adjusted HR, 1.47; 95% CI 1.36-1.58) but not for other respiratory causes (adjusted HR, 1.03; 95% CI 0.99-1.07) or admission for septic shock (adjusted HR, 1.04; 95% CI 0.95-1.13). No substantial increased mortality rate was notable beyond the first year for other admission diagnoses.

Conclusion: Older ICU patients that survive the first year after an ICU admission return to a mortality rate close to that of the general population having similar baseline comorbidity, but variability is seen depending on the ICU admission diagnosis. Trial registration ClinicalTrials.gov ID: NCT06234709, date 02/01/2024.

背景:了解原有的合并症如何与危重症相互作用,对于评估入住重症监护病房的老年患者的长期生存概率非常重要:将瑞典重症监护登记处登记的 55 岁以上患者首次入住重症监护室后的死亡率与普通人群中年龄和性别匹配的患者进行比较,以 1 年后的死亡率为基准。比较采用 Cox 回归法对年龄、性别和基线合并症进行了调整:为期 7 年的研究共纳入 140 008 名患者,其中 23% 为 80 岁或以上。与普通人群相比,第一年存活的患者风险仍然较高,但在调整基线合并症后,这种差异有所减小(HR,1.03;95% CI 1.02-1.04)。剔除入住心胸重症监护室的患者后,增加的风险仍略有上升(调整后的 HR 为 1.15;95% CI 为 1.13-1.16)。此外,≥75 岁的亚组在第一年存活的死亡率与普通人群相当(HR,0.98;95% CI 0.96-0.99)。根据入院诊断进行分层,急性-慢性呼吸衰竭(调整后 HR,1.47;95% CI,1.36-1.58)的死亡率在第一年后仍会增加,但其他呼吸系统原因(调整后 HR,1.03;95% CI,0.99-1.07)或因脓毒性休克入院(调整后 HR,1.04;95% CI,0.95-1.13)的死亡率则不会增加。其他入院诊断的死亡率在第一年后没有显著增加:结论:ICU老年患者在入院后第一年内的死亡率接近于具有相似基线合并症的普通人群,但根据ICU入院诊断的不同,死亡率也存在差异。试验注册 ClinicalTrials.gov ID:NCT06234709,日期为 2024 年 1 月 2 日。
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引用次数: 0
Impact of fever on the outcome non-anoxic acute brain injury patients: a systematic review and meta-analysis 发烧对无缺氧急性脑损伤患者预后的影响:系统回顾和荟萃分析
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-13 DOI: 10.1186/s13054-024-05132-6
Elisa Gouvêa Bogossian, Michele Salvagno, Marco Fiore, Marta Talamonti, Chiara Prezioso, Federica Montanaro, Sara Fratino, Sophie Schuind, Fabio Silvio Taccone
Fever is a common condition in intensive care unit (ICU) patients, with an incidence between 30 and 50% in non-neurological ICU patients and up to 70–90% in neurological ICU patients. We aim to perform systematic review and meta-analysis of current literature to assess impact of fever on neurological outcomes and mortality of acute brain injury patients. We searched PubMed/Medline, Scopus and Embase databases following the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and we included both retrospective and prospective observational studies, interventional studies, and randomized clinical trials that had data on body temperature and fever during ICU admission. The primary endpoints were neurological outcome and mortality at any time. Secondary outcomes included: early neurological deterioration, delayed cerebral ischemia (DCI, only for patients with subarachnoid hemorrhage), large infarct or hemorrhage size, hemorrhagic transformation (only for patients with ischemic stroke). This study was registered in PROSPERO (CRD42020155903). 180 studies from 14692 records identified after the initial search were included in the final analysis, for a total of 460,825 patients. Fever was associated with an increased probability of unfavorable neurological outcome (pooled OR 2.37 [95% CI 2.08–2.71], I2:92%), death (pooled OR 1.31 [95% CI 1.28–1.34], I2:93%), neurological deterioration (pooled OR 1.10 [95% CI 1.05–1.15]), risk of DCI (pooled OR 1.96 [95% CI 1.73–2.22]), large infarct size (pooled OR 2.94 [95% CI 2.90–2.98]) and hemorrhagic transformation (pooled OR 1.63 [95% CI 1.34–1.97]) and large hemorrhagic volume (pooled OR 2.38 [95% CI 1.94–2.93]). Fever was associated with poor neurological outcomes and mortality in patients with acute brain injury. Whether normothermia should be targeted in the management of all neuro critically ill patients warrants specific research.
发热是重症监护病房(ICU)患者的常见病,非神经重症监护病房患者的发热发生率在 30-50% 之间,而神经重症监护病房患者的发热发生率高达 70-90%。我们旨在对现有文献进行系统回顾和荟萃分析,以评估发热对急性脑损伤患者神经系统预后和死亡率的影响。我们按照《系统综述和荟萃分析首选报告项目》的建议检索了 PubMed/Medline、Scopus 和 Embase 数据库,并纳入了有 ICU 入院期间体温和发热数据的回顾性和前瞻性观察研究、干预研究和随机临床试验。主要研究终点是神经系统预后和任何时间的死亡率。次要结局包括:早期神经功能恶化、延迟性脑缺血(DCI,仅适用于蛛网膜下腔出血患者)、大面积梗死或出血、出血转化(仅适用于缺血性中风患者)。本研究已在 PROSPERO 登记(CRD42020155903)。初步搜索后从 14692 份记录中发现的 180 项研究被纳入最终分析,共计 460,825 名患者。发热与神经系统不良预后(汇总 OR 2.37 [95% CI 2.08-2.71],I2:92%)、死亡(汇总 OR 1.31 [95% CI 1.28-1.34],I2:93%)、神经系统恶化(汇总 OR 1.10 [95% CI 1.05-1.15])、DCI 风险(汇总 OR 1.10 [95% CI 1.08-2.71],I2:92%)的概率增加有关。15])、DCI风险(汇总OR 1.96 [95% CI 1.73-2.22])、大面积梗死(汇总OR 2.94 [95% CI 2.90-2.98])和出血转化(汇总OR 1.63 [95% CI 1.34-1.97])以及大出血量(汇总OR 2.38 [95% CI 1.94-2.93])。发热与急性脑损伤患者的神经功能预后差和死亡率有关。在对所有神经重症患者进行管理时,是否应将正常体温作为目标,还需要进行具体研究。
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引用次数: 0
Based -evidence, an intervention study to improve sleep quality in awake adult ICU patients: a prospective, single-blind, clustered controlled trial 基于证据,一项旨在改善清醒的重症监护病房成人患者睡眠质量的干预研究:前瞻性、单盲、分组对照试验
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-12 DOI: 10.1186/s13054-024-05161-1
Yanting Zhang, Yihua Yang, Chong Cheng, Gui Hou, Xinbo Ding, Jing Ma
Evidence-based guidelines advocate promoting sleep in intensive care unit (ICU) patients, yet many patients experience poor sleep quality. We sought to develop a collaborative evidence-based intervention with healthcare providers and assess whether evidence-based sleep interventions could improve sleep quality in awake adult ICU patients. We conducted a prospective, nonrandomized cluster control trial in two intensive care units (ICUs) at a tertiary general teaching hospital in China. Patients aged 18 years or older who stayed in the ICU for one night or more and were conscious were eligible for enrollment. We only blinded the patients, not the outcome assessors. On the basis of evidence-based practice and clinical reality, we developed intervention measures for the intervention group, which mainly included four aspects: reducing environmental noise in the ICU, adjusting nursing actions, modifying nighttime lighting, and other measures. The assessment tools used were wearable actigraphy sleep monitoring devices and the Richards-Campbell Sleep Questionnaire (RCSQ). The primary outcomes were patient sleep quality, including total sleep time, deep sleep time, light sleep time, rapid eye movement (REM) time, number of awakenings, overall sleep score, and patients' self-assessment of their sleep quality that night. The data collected were analyzed via SPSS and Mplus statistical software for between-group analysis, pre-post comparison, profile analysis, and calculation of the intervention effect size. From September 1, 2023, to January 31, 2024, 713 patients underwent eligibility assessment, and ultimately 246 patients were included in the analysis, with 125 in the intervention group and 121 in the control group. Comparative analysis revealed no statistically significant differences in sleep quality between the two groups when the duration in the ICU = 1 night (P > 0.05), with a small intervention effect size. However, the intervention group had higher sleep quality scores (sleep monitoring wristband: 57.74 ± 22.55 > 57.72 ± 19.39; RCSQ questionnaire: 60.58 ± 22.14 > 57.61 ± 24.4) and total sleep time (440.42 ± 262.11 > 420.31 ± 236.89), a lower awakening frequency (3.98 ± 2.69 < 6.09 ± 4.66) and a lower awakening frequency (3.976 ± 2.693 < 6.09 ± 4.664) than did the control group. The sleep quality of patients who stayed in the ICU for > 1 night significantly improved in all the parameters except rapid eye movement time (min) according to the pre-post-test analyses (P < 0.05), with a medium to large intervention effect size and favorable intervention effects. Evidence-based interventions significantly improve sleep quality in ICU patients hospitalized for more than one day. However, our results do not support the improvement of sleep quality in patients admitted to the ICU for one day. Clinical trial registration: ChiCTR2300075763, Registered 14 September 2023—Retrospectively registered, https://www.chictr.org.cn/bin/userProject
循证指南提倡促进重症监护病房(ICU)患者的睡眠,但许多患者的睡眠质量很差。我们试图与医疗服务提供者合作开发一种循证干预措施,并评估循证睡眠干预措施能否改善清醒的 ICU 成年患者的睡眠质量。我们在中国一家三级综合教学医院的两个重症监护病房(ICU)开展了一项前瞻性、非随机分组对照试验。年龄在 18 周岁或以上、在重症监护室住院一晚或以上且神志清醒的患者均符合报名条件。我们只对患者进行盲法评估,而不对结果评估者进行盲法评估。在循证实践和临床实际的基础上,我们为干预组制定了干预措施,主要包括四个方面:降低重症监护室环境噪声、调整护理操作、改变夜间照明和其他措施。使用的评估工具为可穿戴的动静脉睡眠监测设备和理查兹-坎贝尔睡眠问卷(RCSQ)。主要结果是患者的睡眠质量,包括总睡眠时间、深睡眠时间、浅睡眠时间、快速眼动(REM)时间、觉醒次数、总体睡眠评分以及患者对当晚睡眠质量的自我评估。收集到的数据通过 SPSS 和 Mplus 统计软件进行分析,包括组间分析、前后比较、概况分析和干预效果大小计算。从 2023 年 9 月 1 日至 2024 年 1 月 31 日,共有 713 名患者接受了资格评估,最终有 246 名患者被纳入分析,其中干预组 125 人,对照组 121 人。对比分析显示,当在重症监护室的时间=1晚时,两组患者的睡眠质量差异无统计学意义(P>0.05),干预效果较小。然而,干预组的睡眠质量得分更高(睡眠监测腕带:57.74 ± 22.55 > 57.72 ± 19.39;RCSQ 问卷:60.58 ± 22.14 > 60.58 ± 22.14 > 57.72 ± 19.39):60.58±22.14>57.61±24.4)和总睡眠时间(440.42±262.11>420.31±236.89),觉醒频率较低(3.98±2.69 1晚),根据前测-后测分析,除眼球快速运动时间(分钟)外,其他参数均有显著改善(P<0.05),干预效应大小为中到大,干预效果良好。循证干预能明显改善住院一天以上的重症监护室患者的睡眠质量。然而,我们的结果并不支持入住重症监护室一天的患者的睡眠质量得到改善。临床试验注册:ChiCTR2300075763,2023年9月14日注册-回顾性注册,https://www.chictr.org.cn/bin/userProject
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引用次数: 0
Predictors of weaning failure in ventilated intensive care patients: a systematic evidence map 呼吸机重症监护患者断奶失败的预测因素:系统证据图谱
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-12 DOI: 10.1186/s13054-024-05135-3
Fritz Sterr, Michael Reintke, Lydia Bauernfeind, Volkan Senyol, Christian Rester, Sabine Metzing, Rebecca Palm
Ventilator weaning is of great importance for intensive care patients in order to avoid complications caused by prolonged ventilation. However, not all patients succeed in weaning immediately. Their spontaneous breathing may be insufficient, resulting in extubation failure and the subsequent need for reintubation. To identify patients at high risk for weaning failure, a variety of potential predictors has already been examined in individual studies and meta-analyses over the last decades. However, an overview of all the predictors investigated is missing. To provide an overview of empirically investigated predictors for weaning failure. A systematic evidence map was developed. To this end, we conducted a systematic search in the Medline, Cochrane, and CINAHL databases in December 2023 and added a citation search and a manual search in June 2024. Studies on predictors for weaning failure in adults ventilated in the intensive care unit were included. Studies on children, outpatients, non-invasive ventilation, or explanatory factors of weaning failure were excluded. Two reviewers performed the screening and data extraction independently. Data synthesis followed an inductive approach in which the predictors were thematically analyzed, sorted, and clustered. Of the 1388 records obtained, 140 studies were included in the analysis. The 112 prospective and 28 retrospective studies investigated a total of 145 predictors. These were assigned to the four central clusters ‘Imaging procedures’ (n = 22), ‘Physiological parameters’ (n = 61), ‘Scores and indices’ (n = 53), and ‘Machine learning models’ (n = 9). The most frequently investigated predictors are the rapid shallow breathing index, the diaphragm thickening fraction, the respiratory rate, the P/F ratio, and the diaphragm excursion. Predictors for weaning failure are widely researched. To date, 145 predictors have been investigated with varying intensity in 140 studies that are in line with the current weaning definition. It is no longer just individual predictors that are investigated, but more comprehensive assessments, indices and machine learning models in the last decade. Future research should be conducted in line with international weaning definitions and further investigate poorly researched predictors. Registration, Protocol: https://doi.org/10.17605/OSF.IO/2KDYU
呼吸机断气对重症监护患者非常重要,可避免因长期通气引起并发症。然而,并非所有患者都能立即成功断气。他们的自主呼吸可能不足,导致拔管失败,随后需要重新插管。为了识别断流失败的高风险患者,过去几十年来,已有多项研究和荟萃分析对各种潜在的预测因素进行了研究。然而,目前还缺少对所有预测因素的综述。为了对断奶失败的实证调查预测因素进行概述,我们绘制了一张系统的证据图。我们绘制了一张系统证据图。为此,我们于 2023 年 12 月在 Medline、Cochrane 和 CINAHL 数据库中进行了系统检索,并于 2024 年 6 月增加了引文检索和人工检索。我们纳入了有关重症监护室成人断奶失败预测因素的研究。排除了有关儿童、门诊患者、无创通气或断奶失败解释因素的研究。两名审稿人独立完成了筛选和数据提取工作。数据综合采用归纳法,对预测因素进行主题分析、分类和聚类。在获得的 1388 条记录中,有 140 项研究被纳入分析。112 项前瞻性研究和 28 项回顾性研究共调查了 145 项预测因素。这些预测因子被归入四个中心分组:"成像程序"(22 项)、"生理参数"(61 项)、"评分和指数"(53 项)和 "机器学习模型"(9 项)。最常用的预测指标是快速浅呼吸指数、膈肌增厚分数、呼吸频率、P/F 比值和膈肌偏移。对断奶失败的预测因素进行了广泛研究。迄今为止,已有 140 项符合当前断奶定义的研究对 145 种预测因素进行了不同程度的调查。近十年来,研究的不再仅仅是单个预测因子,而是更全面的评估、指数和机器学习模型。未来的研究应与国际断奶定义保持一致,并进一步调查研究不足的预测因素。注册,协议: https://doi.org/10.17605/OSF.IO/2KDYU
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引用次数: 0
Representation of intensivists’ race/ethnicity, sex, and age by artificial intelligence: a cross-sectional study of two text-to-image models 人工智能对重症监护医生种族/民族、性别和年龄的表征:对两种文本到图像模型的横断面研究
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-11 DOI: 10.1186/s13054-024-05134-4
Mia Gisselbaek, Mélanie Suppan, Laurens Minsart, Ekin Köselerli, Sheila Nainan Myatra, Idit Matot, Odmara L. Barreto Chang, Sarah Saxena, Joana Berger-Estilita
Integrating artificial intelligence (AI) into intensive care practices can enhance patient care by providing real-time predictions and aiding clinical decisions. However, biases in AI models can undermine diversity, equity, and inclusion (DEI) efforts, particularly in visual representations of healthcare professionals. This work aims to examine the demographic representation of two AI text-to-image models, Midjourney and ChatGPT DALL-E 2, and assess their accuracy in depicting the demographic characteristics of intensivists. This cross-sectional study, conducted from May to July 2024, used demographic data from the USA workforce report (2022) and intensive care trainees (2021) to compare real-world intensivist demographics with images generated by two AI models, Midjourney v6.0 and ChatGPT 4.0 DALL-E 2. A total of 1,400 images were generated across ICU subspecialties, with outcomes being the comparison of sex, race/ethnicity, and age representation in AI-generated images to the actual workforce demographics. The AI models demonstrated noticeable biases when compared to the actual U.S. intensive care workforce data, notably overrepresenting White and young doctors. ChatGPT-DALL-E2 produced less female (17.3% vs 32.2%, p < 0.0001), more White (61% vs 55.1%, p = 0.002) and younger (53.3% vs 23.9%, p < 0.001) individuals. While Midjourney depicted more female (47.6% vs 32.2%, p < 0.001), more White (60.9% vs 55.1%, p = 0.003) and younger intensivist (49.3% vs 23.9%, p < 0.001). Substantial differences between the specialties within both models were observed. Finally when compared together, both models showed significant differences in the Portrayal of intensivists. Significant biases in AI images of intensivists generated by ChatGPT DALL-E 2 and Midjourney reflect broader cultural issues, potentially perpetuating stereotypes of healthcare worker within the society. This study highlights the need for an approach that ensures fairness, accountability, transparency, and ethics in AI applications for healthcare.
将人工智能(AI)融入重症监护实践中,可以通过提供实时预测和辅助临床决策来加强对患者的护理。然而,人工智能模型中的偏差可能会破坏多样性、公平性和包容性(DEI)工作,尤其是在医疗保健专业人员的视觉呈现方面。这项工作旨在研究 Midjourney 和 ChatGPT DALL-E 2 这两个人工智能文本到图像模型的人口统计表征,并评估它们在描述重症监护医师人口统计特征方面的准确性。这项横断面研究于 2024 年 5 月至 7 月进行,使用了来自美国劳动力报告(2022 年)和重症监护受训人员(2021 年)的人口统计数据,将真实世界中的重症监护医师人口统计数据与 Midjourney v6.0 和 ChatGPT 4.0 DALL-E 2 这两种人工智能模型生成的图像进行比较。与美国重症监护人员的实际数据相比,人工智能模型表现出明显的偏差,尤其是白人和年轻医生的比例过高。ChatGPT-DALL-E2 生成的女性较少(17.3% vs 32.2%,p < 0.0001),白人较多(61% vs 55.1%,p = 0.002),年轻医生较多(53.3% vs 23.9%,p < 0.001)。而 "中途"(Midjourney)更多的是女性(47.6% vs 32.2%,p < 0.001),更多的是白人(60.9% vs 55.1%,p = 0.003)和更年轻的重症监护医师(49.3% vs 23.9%,p < 0.001)。在两个模型中都观察到了专科之间的巨大差异。最后,如果将两个模型放在一起进行比较,则会发现在对重症监护医生的描述方面存在显著差异。ChatGPT DALL-E 2 和 Midjourney 所生成的人工智能对重症监护医生形象的显著偏差反映了更广泛的文化问题,有可能在社会中延续对医疗工作者的刻板印象。本研究强调,在医疗保健领域应用人工智能时,需要确保公平、问责、透明和道德。
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引用次数: 0
Length of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials 使用雷扎芬净治疗侵袭性念珠菌病和/或念珠菌血症患者的住院时间和重症监护室停留时间:两项随机对照试验的汇总分析
IF 15.1 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2024-11-11 DOI: 10.1186/s13054-024-05152-2
Patrick M. Honoré, Matteo Bassetti, Oliver A. Cornely, Herve Dupont, Jesús Fortún, Marin H. Kollef, Peter Pappas, John Pullman, Jose Vazquez, Inga Bielicka, Sara Dickerson, Nick Manamley, Taylor Sandison, George R. Thompson
Invasive candidiasis/candidemia (IC/C) is associated with a substantial health economic burden driven primarily by prolonged hospital stay. The once-weekly IV echinocandin, rezafungin acetate, has demonstrated non-inferiority to caspofungin in the treatment of IC/C. This paper reports a post hoc pooled exploratory analysis of length of stay (LoS) for hospital and intensive care unit (ICU) stays in two previously published clinical trials (ReSTORE [NCT03667690] and STRIVE [NCT02734862], that compared rezafungin with daily IV caspofungin (stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more). LoS outcomes were analysed descriptively in the pooled modified intention to treat (mITT) population (all patients who had a documented Candida infection in line with trial requirements and received at least one dose of study drug). In addition, to adjust for an imbalance between treatment groups in the proportion receiving mechanical ventilation at baseline, a generalised linear model with mechanical ventilation as a binary covariate was applied. Responses to an exploratory question in the phase 3 trial on possible earlier discharge with weekly rezafungin are also reported. 294 patients were included (rezafungin 139, caspofungin 155), of whom 126 (43%) had ICU admission. Patients treated with rezafungin had a numerically shorter LoS than with caspofungin in all analyses. Mean total LoS was 25.2 days, vs 28.3 days with caspofungin, and mean ICU LoS was 16.1 vs 21.6 days for rezafungin and caspofungin, respectively. After adjustment for mechanical ventilation status the difference in ICU LoS was 4.1 days, a relative difference of 24% (95% CI -11%, 72%). Physicians would have considered earlier discharge for 16% of patients (30/187) with weekly rezafungin, an average of 5–6 days earlier. Rezafungin may enable shorter hospital and ICU LoS in IC/C compared with daily IV caspofungin, with accompanying savings in resource use. Further research is needed to confirm this in the real-world setting. Trial registration. NCT03667690 (ReSTORE; September 12, 2018); NCT02734862 (STRIVE; April 12, 2016).
侵袭性念珠菌病/念珠菌血症(IC/C)主要因住院时间延长而造成巨大的医疗经济负担。在 IC/C 的治疗中,每周一次静脉滴注的棘白菌素类药物醋酸雷沙芬净已被证明不劣于卡泊芬净。本文报告了对之前发表的两项临床试验(ReSTORE [NCT03667690]和 STRIVE [NCT02734862])中住院和重症监护室(ICU)停留时间(LoS)的事后汇总探索性分析,这两项试验比较了雷沙芬净和每日静脉注射的卡泊芬净(卡泊芬净组中符合相关标准的稳定期患者可在 3 天或更长时间后减量至氟康唑)。LoS结果在汇总的修正意向治疗(mITT)人群中进行了描述性分析(所有符合试验要求、有记录的念珠菌感染并至少接受了一剂研究药物的患者)。此外,为了调整治疗组间基线时接受机械通气比例的不平衡,还应用了以机械通气为二元协变量的广义线性模型。此外,还报告了对第 3 期试验中一个探索性问题的答复,即每周使用雷沙芬净可能会提前出院。共纳入 294 例患者(雷沙芬净 139 例,卡泊芬净 155 例),其中 126 例(43%)曾入住 ICU。在所有分析中,接受雷沙芬净治疗的患者的LoS在数量上短于卡泊芬净。雷沙芬净和卡泊芬净的平均总住院时间分别为 25.2 天和 28.3 天,ICU 住院时间分别为 16.1 天和 21.6 天。调整机械通气状态后,ICU LoS 的差异为 4.1 天,相对差异为 24%(95% CI -11%,72%)。16%的患者(30/187)在每周使用雷沙芬净后,医生会考虑提前出院,平均提前5-6天。与每日静脉滴注卡泊芬净相比,雷沙芬净可缩短IC/C患者的住院和重症监护室等待时间,同时节省资源使用。要在实际环境中证实这一点,还需要进一步的研究。试验注册。NCT03667690(ReSTORE;2018年9月12日);NCT02734862(STRIVE;2016年4月12日)。
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