• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

一项评估Optison静脉给药用于儿科患者超声心动图造影增强的疗效(和安全性)的4期、开放标签、非随机、多中心研究。

A Phase 4, Open-Label, Non-Randomized, Multicenter Study to Evaluate Efficacy (and Safety) of Intravenous Administration of Optison for Contrast-Enhanced Echocardiography in Pediatric Patients.

作者信息

Sabati Arash, Wang Shuo, Shivaram Pushpa, Hawley Joshua, Thompson David, Erenberg Francine, Kutty Shelby, Kulkarni Aparna, Doan Tam T, Robinson Joshua D

机构信息

Division of Cardiology, Center for Heart Care, Phoenix Children's Hospital, 1919 E Thomas Road, Phoenix, AZ, 85016, USA.

Children's Hospital Los Angeles, Los Angeles, CA, USA.

出版信息

Pediatr Cardiol. 2025 Aug 27. doi: 10.1007/s00246-025-03993-4.

DOI:10.1007/s00246-025-03993-4
PMID:40866633
Abstract

Contrast-enhanced echocardiography (CE-echo) is commonly used in adult patients to optimize endocardial border delineation (EBD) but there is limited experience in children. A prospective, open-label, non-randomized, multicenter study was performed to evaluate the efficacy of intravenous Optison for CE-echo in pediatric patients and determine the optimal dose of Optison. Subjects ≥ 9 and < 18 years with suboptimal echocardiograms (defined as ≥ 2 contiguous segments that could not be adequately visualized) were enrolled. After a baseline non-contrast echocardiogram (NC-echo), CE-echo was performed with 2 dose levels of Optison based on patient weight. The primary endpoint was visualization of the LV wall segments (LVWS) in apical 2- and 4-chamber views. An EBD score was calculated by assigning a value from 0 (no visualization) to 3 (optimal visualization) for 12 LVWS. 37 subjects across 8 sites completed the study. 30 had complete echocardiograms at both dose levels. 2 patients had usable images at dose 2 only. Mean age was 13.4 years (± 2.6) with 23 males (62%). Mean weight was 73.9 kg (± 36.8) with wide distribution of weight (interquartile range of 42-102 kg). There were 8 patients under 40 kg. Most subjects had a prior medical/surgical history (n = 33, 89%). Both dose levels of Optison CE-echo improved the number of LVWS visualized from 3.7 ± 1.1 on NC-echo to 10.0 ± 0.1 with dose 1 (p < 0.001) and 10.5 ± 0.1 with dose 2 (p < 0.001). EBD score also improved at both dose levels from 11.9 ± 2.5 for NC-echo to 28.5 ± 1.7 for dose 1 (p < 0.001) and 30.2 ± 8.4 for dose 2 (p < 0.001). The number of suboptimal echocardiograms improved from 92.3% ± 10.7 in NC-echo to 26.2% ± 9 with dose 1 (p < 0.001) and 30.8% ± 4.5 with dose 2 (p < 0.001). CE-echo with intravenous Optison in pediatric patients improved the number of LVWS visualized, improved EBD score, and reduced the number of suboptimal echocardiograms at both dosages used in this study. Intravenous Optison can improve LV visualization in pediatric patients with suboptimal echocardiograms.

摘要

对比增强超声心动图(CE-echo)常用于成年患者以优化心内膜边界描绘(EBD),但在儿童中的经验有限。一项前瞻性、开放标签、非随机、多中心研究旨在评估静脉注射Optison用于儿科患者CE-echo的疗效,并确定Optison的最佳剂量。纳入年龄≥9岁且<18岁、超声心动图检查结果欠佳(定义为≥2个连续节段无法充分显影)的受试者。在进行基线非对比超声心动图(NC-echo)后,根据患者体重使用2个剂量水平的Optison进行CE-echo检查。主要终点是在心尖两腔和四腔视图中左心室壁节段(LVWS)的显影情况。通过为12个LVWS分配从0(未显影)到3(最佳显影)的值来计算EBD评分。8个中心的37名受试者完成了研究。30名受试者在两个剂量水平下均获得了完整的超声心动图。2名患者仅在剂量2时有可用图像。平均年龄为13.4岁(±2.6),男性23名(62%)。平均体重为73.9 kg(±36.8),体重分布范围广(四分位间距为从42至102 kg)。有8名患者体重低于40 kg。大多数受试者有既往内科/外科病史(n = 33,89%)。两个剂量水平的Optison CE-echo均使LVWS显影数量从NC-echo时的3.7±1.1增加到剂量1时的10.0±0.1(p<0.001)和剂量2时的10.5±0.1(p<0.001)。两个剂量水平的EBD评分也均有所改善,从NC-echo时的11.9±2.5提高到剂量1时的28.5±1.7(p<0.001)和剂量2时的30.2±8.4(p<0.00)。超声心动图检查结果欠佳的比例从NC-echo时的92.3%±10.7降至剂量1时的26.2%±9(p<0.001)和剂量2时的30.8%±4.5(p<0.001)。本研究中使用的两个剂量的静脉注射Optison进行CE-echo均增加了LVWS显影数量,改善了EBD评分,并减少了超声心动图检查结果欠佳的比例。静脉注射Optison可改善超声心动图检查结果欠佳的儿科患者的左心室显影情况。

相似文献

1
A Phase 4, Open-Label, Non-Randomized, Multicenter Study to Evaluate Efficacy (and Safety) of Intravenous Administration of Optison for Contrast-Enhanced Echocardiography in Pediatric Patients.一项评估Optison静脉给药用于儿科患者超声心动图造影增强的疗效(和安全性)的4期、开放标签、非随机、多中心研究。
Pediatr Cardiol. 2025 Aug 27. doi: 10.1007/s00246-025-03993-4.
2
Prescription of Controlled Substances: Benefits and Risks管制药品的处方:益处与风险
3
Sertindole for schizophrenia.用于治疗精神分裂症的舍吲哚。
Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD001715. doi: 10.1002/14651858.CD001715.pub2.
4
The Black Book of Psychotropic Dosing and Monitoring.《精神药物剂量与监测黑皮书》
Psychopharmacol Bull. 2024 Jul 8;54(3):8-59.
5
Switching to subcutaneous zilucoplan from intravenous complement component 5 inhibitors in generalised myasthenia gravis: a phase IIIb, open-label study.在全身型重症肌无力患者中从静脉注射补体成分5抑制剂转换为皮下注射zilucoplan:一项IIIb期开放标签研究。
Ther Adv Neurol Disord. 2025 Jul 5;18:17562864251347283. doi: 10.1177/17562864251347283. eCollection 2025.
6
Interventions for preventing weight gain after smoking cessation.戒烟后预防体重增加的干预措施。
Cochrane Database Syst Rev. 2012 Jan 18;1:CD006219. doi: 10.1002/14651858.CD006219.pub3.
7
Signs and symptoms to determine if a patient presenting in primary care or hospital outpatient settings has COVID-19.在基层医疗机构或医院门诊环境中,如果患者出现以下症状和体征,可判断其是否患有 COVID-19。
Cochrane Database Syst Rev. 2022 May 20;5(5):CD013665. doi: 10.1002/14651858.CD013665.pub3.
8
Home treatment for mental health problems: a systematic review.心理健康问题的居家治疗:一项系统综述
Health Technol Assess. 2001;5(15):1-139. doi: 10.3310/hta5150.
9
Levetiracetam add-on for drug-resistant focal epilepsy: an updated Cochrane Review.左乙拉西坦添加治疗耐药性局灶性癫痫:Cochrane系统评价的更新版
Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD001901. doi: 10.1002/14651858.CD001901.pub2.
10
Heliox for croup in children.氦氧混合气治疗儿童喉炎。
Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD006822. doi: 10.1002/14651858.CD006822.pub6.

本文引用的文献

1
Safety and Efficacy of Cardiac Ultrasound Contrast in Children and Adolescents for Resting and Stress Echocardiography.
J Am Soc Echocardiogr. 2016 Jul;29(7):655-62. doi: 10.1016/j.echo.2016.02.019. Epub 2016 Apr 1.
2
Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.成人经超声心动图进行心腔定量的建议:美国超声心动图学会和欧洲心血管影像学会的更新版
Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.
3
Safety and efficacy of commercially available ultrasound contrast agents for rest and stress echocardiography a multicenter experience.用于静息和负荷超声心动图的市售超声造影剂的安全性和有效性:一项多中心经验
J Am Coll Cardiol. 2009 Jan 6;53(1):32-8. doi: 10.1016/j.jacc.2008.08.066.
4
Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent (multicenter registry results in 4,300,966 consecutive patients).接受超声心动图检查时使用和未使用超声造影剂的住院患者的急性死亡率(4300966例连续患者的多中心登记结果)
Am J Cardiol. 2008 Dec 15;102(12):1742-6. doi: 10.1016/j.amjcard.2008.08.019. Epub 2008 Oct 23.
5
The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses.用于超声图像增强的德芬蒂尼(Definity)和欧普蒂森(Optison)的安全性:对78383次给药造影剂剂量的回顾性分析
J Am Soc Echocardiogr. 2008 Nov;21(11):1202-6. doi: 10.1016/j.echo.2008.07.019. Epub 2008 Oct 10.
6
Baseline values from the electrocardiograms of children and adolescents with ADHD.注意缺陷多动障碍(ADHD)儿童和青少年的心电图基线值。
Child Adolesc Psychiatry Ment Health. 2007 Sep 28;1(1):11. doi: 10.1186/1753-2000-1-11.
7
Safety and efficacy of intravenous contrast imaging in pediatric echocardiography.儿科超声心动图中静脉造影成像的安全性和有效性。
Pediatr Cardiol. 2005 Jul-Aug;26(4):413-7. doi: 10.1007/s00246-004-0795-1.
8
Is there a role for intravenous transpulmonary contrast imaging in pediatric stress echocardiography?静脉注射经肺对比成像在小儿负荷超声心动图中是否有作用?
J Am Soc Echocardiogr. 2003 Jan;16(1):9-14. doi: 10.1067/mje.2003.41.
9
Contrast echocardiography: current and future applications.对比超声心动图:当前及未来应用
J Am Soc Echocardiogr. 2000 Apr;13(4):331-42. doi: 10.1067/mje.2000.105462.
10
Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent. Results of a phase III Multicenter Trial.新型超声心动图造影剂OPTISON(FS069)改善左心室心内膜边界描绘及显影。一项III期多中心试验的结果
J Am Coll Cardiol. 1998 Sep;32(3):746-52. doi: 10.1016/s0735-1097(98)00311-8.