超声增强剂的安全性比较:系统回顾与贝叶斯网络荟萃分析》:Optison的安全性比较评估。

IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Ricardo De La Fuente Gonzalez, Arturo Cabra, Daphne Liu, Myra Gueco, Emi Naslazi, Shuai Fu, Zuzanna Maliszewska, Noemi Hummel, Dustin M Dunham
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引用次数: 0

摘要

包括 Optison、Definity 和 Lumason 在内的超声增强剂 (UEA) 可提高超声心动图的诊断性能,尤其是在声窗不理想的患者中。然而,美国食品和药物管理局(FDA)批准的 UEAs 之间的安全性比较评估仍然很少。2023 年 8 月,一项在 PRISMA 指导下进行的系统性文献综述检索了 Medline、Embase、Cochrane 图书馆和灰色文献。纳入了有关造影剂增强手术安全性的随机和非随机比较证据。可行性评估通过比较患者特征和结果,确保了各研究之间的同质性。采用贝叶斯分层网络元回归法间接比较不同 UEA 的已发表安全性结果。此外,还从FDA不良事件报告系统(FAERS)中检索了2019-2023年间每种UEA的不良事件(AEs),并根据美国每年的UEA用药情况得出了比较安全性结果。在对 4146 条记录进行筛选后,经过可行性评估,有 19 项研究被纳入间接对比分析。在与 Definity 和 Lumason 的直接比较中,Optison 在大多数调查的 AEs 方面都表现出良好的安全性。关于 30 分钟内严重不良事件 (SAE) 的网络元回归结果显示,Optison 与 Lumason 和 Definity 的几率比 (OR) 分别为 0.59(95% 置信区间:0.27-1.23)和 0.63(0.29-1.33),这表明 Optison 与 Lumason 和 Definity 的 SAE 风险有所降低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative Safety of Ultrasound Enhancing Agents: A Systematic Review and Bayesian Network Meta-Analysis.

Ultrasound enhancing agents (UEAs), including Optison, DEFINITY, and LUMASON, enhance the diagnostic performance of echocardiography, particularly, in patients with suboptimal acoustic windows. However, there remains a paucity of comparative safety assessments among the Food and Drug Administration-approved UEAs. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic literature review performed in August 2023 searched Medline, Embase, Cochrane Library, and gray literature. Randomized and nonrandomized comparative evidence on safety of contrast-enhanced procedures were included. A feasibility assessment ensured homogeneity across studies by comparing patient characteristics and outcomes. Bayesian hierarchical network meta-regression was used to indirectly compare published safety outcomes across different UEAs. In addition, adverse events (AEs) between 2019 and 2023 for each UEA were retrieved from the Food and Drug Administration Adverse Events Reporting System (FAERS), and comparative safety outcomes were derived using annual UEA administration in the United States. The screening of 4,146 records rendered 19 studies for inclusion in the indirect comparison analysis after feasibility assessment. Optison demonstrated favorable safety in direct comparisons with DEFINITY and LUMASON across the majority of investigated AEs. Network meta-regression results on serious AEs within 30 minutes revealed odds ratios (ORs) of 0.59 (95% confidence interval 0.27 to 1.23) and 0.63 (0.29 to 1.33) for Optison versus LUMASON and DEFINITY, respectively, indicating a decreased risk of serious AEs for Optison versus LUMASON and DEFINITY, further supported by statistically significant ORs within FAERS: 0.01 (0 to 0.02), p <0.001 and 0.15 (0.05 to 0.48), p = 0.001 for Optison versus LUMASON and DEFINITY, respectively. In conclusion, our results restate the favorable comparative safety profile of Optison, providing new evidence to inform clinical decision-making.

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来源期刊
American Journal of Cardiology
American Journal of Cardiology 医学-心血管系统
CiteScore
4.00
自引率
3.60%
发文量
698
审稿时长
33 days
期刊介绍: Published 24 times a year, The American Journal of Cardiology® is an independent journal designed for cardiovascular disease specialists and internists with a subspecialty in cardiology throughout the world. AJC is an independent, scientific, peer-reviewed journal of original articles that focus on the practical, clinical approach to the diagnosis and treatment of cardiovascular disease. AJC has one of the fastest acceptance to publication times in Cardiology. Features report on systemic hypertension, methodology, drugs, pacing, arrhythmia, preventive cardiology, congestive heart failure, valvular heart disease, congenital heart disease, and cardiomyopathy. Also included are editorials, readers'' comments, and symposia.
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