Touboul P-J, Hennerici M G, Meairs S, Adams H, Amarenco P, Desvarieux M, Ebrahim S, Fatar M, Hernandez Hernandez R, Kownator S, Prati P, Rundek T, Taylor A, Bornstein N, Csiba L, Vicaut E, Woo K S, Zannad F
Cerebrovasc Dis. 2004;18(4):346-9. doi: 10.1159/000081812. Epub 2004 Nov 2.
Intima-media thickness (IMT) is increasingly used in clinical trials as a surrogate end point for determining the success of interventions that lower risk factors for atherosclerosis. The necessity for unified criteria to distinguish early atherosclerotic plaque formation from thickening of IMT and to standardize IMT measurements is addressed in this consensus statement. Plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness of > or =1.5 mm as measured from the media-adventitia interface to the intima-lumen interface. Standard use of IMT measurements is recommended in all epidemiological and interventional trials dealing with vascular diseases to improve characterization of the population investigated. The consensus concludes that there is no need to 'treat IMT values' nor to monitor IMT values in individual patients apart from few exceptions. Although IMT has been suggested to represent an important risk marker, it does not fulfill the characteristics of an accepted risk factor. Standardized methods recommended in this consensus statement will foster homogenous data collection and analysis. This will help to improve the power of studies incorporating IMT measurements and to facilitate the merging of large databases for meta-analyses.
内膜中层厚度(IMT)在临床试验中越来越多地被用作替代终点,以确定降低动脉粥样硬化危险因素的干预措施是否成功。本共识声明讨论了制定统一标准以区分早期动脉粥样硬化斑块形成与IMT增厚以及规范IMT测量的必要性。斑块定义为一种局灶性结构,其侵入动脉管腔至少0.5毫米或周围IMT值的50%,或者从外膜-中膜界面到内膜-管腔界面测量显示厚度≥1.5毫米。建议在所有涉及血管疾病的流行病学和干预试验中标准使用IMT测量,以改善对所研究人群的特征描述。共识得出结论,除少数例外情况外,无需“处理IMT值”,也无需对个体患者监测IMT值。尽管有人认为IMT代表一个重要的风险标志物,但它并不具备公认风险因素的特征。本共识声明中推荐的标准化方法将促进统一的数据收集和分析。这将有助于提高纳入IMT测量的研究的效能,并便于合并大型数据库进行荟萃分析。