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血管超声对疑似巨细胞动脉炎患者的诊断准确性(EUREKA):一项前瞻性、多中心、非干预性队列研究。

Diagnostic accuracy of vascular ultrasound in patients with suspected giant cell arteritis (EUREKA): a prospective, multicentre, non-interventional, cohort study.

作者信息

Chrysidis Stavros, Døhn Uffe Møller, Terslev Lene, Fredberg Ulrich, Lorenzen Tove, Christensen Robin, Larsen Knud, Diamantopoulos Andreas P

机构信息

Research Unit of Rheumatology, Department of Clinical Research, Hospital of South West Jutland, University of Southern Denmark, Denmark; OPEN, Odense Patient Data Explorative Network, Odense University Hospital, Odense, Denmark; Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.

出版信息

Lancet Rheumatol. 2021 Dec;3(12):e865-e873. doi: 10.1016/S2665-9913(21)00246-0. Epub 2021 Oct 26.

DOI:10.1016/S2665-9913(21)00246-0
PMID:38287632
Abstract

BACKGROUND

Temporal artery biopsy is considered the diagnostic gold standard for giant cell arteritis, despite approximately 39% of patients who are negative for the condition by biopsy subsequently being given a clinical diagnosis of giant cell arteritis. We aimed to assess the diagnostic accuracy of ultrasound examination in patients with suspected giant cell arteritis.

METHODS

In this prospective, multicentre, non-interventional, cohort study (evaluation of ultrasound's role in patients suspected of having extracranial and cranial giant cell arteritis; EUREKA), we consecutively recruited patients aged 50 years or older, with clinically suspected giant cell arteritis from three Danish hospitals (South West Jutland Hospital in Esbjerg, Silkeborg Regional Hospital, and Rigshospitalet, Glostrup). Participants had a bilateral ultrasound of the temporal, facial, common carotid, and axillary arteries. Ultrasounds were done by ultrasonographers who were systematically trained in vascular ultrasound using appropriate equipment and settings. Participants then had a temporal artery biopsy within 7 days of initiation of corticosteroid treatment. A blinded ultrasound expert assessed all ultrasound images. Ultrasound vasculitis was defined in cranial arteries as a homogeneous, hypoechoic, intimamedia complex thickness and a positive compression sign and as a homogeneous intimamedia complex of 1 mm in thickness or wider in the axillary arteries and of 1·5 mm thickness or wider in the common carotid artery. Participants were followed up at 6 months. During this 6 month period, clinicians were able to collect data from all clinical examinations to enable a full clinical diagnosis at 6 months. Clinical diagnosis was based on the expert opinion of the treating rheumatologist. The diagnostic criterion standard was diagnosis confirmed after 6 months of follow-up. We used logistic regression analyses to calculate the odds ratio and 95% CI of ultrasound as a predictor for giant cell arteritis.

FINDINGS

Between April 1, 2014, and July 31, 2017, 118 patients were screened for inclusion, of whom 106 had both ultrasound examinations and an eligible temporal artery biopsy and were included in the intention-to-diagnose population. The mean age was 72·7 years (SD 7·9), 63 (59%) participants were women, and 43 (41%) were men. Temporal artery biopsy was positive in 46 (43%) of 106 patients, and 62 (58%) of 106 patients had a clinically confirmed diagnosis of giant cell arteritis at 6 months (temporal artery biopsy sensitivity 74% [95% CI 62-84], specificity 100% [95% CI 92-100]). Cranial artery ultrasound was positive in all patients who had a positive temporal artery biopsy, and seven (58%) of 12 patients who were positive by ultrasound and negative by temporal artery biopsy were confirmed to have large-vessel giant cell arteritis via other imaging methods. The sensitivity of ultrasound diagnosis of giant cell arteritis was 94% (84-98) and specificity was 84% (70-93). Logistic regression analysis confirmed that ultrasound was the strongest baseline predictor for a clinically confirmed diagnosis of giant cell arteritis at 6 months (crude odds ratio 76·6 [95% CI 21·0-280·0]; adjusted for sex and age 141·0 [27·0-743·0]).

INTERPRETATION

Vascular ultrasound might effectively replace temporal artery biopsy as a first-line diagnostic method in patients suspected of having giant cell arteritis when done by systematically trained ultrasonographers using appropriate equipment and settings.

FUNDING

The Institute for Regional Research at Hospital of Southwest Jutland, Esbjerg, Denmark.

摘要

背景

颞动脉活检被认为是巨细胞动脉炎的诊断金标准,尽管约39%活检结果为阴性的患者随后被临床诊断为巨细胞动脉炎。我们旨在评估超声检查对疑似巨细胞动脉炎患者的诊断准确性。

方法

在这项前瞻性、多中心、非干预性队列研究(评估超声在疑似颅外和颅内巨细胞动脉炎患者中的作用;EUREKA)中,我们连续招募了来自丹麦三家医院(埃斯比约的西南日德兰医院、锡尔克堡地区医院和格洛斯楚普的里格霍斯皮塔尔)的50岁及以上临床疑似巨细胞动脉炎患者。参与者接受了颞动脉、面动脉、颈总动脉和腋动脉的双侧超声检查。超声检查由经过使用适当设备和设置进行血管超声系统培训的超声检查人员进行。参与者随后在开始使用皮质类固醇治疗的7天内进行了颞动脉活检。一位不知情的超声专家评估了所有超声图像。颅动脉超声血管炎定义为均匀的低回声内膜中层复合体增厚和阳性压迫征,腋动脉内膜中层复合体厚度为1mm或更宽,颈总动脉厚度为1.5mm或更宽。对参与者进行了6个月的随访。在这6个月期间,临床医生能够从所有临床检查中收集数据,以便在6个月时做出全面的临床诊断。临床诊断基于主治风湿病学家的专家意见。诊断标准是随访6个月后确诊。我们使用逻辑回归分析来计算超声作为巨细胞动脉炎预测指标的比值比和95%置信区间。

结果

在2014年4月1日至2017年7月31日期间,筛选了118例患者纳入研究,其中106例同时进行了超声检查和符合条件的颞动脉活检,并被纳入意向性诊断人群。平均年龄为72.7岁(标准差7.9),63例(59%)参与者为女性,43例(41%)为男性。106例患者中46例(43%)颞动脉活检呈阳性,106例患者中有62例(58%)在6个月时临床确诊为巨细胞动脉炎(颞动脉活检敏感性74%[95%置信区间62 - 84],特异性100%[95%置信区间92 - 100])。颞动脉活检呈阳性的所有患者颅动脉超声均为阳性,超声阳性但颞动脉活检阴性的12例患者中有7例(58%)通过其他影像学方法确诊为大血管巨细胞动脉炎。超声诊断巨细胞动脉炎的敏感性为94%(84 - 98),特异性为84%(70 - 93)。逻辑回归分析证实,超声是6个月时临床确诊巨细胞动脉炎的最强基线预测指标(粗比值比76.6[95%置信区间21.0 - 280.0];经性别和年龄调整后为141.0[27.0 - 743.0])。

解读

当由经过系统培训的超声检查人员使用适当设备和设置进行检查时,血管超声可能有效地替代颞动脉活检,作为疑似巨细胞动脉炎患者的一线诊断方法。

资助

丹麦埃斯比约西南日德兰医院区域研究所。

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