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几种滑膜炎超声评分系统的评估及其与临床检查的比较:来自类风湿关节炎前瞻性多中心研究的结果。

Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis.

机构信息

Medicine Faculty, Rheumatology B Department, Descartes University; UPRES-EA 4058; APHP, Cochin Hospital, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.

出版信息

Ann Rheum Dis. 2010 May;69(5):828-33. doi: 10.1136/ard.2009.115493. Epub 2009 Sep 9.

Abstract

OBJECTIVES

To evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter.

METHODS

To study selected global scoring systems, for the clinical, B mode and power Doppler techniques, the following joints were evaluated: 28 joints (28-joint Disease Activity Score (DAS28)), 20 joints (metacarpophalangeals (MCPs) + metatarsophalangeals (MTPs)) and 38 joints (28 joints + MTPs) using either a binary (yes/no) or a 0-3 grade. The study was a prospective, 4-month duration follow-up of 76 patients with RA requiring anti-tumour necrosis factor (TNF) therapy (complete follow-up data: 66 patients). Intraobserver reliability was evaluated using the intraclass correlation coefficient (ICC), construct validity was evaluated using the Cronbach alpha test and external validity was evaluated using level of correlation between scoring system and C reactive protein (CRP). Sensitivity to change was evaluated using the standardised response mean. Discriminating capacity was evaluated using the standardised mean differences in patients considered by the doctor as significantly improved or not at the end of the study.

RESULTS

Different clinimetric properties of various US scoring systems were at least as good as the clinical scores with, for example, intraobserver reliability ranging from 0.61 to 0.97 versus from 0.53 to 0.82, construct validity ranging from 0.76 to 0.89 versus from 0.76 to 0.88, correlation with CRP ranging from 0.28 to 0.34 versus from 0.28 to 0.35 and sensitivity to change ranging from 0.60 to 1.21 versus from 0.96 to 1.36 for US versus clinical scoring systems, respectively.

CONCLUSION

This study suggests that US evaluation of synovitis is an outcome measure at least as relevant as physical examination. Further studies are required in order to achieve optimal US scoring systems for monitoring patients with RA in clinical trials and in clinical practice.

摘要

目的

根据疗效评估的关节炎临床试验结果测量(OMERACT)标准,评估不同的全球超声(US)滑膜炎评分系统作为类风湿关节炎(RA)的潜在结局指标。

方法

为了研究选定的全球评分系统,对于临床、B 型和功率多普勒技术,评估了以下关节:28 个关节(28 关节疾病活动度评分(DAS28))、20 个关节(掌指关节(MCPs)+跖趾关节(MTPs))和 38 个关节(28 个关节+MTPs),采用二进制(是/否)或 0-3 级评分。这项研究是一项前瞻性、为期 4 个月的 76 例需要抗肿瘤坏死因子(TNF)治疗的 RA 患者的随访研究(完整随访数据:66 例患者)。采用组内相关系数(ICC)评估观察者内可靠性,采用 Cronbach alpha 检验评估结构有效性,采用评分系统与 C 反应蛋白(CRP)之间的相关性评估外部有效性。采用标准化反应均值评估对变化的敏感性。采用考虑医生认为在研究结束时明显改善或未改善的患者的标准化均数差值评估鉴别能力。

结果

各种 US 评分系统的不同临床计量学特性至少与临床评分一样好,例如,观察者内可靠性范围为 0.61 至 0.97,而 0.53 至 0.82;结构有效性范围为 0.76 至 0.89,而 0.76 至 0.88;与 CRP 的相关性范围为 0.28 至 0.34,而 0.28 至 0.35;对变化的敏感性范围为 0.60 至 1.21,而 0.96 至 1.36,分别为 US 与临床评分系统。

结论

这项研究表明,超声评估滑膜炎是一种与体格检查一样相关的结局指标。需要进一步研究以实现用于监测临床试验和临床实践中 RA 患者的最佳 US 评分系统。

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