Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial.
Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial.
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DOI：
10.1136/bmj.i4205
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发表时间：
2016-08-16
期刊：
影响因子：
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通讯作者：
Kvien TK
中科院分区：
文献类型：
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作者：
Haavardsholm EA;Aga AB;Olsen IC;Lillegraven S;Hammer HB;Uhlig T;Fremstad H;Madland TM;Lexberg ÅS;Haukeland H;Rødevand E;Høili C;Stray H;Noraas A;Hansen IJ;Bakland G;Nordberg LB;van der Heijde D;Kvien TK
目的确定与传统治疗策略相比，基于结构化超声评估的治疗策略是否会改善类风湿关节炎的预后。设计多中心、开放标签、两组、平行组、随机对照策略试验。从2010年9月到2015年9月，挪威有10个风湿病学部门和一个专家中心。2010年9月至2013年4月期间招募了238名患者，其中230名（141名（61%）女性）接受了分配的干预措施，并对主要结局进行了分析。主要入选标准为年龄18-75岁，符合2010年美国风湿病学会/欧洲抗风湿病联盟类风湿性关节炎分类标准，具有疾病缓解药物治疗适应症的疾病缓解抗风湿药物幼稚，以及首例患者报告关节肿胀的时间小于2年。排除了肾功能或肝功能异常或严重合并症的患者。干预122例患者被随机分配至针对临床和影像学缓解的超声严格控制策略，116例患者被随机分配至针对临床缓解的常规严格控制策略。两组患者均按照相同的疾病缓解抗风湿药物递增策略进行治疗，两年内进行了13次访视。主要终点是临床缓解16 - 24个月、无关节肿胀和放射学关节损伤无进展的患者比例。次要结果包括疾病活动度、放射学进展、功能、生活质量和不良事件的测量。所有参加至少一次随访的参与者都被纳入全分析集。结果超声严格对照组118例分析患者中的26例（22%）和临床严格对照组112例分析患者中的21例（19%）达到主要终点（平均差异3.3%，95%置信区间-7.1%至13.7%）。两组的次要终点（疾病活动度、身体功能和关节损伤）相似。超声严格控制组6例（5%）患者和常规组7例（6%）患者发生严重不良事件。结论：根据ARCTIC结果，根据目前的建议，在早期类风湿关节炎患者的随访中系统使用超声是不合理的。这些发现强调了随机试验评估医疗技术临床应用的必要性。临床试验NCT 01205854。
Objective To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy. Design Multicentre, open label, two arm, parallel group, randomised controlled strategy trial. Setting Ten rheumatology departments and one specialist centre in Norway, from September 2010 to September 2015. Participants 238 patients were recruited between September 2010 and April 2013, of which 230 (141 (61%) female) received the allocated intervention and were analysed for the primary outcome. The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. Patients with abnormal kidney or liver function or major comorbidities were excluded. Interventions 122 patients were randomised to an ultrasound tight control strategy targeting clinical and imaging remission, and 116 patients were randomised to a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same disease modifying anti-rheumatic drug escalation strategy, with 13 visits over two years. Main outcome measures The primary endpoint was the proportion of patients with a combination between 16 and 24 months of clinical remission, no swollen joints, and non-progression of radiographic joint damage. Secondary outcomes included measures of disease activity, radiographic progression, functioning, quality of life, and adverse events. All participants who attended at least one follow-up visit were included in the full analysis set. Results 26 (22%) of the 118 analysed patients in the ultrasound tight control arm and 21 (19%) of the 112 analysed patients in the clinical tight control arm reached the primary endpoint (mean difference 3.3%, 95% confidence interval −7.1% to 13.7%). Secondary endpoints (disease activity, physical function, and joint damage) were similar between the two groups. Six (5%) patients in the ultrasound tight control arm and seven (6%) patients in the conventional arm had serious adverse events. Conclusions The systematic use of ultrasound in the follow-up of patients with early rheumatoid arthritis treated according to current recommendations is not justified on the basis of the ARCTIC results. The findings highlight the need for randomised trials assessing the clinical application of medical technology. Trial registration Clinical trials NCT01205854.