Okano Y, Akizuki M, Kondo H, Kawai S, Suzuki Y, Takeuchi T, Matsuoka Y, Kawaguchi Y, Kashiwazaki S
Department of Medicine, Nippon Kokan Hospital, Kanagawa.
Ryumachi. 1997 Jun;37(3):467-75.
To characterize the American College of Rheumatology core set of disease activity measures for rheumatoid arthritis (RA) clinical trials (ACR core set measures) and the ACR definition of improvement of RA (ACR improvement definition), we studied 42 Japanese patients with active RA who were treated with DMARDs including mizoribine. Each patient's disease activity was assessed at the time of enrollment to the study and after 24 weeks using the ACR core set measures as well as the physical global assessment through the conventional measures. Twenty-five (60%) patients were discerned as showing improved by physicians through the conventional measures. This decision appeared to be based on improvement in Lansbury activity index (LAI) and C-reactive protein (CRP) value. Twelve of the 25 "improved" patients satisfied the ACR improvement definition. The 12 patients showed significant improvement in "outcome" measures including patients assessments of pain, disease activity, and physical function, compared to the 30 patients not satisfying the ACR definition. However, no significant differences were observed between these two groups in "process" measures including LAI, tender joint count, swallen joint count, or CRP value. In conclusion, the ACR core set measures including both process and outcome measures have potential to reflect clinical important changes on "real life" of patients with RA.
为了描述美国风湿病学会类风湿关节炎（RA）临床试验疾病活动度测量核心集（ACR核心集测量指标）以及RA改善的ACR定义（ACR改善定义），我们研究了42例接受包括咪唑立宾在内的改善病情抗风湿药（DMARDs）治疗的活动期日本RA患者。在入组研究时以及24周后，使用ACR核心集测量指标以及通过传统测量方法进行的整体身体评估，对每位患者的疾病活动度进行评估。通过传统测量方法，25例（60%）患者被医生判定为病情改善。这一判定似乎基于兰斯伯里活动指数（LAI）和C反应蛋白（CRP）值的改善情况。25例“改善”患者中有12例符合ACR改善定义。与30例不符合ACR定义的患者相比，这12例患者在包括患者对疼痛、疾病活动度和身体功能的评估等“结局”测量指标上有显著改善。然而，在包括LAI、压痛关节计数、肿胀关节计数或CRP值等“过程”测量指标上，这两组之间未观察到显著差异。总之，包括过程和结局测量指标的ACR核心集测量指标有潜力反映RA患者“现实生活”中的临床重要变化。
