Weisman M H
Department of Medicine, University of California, San Diego School of Medicine.
Am J Med. 1987 Oct 30;83(4B):96-100. doi: 10.1016/0002-9343(87)90604-8.
Currently, radiographic analysis of the hands and wrists provides the most practical, useful, and objective biologic endpoint for measurement of outcome in rheumatoid arthritis. Semiquantitative scoring methods for cartilage loss and osseous erosions developed by Sharp (Arthritis Rheum 1971; 14: 706-720) and Larsen (Scand J Rheum 1973; 2: 136-138) have established standards for sensitivity and interobserver reliability. Sharp (Arthritis Rheum 1985; 28: 16-24) has shown that in order to reliably measure change in erosion score, a certain degree of worsening (i.e., progression) must take place. At least one year is necessary, preferably two. Others have shown that rheumatoid arthritis erosions take place and progress early (Years 1 to 3) in most patients, and once destruction is established it may not be possible to adequately assess further change radiographically. Therefore, in order to perform a clinical trial of "disease modifying" agents with radiographic analysis as endpoint, the selections of a proper study population and time interval are most critical. Although it may be difficult to perform, an ideal clinical study for a therapeutic intervention would use patients with rheumatoid arthritis of less than five years' disease duration and perform radiographic analysis at a 24-month minimum interval. The selection of a proper control group may be a near impossibility under these circumstances.
目前，对手部和腕部进行影像学分析，为评估类风湿关节炎的治疗效果提供了最实用、最有效的客观生物学指标。由夏普（《关节炎与风湿病》1971年；14卷：706 - 720页）和拉森（《斯堪的纳维亚风湿病学杂志》1973年；2卷：136 - 138页）制定的软骨损伤和骨质侵蚀的半定量评分方法，确立了敏感度和观察者间可靠性的标准。夏普（《关节炎与风湿病》1985年；28卷：16 - 24页）指出，为了可靠地测量侵蚀评分的变化，必须发生一定程度的恶化（即进展）。至少需要一年时间，最好是两年。其他人已经表明，大多数类风湿关节炎患者的侵蚀在早期（第1至3年）就会发生并进展，一旦破坏形成，可能无法通过影像学充分评估进一步的变化。因此，为了以影像学分析为终点进行“改善病情”药物的临床试验，选择合适的研究人群和时间间隔最为关键。尽管可能很难做到，但针对治疗干预的理想临床研究应使用病程少于五年的类风湿关节炎患者，并至少每24个月进行一次影像学分析。在这种情况下，选择合适的对照组几乎是不可能的。
