Berger R, Nowak H
Degussa Pharma Gruppe, Frankfurt am Main, Federal Republic of Germany.
Am J Med. 1987 Nov 20;83(5A):84-8. doi: 10.1016/0002-9343(87)90858-8.
A non-controlled clinical phase IV trial was carried out involving 20,641 patients with osteoarthritis of the knee, the hip, and the spine and also with osteoarthritic polyarthritis of the fingers, who were treated with ademetionine tablets given in a fixed dosage schedule for eight weeks. No additional analgesic/antirheumatic treatment was allowed. Nevertheless, concomitant medication for other diseases was permissible. The efficacy was described as "very good" or "good" in 71 percent of cases, as "moderate" in 21 percent, and as "poor" in 9 percent of cases. The tolerance was assessed as very good or good in 87 percent, as moderate in 8 percent, and as poor in 5 percent of cases. The trial therapy was discontinued prematurely because of symptoms of intolerance in 5 percent of the patients and because of a lack of efficacy in 2.3 percent of cases.
开展了一项非对照的IV期临床试验，涉及20641例膝、髋和脊柱骨关节炎以及手指骨关节炎性多关节炎患者，这些患者按照固定剂量方案服用腺苷蛋氨酸片，持续8周。不允许使用额外的镇痛/抗风湿治疗。然而，允许使用治疗其他疾病的伴随药物。71%的病例疗效被描述为“非常好”或“好”，21%为“中等”，9%为“差”。87%的病例耐受性评估为非常好或好，8%为中等，5%为差。5%的患者因不耐受症状而提前终止试验治疗，2.3%的病例因缺乏疗效而提前终止。
