Malaise M G, Hauwaert C, Franchimont P, Danneskiold-Samsoe B, Bach-Andersen R, Gross D, Gerber H, Gerschpacher H, Stocker H, Bolla K
Lancet. 1985 Apr 13;1(8433):832-6. doi: 10.1016/s0140-6736(85)92205-6.
41 patients with active rheumatoid arthritis entered a placebo-controlled double-blind randomised study in which 21 received slow intravenous injections (given in fractions over 10 min) of thymopentin (TP-5) 50 mg 3 times a week for 3 consecutive weeks and 20 received placebo in the same way. After 3 weeks of treatment the TP-5 group showed improvement (p less than 0.05 or p less than 0.01) in all but one of the clinical variables tested. There was improvement in the number of joints painful at rest, the number of joints painful on motion, scores for tenderness on pressure and swollen joints, severity of pain on awakening and morning stiffness, and right-hand grip strength; left-hand grip strength remained unchanged. In the placebo group, only morning stiffness improved significantly. The intergroup comparisons showed that thymopentin was significantly better than placebo in reducing tenderness, joint swelling, severity of pain on awakening, and disease activity. 4 weeks after the end of the TP-5 therapy, the improvement was still present although there was a trend towards relapses. No significant modifications occurred in any of the laboratory variables tested and only minor side-effects were experienced by either group.
41例活动期类风湿关节炎患者进入一项安慰剂对照的双盲随机研究，其中21例接受胸腺五肽（TP - 5）50mg缓慢静脉注射（分10分钟注射），每周3次，连续3周，另外20例以同样方式接受安慰剂治疗。治疗3周后，TP - 5组除一项临床变量外，其余所有测试的临床变量均有改善（p小于0.05或p小于0.01）。静息时疼痛关节数、活动时疼痛关节数、压痛评分、关节肿胀、晨起疼痛严重程度和晨僵以及右手握力均有改善；左手握力保持不变。在安慰剂组，仅晨僵有显著改善。组间比较显示，胸腺五肽在减轻压痛、关节肿胀、晨起疼痛严重程度和疾病活动方面明显优于安慰剂。TP - 5治疗结束4周后，改善仍然存在，尽管有复发趋势。所测试的任何实验室变量均未发生显著变化，两组仅出现轻微副作用。
