Lemmel E M, Bach G L, Bolten W, Brackertz D, Fahmy Z, Mattern H, Stroehmann I, Wittenborg A
Staatliches Rheumakrankenhaus, Wildbad.
Dtsch Med Wochenschr. 1988 Feb 5;113(5):172-6. doi: 10.1055/s-2008-1067614.
In a multicenter, placebo-controlled and randomized double-blind trial 119 patients with rheumatoid arthritis were treated with thymopentin, an immunoregulating drug. The data of 107 patients were complete enough to be evaluated: 51 were given intravenous injections over ten minutes of 50 mg thymopentin three times weekly, 56 were similarly treated with a placebo solution. Significant improvement of five among nine clinical criteria were obtained with thymopentin after the third week of treatment. The response rate (improvement of a clinical parameter by at least 40%) was significantly greater for all clinical parameters in the thymopentin group. Regression to a functionally more favourable class (Steinbrocker's classification) occurred in seven thymopentin-treated, but in none of the placebo-treated patients. The improvement gradually subsided over four weeks after the end of treatment. There were no changes during the trial with respect to immunological, biochemical or haematological findings. Except for one systemic allergic reaction there were no side effects.
在一项多中心、安慰剂对照的随机双盲试验中，119名类风湿性关节炎患者接受了免疫调节药物胸腺五肽治疗。107名患者的数据完整，足以进行评估：51名患者每周三次静脉注射50毫克胸腺五肽，每次注射持续十分钟；56名患者接受安慰剂溶液的类似治疗。治疗三周后，胸腺五肽组在九个临床标准中的五个方面取得了显著改善。胸腺五肽组所有临床参数的反应率（临床参数至少改善40%）显著更高。七名接受胸腺五肽治疗的患者病情回归到功能更有利的类别（斯坦布鲁克分类），而接受安慰剂治疗的患者无一如此。治疗结束后四周内，改善情况逐渐消退。试验期间，免疫学、生化或血液学检查结果无变化。除了一例全身性过敏反应外，未出现副作用。
