Rau R, Herborn G, Karger T, Menninger H, Elhardt D, Schmitt J
Department of Rheumatology, Evangelisches Fachkrankenhaus, Ratingen, West Germany.
J Rheumatol. 1991 Mar;18(3):328-33.
In a double blind study 57 patients with active erosive rheumatoid arthritis without malalignment or deformities (median disease duration 13 months) were randomly treated with 50 mg gold sodium thiomalate (GSTM) or 15 mg methotrexate (MTX) intramuscularly for 6 months. In the GSTM group, 5/28 patients had to be withdrawn because of side effects; in 2/28 the dose was reduced. In the MTX group, 2/29 were withdrawn, one was lost to followup. The number of swollen joints improved by over 6 in 18/26 (MTX) and in 15/21 (GSTM). Five clinical variables and the sedimentation rate improved significantly in both groups without significant intergroup differences. The radiographs of hands, wrists and forefeet (32 joints evaluated according to Larsen) showed a radiological progression in 11/26 (MTX) and in 8/20 patients (GSTM); however, the deterioration of the mean Larsen index was not significant. While there was no significant difference in effectivity, tolerability was better in the MTX group.
在一项双盲研究中，57例无关节对线不良或畸形的活动性侵蚀性类风湿关节炎患者（疾病持续时间中位数为13个月）被随机分为两组，分别接受50mg硫代苹果酸金钠（GSTM）或15mg甲氨蝶呤（MTX）肌肉注射治疗6个月。在GSTM组中，5/28例患者因副作用而停药；2/28例患者减少了剂量。在MTX组中，2/29例患者停药，1例失访。肿胀关节数量改善超过6个的患者在MTX组为18/26例，在GSTM组为15/21例。两组的5项临床变量和血沉均有显著改善，组间差异无统计学意义。手部、腕部和前足的X线片（根据Larsen法评估32个关节）显示，MTX组11/26例、GSTM组8/20例患者有放射学进展；然而，Larsen指数的平均恶化情况无统计学意义。虽然两组疗效无显著差异，但MTX组的耐受性更好。
