Müller-Fassbender H R
Medical School, Ludwig-Maximilian University, Münich, Germany.
Br J Rheumatol. 1993 Aug;32(8):746-50. doi: 10.1093/rheumatology/32.8.746.
Sixty patients with active RA were evaluated over 6 months in a double-blind randomized dose range multicentre study comparing the efficacy and tolerance of three different doses of the slow-acting anti-rheumatic bacterial extract OM-8980 (6, 24 and 48 mg of active principle). No patients were withdrawn during the study. At the end of the 6-month trial, significant improvements were observed for the different RA signs and symptoms (Ritchie index, morning stiffness, swollen joints, grip strength, ESR, pain scale and categories) as well as for the concomitant intake of symptomatic drugs in the 24-mg dose group with respect to the 6-mg group and without significant differences between the 24- and 48-mg groups. Tolerance was very good with nine minor and transient side effects (five itching and four diarrhoea) reported altogether by seven patients, without establishment of a dose-effect correlation. In conclusion, the two higher doses of OM-8980, 24 and 48 mg, were significantly more efficient than 6 mg, with the effect of the 24-mg dose being even slightly superior to the 48-mg dose, confirming the former as the optimal and well-tolerated dose for the treatment of RA.
在一项双盲随机剂量范围多中心研究中，对60例活动性类风湿关节炎（RA）患者进行了为期6个月的评估，比较了三种不同剂量的慢作用抗风湿细菌提取物OM - 8980（活性成分6、24和48毫克）的疗效和耐受性。研究期间无患者退出。在6个月试验结束时，与6毫克组相比，24毫克剂量组在不同的RA体征和症状（里奇指数、晨僵、关节肿胀、握力、红细胞沉降率、疼痛量表和分类）以及对症药物的联合使用方面均有显著改善，而24毫克组和48毫克组之间无显著差异。耐受性非常好，7名患者共报告了9例轻微和短暂的副作用（5例瘙痒和4例腹泻），未发现剂量 - 效应相关性。总之，OM - 8980的两个较高剂量24毫克和48毫克比6毫克显著更有效，24毫克剂量的效果甚至略优于48毫克剂量，证实前者是治疗RA的最佳且耐受性良好的剂量。
