Hauzeur J P, Appelboom T
Division of Rheumatology, Erasmus University Hospital, University of Brussels, Belgium.
Rheumatol Int. 1989;9(2):71-6. doi: 10.1007/BF00270248.
A total of 95 patients suffering from active rheumatoid arthritis were included in this double-blind, placebo-controlled study of the immunomodulator OM-8980. Treatment was one capsule daily of OM-8980 or placebo for 6 months. A significant improvement was observed in the OM-8980 group in comparison with the placebo group as regards the Ritchie index (P = 0.002), grip strength (P = 0.02) and pain (P = 0.03). The number of swollen joints, duration of morning stiffness and erythrocyte sedimentation rate decreased more markedly under OM-8980 than under the placebo, without reaching the level of statistical significance. A significant difference in favour of OM-8980 was observed in the intake of non-steroidal anti-inflammatory drugs and oral corticosteroids. Clinical tolerance was on the whole good (10 cases with side effects out of 49 in the OM-8980 group and 7 out of 46 in the placebo group, ns), with the majority of the side effects concerning the gastrointestinal system. The global assessment of the therapeutic efficacy both by the physician and the patient showed a highly significant superiority of OM-8980 over the placebo (P = 0.001).
共有95名活动性类风湿性关节炎患者被纳入这项免疫调节剂OM - 8980的双盲、安慰剂对照研究。治疗方法为每日服用一粒OM - 8980胶囊或安慰剂，持续6个月。与安慰剂组相比，OM - 8980组在里奇指数（P = 0.002）、握力（P = 0.02）和疼痛（P = 0.03）方面有显著改善。OM - 8980治疗下肿胀关节数量、晨僵持续时间和红细胞沉降率的下降比安慰剂组更明显，但未达到统计学显著水平。在非甾体抗炎药和口服皮质类固醇的摄入量方面，观察到有利于OM - 8980的显著差异。总体而言，临床耐受性良好（OM - 8980组49例中有10例出现副作用，安慰剂组46例中有7例出现副作用，无显著差异），大多数副作用与胃肠道系统有关。医生和患者对治疗效果的总体评估显示，OM - 8980比安慰剂具有高度显著的优越性（P = 0.001）。
