van Rijthoven A W, Dijkmans B A, Goei The H S, Hermans J, Montnor-Beckers Z L, Jacobs P C, Cats A
Ann Rheum Dis. 1986 Sep;45(9):726-31. doi: 10.1136/ard.45.9.726.
The efficacy and safety of cyclosporin for patients with rheumatoid arthritis (RA) were assessed in a six month double blind, placebo controlled, multicentre study. The initial dosage of the drug was 10 mg/kg daily for two months. There were many discontinuations in both the cyclosporin group (eight out of 17) and the placebo group (six out of 19). Of the patients who completed the six months of therapy, those who had received cyclosporin showed a significant improvement in the number of swollen joints, the Ritchie articular index, and pain at active movement and at rest, compared not only with their condition at the start of the study, but also with the end results of the placebo group. Major adverse reactions to the drug were gastrointestinal disturbances and nephrotoxicity, which were probably due to the relatively high dosages of cyclosporin given in combination with non-steroidal anti-inflammatory drugs.
在一项为期六个月的双盲、安慰剂对照、多中心研究中，评估了环孢素对类风湿性关节炎（RA）患者的疗效和安全性。药物初始剂量为每日10mg/kg，持续两个月。环孢素组（17例中有8例）和安慰剂组（19例中有6例）均有许多患者停药。在完成六个月治疗的患者中，接受环孢素治疗的患者在肿胀关节数量、里奇关节指数以及主动活动和休息时的疼痛方面均有显著改善，这不仅与研究开始时的状况相比，而且与安慰剂组的最终结果相比也是如此。该药物的主要不良反应是胃肠道紊乱和肾毒性，这可能是由于环孢素与非甾体抗炎药联合使用时剂量相对较高所致。
