Dougados M, Duchesne L, Awada H, Amor B
Department of Rheumatology, René Descartes University, Hôpital Cochin, Paris, France.
Ann Rheum Dis. 1989 Jul;48(7):550-6. doi: 10.1136/ard.48.7.550.
The efficacy of cyclosporin in a double blind, placebo controlled trial of four months' duration has previously been reported by us. To assess the benefit-to-risk of cyclosporin this study was followed by a one year open trial including 49 of the previous 52 patients. Cyclosporin was given at an initial dosage of 5 mg/kg/day and then modulated on the basis of efficacy and renal toxicity. During the study the drug had to be discontinued in 32 patients: because of inefficacy in 10, side effects in 11, both in nine, and in two because of unrelated events. The significant clinical improvement noted at four months persisted through one year in the 17 patients who continued to receive treatment. Nephrotoxicity of the drug (24 patients) required constant and close monitoring as well as modulation of daily drug dosage during the trial. This study indicated that cyclosporin might be valuable in the treatment of patients with advanced rheumatoid arthritis, in whom other second line agents have failed.
我们之前曾报道过环孢素在一项为期四个月的双盲、安慰剂对照试验中的疗效。为了评估环孢素的效益风险比，在这项研究之后进行了一项为期一年的开放试验，纳入了之前52例患者中的49例。环孢素初始剂量为5mg/kg/天，然后根据疗效和肾毒性进行调整。在研究期间，有32例患者不得不停药：10例因无效，11例因副作用，9例因两者皆有，2例因无关事件。在继续接受治疗的17例患者中，四个月时观察到的显著临床改善持续了一年。药物的肾毒性（24例患者）在试验期间需要持续密切监测以及调整每日药物剂量。这项研究表明，环孢素对于其他二线药物治疗失败的晚期类风湿关节炎患者可能具有治疗价值。
