Kappos L, Patzold U, Dommasch D, Poser S, Haas J, Krauseneck P, Malin J P, Fierz W, Graffenried B U, Gugerli U S
Max Planck Society, Clinical Research Unit for MS, Würzburg, Federal Republic of Germany.
Ann Neurol. 1988 Jan;23(1):56-63. doi: 10.1002/ana.410230110.
In a double-blind controlled trial of 194 patients with clinically definite active multiple sclerosis, 98 were randomized to treatment with cyclosporine (CyA, 5 mg/kg/day), and 96 to treatment with azathioprine (Aza, 2.5 mg/kg/day). Eighty-five patients in the CyA group and 82 in the Aza group completed a treatment period of 24 to 32 months in accordance with the study protocol. No significant differences could be detected between the two treatment groups at the end of the trial. Assessment was done by serial quantitative neurological examinations and Kurtzke's Expanded Disability Status Scale. Frequency of relapse and patient self-evaluation also failed to show significant differences. Overall deterioration observed in both groups during the trial was only minor. The incidence of side effects in the CyA group was more than two times that in the Aza group. We conclude that CyA as a single agent cannot be the drug of final choice in long-term immunosuppressive treatment of relapsing-remitting and relapsing-progressive multiple sclerosis.
在一项针对194例临床确诊为活动性多发性硬化症患者的双盲对照试验中，98例患者被随机分配接受环孢素（CyA，5毫克/千克/天）治疗，96例患者接受硫唑嘌呤（Aza，2.5毫克/千克/天）治疗。CyA组的85例患者和Aza组的82例患者按照研究方案完成了24至32个月的治疗期。试验结束时，两个治疗组之间未检测到显著差异。通过系列定量神经学检查和Kurtzke扩展残疾状态量表进行评估复发频率和患者自我评估也未显示出显著差异。试验期间两组观察到的总体病情恶化程度较轻。CyA组的副作用发生率是Aza组的两倍多。我们得出结论，在复发缓解型和复发进展型多发性硬化症的长期免疫抑制治疗中，环孢素作为单一药物不能成为最终选择的药物。
