Feutren G, Papoz L, Assan R, Vialettes B, Karsenty G, Vexiau P, Du Rostu H, Rodier M, Sirmai J, Lallemand A
Lancet. 1986 Jul 19;2(8499):119-24. doi: 10.1016/s0140-6736(86)91943-4.
In a double-blind trial 122 patients aged 15-40 years with insulin-dependent diabetes of recent onset were randomly assigned to cyclosporin 7.5 mg/kg per day or placebo. At the sixth month 25.4% of the cyclosporin group and 18.6% of the placebo group were in complete remission (not a significant difference). Treatment was continued in those patients with complete or partial remission (insulin requirement less than 0.25 U/kg per day) and 106 patients were followed to nine months, at which stage 24.1% of the original cyclosporin group and 5.8% of the original placebo group were in complete remission (p less than 0.01). For those patients whose whole-blood trough cyclosporin levels in the first three months averaged 300 ng/ml or more, the rates of complete remission at six and nine months were 37.5% and 37%. The rates of partial remission were also higher in the cyclosporin group and at six months the rate of complete or partial remission was 46% in the whole cyclosporin group and 65.6% in those with an average blood level exceeding 300 ng/ml in the first three months, versus 28.8% in the placebo group. The principal side-effect of cyclosporin was a modest and reversible increase in plasma creatinine. These results indicate that cyclosporin promotes the remission of type I diabetes and suggest the need for new controlled protocols aimed at evaluating the length of the effect and selecting the best drug regimen.
在一项双盲试验中，122名年龄在15至40岁之间、近期发病的胰岛素依赖型糖尿病患者被随机分为两组，一组每天服用7.5毫克/千克的环孢素，另一组服用安慰剂。在第六个月时，环孢素组有25.4%的患者完全缓解，安慰剂组为18.6%（无显著差异）。完全缓解或部分缓解（胰岛素需求量低于每天0.25单位/千克）的患者继续接受治疗，106名患者被随访至九个月，此时原环孢素组有24.1%的患者完全缓解，原安慰剂组为5.8%（p<0.01）。对于前三个月全血环孢素谷浓度平均为300纳克/毫升或更高的患者，六个月和九个月时的完全缓解率分别为37.5%和37%。环孢素组的部分缓解率也更高，六个月时，整个环孢素组的完全或部分缓解率为46%，前三个月平均血药浓度超过300纳克/毫升的患者中这一比例为65.6%，而安慰剂组为28.8%。环孢素的主要副作用是血浆肌酐适度且可逆性升高。这些结果表明环孢素可促进I型糖尿病的缓解，并提示需要新的对照方案来评估疗效持续时间并选择最佳用药方案。
