CYCLOSPORIN INCREASES THE RATE AND LENGTH OF REMISSIONS IN INSULIN-DEPENDENT DIABETES OF RECENT ONSET Results of a Multicentre Double-blind Trial
CYCLOSPORIN INCREASES THE RATE AND LENGTH OF REMISSIONS IN INSULIN-DEPENDENT DIABETES OF RECENT ONSET Results of a Multicentre Double-blind Trial
复制标题
环孢素可提高胰岛素依赖型糖尿病近期发病的缓解率和缓解时间 多中心双盲试验结果
DOI：
10.1016/s0140-6736(86)91943-4
复制
发表时间：
1986
期刊：
影响因子：
--
通讯作者：
J. Bach
中科院分区：
文献类型：
--
作者：
G. Feutren;R. Assan;G. Karsenty;H. D. Rostu;J. Sirmai;L. Papoz;B. Vialettes;P. Vexiau;M. Rodier;A. Lallemand;J. Bach
在一项双盲试验中，122 名 15-40 岁的新近发病的胰岛素依赖型糖尿病患者被随机分配接受环孢素 7·5 mg/kg 每天或安慰剂治疗。第六个月时，环孢菌素组有 25·4% 的患者和安慰剂组有 18·6% 的患者完全缓解（无显着差异）。完全缓解或部分缓解（胰岛素需要量<0·25 U/kg/天）的患者继续治疗，106 例患者随访至 9 个月，在该阶段，原始环孢素组中 24·1% 和原始安慰剂组中 5·8% 达到完全缓解（p<0·01）。对于前三个月全血环孢素谷值平均为300 ng/ml或以上的患者，第6个月和第9个月的完全缓解率分别为37·5%和37%。环孢素组的部分缓解率也较高，六个月时，整个环孢素组的完全或部分缓解率为 46%，前三个月平均血液水平超过 300 ng/ml 的患者为 65·6%，而安慰剂组为 28·8%。环孢菌素的主要副作用是血浆肌酐适度且可逆地升高。这些结果表明环孢菌素可促进 I 型糖尿病的缓解，并表明需要新的对照方案来评估效果的持续时间并选择最佳的药物治疗方案。
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 <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<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.
影响因子：
29.7
作者：
A. Rossini;J. Mordes;A. Like
通讯作者：
A. Rossini;J. Mordes;A. Like