A DOUBLE-BLIND-STUDY OF THE EFFECTIVENESS OF CYCLOSPORINE IN AMYOTROPHIC LATERAL SCLEROSIS
A DOUBLE-BLIND-STUDY OF THE EFFECTIVENESS OF CYCLOSPORINE IN AMYOTROPHIC LATERAL SCLEROSIS
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DOI：
10.1001/archneur.1988.00520280027011
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发表时间：
1988-04-01
影响因子：
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通讯作者：
BELENDIUK, GW
中科院分区：
文献类型：
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作者：
APPEL, SH;STEWART, SS;BELENDIUK, GW
在一项环孢霉素治疗肌萎缩侧索硬化症的双盲安慰剂对照试验中，将38例随机分配至安慰剂组的患者与36例随机分配至环孢霉素组的患者进行比较，未观察到每月进展率或进展的相对风险存在差异。在比较三个亚组的患者中，环孢素似乎对首次症状发作后18个月内进入研究的男性有益，而对女性或晚于18个月进入研究的男性没有价值。对于近期发病的男性，进展的相对风险为0.403;月进展率为5.2 ±。1.1安慰剂组和3.5 ±. 0.7环孢霉素的要点。这些挑衅性的结果支持需要一个完整的研究环孢素在男性最近发病。
In a double-blind placebo-controlled trial of cyclosporine in amyotrophic lateral sclerosis, no differences were observed in the monthly rate of progression or the relative risk of progression in comparing 38 patients randomized to the placebo group and 36 patients randomized to the cyclosporine group. In comparing three subgroups of patients, cyclosporine appeared to benefit men who entered the study within 18 months of the onset of first symptoms, whereas it was of no value to women or to men who entered later than 18 months. For the men with recent onset of disease, the relative risk of progression was 0.403; the monthly rate of progression was 5.2 .+-. 1.1 points with placebo and 3.5 .+-. 0.7 points with cyclosporine. These provocative results support the need for a full study of cyclosporine in men with recent onset of disease.