Placebo-controlled phase I/II studies of minocycline in amyotrophic lateral sclerosis
Placebo-controlled phase I/II studies of minocycline in amyotrophic lateral sclerosis
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DOI：
10.1212/01.wnl.0000125321.92112.7e
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发表时间：
2004-05-25
期刊：
影响因子：
9.9
通讯作者：
Miller, RG
中科院分区：
文献类型：
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作者：
Gordon, PH;Moore, DH;Miller, RG
进行了两项双盲、随机、安慰剂对照的二甲胺四环素治疗ALS的可行性试验。在试验1中，19名受试者接受200毫克/天或安慰剂治疗6个月；两组不良事件（AE）差异无统计学意义。在试验2中，23名受试者在8个月的交叉试验中接受高达400mg /天的治疗。平均耐受剂量为387 mg/d，有胃肠道AE加重的趋势（p = 0.057），血尿素氮和肝酶升高（p < 0.05）。利用这些数据，作者设计并启动了一项III期试验。
Two double-blind, randomized, placebo-controlled feasibility trials of minocycline in ALS were conducted. In Trial 1, 19 subjects received 200 mg/day or placebo for 6 months; there were no significant differences in adverse events (AE). In Trial 2, 23 subjects received up to 400 mg/day in an 8-month crossover trial. The mean tolerated dose was 387 mg/day, there was a trend toward more gastrointestinal AE ( p = 0.057), and blood urea nitrogen and liver enzymes became elevated ( p < 0.05). Using these data, the authors have designed and launched a phase III trial.