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Lancet Neurol：美金刚无益于额颞叶变性患者

2013-01-14 lancet neurol CMT 程蓓 编译

FTD美金刚
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　　美国一项多中心随机对照双盲研究显示，额颞叶变性（FTD）患者接受美金刚治疗未获益，因此不支持FTD患者使用美金刚。论文2013年1月2日在线发表于《柳叶刀·神经病学》（Lancet Neurol）杂志。 　　研究纳入100例FTD患者，其中81例被随机分入美金刚组（n=39，每天口服20 mg）和安慰剂组（n=42），治疗26周。患者均符合尼瑞标准中行为异常型FTD或语义

　　美国一项多中心随机对照双盲研究显示，额颞叶变性（FTD）患者接受美金刚治疗未获益，因此不支持FTD患者使用美金刚。论文2013年1月2日在线发表于《柳叶刀·神经病学》（Lancet Neurol）杂志。

　　研究纳入100例FTD患者，其中81例被随机分入美金刚组（n=39，每天口服20 mg）和安慰剂组（n=42），治疗26周。患者均符合尼瑞标准中行为异常型FTD或语义性痴呆的诊断，且存在典型的脑萎缩。研究中禁止使用乙酰胆碱酯酶抑制剂。主要终点是治疗26周后患者神经精神量表（NPI）总分和临床总体印象变化（CGIC）评分改变。

　　结果显示，76例患者完成了26周的治疗。治疗26周后，美金刚组患者在NPI评分（平均差为2.2，P=0.47）和CGIC评分（平均差为0.0，P=0.90）方面均无改善。患者对该药一般具有良好的耐受性，但与安慰剂组相比，美金刚组患者认知不良事件的发生更频繁（6次对1次）。


Background

Memantine has been used off-label to treat frontotemporal lobar degeneration (FTD). A previous 26-week open-label study suggested a transient, modest benefit on neuropsychiatric symptoms as measured by the neuropsychiatric inventory (NPI). We aimed to determine whether memantine is an effective treatment for FTD.

Methods

We did a randomised, parallel group, double-blind, placebo-controlled trial of 20 mg memantine taken orally daily for 26 weeks in patients with FTD. Participants met Neary criteria for behavioural variant FTD (bvFTD) or semantic dementia and had characteristic brain atrophy. Use of acetylcholinesterase inhibitors was prohibited. Individuals were randomly assigned to receive either memantine or matched placebo tablets (1:1) in blocks of two and four patients. All patients and study personnel were masked to treatment assignment. Primary endpoints were the change in total NPI score and clinical global impression of change (CGIC) score after 26 weeks and were analysed by intention to treat. This study is registered with Clinicaltrials.gov, numberNCT00545974.

Findings

Of 100 patients screened, 81 were randomly assigned to receive memantine (39 patients) or placebo (42 patients). Five (6%) patients discontinued, and 76 completed the 26-week treatment. Enrolment numbers were lower than planned because of many patients’ preference to take memantine or cholinesterase inhibitors off-label rather than participate in a clinical trial. Memantine treatment had no effect on either the NPI (mean difference 2·2, 95% CI −3·9 to 8·3, p=0·47) or CGIC (mean difference 0·0, −0·4 to 0·4, p=0·90) after 26 weeks of treatment. Memantine was generally well tolerated; however, patients in the memantine group had more frequent cognitive adverse events (six patients) than those in the placebo group (one).

Interpretation

Memantine treatment showed no benefit in patients with FTD. These data do not support memantine use in FTD.

Funding

Forest Research Institute.

    

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    2013-05-14 yinhl1978

    #Neurol#

    0

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    2013-05-29 chendoc242

    #美金刚#

    0

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    2013-09-09 howi

    #Lancet#

    0

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    2013-01-16 huangdf

    #变性#

    0