Memantine in systemic lupus erythematosus: a randomized, double-blind placebo-controlled trial.

Memantine in systemic lupus erythematosus: a randomized, double-blind placebo-controlled trial.
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DOI:
10.1016/j.semarthrit.2011.02.005
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发表时间:
2011-10
影响因子:
5
通讯作者:
Carson KA
Carson KA
中科院分区:
医学2区
文献类型:
--
作者:
Petri M;Naqibuddin M;Sampedro M;Omdal R;Carson KA

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认知障碍影响高达80%的系统性红斑狼疮(SLE)患者在10年内诊断。美金刚是一种血清能受体和尼古丁乙酰胆碱受体拮抗剂,通过NMDA受体作用于谷氨酸能系统,用于治疗痴呆。我们调查了它是否对SLE认知障碍有益。在51例SLE患者中,采用2:1的随机化比例,随机双盲、安慰剂对照的单中心试验,美金刚滴定至20mg/天,为期12周。主要结局指标是12周时自动神经心理评估指标(ANAM)吞吐量评分的变化。在6周或12周时,治疗组之间的ANAM吞吐量评分从基线变化没有统计学意义上的显着差异。对于ACR认知电池,唯一有统计学意义的发现是在第6周和第12周的受控口头单词联想测试中。在12周时,美金刚组比安慰剂组表现出更大的改善(3.6±1.8 vs 0.5±3.8,p=0.03)。在一项亚组分析中,仅限基线时得分低于正常对照≥1个标准差的患者,治疗组之间没有发现显著差异。在这项首个用美金刚治疗SLE的临床试验中,与安慰剂组相比,接受美金刚治疗的患者在认知能力方面没有明显的改善,无论基线时的损伤程度如何,除了控制口头单词联想。
Cognitive impairment affects up to 80% of systemic lupus erythematosus (SLE) patients within ten years of diagnosis. Memantine, a seronergic receptor and nicotine acetylcholine receptor antagonist, acts on the glutamatergic system through the NMDA receptor, and is used to treat dementia. We investigated whether it had benefit for SLE cognitive impairment. A randomized double-blind, placebo-controlled single center 12 week trial of memantine titrated to 20mg/day was performed, using a 2:1 randomization ratio, in 51 SLE patients. The primary outcome measures were change in the Automated Neuropsychological Assessment Metrics (ANAM) throughput scores at 12 weeks. There were no statistically significant differences between treatment groups on change from baseline in any of the ANAM throughput scores at 6 or 12 weeks. For the ACR cognitive battery, the only statistically significant finding was for the Controlled Oral Word Association Test - S words at 6 and 12 weeks. At 12 weeks, the memantine group exhibited greater improvement compared to the placebo group (3.6 ±1.8 vs. 0.5 ± 3.8 words, p=0.03). In a subset analysis limited to patients that scored ≥ 1 standard deviation below normal controls at baseline, no significant differences between treatment groups were found. In this first clinical trial of memantine in SLE, patients treated with memantine did not exhibit significant improvement in cognitive performance compared to the placebo group, regardless of the degree of impairment at baseline, with the exception of controlled oral word association.
DOI: 10.1001/archneur.1986.00520030063016
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