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美金刚治疗脑卒中后认知障碍的随机、安慰剂对照研究
Effects of memantine on cognitive impairment of patients with stroke: a randomized, placebo-controlled trial
【摘要】 目的探讨美金刚对脑卒中后认知障碍患者认知功能的疗效及安全性。方法 42例脑卒中后认知障碍患者,入组时简明精神状态检查表(MMSE)分数介于7至25之间,随机分为美金刚组和安慰剂组(每组21例)。美金刚组口服起始剂量为5 mg.d-1,每日1次;渐加量至20 mg.d-1,每日分2次口服,之后维持此剂量持续用药至12 wk。安慰剂组给予相同剂量安慰剂及增量过程。分别于治疗前和治疗后4、8和12 wk使用MMSE和神经行为认知状况检查表(NCSE)进行疗效评定,同时观察不良反应。2组均进行认知康复训练。结果美金刚组在治疗后各观察时间点与治疗前比较,MMSE评分和NCSE各分项(专注力分项治疗后4 wk时除外)评分均明显增加(P<0.01);且语言理解、记忆力、推理判断能力的总改善率分别达39%、43%和34%,与安慰剂组相比有非常显著差异(P<0.01)。安慰剂组治疗8 wk后各分项评分也比治疗前有显著改进(P<0.05,P<0.01),但总改善率显著低于美金刚组(P<0.05,P<0.01)。2组不良反应发生率没有差异(P>0.05)。结论美金刚可以持续改善脑卒中后认知障碍患者的认知功能各个方面,且不良反应发生率低,是一种安全有效的药物。
【Abstract】 AIM To investigate the efficacy and safety of memantine on treatment of cognitive impairment in stroke survivors.METHODS Forty-two stroke patients with mini-mental state examination(MMSE) scores between 7 and 25 were randomly divided into two groups: memantine group and placebo group(n = 21 for each).Memantine group received oral administration of memantine from 5 mg qd to 10 mg bid and continued this dose to wk 12.The placebo group received placebo as same dose and course.All patients were treated with cognitive rehabilitation techniques.MMSE and neurobehavioral cognitive status examination(NCSE)were evaluated before administration and 4,8,and 12 weeks after administration,and adverse reactions were observed.RESULTS The scores of MMSE and subitems of NCSE in the memantine group showed significant difference compared with pretreatment except attention at week 4 posttreatment(P < 0.01),and the total improvement rates of cognitive function for language,memory,and judgment were 39%,43%,and 34%,respectively,significantly different with the placebo group(P < 0.01).There were also significant differences between before and after 8 weeks treatment in the placebo group(P < 0.05,P < 0.01),but its total improvement rates were lower than those of the memantine group(P < 0.05,P < 0.01).The incidence of adverse reactions showed no difference between the two groups(P > 0.05).CONCLUSION Memantine is helpful for improving every aspects of cognitive function in stroke survivors,and it is a safety and effective medicine with low incidence of adverse reactions.
- 【文献出处】 中国新药与临床杂志 ,Chinese Journal of New Drugs and Clinical Remedies , 编辑部邮箱 ,2010年05期
- 【分类号】R749.1
- 【被引频次】23
- 【下载频次】336