美金刚治疗阿尔茨海默病随机对照试验的系统评价
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Memantine for Alzheimer?s disease: a systematic review of randomized controlled trials in China
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    摘要:

    目的 系统评价国内美金刚治疗阿尔茨海默病(AD)的疗效和安全性。方法 通过计算机检索及手工检索, 全面收集国内美金刚治疗AD的随机对照试验, 按Cochrane协作网系统评价的方法进行评价。结果 共纳入9个试验(1273例患者), 包括2个安慰剂对照试验和7个非安慰剂(多奈哌齐、吡拉西坦)对照试验。2个安慰剂对照试验中, MMSE, SIB, ADCS-ADL19, ADAS-Cog评分美金刚组较安慰剂组明显提高(P<0.05), NPI评分美金刚组在数值上优于安慰剂组, 但组间差异无统计学意义(P>0.05)。6个多奈哌齐对照试验中, MMSE, ADAS-Cog, ADL, Blessed- Roth, NPI和CIBIC-Plus评分组间差异无统计学意义(P>0.05)。1个吡拉西坦对照试验中, MMSE和BI评分组间差异有统计学意义(P<0.05)。1个空白对照试验中, MMSE、ADL评分组间差异有统计学意义(P<0.05)。共7个试验报道了与治疗相关的不良反应, 主要为瞌睡、疲劳、头晕、幻觉、妄想、易激惹、食欲减退、恶心等, 无严重不良反应发生。结论 美金刚治疗能使AD患者在认知功能、日常生活能力、精神行为、总体功能等方面得到改善, 其疗效明显优于安慰剂和吡拉西坦, 与多奈哌齐相当, 安全性较好。

    Abstract:

    Objective To assess the efficacy and safety of memantine for domestic patients with Alzheimer?s disease (AD). Methods Randomized controlled trials carried in China, which compared memantine with placebo or other medicines in patients with AD, were searched from the electronic bibliographic databases, references listed in articles and journals. A systematic review was conducted based on the methods recommended by the Cochrane Collaboration. Results Nine trials involving 1273 patients were included, of which two were placebo-controlled trials and seven non-placebo-controlled trials (piacetam and donepezil). Two placebo-controlled trials, in which neurological changes were assessed by some neuropsychometric questionnaires, showed that there were significant differences in mini-mental state examination(MMSE), Severe Impairment Battery(SIB), Alzheimer?s Disease Cooperative Study-Activities of Daily Living Inventory(ADCS-ADL19) and Alzheimer?s Disease Assessment Scale-Cognitive Subscale(ADAS-Cog) scores between two groups (P<0.05), and there was no significant difference in Neuropsychiatric Inventory(NPI) score (P>0.05) although memantine group had better score than placebo group. Six donepezil-controlled trials showed that there was no significant difference in MMSE, ADAS-Cog, Activities of Daily Living Scale(ADL), Blessed-Roth, NPI and Clinician?s Interview Based Impression of Change-Plus Caregiver Input(CIBIC-Plus) scores between two groups (P>0.05). One piacetam-controlled trial showed that there were significant differences in MMSE and Barthel Index(BI) scores between two groups (P<0.05). One blank-controlled trial showed that there were significant differences in MMSE and ADL scores between the two groups (P<0.05). Adverse reactions associated with medicines were reported in seven trials, including doze, fatigue, dizziness, confusion, deliria, agitation, anorexia, nausea, etc. However, no severe adverse reaction was reported. Conclusions Memantine can improve the general condition of patients with AD, including the cognitive function, daily life ability, mental behavior and global function. It has better therapeutic effects than piacetam, and at least equal tharapeutic effects to donepezil. It is safe for patients with AD.

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杜文津, 陈晋文, 徐巍.美金刚治疗阿尔茨海默病随机对照试验的系统评价[J].中华老年多器官疾病杂志,2011,10(4):321~325

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