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加兰他敏与多奈哌齐治疗中国阿尔茨海默病患者的随机、双盲研究。

Galantamine versus donepezil in Chinese patients with Alzheimer's disease: results from a randomized, double-blind study.

机构信息

Department of Neurology of Peking Union Medical College Hospital, Beijing, China.

出版信息

Neuropsychiatr Dis Treat. 2012;8:571-7. doi: 10.2147/NDT.S38747. Epub 2012 Dec 4.

Abstract

BACKGROUND

Acetylcholinesterase inhibitors are considered standard of care for Alzheimer's disease in many countries. Galantamine is an acetylcholinesterase inhibitor that may also act via allosteric modulation of nicotinic acetylcholine receptors. Therefore, it may provide benefits compared with other acetylcholinesterase inhibitors. The present study compared galantamine (n = 116) with donepezil (n = 117) in a double-blind trial at nine hospitals in China.

METHODS

After washout of any previous acetylcholinesterase inhibitors, subjects with mild to moderate Alzheimer's disease received galantamine or donepezil for 16 weeks.

RESULTS

Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog/11) scores improved significantly from baseline in both treatment arms, with a significant difference in favor of galantamine on the "language" functional area (P = 0.035). Significantly more galantamine-treated patients responded to treatment (defined as a reduction in ADAS-cog/11 score of >4, >7, or >10 points; all P < 0.05), and had an ADAS-cog/11 score < 20 at end point (P = 0.015). Both treatments were well tolerated, although fewer galantamine-treated patients experienced gastrointestinal adverse events compared with donepezil (30% versus 48%).

CONCLUSION

Cognitive function improved significantly in subjects with mild to moderate Alzheimer's disease treated with galantamine or donepezil, and both treatments were generally well tolerated. Significant benefits for galantamine over donepezil were observed for language and response to treatment.

摘要

背景

在许多国家,乙酰胆碱酯酶抑制剂被认为是治疗阿尔茨海默病的标准疗法。加兰他敏是一种乙酰胆碱酯酶抑制剂,它也可能通过变构调节烟碱型乙酰胆碱受体发挥作用。因此,与其他乙酰胆碱酯酶抑制剂相比,它可能具有优势。本研究在中国的 9 家医院进行了一项双盲试验,比较了加兰他敏(n = 116)与多奈哌齐(n = 117)的疗效。

方法

在洗脱任何先前的乙酰胆碱酯酶抑制剂后,轻度至中度阿尔茨海默病患者接受加兰他敏或多奈哌齐治疗 16 周。

结果

两组治疗组的阿尔茨海默病评估量表-认知子量表(ADAS-cog/11)评分均较基线显著改善,加兰他敏在“语言”功能区具有显著优势(P = 0.035)。更多的加兰他敏治疗组患者对治疗有反应(定义为 ADAS-cog/11 评分下降≥4、≥7 或≥10 分;均 P < 0.05),并且在终点时 ADAS-cog/11 评分<20(P = 0.015)。两种治疗方法均耐受良好,尽管加兰他敏治疗组比多奈哌齐治疗组胃肠道不良反应更少(30%比 48%)。

结论

在轻度至中度阿尔茨海默病患者中,加兰他敏或多奈哌齐治疗可显著改善认知功能,且两种治疗方法通常均耐受良好。与多奈哌齐相比,加兰他敏在语言和治疗反应方面具有显著优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39c5/3518285/3c7466bd41bd/ndt-8-571f1.jpg

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