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美金刚治疗阿尔茨海默病的真实世界实践:一项针对大量具有代表性的法国患者样本的观察性研究。

Memantine therapy for Alzheimer disease in real-world practice: an observational study in a large representative sample of French patients.

作者信息

Vidal Jean-Sébastien, Lacombe Jean-Marc, Dartigues Jean-François, Pasquier Florence, Robert Philippe, Tzourio Christophe, Alpérovitch Annick

机构信息

Institut National de la Santé et de la Recherche Médicale (INSERM-U708), Paris, France.

出版信息

Alzheimer Dis Assoc Disord. 2008 Apr-Jun;22(2):125-30. doi: 10.1097/WAD.0b013e31815a9e10.

Abstract

Clinical trials have shown modest effects of memantine, an N-methyl-D aspartate receptor antagonist, in Alzheimer disease patients and memantine effectiveness in routine clinical practice needs to be established further. In 2003, memantine was recommended in France for Alzheimer disease patients with disease severity ranging from 15 to 3 on the mini-mental state examination at the first prescription. Our study aimed at describing memantine use in real-world practice in a cohort of 5283 memantine-treated patients (mean age: 80.1 y; women: 69.4%) randomly selected from the database of the national healthcare insurance, which covers 70% of the French elderly population. Mean follow-up after starting memantine prescription was 10.4 months (range: 1 to 20 mo). Patients were older and had a less severe cognitive impairment than patients included in the first controlled clinical trials. Memantine was prescribed with a cholinesterase inhibitor in 53.3% of cases. At 6 months, 26% of the patients had stopped memantine therapy (36% at 12 mo); conversely, patients who continued treatment were highly compliant. The 1-year mortality rate (12.5%) was similar for a comparative cohort of untreated demented patients and the memantine-treated ones. Approximately one-third of the memantine-treated patients did not strictly fit with the French summary of product characteristic recommendations for the first memantine prescription.

摘要

临床试验表明,N-甲基-D-天冬氨酸受体拮抗剂美金刚对阿尔茨海默病患者有一定疗效,但其在常规临床实践中的有效性仍需进一步确定。2003年,在法国,对于首次处方时简易精神状态检查评分在15至3分之间的阿尔茨海默病患者,推荐使用美金刚。我们的研究旨在描述从覆盖70%法国老年人口的国家医疗保险数据库中随机选取的5283名接受美金刚治疗患者(平均年龄:80.1岁;女性:69.4%)在实际临床中的用药情况。开始美金刚处方后的平均随访时间为10.4个月(范围:1至20个月)。这些患者比首批对照临床试验纳入的患者年龄更大,认知障碍程度更轻。53.3%的病例中,美金刚与胆碱酯酶抑制剂联合使用。6个月时,26%的患者停止了美金刚治疗(12个月时为36%);相反,继续治疗的患者依从性很高。未接受治疗的痴呆患者对比队列与接受美金刚治疗的患者的1年死亡率(12.5%)相似。约三分之一接受美金刚治疗的患者并不完全符合法国药品说明书中关于首次美金刚处方的建议。

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