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美金刚对路易体痴呆和帕金森病痴呆患者生存的治疗效果:一项前瞻性研究。

Treatment effect of memantine on survival in dementia with Lewy bodies and Parkinson's disease with dementia: a prospective study.

作者信息

Stubendorff Kajsa, Larsson Victoria, Ballard Clive, Minthon Lennart, Aarsland Dag, Londos Elisabet

机构信息

Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, Malmö, Sweden Department of Rheumatology, Skaraborg Central Hospital, Skövde, Sweden.

Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, Malmö, Sweden.

出版信息

BMJ Open. 2014 Jul 3;4(7):e005158. doi: 10.1136/bmjopen-2014-005158.

Abstract

OBJECTIVE

To investigate the effect on survival of treatment with memantine in patients with dementia with Lewy bodies (DLB) and Parkinson's disease with dementia (PDD).

METHODS

75 patients with DLB and PDD were included in a prospective double-blinded randomised placebo-controlled trial (RCT) of memantine, of whom long-term follow-up was available for 42. Treatment response was recorded 24 weeks from baseline and measured by Clinical Global Impression of Change (CGIC). The participants were grouped as responders (CGIC 1-3) or non-responders (CGIC 4-7). The 24-week RCT was followed by open-label treatment and survival was recorded at 36 months.

RESULTS

After 36-month follow-up, patients in the memantine group had a longer length of survival compared with patients in the placebo group (log rank x²=4.02, p=0.045). Within the active treatment group, survival analysis 36 months from baseline showed that the memantine responders, based on CGIC, had higher rates of survival compared with the non-responders (log rank x²=6.595, p=0.010). Similar results were not seen in the placebo group.

CONCLUSIONS

Early treatment with memantine and a positive clinical response to memantine predicted longer survival in patients with DLB and PDD. This suggests a possible disease-modifying effect and also has implications for health economic analysis. However, owing to the small study sample, our results should merely be considered as generating a hypothesis which needs to be evaluated in larger studies.

TRIAL REGISTRATION NUMBER

ISRCTN89624516.

摘要

目的

探讨美金刚治疗路易体痴呆(DLB)和帕金森病痴呆(PDD)患者对生存的影响。

方法

75例DLB和PDD患者纳入美金刚前瞻性双盲随机安慰剂对照试验(RCT),其中42例可进行长期随访。从基线起24周记录治疗反应,采用临床总体印象变化量表(CGIC)进行测量。参与者分为反应者(CGIC 1 - 3)或无反应者(CGIC 4 - 7)。24周的RCT之后是开放标签治疗,并记录36个月时的生存率。

结果

36个月随访后,美金刚组患者的生存期长于安慰剂组(对数秩检验x² = 4.02,p = 0.045)。在积极治疗组中,从基线起36个月的生存分析显示,基于CGIC,美金刚反应者的生存率高于无反应者(对数秩检验x² = 6.595,p = 0.010)。安慰剂组未观察到类似结果。

结论

美金刚早期治疗及对美金刚的积极临床反应预示着DLB和PDD患者生存期更长。这表明可能具有疾病修饰作用,也对卫生经济分析有影响。然而,由于研究样本量小,我们的结果仅应被视为提出一个假设,需要在更大规模的研究中进行评估。

试验注册号

ISRCTN89624516。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4ac/4091277/8e3c4fd4bc7a/bmjopen2014005158f01.jpg

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