Freund-Levi Yvonne, Jedenius Erik, Tysen-Bäckström Ann Christine, Lärksäter Marie, Wahlund Lars-Olof, Eriksdotter Maria
Division of Clinical Geriatrics, Department of Neurobiology, Caring Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden; Department of Geriatric Medicine, Karolinska University Hospital, Stockholm, Sweden.
Division of Clinical Geriatrics, Department of Neurobiology, Caring Sciences and Society (NVS), Karolinska Institutet, Stockholm, Sweden.
Am J Geriatr Psychiatry. 2014 Apr;22(4):341-8. doi: 10.1016/j.jagp.2013.05.005. Epub 2013 Sep 10.
To examine the effects of galantamine and risperidone on neuropsychiatric symptoms in dementia (NPSD) and global function.
Using a randomized, controlled and open-blind, one-center trial at an in- and outpatient clinic at a university hospital, we studied 100 adults with probable dementia and NPSD. Participants received galantamine (N = 50, target dose 24 mg) or risperidone (N = 50, target dose 1.5 mg) for 12 weeks. The primary outcome was effects on NPSD assessed by the Neuropsychiatric Inventory (NPI). Secondary measures included the Mini-Mental State Examination (MMSE), Clinical Dementia Rating, Clinical Global Impression, and Simpson Angus scales. All tests were performed before and after treatment.
Outcome measures were analyzed using analysis of covariance. Ninety-one patients (67% women, mean age 79 ± 7.5 years) with initial NPI score of 51.0 (± 25.8) and MMSE of 20.1 (± 4.6) completed the trial. Both galantamine and risperidone treatments resulted in improved NPSD symptoms and were equally effective in treating several NPI domains. However, risperidone showed a significant treatment advantage in the NPI domains irritation and agitation, F(1, 97) = 5.2, p = 0.02. Galantamine treatment also ameliorated cognitive functions where MMSE scores increased 2.8 points compared with baseline (95% confidence interval: 1.96-3.52). No treatment-related severe side effects occurred.
These results support that galantamine, with its benign safety profile, can be used as first-line treatment of NPSD symptoms, unless symptoms of irritation and agitation are prominent, where risperidone is more efficient.
研究加兰他敏和利培酮对痴呆患者神经精神症状（NPSD）及整体功能的影响。
在一家大学医院的门诊和住院部进行了一项随机、对照、开放-盲法的单中心试验，我们研究了100名患有可能痴呆和NPSD的成年人。参与者接受加兰他敏（N = 50，目标剂量24毫克）或利培酮（N = 50，目标剂量1.5毫克）治疗12周。主要结局是通过神经精神科问卷（NPI）评估对NPSD的影响。次要指标包括简易精神状态检查表（MMSE）、临床痴呆评定量表、临床总体印象量表和辛普森·安格斯量表。所有测试均在治疗前后进行。
采用协方差分析对结局指标进行分析。91名患者（67%为女性，平均年龄79±7.5岁）完成了试验，初始NPI评分为51.0（±25.8），MMSE评分为20.1（±4.6）。加兰他敏和利培酮治疗均使NPSD症状得到改善，且在治疗几个NPI领域同样有效。然而，利培酮在NPI领域的激惹和躁动方面显示出显著的治疗优势，F(1, 97) = 5.2，p = 0.02。加兰他敏治疗还改善了认知功能，MMSE评分较基线增加了2.8分（95%置信区间：1.96 - 3.52）。未发生与治疗相关的严重副作用。
这些结果支持，加兰他敏安全性良好，可作为NPSD症状的一线治疗药物，除非激惹和躁动症状突出，此时利培酮更有效。
