[血管性痴呆患者认知、行为和精神障碍的治疗：一项多中心、随机、双盲、安慰剂对照临床试验的结果]

[Treatment of cognitive, behavioral and mental disorders in patients with vascular dementia: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial].

作者信息

Tkacheva O N, Mkhitaryan E A, Kolykhalov I V, Belova A N, Kolokolov O V, Zaslavsky L G, Khasanova N M, Akhmadeeva L R, Bogdanov E I

机构信息

Pirogov Russian National Research Medical University, Moscow, Russia.

Russian Clinical and Research Center of Gerontology of the Pirogov Russian National Research Medical University, Moscow, Russia.

出版信息

Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(7):41-49. doi: 10.17116/jnevro202312307141.

DOI:10.17116/jnevro202312307141

PMID:37490664

Abstract

OBJECTIVE

Evaluation of the efficacy and safety of Prospect in the treatment of cognitive, behavioral and mental disorders in patients with vascular dementia (VSD).

MATERIAL AND METHODS

In a double-blind, placebo-controlled, parallel-group randomised clinical trial, 406 patients aged 60-85 years old with a diagnosis of mild/moderate vascular dementia (10-24 on the Mini-Mental State Examination (MMSE)) and without signs of depression (Cornell Scale for Depression in Dementia (CSDD) scores ≤10) were included. At Visit 1, complaints and medical history were collected, vital signs were recorded, cognitive impairment was assessed using MMSE and MoCA, NPI-C and CSDD were completed, and an MRI brain scan was performed. Patients were randomised into two groups: patients in group 1 received Prospekta in a dosage of 2 tablets two times a day for 24 weeks, and patients in group 2 received Placebo according to the study drug regimen.

RESULTS

Patients in both groups had no differences in demographic and baseline clinical characteristics. Administration of Prospekta for 24 weeks reduced cognitive impairment in patients with vascular dementia compared to the placebo group. The mean MoCA score increased from 17.0±3.6 [17.1±3.6] to 20.5±4.7 [20.4±4.7] in patients treated with Prospekta, whereas it increased from 17.3±3.7 [17.3±3.8] to 19.2±4.9 [19.2±5.0] in the Placebo group. Treatment with the medication also reduced the severity of neuropsychiatric symptoms as measured by the NPI-C scale. The mean score on this scale decreased from 57.0±26.7 [56.7±25.4] to 39.8±23.6 [39.8±23.5] in the Prospekta group and from 55.5±25.5 [55.3±24.4] to 42.8±27.6 [42.3±25.3] in the Placebo group. The difference in mean MoCA and NPI-C scores between the Prospekta and Placebo groups was statistically significant.

CONCLUSION

Prospekta is an effective and safe drug for treating cognitive, behavioural and mental disturbances in patients with vascular dementia.

摘要

目的

评估Prospect治疗血管性痴呆（VSD）患者认知、行为和精神障碍的疗效及安全性。

材料与方法

在一项双盲、安慰剂对照、平行组随机临床试验中，纳入了406例年龄在60 - 85岁、诊断为轻度/中度血管性痴呆（简易精神状态检查表（MMSE）评分10 - 24分）且无抑郁迹象（痴呆抑郁量表（CSDD）评分≤10）的患者。在第1次就诊时，收集主诉和病史，记录生命体征，使用MMSE和蒙特利尔认知评估量表（MoCA）评估认知障碍，完成神经精神症状问卷认知版（NPI-C）和CSDD评估，并进行脑部MRI扫描。患者被随机分为两组：第1组患者每天两次，每次两片服用Prospekta，共24周；第2组患者根据研究药物方案服用安慰剂。

结果

两组患者在人口统计学和基线临床特征方面无差异。与安慰剂组相比，服用Prospekta 24周可减轻血管性痴呆患者的认知障碍。接受Prospekta治疗的患者，MoCA平均评分从17.0±3.6 [17.1±3.6]提高到20.5±4.7 [20.4±4.7]，而安慰剂组从17.3±3.7 [17.3±3.8]提高到19.2±4.9 [19.2±5.0]。该药物治疗还降低了用NPI-C量表测量的神经精神症状的严重程度。Prospekta组该量表的平均评分从57.0±26.7 [56.7±25.4]降至39.8±23.6 [39.8±23.5]，安慰剂组从55.5±25.5 [55.3±24.4]降至42.8±27.6 [42.3±25.3]。Prospekta组与安慰剂组MoCA和NPI-C平均评分的差异具有统计学意义。