一项随机、双盲、安慰剂对照临床试验，旨在评估普瑞巴林治疗阿尔茨海默病患者痴呆行为和心理症状的疗效。
A randomized, double-blind, placebo-controlled clinical trial to evaluate pregabalin efficacy in the treatment of behavioral and psychological symptoms of dementia in patients with Alzheimer's disease.
作者信息
Maleki Leyla, Mohammadian Fatemeh, Panahishokouh Mahsa, Mohebbi Niayesh
机构信息
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
Front Neurosci. 2024 Nov 27;18:1460325. doi: 10.3389/fnins.2024.1460325. eCollection 2024.
BACKGROUND
Behavioral and Psychological Symptoms of Dementia (BPSD) are common during Alzheimer's disease and cause severe problems for patients and their caregivers.
OBJECTIVES
To assess the therapeutic efficacy of Pregabalin in comparison with a placebo in treating BPSD in patients with Alzheimer's disease (AD) visiting the memory and cognition clinic of Roozbeh Psychiatric Hospital in Tehran, Iran.
METHODS
A 12-week double-blind, randomized comparison of Pregabalin and placebo treatments was conducted in 53 patients with DSM-V diagnosis of dementia of Alzheimer's type. They were randomly assigned to receive Pregabalin (doses: 50 titrated up to 300 mg/day) or a placebo. Clinical response was evaluated using the Neuropsychiatric Inventory (NPI), and the Behavioral Pathology in AD Rating Scale (BEHAVE-AD) scores compared with baseline. Side effects were also recorded carefully.
RESULTS
Patients receiving Pregabalin had better outcomes in comparison with patients receiving a placebo regarding both NPI and BEHAVE-AD scores after 12 weeks (-value = 0.009 for NPI and -value = 0.003 for BEHAVE-AD). There was also a statistically significant decrease in the treatment group depression sub-score regarding NPI and BEHAVE-AD (respectively, -value =0.000, 0.003). The caregiver burden sub-score of the NPI test was also lower in patients receiving pregabalin (-value = 0.000). There was no statistically significant difference between the occurrence of adverse effects between the two groups (-value = 1.00).
CONCLUSION
Pregabalin at a dose of 300 mg/day was well tolerated and associated with reductions in the severity and frequency of behavioral symptoms in patients with AD. Pregabalin could be considered a favorable choice for treating BPSD in adults with mild to moderate stages of Alzheimer 's-type dementia, considering its befitting safety profile.
CLINICAL TRIAL REGISTRATION
https://www.irct.ir/trial/52750, identifier IRCT20201201049553N1.
背景
痴呆的行为和心理症状（BPSD）在阿尔茨海默病期间很常见，给患者及其照顾者带来严重问题。
目的
在伊朗德黑兰鲁兹贝精神病医院记忆与认知诊所就诊的阿尔茨海默病（AD）患者中，评估普瑞巴林与安慰剂相比治疗BPSD的疗效。
方法
对53例符合DSM-V阿尔茨海默病型痴呆诊断标准的患者进行了为期12周的普瑞巴林与安慰剂治疗的双盲随机对照试验。他们被随机分配接受普瑞巴林（剂量：50mg滴定至300mg/天）或安慰剂。使用神经精神科问卷（NPI）评估临床反应，并将阿尔茨海默病行为病理评定量表（BEHAVE-AD）评分与基线进行比较。同时仔细记录副作用。
结果
12周后，就NPI和BEHAVE-AD评分而言，接受普瑞巴林治疗的患者比接受安慰剂治疗的患者有更好的结果（NPI的P值=0.009，BEHAVE-AD的P值=0.003）。治疗组在NPI和BEHAVE-AD的抑郁子评分方面也有统计学显著下降（分别为P值=0.000、0.003）。接受普瑞巴林治疗的患者NPI测试的照顾者负担子评分也较低（P值=0.000）。两组间不良反应发生率无统计学显著差异（P值=1.00）。
结论
每天300mg剂量的普瑞巴林耐受性良好，且与AD患者行为症状的严重程度和频率降低相关。考虑到其合适的安全性，普瑞巴林可被视为治疗轻度至中度阿尔茨海默病型痴呆成人BPSD的有利选择。
临床试验注册
Zotero 插件