卡巴拉汀贴片疗法治疗伴有轻度和中度缺血性脑白质高信号的轻至中度阿尔茨海默病性痴呆患者的疗效和耐受性：一项多中心前瞻性开放标签临床试验
Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer's dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial.
作者信息
Park Kyung Won, Kim Eun-Joo, Han Hyun Jeong, Shim Yong S, Kwon Jae C, Ku Bon D, Park Kee Hyung, Yi Hyon-Ah, Kim Kwang K, Yang Dong Won, Lee Ho-Won, Kang Heeyoung, Kwon Oh Dae, Kim SangYun, Lee Jae-Hyeok, Chung Eun Joo, Park Sang-Won, Park Mee Young, Yoon Bora, Kim Byeong C, Seo Sang Won, Choi Seong Hye
机构信息
Department of Neurology, Cognitive Disorders and Dementia Center, Dong-A University College of Medicine and Institute of Convergence Bio-Health, Busan, South Korea.
Department of Neurology, Pusan National University Hospital and Biomedical Research Institute, Pusan National University School of Medicine, Busan, South Korea.
出版信息
PLoS One. 2017 Aug 7;12(8):e0182123. doi: 10.1371/journal.pone.0182123. eCollection 2017.
BACKGROUND AND OBJECTIVE
Studies investigating the impact of white matter hyperintensities (WMHs) on the response of acetylcholinesterase inhibitors in patients with Alzheimer's disease (AD) have presented inconsistent results. We aimed to compare the effects of the rivastigmine patch between patients with AD with minimal WMHs and those with moderate WMHs.
METHODS
Three hundred patients with mild to moderate AD were enrolled in this multicenter prospective open-label study and divided into two groups. Group 1 comprised patients with AD with minimal WMHs and group 2 comprised those with moderate WMHs. The patients were treated with a rivastigmine patch for 24 weeks. Efficacy measures were obtained at baseline and after 24 weeks. The primary endpoint was the change in the AD Assessment Scale-Cognitive subscale (ADAS-Cog) from the baseline to the end of the study.
RESULTS
Of the 300 patients, there were 206 patients in group 1 and 94 patients in group 2. The intention-to-treat group comprised 198 patients (group 1, n = 136; group 2, n = 46) during the 24-week study period. Demographic factors did not differ between group 1 and group 2. There were no significant differences in change in ADAS-cog between group 1 (-0.62±5.70) and group 2 (-0.23±5.98) after the 24-week rivastigmine patch therapy (p = 0.378). The patients in group 1 had a 0.63-point improvement from baseline on the Frontal Assessment Battery, while group 2 had a 0.16-point decline compared to baseline at the end of the study (p = 0.037). The rates of adverse events (AEs) (42.6 vs. 40.3%) and discontinuation due to AEs (10.3% vs. 4.3%) did not differ between the groups.
CONCLUSIONS
Although the efficacy and tolerability of rivastigmine patch therapy were not associated with WMH severity in patients with AD, some improvement in frontal function was observed in those with minimal WMHs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01380288.
背景与目的
关于白质高信号（WMHs）对阿尔茨海默病（AD）患者乙酰胆碱酯酶抑制剂反应影响的研究结果并不一致。我们旨在比较轻度白质高信号的AD患者与中度白质高信号的AD患者使用卡巴拉汀透皮贴剂的效果。
方法
300例轻至中度AD患者纳入这项多中心前瞻性开放标签研究，并分为两组。第1组为轻度白质高信号的AD患者，第2组为中度白质高信号的AD患者。患者接受卡巴拉汀透皮贴剂治疗24周。在基线和24周后获取疗效指标。主要终点是从基线到研究结束时AD评定量表认知分量表（ADAS-Cog）的变化。
结果
300例患者中，第1组有206例，第2组有94例。在24周的研究期间，意向性治疗组包括198例患者（第1组，n = 136；第2组，n = 46）。第1组和第2组的人口统计学因素无差异。在24周的卡巴拉汀透皮贴剂治疗后，第1组（-0.62±5.70）和第2组（-0.23±5.98）的ADAS-cog变化无显著差异（p = 0.378）。在研究结束时，第1组患者的额叶评估量表较基线改善了0.63分，而第2组较基线下降了0.16分（p = 0.037）。两组之间的不良事件（AE）发生率（42.6%对40.3%）和因AE停药率（10.3%对4.3%）无差异。
结论
虽然卡巴拉汀透皮贴剂治疗的疗效和耐受性与AD患者的白质高信号严重程度无关，但在轻度白质高信号患者中观察到额叶功能有一些改善。
试验注册
ClinicalTrials.gov NCT01380288。
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