Savaskan Egemen, Mueller Heiko, Hoerr Robert, von Gunten Armin, Gauthier Serge
Department of Geriatric Psychiatry,University Hospital of Psychiatry,Zurich,Switzerland.
Clinical Research Department,Dr. Willmar Schwabe GmbH & Co. KG,Karlsruhe,Germany.
Int Psychogeriatr. 2018 Mar;30(3):285-293. doi: 10.1017/S1041610217001892. Epub 2017 Sep 21.
ABSTRACTBackground:In randomized controlled trials, Ginkgo biloba extract EGb 761® has been found to be effective in the treatment of behavioral and psychological symptoms of dementia (BPSD).
To assess the effects of EGb 761® on specific BPSD, we analyzed data from all randomized, placebo-controlled, at least 20-week, trials of EGb 761® enrolling patients with dementia (probable Alzheimer's disease (AD), probable vascular dementia or probable AD with cerebrovascular disease) who had clinically significant BPSD (Neuropsychiatric Inventory (NPI) total score at least 6). Data were pooled and joint analyses of NPI single item composite and caregiver distress scores were performed by meta-analysis with a fixed effects model.
Four trials involving 1628 patients (EGb 761®, 814; placebo, 814) were identified; treatment duration was 22 or 24 weeks; the daily dose of EGb 761® was 240 mg in all trials. Pooled analyses including data from the full analysis sets of all trials (EGb 761®, 796 patients; placebo, 802 patients) revealed significant superiority of EGb 761® over placebo in total scores and 10 single symptom scores. Regarding caregiver distress scores, EGb 761®-treated patients improved significantly more than those receiving placebo in all symptoms except delusions, hallucinations, and elation/euphoria. The benefit of EGb 761® mainly consists of improvement in symptoms present at baseline, but the incidence of some symptoms was also decreased.
Twenty two- to twenty four-week treatment with Ginkgo biloba extract EGb 761® improved BPSD (except psychotic-like features) and caregiver distress caused by such symptoms.
摘要
在随机对照试验中,已发现银杏叶提取物EGb 761®对治疗痴呆的行为和心理症状(BPSD)有效。
为评估EGb 761®对特定BPSD的影响,我们分析了所有纳入痴呆患者(可能为阿尔茨海默病(AD)、可能的血管性痴呆或伴有脑血管疾病的可能AD)且具有临床显著BPSD(神经精神科问卷(NPI)总分至少为6)的EGb 761®随机、安慰剂对照、至少20周的试验数据。汇总数据并采用固定效应模型通过荟萃分析对NPI单项综合评分和照料者痛苦评分进行联合分析。
确定了四项试验,涉及1628例患者(EGb 761®组814例;安慰剂组814例);治疗持续时间为22或24周;所有试验中EGb 761®的每日剂量均为240mg。包括所有试验完整分析集数据(EGb 761®组796例患者;安慰剂组802例患者)的汇总分析显示,EGb 761®在总分和10个单项症状评分方面显著优于安慰剂。关于照料者痛苦评分,除妄想、幻觉和欣快/狂喜外,接受EGb 761®治疗的患者在所有症状方面的改善均显著优于接受安慰剂治疗的患者。EGb 761®的益处主要包括基线时存在的症状得到改善,但某些症状的发生率也有所降低。
银杏叶提取物EGb 761®进行22至24周的治疗可改善BPSD(除类精神病性特征外)以及由此类症状引起的照料者痛苦。