Alzheimer Research Center and Memory Clinic, Instituto Andaluz de Neurociencia (IANEC), C/ Álamos, 17, 29102, Málaga, Spain.
Clin Drug Investig. 2022 May;42(5):391-402. doi: 10.1007/s40261-022-01136-8. Epub 2022 Mar 28.
Vascular dementia (VaD) is the most severe manifestation of cognitive impairment caused by cerebrovascular disease. There are currently no specific drug treatments approved for VaD, with cholinesterase inhibitors (AChEI) being frequently used in VaD. However, the benefits they provide are small and short-lived. The standardized extract of Ginkgo biloba EGb 761 has demonstrated protective properties against neuronal and vascular damage and has been used as a pharmacological treatment for VaD.
This study aims to study the efficacy of EGb 761 alone and in combination with AChEI in a real-life setting. We carried out a retrospective analysis of data over a 12-month period in a sample of people suffering from VaD.
We retrospectively identified 77 patients with a diagnosis of VaD who had received treatment with any of the following drugs: Ginkgo biloba extract EGb 761 (240 mg daily), donepezil (10 mg daily), galantamine (16 or 24 mg daily), or rivastigmine patch (9.5 or 13.3 mg daily). Subjects were divided into three groups according to the treatment they had received: EGb 761 alone (n = 25), AChEI alone (n = 26), and EGb 761+AChEI (n = 26). Cognitive functioning was assessed by Mini-Mental State Examination (MMSE), Rey Auditory Verbal Learning Test (RAVLT), Symbol Digit Modalities Test (SDMT), Boston Naming Test (BNT), Trail Making Test forms A (TMTA) and B (TMTB), Letter (LFT) and Category Fluency Test (CFT); neuropsychiatric symptoms were assessed by the Neuropsychiatric Inventory (NPI); functional capacity was assessed by Interview for Deterioration in Daily Living (IDDD).
A statistically significant improvement was observed in the EGb 761 group versus the AChEI group at 12 months' follow-up in CFT (+1.74, p < 0.001), TMTA (-17.91, p = 0.031) and NPI (-5.89, p < 0.001). With regard to the combined treatment, a statistically significant improvement was shown in the EGb 761 plus AChEI treatment group versus AChEI group at the 12-month follow-up in MMSE (+2.0, p = 0.001), RAVLT (+2.23, p = 0.007), CFT (+1.15, p = 0.013), TMTA (-19.92, p = 0.012), TMTB (-46.50, p < 0.001) and NPI (-6.77, p < 0.001). In the same line, a statistically significant improvement was observed in the EGb 761 plus AChEI treatment group versus EGb 761 at 12-month follow-up regarding MMSE (+2.11, p = 0.001), RAVLT (+2.35, p = 0.004) and TMTB (-25.25, p = 0.015).
After 12 months of treatment EGb 761 alone or combined with AChEI showed cognitive and behavioral benefits in patients suffering from VaD. This study thus provides additional real-world evidence for the combined use of EGb 761 and anti-dementia drugs in VaD patients.
血管性痴呆（VaD）是由脑血管疾病引起的最严重的认知障碍表现。目前，尚无专门批准用于 VaD 的药物治疗方法，常使用胆碱酯酶抑制剂（AChEI）治疗 VaD。然而，它们提供的益处较小且短暂。银杏叶提取物 EGb 761 的标准化提取物具有保护神经元和血管损伤的特性，已被用作 VaD 的药理学治疗方法。
本研究旨在研究 EGb 761 单独使用和与 AChEI 联合使用在真实环境中的疗效。我们对患有 VaD 的患者进行了为期 12 个月的回顾性数据分析。
我们回顾性地确定了接受以下任何药物治疗的 77 名 VaD 患者：银杏叶提取物 EGb 761（每天 240 毫克）、多奈哌齐（每天 10 毫克）、加兰他敏（每天 16 或 24 毫克）或利斯的明贴片（每天 9.5 或 13.3 毫克）。根据所接受的治疗，将受试者分为三组：EGb 761 单独组（n=25）、AChEI 单独组（n=26）和 EGb 761+AChEI 联合组（n=26）。使用简易精神状态检查（MMSE）、 Rey 听觉言语学习测试（RAVLT）、符号数字模态测试（SDMT）、波士顿命名测试（BNT）、连线测试 A（TMTA）和 B（TMTB）、字母（LFT）和类别流畅性测试（CFT）评估认知功能；使用神经精神问卷（NPI）评估神经精神症状；使用日常生活恶化访谈（IDDD）评估功能能力。
在 12 个月的随访中，与 AChEI 组相比，EGb 761 组在 CFT（+1.74，p<0.001）、TMTA（-17.91，p=0.031）和 NPI（-5.89，p<0.001）方面有统计学显著改善。关于联合治疗，与 AChEI 组相比，在 12 个月的随访中，EGb 761+AChEI 治疗组在 MMSE（+2.0，p=0.001）、RAVLT（+2.23，p=0.007）、CFT（+1.15，p=0.013）、TMTA（-19.92，p=0.012）、TMTB（-46.50，p<0.001）和 NPI（-6.77，p<0.001）方面有统计学显著改善。同样，在 12 个月的随访中，与 EGb 761 组相比，EGb 761+AChEI 治疗组在 MMSE（+2.11，p=0.001）、RAVLT（+2.35，p=0.004）和 TMTB（-25.25，p=0.015）方面有统计学显著改善。
在 12 个月的治疗后，EGb 761 单独或与 AChEI 联合使用可改善 VaD 患者的认知和行为能力。因此，这项研究为在 VaD 患者中联合使用 EGb 761 和抗痴呆药物提供了额外的真实世界证据。
