Department of Integrated Internal Medicine, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, Zhejiang, P.R. China.
Int J Med Sci. 2012;9(3):248-55. doi: 10.7150/ijms.4363. Epub 2012 May 7.
To evaluate the efficacy and safety of donepezil plus natural hirudin in patients with mild-to-moderate Alzheimer's Disease.
In the 20-week, randomized, open-label and controlled study, 84 patients received either donepezil (5 mg/day for the first 4 weeks and 10 mg/day thereafter) or donepezil plus natural hirudin (3 g/day) treatment. Efficacy was reflected by the change of the total scores of Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog), Activities of Daily Life (ADL) and Neuropsychiatric Inventory (NPI).
The patients with the donepezil plus natural hirudin treatment showed more significant improvement in the daily activities and the decline of the cognition than those with donepezil treatment. Significant difference was present in the groups since the 8th week. No group difference was found in the NPI change. However, within the hirudin treatment group, more powerful efficacy including NPI assessment was found in the patients with vascular risk factors (VRF) as comparing to with those without VRF. The combination of donepezil and natural hirudin was well tolerated. The dropout rate was greater in the donepezil and natural hirudin (50%) treatment group than in the donepezil (39%) treatment group. Similar result was found in the incidence of adverse events (23.8% vs 19.0%), but there was no statistical difference between the two groups. Adverse events were the most common reason for the dropout. Although hemorrhage and hypersensitiveness were more common in donepezil plus Maixuekang treatment (11.9% and 7.1%) group than in donepezil treatment (2.4% and 2.4%) group, no significant difference was present between the two groups. Economic problem was another important reason for the patients' withdrawal.
Compared with the donepezil treatment in the patients with mild-to-moderate AD, our results suggest that donepezil combined with natural hirudin may improve the treatment effects in the ADL, BPSD and cognition of the patients. Furthermore, this joint treatment is safe.
评价多奈哌齐联合天然水蛭素治疗轻、中度阿尔茨海默病的疗效和安全性。
在这项 20 周、随机、开放标签、对照研究中，84 例患者分别接受多奈哌齐（前 4 周 5mg/天，之后 10mg/天）或多奈哌齐联合天然水蛭素（3g/天）治疗。采用阿尔茨海默病评估量表认知分量表（ADAS-Cog）、日常生活能力量表（ADL）和神经精神问卷（NPI）总分的变化评估疗效。
与多奈哌齐治疗组相比，多奈哌齐联合天然水蛭素治疗组患者日常生活活动能力改善更显著，认知功能下降更少，自第 8 周起两组间差异有统计学意义。两组间 NPI 变化无差异。然而，在水蛭素治疗组中，有血管危险因素（VRF）的患者与无 VRF 的患者相比，NPI 评估疗效更显著。多奈哌齐联合天然水蛭素治疗耐受性良好。多奈哌齐联合天然水蛭素（50%）治疗组的脱落率大于多奈哌齐（39%）治疗组。不良反应发生率相似（23.8%比 19.0%），但两组间无统计学差异。不良反应是脱落的最常见原因。多奈哌齐联合脉血康治疗组（11.9%和 7.1%）较多奈哌齐治疗组（2.4%和 2.4%）更常见出血和过敏反应，但两组间无显著差异。经济问题是患者停药的另一个重要原因。
与多奈哌齐治疗轻、中度 AD 患者相比，我们的结果提示多奈哌齐联合天然水蛭素可能改善患者的日常生活能力、行为和认知。此外，该联合治疗是安全的。
