Division of Neurosurgery, The Chinese University of Hong Kong, Hong Kong, China.
J Clin Pharm Ther. 2009 Dec;34(6):657-63. doi: 10.1111/j.1365-2710.2009.01056.x.
Rivastigmine has been shown to be effective for patients with mild-to-moderate Alzheimer's disease. Its effect on cognitive impairment after aneurysmal subarachnoid haemorrhage has not been previously studied. The aim of the study is to evaluate the efficacy and safety of rivastigmine 3 mg/day over 12 weeks in patients with aneurysmal subarachnoid haemorrhage and persistent cognitive impairment.
Twenty Chinese patients with spontaneous subarachnoid haemorrhage at least 9 months after the initial ictus, and with persistent cognitive impairment, were recruited. The primary outcome measure was Cognitive Subscale of Alzheimer Disease Assessment Scale (ADAS-cog) for global function; the secondary outcome measures were the Frontal Assessment Battery (FAB) for frontal lobe function and the Rivermead Behavioural Memory Test (RBMT) for prospective memory. Baseline cholinergic dysfunction (with pupillometry) was assessed for relationship with treatment efficacy.
Sixteen of 20 (80%) patients completed the 12-week course of rivastigmine 1.5 mg twice daily. In comparison with the baseline assessment, ADAS-cog showed significant improvement after treatment (mean difference 6.5, 95% CI 3.5-9.5, P < 0.001); FAB and RBMT also showed significant improvement. Baseline cholinergic dysfunction (with pupillometry) was not correlated with improvement in ADAS-cog, FAB or RBMT.
The use of rivastigmine was safe in patients with spontaneous subarachnoid haemorrhage and persistent cognitive impairment. A prospective double-blind placebo-controlled trial is required to establish the efficacy of rivastigmine for patients with spontaneous subarachnoid hemorrhage and persistent cognitive impairment and whether it can be translated to improvement in instrumental activity of daily living and quality of life.
多奈哌齐已被证明对轻度至中度阿尔茨海默病患者有效。其对蛛网膜下腔出血后认知障碍的影响尚未被研究过。本研究旨在评估多奈哌齐 3mg/天治疗 12 周对蛛网膜下腔出血后持续认知障碍患者的疗效和安全性。
20 例自发性蛛网膜下腔出血后至少 9 个月且持续认知障碍的中国患者入选本研究。主要结局指标为阿尔茨海默病评估量表认知子量表（ADAS-cog）的整体功能；次要结局指标为额叶评估量表（FAB）的额叶功能和 Rivermead 行为记忆测验（RBMT）的前瞻性记忆。基线时进行瞳孔测量以评估胆碱能功能障碍与治疗疗效的关系。
20 例患者中有 16 例（80%）完成了 12 周的多奈哌齐 1.5mg 每日 2 次治疗。与基线评估相比，ADAS-cog 在治疗后有显著改善（平均差值 6.5，95%CI 3.5-9.5，P<0.001）；FAB 和 RBMT 也有显著改善。基线时的胆碱能功能障碍（通过瞳孔测量）与 ADAS-cog、FAB 或 RBMT 的改善无关。
多奈哌齐在自发性蛛网膜下腔出血后持续认知障碍患者中使用是安全的。需要进行前瞻性双盲安慰剂对照试验，以确定多奈哌齐对自发性蛛网膜下腔出血后持续认知障碍患者的疗效，以及是否能改善日常生活活动能力和生活质量。
