Poewe Werner, Wolters Erik, Emre Murat, Onofrj Marco, Hsu Chuanchieh, Tekin Sibel, Lane Roger
Innsbruck Medical University, Innsbruck, Austria.
Mov Disord. 2006 Apr;21(4):456-61. doi: 10.1002/mds.20700.
In patients with dementia associated with Parkinson's disease (PD), the efficacy and safety of rivastigmine, an inhibitor of acetylcholinesterase and butyrylcholinesterase, were previously demonstrated in a 24-week double-blind placebo-controlled trial. Our objective was to determine whether benefits were sustained over the long term. Following the double-blind trial, all patients were permitted to enter an active treatment extension study, during which they received rivastigmine 3-12 mg/day. Standard safety assessments were performed. Efficacy assessments included the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) and other measures of cognition, daily function, neuropsychiatric symptoms, and executive function. Of 433 patients who completed the double-blind trial, 334 entered and 273 completed the active treatment extension. At 48 weeks, the mean ADAS-cog score for the whole group improved by 2 points above baseline. Placebo patients switching to rivastigmine for the active treatment extension experienced a mean cognitive improvement similar to that of the original rivastigmine group during the double-blind trial. The adverse event profile was comparable to that seen in the double-blind trial. Long-term rivastigmine treatment appeared well tolerated and may provide sustained benefits in dementia associated with PD patients who remain on treatment for up to 48 weeks.
在帕金森病（PD）相关痴呆患者中，乙酰胆碱酯酶和丁酰胆碱酯酶抑制剂卡巴拉汀的疗效和安全性此前已在一项为期24周的双盲安慰剂对照试验中得到证实。我们的目标是确定其益处是否能长期持续。双盲试验结束后，所有患者均被允许进入一项积极治疗延长期研究，在此期间他们接受3 - 12毫克/天的卡巴拉汀治疗。进行了标准的安全性评估。疗效评估包括阿尔茨海默病评估量表认知分量表（ADAS - cog）以及其他认知、日常功能、神经精神症状和执行功能的测量指标。在完成双盲试验的433名患者中，334名进入并273名完成了积极治疗延长期。在48周时，整个组的平均ADAS - cog评分比基线提高了2分。在积极治疗延长期从安慰剂转换为卡巴拉汀治疗的患者，其平均认知改善情况与双盲试验中原卡巴拉汀组相似。不良事件情况与双盲试验中所见相当。长期卡巴拉汀治疗耐受性良好，对于持续接受治疗长达48周的PD相关痴呆患者可能会带来持续的益处。
