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从口服胆碱酯酶抑制剂转换为卡巴拉汀透皮贴剂的有效性:一项针对阿尔茨海默病的自然前瞻性研究。

Effectiveness of switching to the rivastigmine transdermal patch from oral cholinesterase inhibitors: a naturalistic prospective study in Alzheimer's disease.

作者信息

Cagnin Annachiara, Cester Alberto, Costa Bruno, Ermani Mario, Gabelli Carlo, Gambina Giuseppe

机构信息

Department of Neurosciences SNPSRR, University of Padova Medical School, Via Giustiniani 5, 35128, Padova, Italy,

出版信息

Neurol Sci. 2015 Mar;36(3):457-63. doi: 10.1007/s10072-014-2002-3. Epub 2014 Nov 14.

Abstract

Oral donepezil and rivastigmine are two commonly used cholinesterase inhibitors (ChEIs) used in Alzheimer's disease (AD). The rivastigmine transdermal patch formulation has high tolerability profile, allowing patients to achieve optimal therapeutic doses and providing potential advantages over oral ChEIs. This is a 6-month, multicentre, observational efficacy and tolerability study of switching from oral ChEIs to rivastigmine patch in AD patients who failed to show benefit from previous treatment. The reasons of the switch were: (1) lack/loss of benefit from previous oral ChEI treatment; (2) tolerability problems. The primary outcome was cognitive changes measured with the mini-mental state examination (MMSE) test. Secondary outcomes were modifications of functional independence and behavioral disturbances and occurrence of adverse events (AEs) after switching. 174 patients, over 180 patients screened, entered the study (lack/loss of efficacy: 57 %, tolerability problems: 33 %, both reasons: 10 %). 6 months after switching 56 % of patients stabilized or increased the MMSE score respect to baseline. The only predictor of this outcome was the response at 3 months. In the group with lack/loss of response to oral ChEI, the decline of the MMSE score changed from -3.4 ± 2.5 points in the 6 months before switching to -0.5 ± 3.2 in the 6 months after the switch (p < 0.001). There were no significant changes in the IADL or NPI scores. Drug discontinuation rate was 20 %, due to AEs (18 %) and lack of compliance (2 %). Switching from an unsuccessful oral ChEI therapy to rivastigmine patch is effective and safe in more than half of the switched patients after a 6-month period.

摘要

口服多奈哌齐和卡巴拉汀是常用于治疗阿尔茨海默病(AD)的两种胆碱酯酶抑制剂(ChEIs)。卡巴拉汀透皮贴剂配方具有高耐受性,使患者能够达到最佳治疗剂量,相较于口服ChEIs具有潜在优势。这是一项为期6个月的多中心观察性疗效和耐受性研究,研究对象为之前治疗未显效的AD患者,他们从口服ChEIs转换为卡巴拉汀贴剂。转换的原因包括:(1)之前口服ChEI治疗缺乏/丧失疗效;(2)耐受性问题。主要结局是用简易精神状态检查表(MMSE)测试衡量的认知变化。次要结局是转换后功能独立性和行为障碍的改善以及不良事件(AEs)的发生情况。174名患者(超过180名筛查患者)进入研究(缺乏/丧失疗效:57%,耐受性问题:33%,两种原因均有:10%)。转换6个月后,56%的患者MMSE评分相对于基线稳定或升高。该结局的唯一预测因素是3个月时的反应。在对口服ChEI无反应/反应丧失的组中,MMSE评分的下降从转换前6个月的-3.4±2.5分变为转换后6个月的-0.5±3.2分(p<0.001)。日常生活活动能力量表(IADL)或神经精神症状量表(NPI)评分无显著变化。药物停用率为20%,原因是不良事件(18%)和依从性差(2%)。在6个月期间内,超过一半转换的患者从无效的口服ChEI治疗转换为卡巴拉汀贴剂是有效且安全的。

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