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一项在常规临床环境中使用卡巴拉汀透皮贴剂治疗阿尔茨海默病性痴呆的前瞻性研究。

A prospective study on the use of rivastigmine transdermal patch in Alzheimer's dementia in a routine clinical setting.

作者信息

Nazir Ejaz, Mushtaq Muhammad

机构信息

Consultant Old Age Psychiatrist, Services For Older People, Shelton Hospital, Shrewsbury, Shropshire, UK.

Specialty Registrar, Services For Older People, Shelton Hospital, Shrewsbury, Shropshire, UK.

出版信息

Dement Neuropsychol. 2010 Jul-Sep;4(3):245-249. doi: 10.1590/S1980-57642010DN40300014.

Abstract

UNLABELLED

There is not much published literature on the use of rivastigmine patch in a "routine" clinical setting.

OBJECTIVES

In this naturalistic longitudinal observational study we sought to evaluate the safety, tolerability and efficacy of the rivastigmine patch in patients with early and late onset moderate Alzheimer's disease in a routine clinical setting.

METHODS

Out of all routine clinical referrals, the first 30 patients with diagnosis of moderate Alzheimer's dementia who were started on rivastigmine patch were included in the study. Rivastigmine patch dose was titrated from 4.6 to 9.5mg/24 hours as appropriate. The primary outcome measure was safety and tolerability, measured by the incidence of adverse events and discontinuation due to any reason. The secondary outcome measure was to examine improvement on global, functional and behavioral domains as demonstrated by the MMSE (Mini Mental State Examination) score, BADLS (Bristol Activities of Daily Living Skills) score, patient and carer feedback and clinical judgment.

RESULTS

Adverse events were reported in 20% of patients and 10% of total patients needed discontinuation of treatment. Improvement on global, functional and behavioral domains was observed in two thirds of patients whereas one third showed a relative decline. The most common side effect was skin irritation or erythema.

CONCLUSIONS

The rivastigmine transdermal patch may provide a treatment option for those patients who require a change in their current oral cholinesterase inhibitor therapy due to safety or tolerability concerns.

摘要

未标注

关于在“常规”临床环境中使用卡巴拉汀贴片的已发表文献不多。

目的

在这项自然主义纵向观察研究中,我们试图评估在常规临床环境中,卡巴拉汀贴片对早发和晚发中度阿尔茨海默病患者的安全性、耐受性和疗效。

方法

在所有常规临床转诊病例中,纳入了最初30例开始使用卡巴拉汀贴片治疗的中度阿尔茨海默病痴呆患者。卡巴拉汀贴片剂量根据情况从4.6毫克/24小时滴定至9.5毫克/24小时。主要结局指标是安全性和耐受性,通过不良事件发生率和因任何原因停药情况来衡量。次要结局指标是通过简易精神状态检查表(MMSE)评分、布里斯托尔日常生活技能活动量表(BADLS)评分、患者和护理人员反馈以及临床判断,来检查在整体、功能和行为领域的改善情况。

结果

20%的患者报告了不良事件,10%的患者需要停药。三分之二的患者在整体、功能和行为领域有改善,而三分之一的患者出现相对下降。最常见的副作用是皮肤刺激或红斑。

结论

对于那些因安全性或耐受性问题需要改变当前口服胆碱酯酶抑制剂治疗的患者,卡巴拉汀透皮贴片可能提供一种治疗选择。

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