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重酒石酸卡巴拉汀口服溶液用于轻至中度阿尔茨海默病痴呆患者的耐受性、安全性及有效性的真实世界评估

Real-world Evaluation of Tolerability, Safety and Efficacy of Rivastigmine Oral Solution in Patients with Mild to Moderate Alzheimer's Disease Dementia.

作者信息

Hsieh Sun-Wung, Chen Jui-Cheng, Chen Nai-Ching, Jhang Kai-Ming, Wang Wenfu, Yang Yuan-Han

机构信息

Department of Neurology, Kaohsiung Municipal Siao-Gang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.

Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.

出版信息

Clin Psychopharmacol Neurosci. 2021 Aug 31;19(3):459-469. doi: 10.9758/cpn.2021.19.3.459.

Abstract

OBJECTIVE

The purpose of this study is to investigate the safety, tolerability and efficacy of titrating dose of rivastigmine oral solution in patients with mild to moderate Alzheimer's disease (AD) in Taiwan.

METHODS

We recruited 108 mild to moderate AD patients with Rivast (rivastigmine oral solution 2 mg/ml) treatment for 52 weeks. We recorded the demographic characteristics, initial cognition by mini-mental state examination (MMSE), initial global status by clinical dementia rating (CDR) with CDR-Sum of Boxes (CDR-SB), initial dose, and titrating dose at each visit. We investigated the adherence, proportion of possible side effects, optimal dose, and time to optimal dose. We demonstrated the proportion of cognitive decline and its possible risk factors.

RESULTS

During the course, 9 patients discontinued the rivastigmine oral solution due to poor compliance or preference. Twelve out of 99 patients (12.1%) reported possible side effects. Among 87 patients, the mean age was 77.2 ± 9.0 years ago with female predominant (65.2%). The optimal dose was 3.6 ± 1.4 ml in average and 4 ml (n = 31, 35.6%) in mode. The duration to optimal dose was 12.5 ± 10.2 weeks and 24 weeks (n = 35, 40.2%) in mode. It presented 25% with cognitive decline in MMSE, 27% with global function decline in CDR and 63% with global function decline in CDR-SB.

CONCLUSION

We demonstrated the clinical experience of rivastigmine oral solution in mild to moderate AD patients. It suggested rivastigmine oral solution 4ml is the optimal dose with 24 weeks to the optimal dose for at least one third of patients.

摘要

目的

本研究旨在探讨在台湾轻度至中度阿尔茨海默病(AD)患者中滴定剂量的卡巴拉汀口服溶液的安全性、耐受性和疗效。

方法

我们招募了108例轻度至中度AD患者,用Rivast(卡巴拉汀口服溶液2mg/ml)治疗52周。我们记录了人口统计学特征、通过简易精神状态检查(MMSE)得出的初始认知、通过临床痴呆评定量表(CDR)及CDR-方框总和(CDR-SB)得出的初始整体状况、初始剂量以及每次就诊时的滴定剂量。我们调查了依从性、可能的副作用比例、最佳剂量以及达到最佳剂量的时间。我们展示了认知下降的比例及其可能的风险因素。

结果

在治疗过程中,9例患者因依从性差或个人偏好而停用卡巴拉汀口服溶液。99例患者中有12例(12.1%)报告了可能的副作用。在87例患者中,平均年龄为77.2±9.0岁,女性占主导(65.2%)。最佳剂量平均为3.6±1.4ml,众数为4ml(n=31,35.6%)。达到最佳剂量的持续时间为12.5±10.2周且众数为24周(n=35,40.2%)。MMSE显示25%的患者有认知下降,CDR显示27%的患者整体功能下降,CDR-SB显示63%的患者整体功能下降。

结论

我们展示了卡巴拉汀口服溶液在轻度至中度AD患者中的临床经验。这表明卡巴拉汀口服溶液4ml是最佳剂量,至少三分之一的患者达到最佳剂量的时间为24周。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecbb/8316665/1f5d90f7df50/cpn-19-3-459-f1.jpg

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