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[口服加兰他敏与卡巴拉汀透皮贴剂的比较:荷兰一家记忆诊所的描述性研究]

[Oral galantamine versus rivastigmine transdermal patch: a descriptive study at a memory clinic in The Netherlands].

作者信息

Wouters C J, Dautzenberg L, Thissen A, Dautzenberg P L J

机构信息

Afdeling Geriatrie Jeroen Bosch Ziekenhuis, 's-Hertogenbosch.

出版信息

Tijdschr Gerontol Geriatr. 2010 Jun;41(3):146-50. doi: 10.1007/BF03096196.

Abstract

OBJECTIVES

Since January 2008 in The Netherlands, two cholinesterase inhibitors, oral galantamine and rivastigmine transdermal patch, are registered as a one-day symptomatic treatment for Alzheimer's disease. As no head to head study was performed yet, the objective of this study was to describe the daily practice of oral galantamine and rivastigmine transdermal patch in a real life population of a memory clinic of a suburban teaching hospital in The Netherlands.

METHODS

A randomized open label study in 84 ambulant Alzheimer's patients with at least 6 months follow-up and treated either with oral galantamine (group G) or rivastigmine transdermal patch (group R). Data collection included patients' demographic and disease variables. Adverse events were collected and, in case of interruption of the primary treatment, the alternative treatment was registered.

RESULTS

Serious adverse events did not occur. In group G respectively group R adverse events occurred in 20 patients (50%) and 18 patients (41%). No difference occurred in the frequency of nausea or vomiting. In group R more patients noted dermatological adverse events. In group G respectively group R medication was stopped in 12 patients (30%) and 14 patients (32%). However, compared to group G after stopping the treatment in group R more patients received a new anti-dementia medication (respectively 11 patients (79%) and 4 patients (33%)) (chi2(1) = 5.418, p = .026).

CONCLUSION

Despite different forms, the use of oral galantamine and rivastigmine transdermal patch showed neither difference in the frequency of adverse events neither in the frequency of stopping primary treatment. However, compared to oral galantamine use, rivastigmine transdermal patch resulted in more dermatological adverse events and after stopping rivastigmine transdermal patch, new anti-dementia medication or form was more often started. More research is urgently needed.

摘要

目的

自2008年1月起在荷兰,两种胆碱酯酶抑制剂,即口服加兰他敏和卡巴拉汀透皮贴剂,被注册用于阿尔茨海默病的一日对症治疗。由于尚未进行头对头研究,本研究的目的是描述荷兰一家郊区教学医院记忆门诊的实际患者群体中口服加兰他敏和卡巴拉汀透皮贴剂的日常使用情况。

方法

一项随机开放标签研究,纳入84例门诊阿尔茨海默病患者,至少随访6个月,分别接受口服加兰他敏治疗(G组)或卡巴拉汀透皮贴剂治疗(R组)。数据收集包括患者的人口统计学和疾病变量。收集不良事件,若主要治疗中断,则记录替代治疗情况。

结果

未发生严重不良事件。G组和R组分别有20例患者(50%)和18例患者(41%)发生不良事件。恶心或呕吐的发生率无差异。R组有更多患者出现皮肤不良事件。G组和R组分别有12例患者(30%)和14例患者(32%)停止用药。然而,与G组相比,R组停药后有更多患者接受了新的抗痴呆药物治疗(分别为11例患者(79%)和4例患者(33%))(χ²(1)=5.418,p = 0.026)。

结论

尽管剂型不同,但口服加兰他敏和卡巴拉汀透皮贴剂在不良事件发生率和主要治疗停药率方面均无差异。然而,与口服加兰他敏相比,卡巴拉汀透皮贴剂导致更多的皮肤不良事件,且停用卡巴拉汀透皮贴剂后,更常开始使用新的抗痴呆药物或剂型。迫切需要更多研究。

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