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A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD.一项为期1年的多奈哌齐治疗轻至中度阿尔茨海默病患者的随机、安慰剂对照研究。
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A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients.一项为期1年、以安慰剂为对照的多奈哌齐对阿尔茨海默病患者功能保留生存期的研究。
Neurology. 2001 Aug 14;57(3):481-8. doi: 10.1212/wnl.57.3.481.
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Pharmacotherapy of Alzheimer's disease: is there a need to redefine treatment success?阿尔茨海默病的药物治疗:是否需要重新定义治疗成功的标准?
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Assessing the clinical importance of statistically significant improvement in anti-dementia drug trials.评估抗痴呆药物试验中具有统计学意义的改善的临床重要性。
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Qualitative analysis of the clinician interview-based impression of change (Plus): methodological issues and implications for clinical research.基于临床医生访谈的变化印象(加项)的定性分析:方法学问题及其对临床研究的启示
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Donepezil therapy in clinical practice: a randomized crossover study.多奈哌齐在临床实践中的治疗:一项随机交叉研究。
Arch Neurol. 2000 Jan;57(1):94-9. doi: 10.1001/archneur.57.1.94.
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Treatment of Alzheimer's disease.阿尔茨海默病的治疗
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Goal attainment scaling as a measure of clinically important change in nursing-home patients.目标达成标度作为衡量疗养院患者临床重要变化的指标。
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Do we have drugs for dementia? No.我们有治疗痴呆症的药物吗?没有。
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使用多奈哌齐治疗的阿尔茨海默病患者的目标设定与达成情况。

Goal setting and attainment in Alzheimer's disease patients treated with donepezil.

作者信息

Rockwood K, Graham J E, Fay S

机构信息

Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

出版信息

J Neurol Neurosurg Psychiatry. 2002 Nov;73(5):500-7. doi: 10.1136/jnnp.73.5.500.

DOI:10.1136/jnnp.73.5.500
PMID:12397141
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1738123/
Abstract

OBJECTIVES

To understand the treatment goals of Alzheimer's disease (AD) patients, carers, and physicians; to estimate whether clinically important goals are met during treatment with donepezil; and to compare a measure of goal attainment with standard measures used to evaluate AD treatment.

METHODS

In a 12 month phase IV trial, 108 patients with mild to moderate AD, their primary carers, and treating physicians set goals assigned to five domains, using Goal Attainment Scaling (GAS) as the primary outcome. Goal attainment was assessed quarterly. GAS scores were correlated with standard outcomes, including the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog), and the Clinician's Interview-Based Impression of Change-Plus (CIBIC-plus).

RESULTS

Physicians set fewer goals (342, mean (SD) per patient=3 (1)) than patients/carers (855, mean=9 (3)), particularly in leisure (20% by physicians compared with 76% by patients/carers), and social interaction (24% versus 49%). Physicians observed statistically significant improvement in global goal attainment for six months, and patients/carers for nine months. Patients/carers described consistent goal attainment, whereas physicians observed variable effects, such as decline in cognition but improved social interaction and behaviour. Physician global GAS scores correlated highly with the CIBIC-plus at weeks 12 (r= -0.82) and 52 (r=-0.80), but not with the ADAS-cog (r=0.12 and r=-0.45, respectively). Patient/carer global GAS scores correlated moderately with the physician's CIBIC-plus (week 12 r=-0.51; week 52 r=-0.56), and nominally with the ADAS-cog.

CONCLUSIONS

Patients/carers and physicians differ in their expectations and impressions of treatment effects. Clinically important changes correlated only modestly with psychometric tests. Attainment of treatment goals does not accord with a simplistic model in which successful AD treatment means that all declines uniformly improve.

摘要

目的

了解阿尔茨海默病(AD)患者、护理人员及医生的治疗目标;评估多奈哌齐治疗期间是否实现了具有临床意义的目标;并将目标达成度指标与用于评估AD治疗的标准指标进行比较。

方法

在一项为期12个月的IV期试验中,108例轻度至中度AD患者、其主要护理人员及治疗医生使用目标达成度量表(GAS)为五个领域设定目标,将GAS作为主要结局指标。每季度评估目标达成情况。GAS评分与标准结局指标相关,包括阿尔茨海默病认知评估量表(ADAS-cog)和临床医生基于访谈的变化印象加量表(CIBIC-plus)。

结果

医生设定的目标(342个,平均(标准差)每位患者 = 3(1))少于患者/护理人员(855个,平均 = 9(3)),尤其是在休闲方面(医生设定的占20%,而患者/护理人员设定的占76%)以及社交互动方面(分别为24%和49%)。医生观察到全球目标达成情况在六个月时有统计学显著改善,患者/护理人员观察到在九个月时有改善。患者/护理人员描述目标达成情况一致,而医生观察到效果各异,如认知能力下降但社交互动和行为改善。医生的全球GAS评分在第12周(r = -0.82)和第52周(r = -0.80)时与CIBIC-plus高度相关,但与ADAS-cog不相关(分别为r = 0.12和r = -0.45)。患者/护理人员的全球GAS评分与医生的CIBIC-plus中度相关(第12周r = -0.51;第52周r = -0.56),与ADAS-cog名义相关。

结论

患者/护理人员和医生在对治疗效果的期望和印象方面存在差异。具有临床意义的变化与心理测量测试仅适度相关。治疗目标的达成并不符合一种简单化模式,即成功的AD治疗意味着所有衰退均得到统一改善。