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优化体弱老年人健康结局的药物精简治疗:Opti-med 研究的双盲安慰剂对照随机对照试验结果。

Deprescribing to optimise health outcomes for frail older people: a double-blind placebo-controlled randomised controlled trial-outcomes of the Opti-med study.

机构信息

WA Centre for Health and Ageing, University of Western Australia, M577, 35 Stirling Hwy, Crawley WA 6009, Australia.

Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.

出版信息

Age Ageing. 2023 May 1;52(5). doi: 10.1093/ageing/afad081.

DOI:10.1093/ageing/afad081
PMID:37247404
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10226731/
Abstract

BACKGROUND

potentially harmful polypharmacy is very common in older people living in aged care facilities. To date, there have been no double-blind randomised controlled studies of deprescribing multiple medications.

METHODS

three-arm (open intervention, blinded intervention and blinded control) randomised controlled trial enrolling people aged over 65 years (n = 303, noting pre-specified recruitment target of n = 954) living in residential aged care facilities. The blinded groups had medications targeted for deprescribing encapsulated while the medicines were deprescribed (blind intervention) or continued (blind control). A third open intervention arm had unblinded deprescribing of targeted medications.

RESULTS

participants were 76% female with mean age 85.0 ± 7.5 years. Deprescribing was associated with a significant reduction in the total number of medicines used per participant over 12 months in both intervention groups (blind intervention group -2.7 medicines, 95% CI -3.5, -1.9, and open intervention group -2.3 medicines; 95% CI -3.1, -1.4) compared with the control group (-0.3, 95% CI -1.0, 0.4, P = 0.053). Deprescribing regular medicines was not associated with any significant increase in the number of 'when required' medicines administered. There were no significant differences in mortality in the blind intervention group (HR 0.93, 95% CI 0.50, 1.73, P = 0.83) or the open intervention group (HR 1.47, 95% CI 0.83, 2.61, P = 0.19) compared to the control group.

CONCLUSIONS

deprescribing of two to three medicines per person was achieved with protocol-based deprescribing during this study. Pre-specified recruitment targets were not met, so the impact of deprescribing on survival and other clinical outcomes remains uncertain.

摘要

背景

在老年护理机构居住的老年人中,潜在有害的多种药物治疗非常普遍。迄今为止,尚无关于减少多种药物的双盲随机对照研究。

方法

这项三臂(开放性干预、盲法干预和盲法对照)随机对照试验纳入了年龄在 65 岁以上(n=303,注意预先指定的招募目标 n=954)、居住在养老院的老年人。盲法组的药物被包裹起来以进行去处方治疗,同时药物被去处方(盲法干预)或继续使用(盲法对照)。第三个开放性干预组对目标药物进行了非盲法去处方治疗。

结果

参与者中 76%为女性,平均年龄为 85.0±7.5 岁。在 12 个月的时间里,与对照组相比,两组干预组(盲法干预组减少 2.7 种药物,95%CI-3.5,-1.9;开放性干预组减少 2.3 种药物,95%CI-3.1,-1.4)中每位参与者使用的药物总数显著减少。与对照组相比(增加 0.3,95%CI-1.0,0.4,P=0.053),去处方常规药物不会导致“按需”药物的使用数量显著增加。与对照组相比,盲法干预组的死亡率(HR 0.93,95%CI 0.50,1.73,P=0.83)或开放性干预组(HR 1.47,95%CI 0.83,2.61,P=0.19)均无显著差异。

结论

在这项研究中,通过基于方案的去处方治疗,每人可减少两到三种药物。预先指定的招募目标未达到,因此去处方对生存和其他临床结局的影响仍不确定。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca9c/10226731/9fe1e6b7ce98/afad081f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca9c/10226731/c53c0e3c03ac/afad081f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca9c/10226731/9fe1e6b7ce98/afad081f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca9c/10226731/c53c0e3c03ac/afad081f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca9c/10226731/9fe1e6b7ce98/afad081f2.jpg

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