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老年人跌倒者停药的效果:来自改善药物处方以降低跌倒风险(IMPROveFALL)试验的结果。

Effectiveness of medication withdrawal in older fallers: results from the Improving Medication Prescribing to reduce Risk Of FALLs (IMPROveFALL) trial.

机构信息

Department of Surgery-Traumatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

Section of Geriatric Medicine, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

出版信息

Age Ageing. 2017 Jan 10;46(1):142-146. doi: 10.1093/ageing/afw161.

Abstract

OBJECTIVES

To investigate the effect of withdrawal of fall-risk-increasing-drugs (FRIDs) versus ‘care as usual’ on reducing falls in community-dwelling older fallers.

DESIGN

Randomised multicentre trial

PARTICIPANTS

Six hundred and twelve older adults who visited an Emergency Department (ED) because of a fall.

INTERVENTIONS

Withdrawal of FRIDs.

MAIN OUTCOMES AND MEASURES

Primary outcome was time to the first self-reported fall. Secondary outcomes were time to the second self-reported fall and to falls requiring a general practitioner (GP)-consultation or ED-visit. Intention-to-treat (primary) and a per-protocol (secondary) analysis were conducted. The hazard ratios (HRs) for time-to-fall were calculated using a Cox-regression model. Differences in cumulative incidence of falls were analysed using Poisson regression.

RESULTS

During 12 months follow-up, 91 (34%) control and 115 (37%) intervention participants experienced a fall; 35% of all attempted interventions were unsuccessful, either due to recurrence of the initial indication for prescribing, additional medication for newly diagnosed conditions or non-compliance. Compared to baseline, the overall percentage of users of ≥3 FRIDs at 12 months did not change in either the intervention or the control group. Our intervention did not have a significant effect on time to first fall (HR 1.17; 95% confidence interval 0.89–1.54), time to second fall (1.19; 0.78–1.82), time to first fall-related GP-consultation (0.66; 0.42–1.06) or time to first fall-related ED-visit (0.85; 0.43–1.68).

CONCLUSION

In this population of complex multimorbid patients visiting an ED because of a fall, our single intervention of FRIDs-withdrawal was not effective in reducing falls.

TRIAL REGISTRATION

Netherlands Trial Register NTR1593.

摘要

目的

研究与“常规护理”相比,减少增加跌倒风险药物(FRIDs)的使用对降低社区居住的老年跌倒患者跌倒发生率的影响。

设计

随机多中心试验。

参与者

612 名因跌倒而前往急诊科(ED)就诊的老年患者。

干预措施

减少 FRIDs 的使用。

主要结局和测量指标

主要结局为首次自我报告跌倒的时间。次要结局为第二次自我报告跌倒的时间以及需要全科医生(GP)咨询或 ED 就诊的跌倒时间。采用意向治疗(主要分析)和方案治疗(次要分析)进行分析。使用 Cox 回归模型计算跌倒时间的风险比(HR)。使用泊松回归分析跌倒累积发生率的差异。

结果

在 12 个月的随访期间,91 名(34%)对照组和 115 名(37%)干预组参与者发生跌倒;35%的尝试干预因最初开具处方的适应症复发、新诊断疾病的附加药物或不依从而未能成功。与基线相比,干预组和对照组在 12 个月时使用≥3 种 FRIDs 的患者总体比例均未发生变化。我们的干预措施对首次跌倒时间(HR 1.17;95%置信区间 0.89-1.54)、第二次跌倒时间(1.19;0.78-1.82)、首次跌倒相关 GP 咨询时间(0.66;0.42-1.06)或首次跌倒相关 ED 就诊时间(0.85;0.43-1.68)均无显著影响。

结论

在因跌倒而前往 ED 的复杂多病共存患者人群中,我们单一的 FRIDs 停药干预措施并不能有效减少跌倒。

试验注册

荷兰临床试验注册中心 NTR1593。

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