Effects of Melatonin for Delirium in Elderly Acute Heart Failure Patients: A Randomized, Single-Center, Double-Blind, and Placebo-Controlled Trial.

B. Yin, Ting Ye, Xinxia Liu, Ronghua Wan, Lilei Gu, Gangjun Zong
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引用次数: 7

Abstract

BACKGROUND Delirium is a common, life-threatening, typical clinical syndrome with the main clinical manifestations of temporary organic mental disorder without specific drug treatment. The aim of the study was to explore the benefits of melatonin for the treatment of delirium after acute heart failure in elderly patients. METHODS This was a randomized, double-blind, and placebo-controlled trial. This study enrolled patients aged more than 60 years after acute heart failure. A computer-generated randomization sequence (in a 1:1 ratio) was used to randomly assign patients to receive either melatonin (3 mg/day, 7 days) or placebos. The primary endpoint was the incidence of delirium, assessed twice daily with the Confusion Assessment Method during the first 7 days. Analyses were performed by intention-to-treat and safety populations. RESULTS Between October 2015 and October 2019, 584 patients were assessed. A total of 497 patients randomly were assigned to receive either placebo (N = 249) or melatonin (N = 248). The incidence of delirium was significantly lower in the melatonin group than in the placebo group (27.0% vs. 36.9%, P = 0.021). Regarding safety, the occurrence of rhabdomyolysis and abnormal hepatic function did not differ between the two groups. CONCLUSION The current study (clinical trial registered number: CHWX-904-201511) suggests that acute melatonin treatment can reduce the incidence of delirium for elderly acute heart failure. It also can reduce the time of hospital stays and hospitalization costs. The therapy was safe and worth spreading.
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褪黑素对老年急性心力衰竭患者谵妄的影响:一项随机、单中心、双盲和安慰剂对照试验。
背景谵妄是一种常见的、危及生命的、典型的临床综合征,其主要临床表现为暂时性器质性精神障碍,无特异性药物治疗。该研究的目的是探讨褪黑素治疗老年急性心力衰竭后谵妄的益处。方法:随机、双盲、安慰剂对照试验。这项研究招募了年龄超过60岁的急性心力衰竭患者。计算机生成的随机化序列(1:1比例)用于随机分配患者接受褪黑激素(3毫克/天,7天)或安慰剂。主要终点是谵妄的发生率,在前7天内用混淆评估法每天评估两次。意向治疗人群和安全人群进行了分析。结果2015年10月至2019年10月,共评估584例患者。共有497名患者被随机分配接受安慰剂(N = 249)或褪黑激素(N = 248)。褪黑素组谵妄发生率明显低于安慰剂组(27.0% vs 36.9%, P = 0.021)。在安全性方面,两组间横纹肌溶解和肝功能异常的发生率无差异。结论本研究(临床试验注册号:CHWX-904-201511)提示急性褪黑素治疗可降低老年急性心力衰竭患者谵妄的发生率。还可以减少住院时间和住院费用。这种疗法是安全的,值得推广。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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