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低剂量阿司匹林与年龄相关性听力损失进展:ASPREE 随机临床试验的二次分析。

Low-Dose Aspirin and Progression of Age-Related Hearing Loss: A Secondary Analysis of the ASPREE Randomized Clinical Trial.

机构信息

The School of Public Health and Preventive Medicine, Monash University, Victoria, Australia.

Department of Epidemiology and Preventive Medicine, Alfred Hospital, Victoria, Australia.

出版信息

JAMA Netw Open. 2024 Jul 1;7(7):e2424373. doi: 10.1001/jamanetworkopen.2024.24373.

Abstract

IMPORTANCE

Age-related hearing loss is common in an aging population, affecting communication and contributing to a worsened quality of life. It occurs as a result of cochlear degeneration and may be further exacerbated by inflammation and microvascular changes, as observed in animal models.

OBJECTIVE

To compare the effect of daily low-dose aspirin vs placebo on the progression of age-related hearing loss in healthy older adults.

DESIGN, SETTING, AND PARTICIPANTS: A prespecified secondary analysis was conducted of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized clinical trial. Participants were 279 healthy community-dwelling individuals living in Australia who were aged 70 years or older and free of overt cardiovascular diseases, dementia, and life-limiting illnesses. Participants were recruited between January 1, 2010, and December 31, 2014, and followed up over 3 years. Statistical analysis was completed from June to December 2023.

INTERVENTION

A 100-mg daily dose of enteric-coated aspirin or matching placebo.

MAIN OUTCOMES AND MEASURES

Hearing measures were air conduction audiometry and binaural speech perception in noise. Assessments were conducted at baseline, 18 months, and 3 years. The change from baseline hearing measures were analyzed using an intention to treat approach. Aspirin and placebo were compared using mixed linear regression models adjusting for age, sex, diabetes, and smoking.

RESULTS

Of 279 participants, 154 (55%) were male, and the median age at baseline was 73.1 years (IQR, 71.5-76.2 years). A total of 98 of 138 participants (71%) in the aspirin group and 94 of 141 participants (67%) in the placebo group reported experiencing hearing loss at baseline. Compared with placebo, aspirin did not affect the changes in mean (SD) 4-frequency average hearing threshold from baseline to year 3 (aspirin: baseline, 27.8 [13.3] dB; year 3, 30.7 [13.7] dB; difference, 3.3 [3.9] dB; placebo: baseline, 27.5 [12.6] dB; year 3, 30.9 [13.8] dB; difference, 3.0 [4.8] dB; P = .55) nor any other tested frequencies. An increase in air conduction threshold indicates a deterioration in hearing. Similarly, for the mean (SD) speech reception threshold, there was no significant difference observed between the aspirin and placebo group at the year 3 follow-up assessment (aspirin: baseline, -9.9 [3.8] dB; year 3, -9.1 [3.8] dB; difference, 0.9 [2.9] dB; placebo: baseline, -10.5 [7.1] dB; year 3, -9.6 [4.1] dB; difference, 0.9 [5.9] dB; P = .86). The findings were consistent across sex, age groups, diabetic and smoking status.

CONCLUSIONS AND RELEVANCE

In this secondary analysis of the ASPREE randomized clinical trial, low-dose aspirin did not affect the progression of age-related hearing loss. More investigation is warranted on whether a longer follow-up or the use of a more powerful anti-inflammatory agent might prove beneficial.

TRIAL REGISTRATION

anzctr.org.au Identifier: ACTRN12614000496617.

摘要

重要性

随着人口老龄化,与年龄相关的听力损失在老年人群中很常见,这会影响交流并导致生活质量恶化。它是由于耳蜗退化引起的,并且在动物模型中观察到的炎症和微血管变化可能会进一步加剧。

目的

比较每日低剂量阿司匹林与安慰剂对健康老年人与年龄相关的听力损失进展的影响。

设计、地点和参与者:这是对阿司匹林减少老年人事件(ASPREE)随机临床试验的预先指定的二次分析。参与者是居住在澳大利亚的 279 名健康的社区居民,年龄在 70 岁或以上,没有明显的心血管疾病、痴呆和限制生命的疾病。参与者于 2010 年 1 月 1 日至 2014 年 12 月 31 日期间招募,并随访 3 年。统计分析于 2023 年 6 月至 12 月完成。

干预措施

每天 100 毫克肠溶阿司匹林或匹配的安慰剂。

主要结果和测量

听力测量为空气传导听力和双耳语音感知噪声。基线、18 个月和 3 年进行评估。使用意向治疗方法分析从基线听力测量值的变化。使用混合线性回归模型比较阿司匹林和安慰剂,该模型调整了年龄、性别、糖尿病和吸烟状况。

结果

在 279 名参与者中,154 名(55%)为男性,基线时的中位年龄为 73.1 岁(IQR,71.5-76.2 岁)。阿司匹林组 138 名参与者中有 98 名(71%)和安慰剂组 141 名参与者中有 94 名(67%)报告在基线时出现听力损失。与安慰剂相比,阿司匹林对 4 个频率平均听力阈值从基线到第 3 年的变化没有影响(阿司匹林:基线,27.8[13.3]dB;第 3 年,30.7[13.7]dB;差异,3.3[3.9]dB;安慰剂:基线,27.5[12.6]dB;第 3 年,30.9[13.8]dB;差异,3.0[4.8]dB;P=0.55),也没有影响任何其他测试频率。听力阈值的增加表明听力恶化。同样,对于平均(SD)语音接收阈值,阿司匹林组和安慰剂组在第 3 年随访评估时没有观察到显著差异(阿司匹林:基线,-9.9[3.8]dB;第 3 年,-9.1[3.8]dB;差异,0.9[2.9]dB;安慰剂:基线,-10.5[7.1]dB;第 3 年,-9.6[4.1]dB;差异,0.9[5.9]dB;P=0.86)。这些发现在性别、年龄组、糖尿病和吸烟状况方面是一致的。

结论和相关性

在 ASPREE 随机临床试验的这项二次分析中,低剂量阿司匹林不会影响与年龄相关的听力损失的进展。需要进一步研究更长时间的随访或使用更有效的抗炎药物是否可能有益。

试验注册

anzctr.org.au 标识符:ACTRN12614000496617。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41be/11273233/554b080497a9/jamanetwopen-e2424373-g001.jpg

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