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布洛芬对超长马拉松比赛中急性肾损伤的安慰剂效应:一项随机对照试验。

Ibuprofen versus placebo effect on acute kidney injury in ultramarathons: a randomised controlled trial.

机构信息

Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California, USA.

Department of Computational Sciences, University of Colorado at Boulder, Boulder, Colorado, USA.

出版信息

Emerg Med J. 2017 Oct;34(10):637-642. doi: 10.1136/emermed-2016-206353. Epub 2017 Jul 5.

DOI:10.1136/emermed-2016-206353
PMID:28679502
Abstract

BACKGROUND

Despite concerns that non-steroidal anti-inflammatory drugs (NSAIDs) contribute to acute kidney injury (AKI), up to 75% of ultramarathon runners ingest these during competition. The effect of NSAID on AKI incidence in ultramarathon runners is unclear.

METHODS

Multisite randomised double-blind placebo-controlled trial in the Gobi, Atacama, Ecuador and Sri Lankan deserts to determine whether ibuprofen (400 mg every 4 hours) would be non-inferior to placebo during a 50-mile (80 km) foot race. The primary outcome was incidence of AKI defined as severity categories of 'risk' of injury of 1.5× baseline creatinine (Cr) or 'injury' as 2× Cr, combined to calculate total incidence at the finish line. Non-inferiority margin for difference in AKI rates was defined as 15%.

RESULTS

Eighty-nine participants (47% ibuprofen and 53% placebo) were enrolled with similar demographics between groups. The overall incidence of AKI was 44%. Intent-to-treat analysis found 22 (52%) ibuprofen versus 16 (34%) placebo users developed AKI (18% difference, 95% CI -4% to 41%; OR 2.1, 95% CI 0.9 to 5.1) with a number needed to harm of 5.5. Greater severity of AKI was seen with ibuprofen compared with placebo (risk=38% vs 26%; 95% CI -9% to 34%; injury=14% vs 9%; 95% CI -10% to 21%). Slower finishers were less likely to encounter AKI (OR 0.67, 95% CI 0.47 to 0.98) and greater weight loss (-1.3%) increased AKI (OR 1.24, 95% CI 1.00 to 1.63).

CONCLUSION

There were increased rates of AKI in those who took ibuprofen, and although not statistically inferior to placebo by a small margin, there was a number needed to harm of 5.5 people to cause 1 case of AKI. Consideration should therefore be taken before ingesting NSAID during endurance running as it could exacerbate renal injury.

TRIAL REGISTRATION NUMBER

NCT02272725.

摘要

背景

尽管人们担心非甾体抗炎药(NSAIDs)会导致急性肾损伤(AKI),但多达 75%的超长马拉松跑者在比赛中会服用这些药物。NSAID 对超长马拉松跑者 AKI 发病率的影响尚不清楚。

方法

在戈壁、阿塔卡马、厄瓜多尔和斯里兰卡沙漠进行的多地点随机双盲安慰剂对照试验,以确定在 50 英里(80 公里)的徒步比赛中,布洛芬(400mg 每 4 小时)是否不如安慰剂。主要结局是 AKI 的发生率,定义为损伤风险为 1.5×基线肌酐(Cr)或损伤为 2×Cr 的严重程度类别,结合计算终点处的总发生率。AKI 发生率差异的非劣效性边界定义为 15%。

结果

89 名参与者(47%的布洛芬和 53%的安慰剂)入组,两组之间的人口统计学特征相似。AKI 的总体发生率为 44%。意向治疗分析发现,22 名(52%)布洛芬使用者和 16 名(34%)安慰剂使用者发生 AKI(18%的差异,95%CI-4%至 41%;OR 2.1,95%CI 0.9 至 5.1),需要治疗的人数为 5.5。与安慰剂相比,布洛芬使用者的 AKI 更严重(风险=38%比 26%;95%CI-9%至 34%;损伤=14%比 9%;95%CI-10%至 21%)。完成比赛较慢的人发生 AKI 的可能性较小(OR 0.67,95%CI 0.47 至 0.98),体重减轻较多(-1.3%)会增加 AKI(OR 1.24,95%CI 1.00 至 1.63)。

结论

服用布洛芬的患者 AKI 发生率增加,尽管略低于安慰剂,但需要治疗的人数为 5.5 人才能导致 1 例 AKI。因此,在耐力跑步期间摄入 NSAID 之前应考虑到这一点,因为它可能会加重肾脏损伤。

试验注册号

NCT02272725。

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