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唑吡坦与曲唑酮起始治疗与维持性血液透析患者跌倒相关骨折风险的比较。

Zolpidem Versus Trazodone Initiation and the Risk of Fall-Related Fractures among Individuals Receiving Maintenance Hemodialysis.

机构信息

Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina Kidney Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina.

Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina.

出版信息

Clin J Am Soc Nephrol. 2020 Dec 31;16(1):88-97. doi: 10.2215/CJN.10070620. Epub 2020 Dec 18.

Abstract

BACKGROUND AND OBJECTIVES

Zolpidem, a nonbenzodiazepine hypnotic, and trazodone, a sedating antidepressant, are the most common medications used to treat insomnia in the United States. Both drugs have side effect profiles (., drowsiness, dizziness, and cognitive and motor impairment) that can heighten the risk of falls and fractures. Despite widespread zolpidem and trazodone use, little is known about the comparative safety of these medications in patients receiving hemodialysis, a vulnerable population with an exceedingly high fracture rate.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using data from the United States Renal Data System registry (2013-2016), we conducted a retrospective cohort study to investigate the association between the initiation of zolpidem versus trazodone therapy and the 30-day risk of hospitalized fall-related fractures among Medicare-enrolled patients receiving maintenance hemodialysis. We used an active comparator new-user design and estimated 30-day inverse probability of treatment-weighted hazard ratios and risk differences. We treated death as a competing event.

RESULTS

A total of 31,055 patients were included: 18,941 zolpidem initiators (61%) and 12,114 trazodone initiators (39%). During the 30-day follow-up period, 101 fall-related fractures occurred. Zolpidem versus trazodone initiation was associated with a higher risk of hospitalized fall-related fracture (weighted hazard ratio, 1.71; 95% confidence interval, 1.11 to 2.63; weighted risk difference, 0.17%; 95% confidence interval, 0.07% to 0.29%). This association was more pronounced among individuals prescribed higher zolpidem doses (hazard ratio, 1.85; 95% confidence interval, 1.10 to 3.01; and risk difference, 0.20%; 95% confidence interval, 0.04% to 0.38% for higher-dose zolpidem versus trazodone; and hazard ratio, 1.60; 95% confidence interval, 1.01 to 2.55 and risk difference, 0.14%; 95% confidence interval, 0.03% to 0.27% for lower-dose zolpidem versus trazodone). Sensitivity analyses using longer follow-up durations yielded similar results.

CONCLUSIONS

Among individuals receiving maintenance hemodialysis, zolpidem initiators had a higher risk of hospitalized fall-related fracture compared with trazodone initiators.

PODCAST

This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_12_18_CJN10070620_final.mp3.

摘要

背景和目的

佐匹克隆是一种非苯二氮䓬类催眠药,曲唑酮是一种镇静型抗抑郁药,这两种药物都是美国治疗失眠最常用的药物。这两种药物都有副作用(例如嗜睡、头晕、认知和运动障碍),可能会增加跌倒和骨折的风险。尽管佐匹克隆和曲唑酮的使用非常广泛,但对于接受血液透析的患者,这两种药物的相对安全性知之甚少,这些患者是一个极其容易骨折的脆弱群体。

设计、环境、参与者和测量方法:利用美国肾脏数据系统登记处(2013-2016 年)的数据,我们进行了一项回顾性队列研究,以调查佐匹克隆与曲唑酮治疗开始后 30 天内接受维持性血液透析的医疗保险患者住院跌倒相关骨折风险之间的关联。我们使用了一种活性对照新使用者设计,并估计了 30 天的逆概率治疗加权风险比和风险差异。我们将死亡视为竞争事件。

结果

共纳入 31055 名患者:佐匹克隆起始治疗 18941 例(61%),曲唑酮起始治疗 12114 例(39%)。在 30 天的随访期间,发生了 101 例跌倒相关骨折。与曲唑酮相比,佐匹克隆起始治疗与更高的住院跌倒相关骨折风险相关(加权风险比,1.71;95%置信区间,1.11 至 2.63;加权风险差异,0.17%;95%置信区间,0.07%至 0.29%)。在接受较高佐匹克隆剂量的患者中,这种关联更为明显(风险比,1.85;95%置信区间,1.10 至 3.01;风险差异,0.20%;95%置信区间,0.04%至 0.38%,与曲唑酮相比;风险比,1.60;95%置信区间,1.01 至 2.55;风险差异,0.14%;95%置信区间,0.03%至 0.27%,与较低剂量的佐匹克隆相比)。使用更长的随访时间进行敏感性分析得出了类似的结果。

结论

在接受维持性血液透析的患者中,与曲唑酮相比,佐匹克隆起始治疗与更高的住院跌倒相关骨折风险相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0f1/7792650/935becbca7f4/CJN.10070620absf1.jpg

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