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聚磺苯乙烯钠用于急诊科高钾血症的治疗:一项初步研究。

Patiromer for Treatment of Hyperkalemia in the Emergency Department: A Pilot Study.

机构信息

Ben Taub General Hospital, Baylor College of Medicine, Houston, TX.

Dan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX.

出版信息

Acad Emerg Med. 2020 Jan;27(1):54-60. doi: 10.1111/acem.13868. Epub 2019 Nov 24.

Abstract

BACKGROUND

Hyperkalemia is common and potentially life threatening. Patiromer is a Food and Drug Administration (FDA)-cleared oral potassium binder effective in the chronic treatment of hyperkalemia.

OBJECTIVE

The objective was to investigate the potential efficacy and safety of oral patiromer in treating acute hyperkalemia in the emergency department (ED).

METHODS

This is a single-center, randomized, open-label convenience sample pilot study in an inner-city ED. Adult patients with end-stage renal disease and a serum potassium level of ≥ 6.0 mEq/L were randomized to standard of care (SOC) or one dose of 25.2 g oral patiromer plus SOC (PAT). Blood samples and electrocardiograms were collected at enrollment and at 1, 2, 4, and 6 hours thereafter. The primary outcome was the difference in potassium between groups at 6 hours. Secondary outcomes were the amount and number of times insulin and albuterol were given.

RESULTS

Thirty patients were included in the final analysis, 15 in each group. There were no differences in age, sex, or baseline serum potassium. There was no difference in mean serum potassium between SOC and PAT groups at 6 hours (6.32 mEq/L, confidence interval [CI] = 6.0 to 6.63 mEq/L vs. 5.81 mEq/L, CI = 5.48 to 6.14 mEq/L). However, 2 hours posttreatment the serum potassium of the PAT group was lower than SOC group (5.90 mEq/L, CI = 5.63 to 6.17 mEq/L vs. 6.51 mEq/L, CI = 6.25 to 6.78 mEq/L) and also 0.61 mEq/L lower than baseline. There were no differences in the amount or number of administrations of insulin or albuterol between groups, although the amount of albuterol used in the PAT group at 6 hours was lower but not significant (median, 0 mg vs. 12.5 mg; p = 0.097). There were no differences in adverse events between groups.

CONCLUSION

In this open-label pilot study of severe hyperkalemia, a single dose of 25.2 g of oral patiromer reduced serum potassium within 2 hours but did not show a difference at 6 hours. This is the first study showing that patiromer may have a role in the acute management of hyperkalemia; however, more rigorous studies are needed.

摘要

背景

高钾血症很常见,且有潜在生命威胁。培特洛默是一种获得美国食品药品监督管理局(FDA)批准的口服钾结合剂,可有效治疗慢性高钾血症。

目的

本研究旨在探究口服培特洛默治疗急诊科(ED)急性高钾血症的潜在疗效和安全性。

方法

这是一项单中心、随机、开放标签、便利样本的初步研究,在城市内的 ED 中进行。纳入终末期肾病且血清钾水平≥6.0 mEq/L 的成年患者,随机分为标准治疗(SOC)组或 SOC 加单次 25.2 g 口服培特洛默(PAT)组。入组时及此后 1、2、4 和 6 小时采集血样和心电图。主要结局为 6 小时时两组间钾的差异。次要结局为胰岛素和沙丁胺醇的用量和给药次数。

结果

最终有 30 例患者纳入最终分析,每组 15 例。两组患者的年龄、性别和基线血清钾无差异。6 小时时 SOC 组和 PAT 组的平均血清钾无差异(6.32 mEq/L,置信区间 [CI] = 6.0 至 6.63 mEq/L vs. 5.81 mEq/L,CI = 5.48 至 6.14 mEq/L)。然而,治疗后 2 小时,PAT 组的血清钾低于 SOC 组(5.90 mEq/L,CI = 5.63 至 6.17 mEq/L vs. 6.51 mEq/L,CI = 6.25 至 6.78 mEq/L),也比基线低 0.61 mEq/L。两组间胰岛素和沙丁胺醇的用量和给药次数无差异,尽管 PAT 组在 6 小时时使用的沙丁胺醇量较低但无统计学意义(中位数,0 mg 与 12.5 mg;p = 0.097)。两组间不良反应无差异。

结论

在这项严重高钾血症的开放性初步研究中,单次 25.2 g 口服培特洛默可在 2 小时内降低血清钾,但 6 小时时无差异。这是首个表明培特洛默可能在高钾血症急性管理中发挥作用的研究;然而,还需要更严格的研究。

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