住院患者使用钾结合剂发生严重胃肠道不良事件的风险：一项全国性研究。
Risk of Serious Adverse Gastrointestinal Events with Potassium Binders in Hospitalized Patients: A National Study.
作者信息
Holleck Jürgen L, Han Ling, Skanderson Melissa, Bastian Lori A, Gunderson Craig G, Brandt Cynthia A, Perkal Melissa, Chang John J, Akgün Kathleen M
机构信息
Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Department of Medicine, Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA.
出版信息
J Gen Intern Med. 2025 Feb;40(3):518-524. doi: 10.1007/s11606-024-08979-1. Epub 2024 Aug 5.
BACKGROUND
Concerns about serious adverse gastrointestinal (GI) events with sodium polystyrene sulfonate (SPS) led to development of two new potassium binders, patiromer and sodium zirconium cyclosilicate (SZC), for treatment of hyperkalemia.
OBJECTIVE
To compare risk of intestinal ischemia/thrombosis or other serious GI events associated with SPS, patiromer, or SZC in hospitalized patients.
DESIGN
Retrospective cohort study.
PARTICIPANTS
National sample of 3,144,960 veterans hospitalized 2016-2022 in the U.S. Department of Veterans Affairs Healthcare System.
MAIN MEASURES
Demographics, comorbidities, medications and outcomes were ascertained from the VA Corporate Data Warehouse. Exposures were SPS, patiromer, SZC. Outcomes were 30-day intestinal ischemia/thrombosis, and a composite of intestinal ischemia/thrombosis, peptic ulcer/perforation or bowel resection/ostomy.
KEY RESULTS
Potassium binders were used during 39,270 (1.3%) hospitalizations: SPS = 30,040 (1.0%), patiromer = 3,750 (0.1%), and SZC = 5,520 (0.2%). Intestinal ischemia/thrombosis occurred with 106/30,040 (0.4%) SPS, 12/3750 (0.3%) patiromer and 24/5520 (0.4%) SZC, vs. 6998/3,105,650 (0.2%) without potassium binder. Adjusted odds ratios (aOR) were 1.40 [95% CI, 1.16 to 1.69] with SPS, 1.36 [CI, 0.79 to 2.36] with patiromer, and 1.78 [CI, 1.21 to 2.63] with SZC exposures. Composite GI adverse events occurred with 754/30,040 (2.5%) SPS, 96/3750 (2.6%) patiromer, 2.6% SZC, vs. 144/5520 (2.4%) without binder; aOR were 1.00 [CI, 0.94 to 1.08] with SPS, 1.08 [CI, 0.89 to 1.32] with patiromer, and 1.08 [CI, 0.93 to 1.27] with SZC exposures. No statistical difference in intestinal ischemia/thrombosis between each new agent and SPS was seen (p = 0.274 for SPS vs. SZC; p = 0.916 for SPS vs. patiromer).
CONCLUSION
Risk of intestinal ischemia/thrombosis or other serious adverse GI events was low and did not differ across three potassium-binding drugs.
背景
对聚苯乙烯磺酸钠（SPS）严重不良胃肠道（GI）事件的担忧促使开发了两种新的钾结合剂，帕替罗姆和环硅酸锆钠（SZC），用于治疗高钾血症。
目的
比较住院患者中与SPS、帕替罗姆或SZC相关的肠道缺血/血栓形成或其他严重GI事件的风险。
设计
回顾性队列研究。
参与者
2016年至2022年在美国退伍军人事务部医疗保健系统住院的3144960名退伍军人的全国样本。
主要测量指标
从退伍军人事务部企业数据仓库确定人口统计学、合并症、药物和结局。暴露因素为SPS、帕替罗姆、SZC。结局为30天肠道缺血/血栓形成，以及肠道缺血/血栓形成、消化性溃疡/穿孔或肠切除/造口术的综合指标。
关键结果
在39270例（1.3%）住院治疗中使用了钾结合剂：SPS = 30040例（1.0%），帕替罗姆 = 3750例（0.1%），SZC = 5520例（0.2%）。106/30040例（0.4%）使用SPS、12/3750例（0.3%）使用帕替罗姆和24/5520例（0.4%）使用SZC的患者发生了肠道缺血/血栓形成，而未使用钾结合剂的3105650例患者中有6998例（0.2%）发生。使用SPS的调整比值比（aOR）为1.40 [95% CI，1.16至1.69]，使用帕替罗姆的为1.36 [CI，0.79至2.36]，使用SZC暴露的为1.78 [CI，1.21至2.63]。754/30040例（2.5%）使用SPS、96/3750例（2.6%）使用帕替罗姆、2.6%使用SZC的患者发生了综合GI不良事件，而未使用结合剂的144/5520例（2.4%）患者发生；使用SPS的aOR为1.00 [CI，0.94至1.08]，使用帕替罗姆的为1.08 [CI，0.89至1.32]，使用SZC暴露的为1.08 [CI，0.93至1.27]。每种新药与SPS之间在肠道缺血/血栓形成方面未见统计学差异（SPS与SZC比较，p = 0.274；SPS与帕替罗姆比较，p = 0.916）。
结论
肠道缺血/血栓形成或其他严重不良GI事件的风险较低，且三种钾结合药物之间无差异。
Zotero 插件