Flythe Jennifer E, Assimon Magdalene M, Tugman Matthew J, Narendra Julia H, Singh Simran K, Jin Wanting, Li Quefeng, Bansal Nisha, Hostetter Thomas H, Dember Laura M
Division of Nephrology and Hypertension, Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina, USA.
Kidney Int Rep. 2022 Jul 12;7(10):2186-2195. doi: 10.1016/j.ekir.2022.07.003. eCollection 2022 Oct.
Diuretic use may reduce volume-related complications in hemodialysis. We evaluated the efficacy, safety, and tolerability of furosemide in patients with hemodialysis-dependent kidney failure.
We conducted an open label, single-arm, 18-week, dose titration pilot study of oral furosemide (maximum dose 320 mg/day) among patients receiving maintenance hemodialysis who reported at least 1 cup of urine output per day. The primary efficacy outcome was an increase from baseline to a specified threshold of 24-hour urine volume, with the threshold based on baseline urine volume (<200 ml/day ≥200 ml/day). Safety outcomes included hypokalemia and hypomagnesemia, and tolerability was assessed by prespecified patient-reported symptoms.
Of the 39 participants, 28 (72%) received the expected furosemide dose, 3 (8%) underwent dose reduction, 5 (12%) discontinued furosemide without dose reduction, and 3 (8%) underwent dose reduction and subsequently discontinued furosemide. The median (quartile 1, quartile 3) baseline 24-hour urine volume was 290 ml (110, 740), and the maximum, average daily study furosemide dose ranged from 69 mg/day to 320 mg/d. The urine output efficacy outcome was met by 12 (33%), 11 (33%), and 7 (22%) participants at weeks 5, 12, and 18, respectively, in the intention-to-treat analysis, and by 12 (39%), 9 (35%), and 7 (28%) participants at weeks 5, 12, and 18, respectively, in the on-treatment analysis. There were no electrolyte, furosemide level, or patient-reported hearing change safety events.
Furosemide was generally safe and well tolerated, but only one-third of participants met the efficacy definition at week 5. The clinical importance of the efficacy findings is uncertain.
使用利尿剂可能会减少血液透析中与容量相关的并发症。我们评估了速尿对依赖血液透析的肾衰竭患者的疗效、安全性和耐受性。
我们对接受维持性血液透析且每日尿量至少1杯的患者进行了一项开放标签、单臂、为期18周的速尿（最大剂量320毫克/天）剂量滴定试验研究。主要疗效指标是24小时尿量从基线增加到特定阈值，该阈值基于基线尿量（<200毫升/天或≥200毫升/天）。安全性指标包括低钾血症和低镁血症，耐受性通过预先设定的患者报告症状进行评估。
39名参与者中，28名（72%）接受了预期的速尿剂量，3名（8%）减少了剂量，5名（12%）未减少剂量就停用了速尿，3名（8%）减少剂量后随后停用了速尿。24小时基线尿量的中位数（四分位数1，四分位数3）为290毫升（110，740），研究中速尿的最大平均每日剂量范围为69毫克/天至320毫克/天。在意向性分析中，分别有12名（33%）、11名（33%）和7名（22%）参与者在第5周、第12周和第18周达到尿量输出疗效指标；在治疗分析中，分别有12名（39%）、9名（35%）和7名（28%）参与者在第5周、第12周和第18周达到该指标。未发生电解质、速尿水平或患者报告的听力变化等安全性事件。
速尿总体上安全且耐受性良好，但只有三分之一的参与者在第5周达到疗效定义。疗效结果的临床重要性尚不确定。
