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托拉塞米与呋塞米治疗肾病综合征疗效及安全性的随机对照试验

Randomized controlled trial on efficacy and safety of torsemide versus furosemide in patients with nephrotic syndrome.

作者信息

Bindal Tanvi, Sinha Aditi, Yadav Menka, Meena Jitendra, Hari Pankaj, Bagga Arvind

机构信息

Division of Nephrology, Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.

Department of Pediatrics, Indraprastha Apollo Hospitals, New Delhi, India.

出版信息

Pediatr Nephrol. 2025 Oct 14. doi: 10.1007/s00467-025-06990-0.

DOI:10.1007/s00467-025-06990-0
PMID:41083751
Abstract

BACKGROUND

Torsemide is preferred to furosemide in adults with heart failure for its higher bioavailability and longer half-life. Evidence of benefit in children is limited to uncontrolled studies.

METHODS

This single-center, open-label, randomized controlled trial compared the superiority of oral therapy with torsemide administered at a dose of 0.25-0.5 mg/kg twice daily, to furosemide 1-1.5 mg/kg twice daily for 48-h, in inducing diuresis in patients, 3-18 years-old, with nephrotic syndrome and moderate to severe edema without hypovolemia (CTRI/2023/10/058799). Secondary outcomes included proportions of patients with adequate and inadequate diuresis, treatment failure, treatment-emergent adverse events or serious adverse events (TEAE, SAE), percentage weight loss, natriuresis and free water clearance.

RESULTS

Of 173 patients screened, 25 patients each, with no significant baseline differences, were randomized to receive torsemide or furosemide. Nine patients in each group received 4 doses per protocol; others received fewer doses due to treatment failure or TEAE. On intention-to-treat analyses, patients in the torsemide and furosemide groups had similar urine output over 48-h (mean difference, MD 0.42; 95% CI -0.39,1.23 ml/kg/hr) and comparable proportions of patients had adequate diuresis (MD 20%; -3.7, 43.7%), inadequate diuresis (MD 16%; -41, 9.5%), treatment failure (MD -4%; -17.1, 9.1%), and TEAE or SAE. There were no differences in weight loss (MD 0.82; -2.2, 3.8%), natriuresis (MD -2.9; -74.4, 68.5 mEq/day) and free water clearance (MD 150.1; -266.1, 567.2 ml/day). Per-protocol analyses confirmed no intergroup differences.

CONCLUSIONS

Torsemide is not superior to furosemide in inducing diuresis in children with nephrotic syndrome with moderate to severe edema.

摘要

背景

对于成人心力衰竭患者,托拉塞米因其较高的生物利用度和较长的半衰期而优于呋塞米。在儿童中获益的证据仅限于非对照研究。

方法

这项单中心、开放标签、随机对照试验比较了每日两次口服剂量为0.25 - 0.5mg/kg的托拉塞米与每日两次1 - 1.5mg/kg的呋塞米,对3至18岁患有肾病综合征且有中度至重度水肿但无血容量不足的患者进行48小时利尿诱导的优越性(CTRI/2023/10/058799)。次要结局包括利尿充足和不足的患者比例、治疗失败、治疗中出现的不良事件或严重不良事件(TEAE,SAE)、体重减轻百分比、尿钠排泄和自由水清除率。

结果

在173例筛查患者中,每组25例患者被随机分配接受托拉塞米或呋塞米,两组患者基线无显著差异。每组有9例患者按方案接受了4剂治疗;其他患者因治疗失败或TEAE接受的剂量较少。在意向性分析中,托拉塞米组和呋塞米组患者在48小时内的尿量相似(平均差,MD 0.42;95%CI -0.39,1.23ml/kg/小时),利尿充足的患者比例相当(MD 20%;-3.7,43.7%),利尿不足(MD 16%;-41,9.5%),治疗失败(MD -4%;-17.1,9.1%),以及TEAE或SAE。体重减轻(MD 0.82;-2.2,3.8%)、尿钠排泄(MD -2.9;-74.4,68.5mEq/天)和自由水清除率(MD 150.1;-266.1,567.2ml/天)均无差异。按方案分析证实组间无差异。

结论

在患有中度至重度水肿的肾病综合征儿童中,托拉塞米在诱导利尿方面并不优于呋塞米。

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CONSORT 2025 statement: updated guideline for reporting randomized trials.CONSORT 2025声明:报告随机试验的更新指南
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