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达格列净在儿童慢性肾脏病患者中的安全性和有效性

Safety Profile and Effectiveness of Dapagliflozin in Pediatric Patients with Chronic Kidney Disease.

作者信息

Van Reeth Olil, Caliment Ancuta, de la Fuente Garcia Isabel, Niel Olivier

机构信息

Department of Pediatrics, Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.

Pediatric Nephrology, Centre Hospitalier de Luxembourg, Luxembourg, Luxembourg.

出版信息

Am J Nephrol. 2024;55(4):463-467. doi: 10.1159/000539300. Epub 2024 May 14.

Abstract

INTRODUCTION

Nephroprotection in pediatric chronic kidney disease (CKD) has a major positive impact, both on residual renal function and on quality of life, by delaying the need for renal replacement therapy. To this day, nephroprotective drugs used in children are mainly limited to angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers; interestingly, as suggested by trials conducted in adults with CKD, sodium-glucose cotransporter 2 inhibitors (SGLT2i) might also be beneficial to pediatric patients. However, there are no validated data to this date documenting the effect of SGLT2i in pediatric patients with CKD.

METHODS

We present a retrospective single-center study reporting the use of dapagliflozin in pediatric patients with CKD, aiming to evaluate dapagliflozin safety profile as well as its potential for renal protection. Our study describes 7 patients with a mean age of 13.3 years (+/- 7.029) presenting with identified glomerulopathy, leading to CKD and already treated by ACE inhibitors. Patients received a daily dose of dapagliflozin of 5 or 10 mg.

RESULTS

Over a period of 15 months, all patients reported the medication as easy to use. After an initial dip, estimated glomerular filtration rate decline slope stabilized in all patients. Urinary albumin-over-creatinine ratio had a strong tendency to decrease after 6 months of treatment (p = 0.0684). Systolic blood pressure also had a tendency to decrease after 6 months of treatment (p = 0.1). No significant side effect was reported by the patients.

CONCLUSION

The promising results presented in this study support the use of SGLT2i in pediatric patients with CKD, although larger, randomized controlled trials in pediatric patients are necessary to better characterize their effectiveness in this particular population.

摘要

引言

小儿慢性肾脏病(CKD)的肾脏保护对于残余肾功能和生活质量均有重大积极影响,可延迟肾脏替代治疗的需求。时至今日,用于儿童的肾脏保护药物主要局限于血管紧张素转换酶(ACE)抑制剂和血管紧张素受体阻滞剂;有趣的是,正如在成年CKD患者中进行的试验所表明的,钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)可能对儿科患者也有益处。然而,迄今为止尚无经过验证的数据记录SGLT2i对儿科CKD患者的疗效。

方法

我们开展了一项回顾性单中心研究,报告达格列净在儿科CKD患者中的使用情况,旨在评估达格列净的安全性及其肾脏保护潜力。我们的研究描述了7例平均年龄为13.3岁(±7.029)的患者,他们被确诊患有肾小球病,导致CKD,且已接受ACE抑制剂治疗。患者每日服用5或10毫克达格列净。

结果

在15个月的时间里,所有患者均表示该药物易于使用。在最初的下降之后,所有患者的估计肾小球滤过率下降斜率均趋于稳定。治疗6个月后,尿白蛋白与肌酐比值有显著下降趋势(p = 0.0684)。治疗6个月后收缩压也有下降趋势(p = 0.1)。患者未报告明显副作用。

结论

本研究中呈现的有前景的结果支持在儿科CKD患者中使用SGLT2i,尽管有必要在儿科患者中开展更大规模的随机对照试验,以更好地明确其在这一特定人群中的有效性。

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