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达格列净在儿童肾脏病中的疗效和安全性:真实世界数据。

Efficacy and safety of dapagliflozin in children with kidney disease: real-world data.

机构信息

Department of Pediatrics, Korea University Anam Hospital, Seoul, Republic of Korea.

Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea.

出版信息

Pediatr Nephrol. 2024 Dec;39(12):3551-3558. doi: 10.1007/s00467-024-06481-8. Epub 2024 Aug 6.

Abstract

BACKGROUND

Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, has shown results in slowing estimated glomerular filtration rate (eGFR) decline and reducing proteinuria in adult patients with chronic kidney disease. This retrospective study examines dapagliflozin's effects in 22 children with kidney disease and proteinuria.

METHODS

Children with a median age of 15.6 years were treated with dapagliflozin for > 3 months between July 2022 and December 2023. All children had been treated with either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least 1 month before starting dapagliflozin.

RESULTS

The most common kidney disease diagnoses in this study included Alport syndrome (n = 7) and medication-resistant nephrotic syndrome or focal segmental glomerulosclerosis (n = 7). After 6.1 months of treatment, dapagliflozin treatment did not result in significant changes in eGFR or proteinuria. However, at the latest follow-up, a statistically significant decrease in eGFR was noted (65.5 compared to the baseline 71.1 mL/min/1.73 m, P = 0.003). Proteinuria remained stable between baseline and the last follow-up (final spot urine protein/creatinine ratio (uPCR) 0.7 vs. baseline uPCR 0.6 mg/mg, P = 0.489). In the subgroup analysis of children treated for > 8 months, the eGFR decline post-treatment changed from - 0.5 to - 0.2 ml/min/1.73 m per month (P = 0.634). Only two children discontinued dapagliflozin due to suspected adverse events.

CONCLUSIONS

Dapagliflozin has not been associated with serious side effects. Further prospective clinical trials are needed to confirm the efficacy and safety of dapagliflozin in children with kidney disease.

摘要

背景

达格列净是一种钠-葡萄糖共转运蛋白 2 抑制剂,已显示可减缓估算肾小球滤过率(eGFR)下降并减少慢性肾脏病成年患者的蛋白尿。本回顾性研究检查了达格列净在 22 名患有肾病和蛋白尿的儿童中的作用。

方法

中位年龄为 15.6 岁的儿童在 2022 年 7 月至 2023 年 12 月期间接受达格列净治疗超过 3 个月。所有儿童在开始使用达格列净前至少接受了 1 个月的血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂治疗。

结果

本研究中最常见的肾脏疾病诊断包括 Alport 综合征(n=7)和药物抵抗性肾病综合征或局灶节段性肾小球硬化症(n=7)。达格列净治疗 6.1 个月后,eGFR 或蛋白尿没有显著变化。然而,在最近的随访中,eGFR 呈统计学显著下降(与基线相比,65.5 与 71.1 mL/min/1.73 m,P=0.003)。蛋白尿在基线和最后一次随访之间保持稳定(最终点尿蛋白/肌酐比(uPCR)为 0.7 与基线 uPCR 为 0.6 mg/mg,P=0.489)。在治疗时间超过 8 个月的儿童亚组分析中,治疗后 eGFR 下降从每月-0.5 变为-0.2 ml/min/1.73 m(P=0.634)。只有两名儿童因疑似不良反应而停用达格列净。

结论

达格列净未与严重副作用相关。需要进一步的前瞻性临床试验来证实达格列净在儿童肾脏病中的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/589d/11511754/1941bc03e4b2/467_2024_6481_Figa_HTML.jpg

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