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氨茶碱在预防重度围生期窒息足月新生儿急性肾损伤中的作用:一项随机开放标签对照试验。

Role of aminophylline in prevention of acute kidney injury in term neonates with severe perinatal asphyxia: a randomized open-label controlled trial.

机构信息

Department of Neonatology, Medical College and Hospital, Kolkata, West Bengal 700073, India.

Department of Health and Family Welfare, Swasthya Bhawan, Kolkata, West Bengal 700091, India.

出版信息

J Trop Pediatr. 2024 Oct 4;70(6). doi: 10.1093/tropej/fmae036.

DOI:10.1093/tropej/fmae036
PMID:39390900
Abstract

Acute kidney injury (AKI) is one of the frequently observed complications in neonates with severe perinatal asphyxia. The efficacy of aminophylline in preventing or alleviating renal dysfunction in these neonates remains controversial. The current study aimed to explore whether treatment with aminophylline as adjunctive therapy is superior to standard care alone in preventing AKI in severely asphyxiated term neonates and to delineate the changes in other renal parameters. In this open-label randomized clinical trial, term neonates with severe asphyxia (n = 41) received a 5 mg/kg intravenous dose of aminophylline within the first hour after birth, in addition to standard care for birth asphyxia. The control group (n = 40) received standard care alone. Their daily urine output, weight, serum creatinine, renal functional status, and complications during the first 5 days of life were monitored and compared. The statistical package for social sciences version 25 was used for analysis. Approximately 24.39% of neonates in the aminophylline group developed AKI, compared to 35.0% in the control group (P = .088). Although urine output was generally higher in aminophylline-treated newborns than in the control group, this increase was not statistically significant (P > .05), with the most notable differences observed on the second and third postnatal days. Also, the changes in plasma creatinine levels between the two groups during this time were not statistically significant. Administering a single dose of aminophylline (5 mg/kg) within the first hour of life to severely asphyxiated term neonates might temporarily enhance urine output, but does not reduce the overall incidence of AKI.

摘要

急性肾损伤(AKI)是重度围生期窒息新生儿中常见的并发症之一。氨茶碱预防或缓解这些新生儿肾功能障碍的疗效仍存在争议。本研究旨在探讨在重度窒息足月新生儿中,氨茶碱辅助治疗是否优于单纯标准治疗,以及是否能改善其他肾脏参数的变化。在这项开放性随机临床试验中,41 例重度窒息(n=41)的足月新生儿在出生后 1 小时内接受 5mg/kg 的静脉氨茶碱治疗,同时接受标准的窒息复苏治疗。对照组(n=40)仅接受标准治疗。监测并比较两组新生儿在出生后第 1 至 5 天的每日尿量、体重、血清肌酐、肾功能状况和并发症。使用社会科学统计软件包 25 版进行分析。氨茶碱组约有 24.39%的新生儿发生 AKI,而对照组为 35.0%(P=0.088)。虽然氨茶碱治疗组新生儿的尿量通常高于对照组,但差异无统计学意义(P>0.05),在出生后第 2 和第 3 天差异最明显。此外,两组在此期间的血浆肌酐水平变化无统计学意义。在重度窒息的足月新生儿出生后 1 小时内给予单剂量氨茶碱(5mg/kg)可能会暂时增加尿量,但不能降低 AKI 的总体发生率。

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