抗反流配方与NICU婴儿代谢性酸中毒：一项回顾性队列研究
Anti-reflux formula and metabolic acidosis in NICU infants: a retrospective cohort study.
文献信息
| PMID | 42983386 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Jeongmin Shin |
| 作者单位 | Department of Pediatrics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea. |
| 期刊 | BMC pediatrics |
| SCI 分区 | Q2 |
| IF | 2.6 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 确定NICU婴儿中与抗反流（AR）配方相关的代谢性酸中毒的发生率、时间进程和可逆性，并识别相关临床因素。
研究设计： 对161名接受Novalac AR至少3天并具有连续血气数据的NICU婴儿进行回顾性队列研究（IV级NICU，首尔，2021-2025年）。
结果： 预设时间点分析显示，第3天（平均ΔBE -2.14 mEq/L；p < 0.001；n = 110）和第7天（-2.46 mEq/L；p < 0.001；n = 120）出现显著酸碱恶化。基于最低值的分析显示，平均碱剩余从0.53 ± 3.02降至-3.51 ± 3.18 mEq/L（平均ΔBE -4.04 mEq/L；95% CI -4.54至-3.54；p < 0.001）。按主要定义（pH < 7.35、HCO₃⁻ < 20 mmol/L且BE < -4 mEq/L），19/161名婴儿（11.8%）发生新发代谢性酸中毒；按更宽泛定义（HCO₃⁻ < 20 mmol/L且BE < -4 mEq/L），37/161名（23.0%）发生。酸碱恶化在开始后平均2.3天可检测到，并在中位5.4天（IQR 3.3-8.4）达到最低值；37.3%的婴儿记录的最低值出现在第7天之后。在50名停用AR配方的婴儿中，碱剩余平均改善+2.78 mEq/L（p < 0.001），77.8%从最低值改善。两名在确诊代谢性酸中毒后再次激发试验的婴儿均复发代谢性酸中毒。多变量分析中，开始时的较低月经后年龄（PMA）是酸中毒风险的唯一独立预测因素（每增加1周调整OR 0.71；95% CI 0.57-0.89；p = 0.003）。
结论： AR配方使用与符合回顾性安全性信号的酸碱变化存在时间关联，11.8%-23.0%的病例符合代谢性酸中毒标准；大多数病例在停用后这些变化可逆。在获得前瞻性确认之前，考虑在开始后第一周内进行酸碱监测可能是合理的，尤其应关注月经后年龄较低的婴儿。
英文摘要
OBJECTIVE: To determine the incidence, time course, and reversibility of metabolic acidosis associated with anti-reflux (AR) formula in NICU infants, and to identify associated clinical factors.
STUDY DESIGN: Retrospective cohort study of 161 NICU infants receiving Novalac AR for ≥ 3 days with serial blood gas data (Level IV NICU, Seoul, 2021-2025).
RESULTS: Pre-specified time-point analyses demonstrated significant acid-base deterioration at Day 3 (mean ΔBE - 2.14 mEq/L; p < 0.001; n = 110) and Day 7 (- 2.46 mEq/L; p < 0.001; n = 120). Nadir-based analysis showed mean base excess declining from 0.53 ± 3.02 to - 3.51 ± 3.18 mEq/L (mean ΔBE - 4.04 mEq/L; 95% CI - 4.54 to - 3.54; p < 0.001). New-onset metabolic acidosis occurred in 19/161 infants (11.8%) by primary definition (pH < 7.35, HCO₃⁻ <20 mmol/L, and BE < - 4 mEq/L) and 37/161 (23.0%) by broader definition (HCO₃⁻ <20 mmol/L and BE < - 4 mEq/L). Acid-base deterioration was detectable at a mean of 2.3 days after initiation and reached nadir at a median of 5.4 days (IQR 3.3-8.4); 37.3% of infants had their recorded nadir after day 7. Among 50 infants in whom AR formula was discontinued, base excess improved by a mean of + 2.78 mEq/L (p < 0.001), with 77.8% showing improvement from nadir. Both infants who underwent rechallenge following confirmed metabolic acidosis developed recurrent metabolic acidosis. Lower postmenstrual age (PMA) at initiation was the only independent predictor of acidosis risk on multivariable analysis (adjusted OR 0.71 per 1-week increase; 95% CI 0.57-0.89; p = 0.003).
CONCLUSION: AR formula use is temporally associated with acid-base changes consistent with a retrospective safety signal, meeting metabolic acidosis criteria in 11.8-23.0% of cases; these changes were reversible in most cases after discontinuation. Consideration of acid-base monitoring within the first week of initiation may be reasonable, pending prospective confirmation, with particular attention to infants at lower postmenstrual ages.