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随机对照研究 3%氯化钠溶液与 30%氯化钠溶液治疗脐肉芽肿的疗效比较。

Randomised comparative study on the efficacy of 3% versus 30% NaCl solution in the treatment of umbilical granuloma.

机构信息

Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Division of Pharmacy, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

出版信息

J Paediatr Child Health. 2022 Sep;58(9):1566-1570. doi: 10.1111/jpc.16034. Epub 2022 May 31.

DOI:10.1111/jpc.16034
PMID:35638455
Abstract

AIM

This study aimed to compare the efficacy of 3% versus 30% NaCl solution in treating umbilical granuloma (UG) and to evaluate parental satisfaction.

METHODS

A randomised, double-blinded, comparative study in neonates with UG was conducted. Stratified, block-of-four randomisation was used to allocate neonates into two groups, treated with 3% or 30% pharmaceutical-grade NaCl solution, three times daily. The time to resolution was determined by daily photographs of UG and weekly hospital visits. If there was no response after 2 weeks, silver nitrate was used. Parental satisfaction was measured on a rating scale of 1-5.

RESULTS

One hundred neonates were enrolled, 48 in the 3% NaCl group and 52 in the 30% NaCl group. Baseline demographic data were not different between the groups. There was no significant difference in the resolution rate (93.8% vs 98.1%) or the median (interquartile range) time to resolution (7 (5-13) vs 7 (4-11) days) between the 3% and 30% NaCl groups, respectively. No skin burn or cellulitis was detected. About 95% of parents scored >4 for satisfaction.

CONCLUSIONS

Hypertonic NaCl solution is highly effective in treating UG without side effects. Hypertonic NaCl solution should be considered as an alternative treatment for UG.

摘要

目的

本研究旨在比较 3%与 30%氯化钠溶液治疗脐肉芽肿(UG)的疗效,并评估家长满意度。

方法

对患有 UG 的新生儿进行随机、双盲、对照研究。采用分层、四分组随机化将新生儿分为两组,分别用 3%或 30%医药级氯化钠溶液,每日三次治疗。通过每日 UG 照片和每周医院就诊来确定 UG 消退时间。如果 2 周后无反应,则使用硝酸银。家长满意度采用 1-5 分的评分量表进行测量。

结果

共纳入 100 例新生儿,3%氯化钠组 48 例,30%氯化钠组 52 例。两组间基线人口统计学数据无差异。3%氯化钠组和 30%氯化钠组的消退率(93.8% vs 98.1%)或中位(四分位距)消退时间(7(5-13) vs 7(4-11)天)均无显著差异。未发现皮肤烧伤或蜂窝织炎。约 95%的家长对满意度评分>4。

结论

高渗氯化钠溶液治疗 UG 有效,无副作用。高渗氯化钠溶液应作为 UG 的替代治疗方法。

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引用本文的文献

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Umbilical Granuloma: Frequency, Associated Factors, 10-Year Treatment Trends, and Effectiveness at a Single Hospital in Japan.脐肉芽肿:日本一家医院的发病率、相关因素、10年治疗趋势及疗效
J Clin Med. 2023 Sep 21;12(18):6104. doi: 10.3390/jcm12186104.