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盐与硫酸铜治疗脐肉芽肿的疗效比较:一项初步随机对照试验。

Effectiveness of table salt versus copper sulphate in treating umbilical granuloma: A pilot randomized controlled trial.

机构信息

Division of Paediatric and Neonatal Surgery, Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, Malaysia.

Department of Paediatric Surgery, Sarawak General Hospital, Kuching, Sarawak, Malaysia.

出版信息

J Pediatr Surg. 2022 Feb;57(2):261-265. doi: 10.1016/j.jpedsurg.2021.10.032. Epub 2021 Oct 30.

DOI:10.1016/j.jpedsurg.2021.10.032
PMID:34838305
Abstract

BACKGROUND

Umbilical granuloma is a common infantile condition which usually responds to non operative management. Copper sulphate (CuSO) is often used as chemical cauterization but can cause superficial skin burns. An alternative is table salt (NaCl), which osmotically dehydrates wet granulation tissue causing necrosis. We aimed to compare the effectiveness of NaCl versus CuSO in treating umbilical granuloma.

METHOD

We performed a multi centerrandomized controlled trial involving three regional pediatricsurgical units. We included children who presented with umbilical granuloma from December 2018 to May 2020. Children who received treatment prior to index visit were excluded. They were randomly allocated to receive NaCl (twice/day application for 5 days by caregiver) or CuSO (single application by clinician). Demographic data, compliance in the NaCl group by pill counting method, treatment outcomes, and complications were recorded. Treatment success was defined as complete lesion resolution. Partial or no response was considered treatment failure. Subsequent treatment then reverted to the respective center's routine management.

RESULT

We recruited 70 participants with 6 dropouts (2 defaulters, 1 vitellointestinal duct, 3 urachal remnants), leaving 64 subjects for final analysis: 31 NaCl, 33 CuSO. Compliance rate of 77.4% was recorded for NaCl, with 6 (20%) 'poor compliance' participants stopping therapy before completion owing to complete resolution. NaCl group had a significantly higher complete resolution rate (90.4%) compared to CuSO (69.7%), p = 0.040. No NaCl participant developed complications versus 9% (n = 3) in CuSO (periumbilical superficial skin burn).

CONCLUSION

Table salt is an ideal treatment choice for umbilical granuloma as it is effective, safe, and readily available.

LEVEL OF EVIDENCE

II.

摘要

背景

脐肉芽肿是一种常见的婴儿疾病,通常对非手术治疗有反应。硫酸铜(CuSO)常用于化学烧灼,但会导致浅表皮肤烧伤。另一种选择是食盐(NaCl),它通过渗透作用使湿润的肉芽组织脱水,导致坏死。我们旨在比较 NaCl 和 CuSO 治疗脐肉芽肿的效果。

方法

我们进行了一项多中心随机对照试验,涉及三个区域小儿外科单位。我们纳入了 2018 年 12 月至 2020 年 5 月就诊的脐肉芽肿患儿。在就诊前已接受治疗的患儿被排除在外。他们被随机分配接受 NaCl(由照顾者每天两次应用,共 5 天)或 CuSO(由临床医生单次应用)治疗。记录人口统计学数据、NaCl 组的用药依从性(通过药丸计数法)、治疗结果和并发症。治疗成功定义为病变完全消退。部分或无反应被认为是治疗失败。随后的治疗恢复到各中心的常规管理。

结果

我们招募了 70 名参与者,其中 6 名失访(2 名不遵医嘱、1 名卵黄肠管、3 名脐尿管残余),最终有 64 名参与者完成了分析:31 名 NaCl,33 名 CuSO。NaCl 的依从率为 77.4%,有 6 名(20%)“依从性差”的参与者在完全缓解前停止了治疗。NaCl 组的完全缓解率(90.4%)明显高于 CuSO(69.7%),p=0.040。NaCl 组无一例发生并发症,而 CuSO 组有 9%(n=3)发生脐周浅表皮肤烧伤。

结论

食盐是治疗脐肉芽肿的理想选择,因为它有效、安全且易于获得。

证据水平

II 级。

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