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儿童经皮内镜胃造瘘术的抗生素预防:一项随机对照试验。

Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy in Children: A Randomised Controlled Trial.

机构信息

Department of General and Specialistic Surgery "Paride Stefanini", "Sapienza" University of Rome, Rome.

Department of Woman, Child and General and Specialistic Surgery, University of Campania "Luigi Vanvitelli", Naples.

出版信息

J Pediatr Gastroenterol Nutr. 2021 Mar 1;72(3):366-371. doi: 10.1097/MPG.0000000000002981.

DOI:10.1097/MPG.0000000000002981
PMID:33148981
Abstract

OBJECTIVES

Paediatric studies on the role of antibiotic prophylaxis in the prevention of postoperative infections in children undergoing percutaneous endoscopic gastrostomy (PEG) are lacking. The aim of this study was to assess if a single dose of co-amoxiclav before PEG can decrease the rate of peristomal wound and systemic infection in children.

METHODS

In this prospective, randomised, double-blind, multicentre trial, children undergoing PEG were randomized to antibiotic prophylaxis with co-amoxiclav versus placebo and the rate of local and systemic infections were assessed.

RESULTS

Of the 106 patients considered for inclusion, 49 patients were randomized. In the per-protocol analysis, the occurrence of wound infection was 5% (1/20) in the antibiotic group and 21% (4/19) in the placebo group (P = 0.13, 16% difference in proportions, odds ratio [OR] 0.19, 95% confidence interval [CI] 0.02-1.9). The occurrence of systemic infection was 9% (2/22) in the antibiotic group and 27.2% (6/25) in the placebo group [P = 0.17, 18% difference in proportions, OR 0.32, 95% CI 0.06%-1.80%]. Similar results were obtained in intention-to-treat analysis. Interestingly, the overall infection rate was significantly higher in the placebo group as compared with the antibiotic group (40% vs 13.6%; P = 0.04) and the duration of hospital stay was significantly longer in the placebo group as compared with the antibiotic group (4.4 ± 1.6 vs 3.5 ± 1.05; P = 0.02). The number-needed-to-treat (NTT) to prevent 1 peristomal infection on average are 6.7 patients.

CONCLUSIONS

A preoperative dose of co-amoxiclav reduces the overall infection rate and the duration of hospital stay. Our data suggest that antibiotic prophylaxis should be recommended in every children undergoing PEG placement.

摘要

目的

儿科经皮内镜胃造口术(PEG)术后感染预防中抗生素预防作用的研究缺乏儿童数据。本研究旨在评估 PEG 术前单次使用复方阿莫西林能否降低儿童造口周围伤口和全身感染的发生率。

方法

这是一项前瞻性、随机、双盲、多中心试验,将行 PEG 的患儿随机分为接受复方阿莫西林预防治疗和安慰剂组,并评估局部和全身感染的发生率。

结果

在纳入的 106 例患儿中,49 例患儿被随机分组。在符合方案分析中,抗生素组的伤口感染发生率为 5%(1/20),安慰剂组为 21%(4/19)(P=0.13,差异占比 16%,优势比[OR]0.19,95%置信区间[CI]0.02-1.9)。抗生素组的全身感染发生率为 9%(2/22),安慰剂组为 27.2%(6/25)(P=0.17,差异占比 18%,OR 0.32,95%CI 0.06%-1.80%)。意向性治疗分析得到了相似的结果。有趣的是,与抗生素组相比,安慰剂组的总感染率显著更高(40% vs 13.6%;P=0.04),且安慰剂组的住院时间显著更长(4.4±1.6 vs 3.5±1.05;P=0.02)。预防平均 1 例造口周围感染的治疗指数(NTT)为 6.7 例。

结论

术前使用复方阿莫西林可降低总体感染率和住院时间。我们的数据表明,抗生素预防治疗应推荐用于所有行 PEG 置管的儿童。

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Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy in Children: A Randomised Controlled Trial.儿童经皮内镜胃造瘘术的抗生素预防:一项随机对照试验。
J Pediatr Gastroenterol Nutr. 2021 Mar 1;72(3):366-371. doi: 10.1097/MPG.0000000000002981.
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