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临床试验:比较硅胶和乳胶经皮内镜胃造口管耐用性的随机研究。

Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes.

机构信息

Department of Gastrointestinal Endoscopy, Araujo Jorge Hospital, Goias, Brazil.

出版信息

Dig Endosc. 2011 Apr;23(2):135-9. doi: 10.1111/j.1443-1661.2010.01051.x. Epub 2010 Dec 7.

Abstract

BACKGROUND

The use of percutaneous endoscopic gastrostomy (PEG) for nutrition support is increasing worldwide, but few studies have evaluated the durability of and complications related to the different materials used to manufacture gastrostomy tubes. Latex PEG tubes are widely used in our clinical setting, but no studies have compared their durability with silicone PEG tubes. The aim of the present study was to compare the durability of latex tubes with the durability of silicone tubes.

PATIENTS AND METHODS

A randomized clinical trial was conducted in patients with head and neck cancer with indications for PEG. Sixty patients were randomized to receive either latex or silicone PEG tubes and followed up for 90 days. The analyzed outcomes were duration, peristomal infection, granulated tissue formation, and leakage around the tube.

RESULTS

The durability of silicone PEG tubes was significantly greater than the durability of latex PEG tubes. The survival curves showed that silicone PEG tubes lasted twice as long (hazard ratio = 2.0, 95% confidence interval = 1.1-3.7, P = 0.01). No differences were found with regard to rate of peristomal infection, granulated tissue formation, or leakage.

CONCLUSION

Silicone PEG tubes are associated with a reduced need for replacement (attributable to higher durability) compared with latex PEG tubes.

摘要

背景

经皮内镜下胃造口术(PEG)在全球范围内越来越多地用于营养支持,但很少有研究评估用于制造胃造口管的不同材料的耐用性和相关并发症。乳胶 PEG 管在我们的临床环境中广泛使用,但尚无研究比较其与硅酮 PEG 管的耐用性。本研究旨在比较乳胶管与硅酮管的耐用性。

患者和方法

对有 PEG 适应证的头颈部癌症患者进行了一项随机临床试验。将 60 名患者随机分为乳胶或硅酮 PEG 管组,并随访 90 天。分析的结果是持续时间、造口周围感染、肉芽组织形成和管周围漏液。

结果

硅酮 PEG 管的耐用性明显优于乳胶 PEG 管。生存曲线显示,硅酮 PEG 管的寿命是乳胶 PEG 管的两倍(风险比=2.0,95%置信区间=1.1-3.7,P=0.01)。造口周围感染、肉芽组织形成或漏液的发生率无差异。

结论

与乳胶 PEG 管相比,硅酮 PEG 管更换的需求减少(归因于更高的耐用性)。

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