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局部应用丝裂霉素 C 治疗腐蚀性食管狭窄的疗效:一项双盲、随机、安慰剂对照试验。

Topical mitomycin C application is effective in management of localized caustic esophageal stricture: a double-blinded, randomized, placebo-controlled trial.

机构信息

Department of Pediatric Surgery, Ain Shams University, Cairo, Egypt.

出版信息

J Pediatr Surg. 2013 Jul;48(7):1621-7. doi: 10.1016/j.jpedsurg.2013.04.014.

DOI:10.1016/j.jpedsurg.2013.04.014
PMID:23895984
Abstract

BACKGROUND

Frequent sessions of endoscopic dilatation are usually required in the management of benign esophageal strictures, especially caustic induced ones. Topical mitomycin C (MMC) has been recently used in the management of resistant strictures. This study evaluated the efficacy of MMC application in prevention of stricture recurrence after endoscopic dilatation.

PATIENTS AND METHODS

This double-blind, randomized, placebo-controlled trial included forty patients with caustic esophageal strictures dating from January 2008 to October 2010. Patients were randomized into 2 groups to undergo endoscopic dilatation with application of either MMC versus placebo on stricture site. Regular follow up and re-evaluation were done after 6 months of management. The number of dilatation sessions needed for resolution of dysphagia in each group was our primary outcome.

RESULTS

During the specified follow up period, 80 % of strictures in the MMC group got completely resolved compared to only 35% in the placebo group. The mean number of dilatation sessions needed in the MMC group was n = 3.85 ± 2.08 compared to n = 6.9 ± 2.12 in the placebo group which was statistically significant (p < 0.001).

CONCLUSION

Mitomycin C application significantly reduced the number of dilatation sessions needed to alleviate dysphagia in patients with caustic esophageal strictures.

摘要

背景

在良性食管狭窄的治疗中,特别是腐蚀性狭窄,通常需要频繁进行内镜扩张。局部应用丝裂霉素 C(MMC)最近已用于治疗耐药性狭窄。本研究评估了 MMC 应用在预防内镜扩张后狭窄复发中的疗效。

患者和方法

这是一项双盲、随机、安慰剂对照试验,纳入了 2008 年 1 月至 2010 年 10 月期间的 40 例腐蚀性食管狭窄患者。患者随机分为两组,在狭窄部位进行内镜扩张,分别应用 MMC 或安慰剂。管理后 6 个月进行定期随访和重新评估。我们的主要结果是每组需要多少次扩张来缓解吞咽困难。

结果

在指定的随访期间,MMC 组 80%的狭窄完全缓解,而安慰剂组仅为 35%。MMC 组需要的扩张次数平均为 n = 3.85 ± 2.08,而安慰剂组为 n = 6.9 ± 2.12,差异具有统计学意义(p < 0.001)。

结论

MMC 应用显著减少了缓解腐蚀性食管狭窄患者吞咽困难所需的扩张次数。

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