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首页> 外文期刊>Current opinion in gastroenterology >Endoscopic anti-reflux devices: a year of challenges and change.
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Endoscopic anti-reflux devices: a year of challenges and change.

机译：内窥镜防反流设备：挑战与变革的一年。

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摘要

PURPOSE OF REVIEW: Endoscopic antireflux procedures have generated much interest among clinicians and patients. These devices utilize a variety of methods in an attempt to decrease reflux of gastric contents. This work reviews the most notable results of endoscopic antireflux procedure studies published in 2005. RECENT FINDINGS: A variety of studies of different technologies have been published this year. Only a few of these studies report data beyond 12 months to establish longer term efficacy. One sham controlled multicenter trial was published this year. After case reports of complications related to Enteryx (Boston Scientific Corp, Natick, Massachusetts, USA) use, this US Food and Drug Administration-approved device was voluntarily removed from the market. SUMMARY: A review of the literature demonstrates a paucity of long-term studies, as well as a lack of data comparing the devices to active medical therapy. The majority of studies are open-label trials with subjective endpoints, and such study designs are very susceptible to placebo effect. No one technology has demonstrated superiority to another. Additional studies with vigorous attention to methodology, safety evaluation, cost analysis and clinically meaningful endpoints will be required.
机译：审查目的：内窥镜抗反流手术引起了临床医生和患者的极大兴趣。这些装置利用各种方法来尝试减少胃内容物的回流。这项工作回顾了2005年发表的内窥镜抗反流手术研究的最显着结果。最新发现：今年已经发表了各种有关不同技术的研究。这些研究中只有少数报告了超过12个月的数据以建立长期疗效。今年发表了一项假对照多中心试验。在收到与Enteryx（美国马萨诸塞州纳蒂克市的波士顿科学公司）相关的并发症的病例报告后，这种经美国食品药品监督管理局批准的设备被自愿从市场上撤下。简介：对文献的回顾表明，缺乏长期的研究，并且缺乏将器械与积极的药物治疗进行比较的数据。大多数研究是带有主观终点的开放标签试验，并且此类研究设计极易受到安慰剂作用的影响。没有一项技术显示出优于另一项的优势。将需要进行额外的研究，尤其要注意方法，安全性评估，成本分析和具有临床意义的终点。

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