Department of Surgery, The Ohio State University, 548 Doan Hall, 410 W. 10th Avenue, Columbus, OH, 43210, USA,
Surg Endosc. 2013 Oct;27(10):3754-61. doi: 10.1007/s00464-013-2961-0. Epub 2013 May 4.
Gastroesophageal reflux disease (GERD) remains a significant problem for the medical community. Many endoluminal treatments for GERD have been developed with little success. Currently, transoral incisionless fundoplication (TIF) attempts to recreate a surgical fundoplication through placement of full-thickness polypropylene H-fasteners. This, the most recent procedure to gain FDA approval, has shown some promise in the early data. However, questions of its safety profile, efficacy, and durability remain.
The Cochrane Library and MEDLINE through PubMed were searched to identify published studies reporting on subjective and objective GERD indices after TIF. The search was limited to human studies published in English from 2006 up to March 2012. Data collected included GERD-HRQL and RSI scores, PPI discontinuation and patient satisfaction rates, pH study metrics, complications, and treatment failures. Statistical analysis was performed with weighted t tests.
Titles and abstracts of 214 papers were initially reviewed. Fifteen studies were found to be eligible, reporting on over 550 procedures. Both GERD-HRQL scores (21.9 vs. 5.9, p < 0.0001) and RSI scores (24.5 vs. 5.4, p ≤ 0.0001) were significantly reduced after TIF. Overall patient satisfaction was 72 %. The overall rate of PPI discontinuation was 67 % across all studies, with a mean follow-up of 8.3 months. pH metrics were not consistently normalized. The major complication rate was 3.2 % and the failure rate was 7.2 % across all studies.
TIF appears to provide symptomatic relief with reasonable levels of patient satisfaction at short-term follow-up. A well-designed prospective clinical trial is needed to assess the effectiveness and durability of TIF as well as to identify the patient population that will benefit from this procedure.
胃食管反流病（GERD）仍然是医学界的一个重大问题。许多针对 GERD 的内镜治疗方法都收效甚微。目前，经口无切口胃底折叠术（TIF）试图通过放置全层聚丙烯 H 型紧固件来重现手术胃底折叠术。这是最近获得 FDA 批准的程序，在早期数据中显示出了一些希望。然而，其安全性、疗效和持久性仍存在疑问。
通过 Cochrane 图书馆和 MEDLINE 检索 Pubmed 以确定发表的报告 TIF 后主观和客观 GERD 指数的研究。搜索仅限于 2006 年至 2012 年 3 月期间以英文发表的人类研究。收集的数据包括 GERD-HRQL 和 RSI 评分、PPI 停药率和患者满意度、pH 研究指标、并发症和治疗失败。使用加权 t 检验进行统计分析。
最初审查了 214 篇论文的标题和摘要。发现 15 项研究符合条件，报告了 550 多例手术。TIF 后 GERD-HRQL 评分（21.9 与 5.9，p<0.0001）和 RSI 评分（24.5 与 5.4，p≤0.0001）均显著降低。总体患者满意度为 72%。所有研究中 PPI 停药率总体为 67%，平均随访时间为 8.3 个月。pH 指标未得到一致正常化。主要并发症发生率为 3.2%，所有研究的失败率为 7.2%。
TIF 在短期随访中似乎能提供症状缓解，并获得相当程度的患者满意度。需要进行精心设计的前瞻性临床试验来评估 TIF 的有效性和持久性，并确定将从该程序中受益的患者人群。
