Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX
Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX
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DOI：
10.1007/s00464-009-0384-8
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发表时间：
2009-05-01
影响因子：
3.1
通讯作者：
Rajan, Amin
中科院分区：
文献类型：
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作者：
Cadiere, Guy-Bernard;Van Sante, Nathalie;Rajan, Amin
一项可行性研究(n=19)评价了经口腔无切口胃底折叠术(TIF)治疗胃食道疾病(GERD)的安全性和初步疗效。1年后(n=17)的结果表明，TIF是安全的，在减少GERD症状、质子泵抑制剂(PPI)的使用、酸暴露和小型裂孔疝方面有显著效果。这项研究旨在评估TIF的长期安全性和持久性。14名患者(50%女性，中位年龄，34岁)完成了为期2年的随访评估测试。三名患者在一年后被排除在研究之外，因为其中两名患者接受了再次治疗，一名患者失去了随访。两年后，没有与TIF相关的不良事件报告。GERD-HRQL评分较基线改善50%的PPI是由%的患者维持的。TIF对93%的患者胃灼热消除有效，71%患者每日PPI治疗有效。显著的(p<；0.05)与PPI基线相比，更多的患者能够在没有GERD症状的情况下食用引起反流的食物并维持生活方式。折叠器经久耐用，并保持其几何尺寸。TIF有效率为60%，食管炎有效率为55%。对每个患者的所有结果的全球评估显示，79%的患者在TIF后2年内GERD完全治愈(29%)或缓解(50%)。2年后的结果支持TIF的长期安全性和持久性及其在消除烧心、食管炎、千分之二货币符号2厘米裂孔疝气和每日对PPI的依赖方面的持续效果。
A feasibility study (n = 19) evaluated the safety and initial efficacy of transoral incisionless fundoplication (TIF) for the treatment of gastroesophageal disease (GERD). The results at 1 year (n = 17) indicated that TIF was safe and had a significant effect on reducing GERD symptoms, proton pump inhibitor (PPI) usage, acid exposure, and small hiatal hernia. This study was designed to evaluate the long-term safety and durability of TIF.Fourteen patients (50% female; median age, 34 years) completed the 2-year follow-up assessment tests. Three patients were excluded from the study after 1 year because two of them underwent retreatment and one was lost to follow-up.At 2 years, no adverse events related to TIF were reported. A a parts per thousand yen50% improvement in GERD-HRQL scores compared with those at baseline on PPIs was sustained by 64% of patients. TIF was effective in eliminating heartburn in 93% of patients and daily PPI therapy in 71% of patients. Significantly (p < 0.05) more patients were able to consume reflux-causing foods and maintain lifestyle activities without GERD symptoms compared with baseline on PPIs. Fundoplications were durable and maintained their geometric dimensions. TIF was effective in eliminating hiatal hernia in 60% of patients and esophagitis in 55% of patients. Global assessment of all outcomes in each patient revealed that 79% of patients experienced complete cure (29%) or remission (50%) of GERD at 2 years after TIF.The results at 2 years supported the long-term safety and durability of TIF and its sustained effect on the elimination of heartburn, esophagitis, a parts per thousand currency sign2 cm hiatal hernia, and daily dependence on PPIs.