Nonresorbable copolymer implantation for gastroesophageal reflux disease:: A randomized sham-controlled multicenter trial
Nonresorbable copolymer implantation for gastroesophageal reflux disease:: A randomized sham-controlled multicenter trial
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DOI：
10.1053/j.gastro.2004.12.005
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发表时间：
2005-03-01
期刊：
影响因子：
29.4
通讯作者：
Schumacher, B
中科院分区：
文献类型：
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作者：
Devière, J;Costamagna, G;Schumacher, B
背景和目标：本研究旨在确定内镜下植入生物相容性不可吸收共聚物（Enteryx; Boston Scientific Corp，Natick，MA）是否比假手术更有效治疗胃食管反流病（GERD）。研究方法：在一项随机、单盲、前瞻性、多中心临床试验中，纳入了64例GERD患者，这些患者的症状通过质子泵抑制剂（PPI）治疗得到良好控制，并且在停止PPI治疗后迅速复发。32例患者被分配接受Enteryx植入术，32例患者接受由标准上消化道内窥镜检查组成的假手术。两组中3个月后症状缓解不满意的患者有资格接受Enteryx植入术的再次治疗。主要研究终点是PPI使用减少大于或等于50%。次要终点包括GERD评分改善≥ 50%和未接受再次治疗的患者比例。在3个月和6个月时进行随访评价。结果如下：Enteryx治疗组PPI使用减少≥ 50%的患者百分比（81%）高于假手术组（53%），率比为1.52（置信区间[CI]，1.06-2.28; P = 0.023）。Enteryx组（68%）完全停用PPI的比例高于假手术组（41%）（率比，1.67; CI，1.03-2.80; P = 0.033）。Enteryx组与假手术组相比，GERD健康相关生活质量烧心评分改善50%的比例为67%，而假手术组为22%（率比，3.05; CI，1.55-6.33; P <0.001）。Enteryx治疗组（81%）比假治疗组（19%）有更多的患者未接受再治疗（率比，4.33; CI，2.23-9.29; P <0.001）。结论：Enteryx植入比假手术更有效地降低PPI依赖性并减轻GERD症状。
Background & Aims: This aim was to determine whether endoscopic implantation of a biocompatible nonresorbable copolymer (Enteryx; Boston Scientific Corp, Natick, MA) is a more effective therapy for gastroesophageal reflux disease (GERD) than a sham procedure. Methods: In a randomized, single-blind, prospective, multicenter clinical trial, 64 patients with GERD were enrolled whose symptoms were well controlled by proton pump inhibitor (PPI) therapy and rapidly recurred after cessation of PPI therapy. Thirty-two patients were assigned to Enteryx implantation and 32 to a sham procedure consisting of standard upper endoscopy. Patients in both groups with unsatisfactory symptom relief after 3 months were eligible for re-treatment by Enteryx implantation. The primary study end point was greater than or equal to50% reduction in PPI use. Secondary end points included greater than or equal to50% improvement in GERD score and the proportion of patients not undergoing re-treatment procedure. Follow-up evaluations were performed at 3 and 6 months. Results: The percentage of Enteryx-treated patients achieving a greater than or equal to50% reduction in PPI use (81%) was greater than that of the sham group (53%), with a rate ratio of 1.52 (confidence interval [CI], 1.06-2.28; P = .023). A higher proportion of the Enteryx (68%) than sham group (41%) ceased PPI use completely (rate ratio, 1.67; CI, 1.03-2.80; P = .033). GERD health-related quality of life heartburn score improvement 50% was achieved by 67% of the Enteryx group versus 22% of the sham group (rate ratio, 3.05; CI, 1.55-6.33; P < .001). More Enteryx-treated (81%) than sham-treated (19%) patients did not undergo re-treatment (rate ratio, 4.33; CI, 2.23-9.29; P < .001). Conclusions: Enteryx implantation more effectively reduces PPI dependency and alleviates GERD symptoms than a sham procedure.