Schwartz M P, Wellink H, Gooszen H G, Conchillo J M, Samsom M, Smout A J P M
Department of Gastroenterology, University Medical Centre, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Gut. 2007 Jan;56(1):20-8. doi: 10.1136/gut.2006.096842. Epub 2006 Jun 8.
Endoscopic treatment for gastro-oesophageal reflux disease (GORD) is rapidly emerging, but there is a great need for randomised controlled trials to evaluate the efficacy.
A single-centre, double-blind, randomised, sham-controlled trial of endoscopic gastroplication by the Endocinch suturing system.
60 patients with GORD were randomly assigned to three endoscopic gastroplications (n = 20), a sham procedure (n = 20) or observation (n = 20). The research nurse and patients in the active and sham groups were blinded to the procedure assignment. After 3 months, open-label active treatment was offered to all patients.
The primary outcome measures were proton pump inhibitor (PPI) use and GORD symptoms, and secondary measures were quality of life, 24-h oesophageal acid exposure, oesophageal manometry and adverse events. Follow-up assessments were performed at 3, 6 and 12 months.
At 3 months, the percentage of patients who had reduced drug use by > or =50% was greater in the active treatment group (65%) than in the sham (25%) or observation groups (0%) (p<0.02). Symptoms (heartburn and to a lesser extent regurgitation) improved more in the active group than in the sham group. Three Short Form-20 quality of life subscales (role function, general health and bodily pain perception) improved in the active group versus sham. Oesophageal acid exposure was modestly decreased after active treatment (p<0.02), but not significantly greater than after the sham procedure (p = 0.61). The active treatment effects on PPI use, symptoms and quality of life persisted after 6 and 12 months of open-label follow-up (n = 41), but 29% of patients were retreated in this period. No serious adverse events occurred.
Endoscopic gastroplication, using the Endocinch device, reduced acid-inhibitory drug use, improved GORD symptoms and improved the quality of life at 3 months compared with a sham procedure. The effects persisted up to 12 months. However, the reduction in oesophageal acid exposure was not greater after endoscopic treatment than after a sham procedure.
内镜治疗胃食管反流病（GORD）正在迅速兴起，但迫切需要随机对照试验来评估其疗效。
一项采用Endocinch缝合系统进行内镜胃折叠术的单中心、双盲、随机、假手术对照试验。
60例GORD患者被随机分为三组，分别接受三次内镜胃折叠术（n = 20）、假手术（n = 20）或观察（n = 20）。研究护士以及接受积极治疗和假手术治疗的患者对手术分配情况不知情。3个月后，对所有患者提供开放标签的积极治疗。
主要观察指标为质子泵抑制剂（PPI）的使用情况和GORD症状，次要指标为生活质量、24小时食管酸暴露、食管测压和不良事件。在3、6和12个月时进行随访评估。
3个月时，积极治疗组中药物使用减少≥50%的患者比例（65%）高于假手术组（25%）和观察组（0%）（p<0.02）。积极治疗组的症状（烧心，反流程度较轻）改善程度优于假手术组。积极治疗组与假手术组相比，三个简短健康调查问卷20项生活质量子量表（角色功能、总体健康和身体疼痛感知）有所改善。积极治疗后食管酸暴露略有下降（p<0.02），但与假手术后相比无显著差异（p = 0.61）。在开放标签随访6个月和12个月（n = 41）后，积极治疗对PPI使用、症状和生活质量的影响仍然存在，但在此期间29%的患者接受了再次治疗。未发生严重不良事件。
与假手术相比, 使用Endocinch装置进行内镜胃折叠术在3个月时减少了抑酸药物的使用，改善了GORD症状并提高了生活质量。这些效果持续了12个月。然而，内镜治疗后食管酸暴露的减少并不比假手术后更大。
