A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease
A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease
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DOI：
10.1007/s00464-009-0671-4
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发表时间：
2010-04-01
影响因子：
3.1
通讯作者：
Lehman, Glen A.
中科院分区：
文献类型：
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作者：
Aziz, Ayman M. Abdel;El-Khayat, Hisham R.;Lehman, Glen A.
胃食管反流病（GERD）是一种常见的疾病，通常需要长期的药物治疗或手术。几项研究表明，放射性（RF）能量输送（Stretta手术）可改善约三分之二患者的GERD症状和生活质量。作者提出增加Stretta的剂量将进一步改善这种治疗的反应。在这项研究中，36名患者被随机分为三组。在A组中，12名患者接受了单次Stretta手术。在B组中，12名患者接受了假Stretta手术（除了没有展开电极外，所有方面均与主动手术相同）。在C组中，12名患者接受了单次Stretta治疗，如果GERD健康相关生活质量（HRQL）在4个月后改善不超过75%，则重复Stretta治疗。对于每例患者，每次治疗创建56个射频损伤。主要结局为GERD HRQL改善。次要结局为药物使用、下食管括约肌（LES）基础压、食管炎内镜分级和pH探头测得的食管酸暴露。两个积极治疗组的所有患者均成功完成Stretta手术。在12个月时，两个Stretta组中停药患者的平均HRQL评分、LES基础压、24小时pH评分和质子泵抑制剂（PPI）每日剂量消耗量均较基线显著改善（p < 0.01）。在平均HRQL、平均24 h pH、平均LES压力和PPI使用方面，双Stretta在数值上但并不显著优于单Stretta。双Stretta治疗组中有7例患者在12个月时HRQL正常化，而单治疗组中有2例患者（p = 0.035）。假手术组患者的每日PPI剂量（p < 0.05）和平均HRQL评分（p < 0.05）略有下降，但具有统计学显著性。未发生严重并发症（出血、穿孔或死亡）。然而，两名患者在第二次Stretta治疗后出现了显著的胃排空延迟，与假手术相比，Stretta手术显著降低了GERD HRQL、PPI药物的使用、食管酸暴露、LES压力和食管炎分级。与单次Stretta治疗相比，双次Stretta治疗在大多数参数方面具有数值上的上级结局，并且HRQL评分的正常化频率显著更高。
Gastroesophageal reflux disease (GERD) is a prevalent disorder that often requires long-term medical therapy or surgery. Radiofrequency (RF) energy delivery (Stretta procedure) has been shown in several studies to improve GERD symptoms and quality of life for approximately two-thirds of patients. The authors proposed that increasing the dose of Stretta would further improve the response to this therapy.For this study, 36 patients were randomized into three groups. In group A, 12 patients underwent a single-session Stretta procedure. In group B, 12 patients underwent a sham Stretta procedure (mirror of the active procedure in all aspects except there was no deployment of the electrodes). In group C, 12 patients underwent a single Stretta treatment followed by repeat Stretta if GERD health-related quality of life (HRQL) was not 75% improved after 4 months. For each patient, 56 RF lesions were created per session. The principal outcome was GERD HRQL improvement. The secondary outcomes were medication use, lower esophageal sphincter (LES) basal pressure, endoscopic grade of esophagitis, and esophageal acid exposure by pH probe.The Stretta procedure was completed successfully for all the patients in both active treatment groups. At 12 months, the mean HRQL scores of those off medications, the LES basal pressure, the 24-h pH scores, and the proton pump inhibitor (PPI) daily dose consumption were significantly improved from baseline in both Stretta groups (p < 0.01). The double Stretta was numerically but not significantly better than the single Stretta for mean HRQL, mean 24 h pH, mean LES pressure, and PPI use. Seven patients in the double Stretta treatment group had normalized their HRQL at 12 months compared with 2 patients in the single-treatment group (p = 0.035). The sham patients had a small but statistically significant decrease in their daily PPI dosages (p < 0.05) and mean HRQL scores (p < 0.05). No serious complications (bleeding, perforation, or death) occurred. However, two patients experienced significant delayed gastric emptying after the second Stretta treatment.The Stretta procedure significantly reduced GERD HRQL, use of PPI drugs, esophageal acid exposure, LES pressure, and grade of esophagitis compared with the sham procedure. The double Stretta therapy had numerically superior outcomes for most parameters and a significantly more frequent normalization of HRQL scores compared with the single Stretta.