内镜下抗反流黏膜切除术与热能射频治疗难治性胃食管反流病的临床疗效对比:一项单中心随机试验

Anti-reflux mucosectomy versus radiofrequency energy delivery for refractory gastroesophageal reflux disease: a single-center randomized controlled trial

目的比较抗反流黏膜切除术(ARMS)和热能射频消融(RF)治疗难治性胃食管反流病(RGERD)的临床疗效。方法本研究为单中心的随机对照研究,研究对象为2018年4月至2019年7月在南京医科大学第一附属医院消化科就诊的RGERD患者。将RGERD患者1∶1随机分为ARMS组和RF组,在术前和术后2年对患者进行GERD问卷(GERD-Q)和反流性疾病问卷(RDQ)评分,主要结局指标为术后2年GERD-Q及RDQ评分,次要结局指标为术后2年质子泵抑制剂(PPI)停用率和患者满意率。结果本研究共纳入分析34例患者(ARMS组18例,RF组16例),2组患者的手术操作成功率均为100%。与RF组相比,ARMS组患者住院时间更长[(7.50±1.76)比(6.06±2.24)d,P=0.044],术后吞咽困难发生率更高(27.78%比0%,P=0.046)。术后2年,2组患者间GERD-Q和RDQ评分无统计学差异[(9.56±7.16)比(8.06±6.64)分,(10.00±6.00)比(9.81±4.71)分;P均>0.05]。ARMS与RF组患者间PPI停用率和患者满意率无统计学差异[61.11%比68.75%,61.11%比62.50%;P均>0.05]。结论内镜下ARMS与射频消融治疗RGERD的临床疗效相当,疗效可维持至少2年,ARMS在RGERD治疗上具有应用前景。

Objective To compare the efficacy of Anti-reflux mucosectomy(ARMS)and radiofrequency(RF)energy delivery in gastroesophageal reflux disease(GERD).Methods Patients with refractory GERD(RGERD)were 1:1 randomly assigned to either ARMS group or RF group.GERD questionnaire(GERD-Q)and reflux disease questionnaire(RDQ)were performed before and 2 years after the procedures.Primary outcome was the scores of GERD-Q and RDQ at 2 years postoperatively.The Secondary outcomes were proportions of patients who completely stopped proton pump inhibitor(PPI)use and who were satisfied with the treatment postoperatively.Results Thirty-four patients were analyzed,with 18 in ARMS group and 16 in RF group.In both groups,the operation success rate was 100%.Compared to RF group,the length of stay in ARMS group was significantly longer[(7.50±1.76)vs(6.06±2.24)d,P=0.044],and the incidence rate of dysphagia was higher(27.78%vs 0%,P=0.046).At 2 years postoperatively,the scores of GERD-Q and RDQ did not differ between the two groups[(9.56±7.16)vs(8.06±6.64)points,(10.00±6.00)vs(9.81±4.71)points;P all>0.05].The PPIs cessation and patient satisfaction rates did not differ between ARMS and RF group(61.11%vs 68.75%,61.11%vs 62.50%;P all>0.05).Conclusion The clinical efficacy of ARMS and RF for RGERD is equivalent.ARMS,the efficacy of which could be maintained for at least 2 years,is a promising endoscopic management for RGERD.