MUSETM内镜下胃底折叠术治疗13例胃食管反流病的疗效分析

摘要

Objective To evaluate the efficacy and safety of endoscopic anterior fundoplication by the MUSETM endoscopic stapling device in gastroesophageal reflux disease (GERD).Methods From March to November 2017,in the Department of Gastroenterology of Chinese PLA General Hospital in Beijing,The First People's Hospital Affiliated to Shanghai Jiao Tong University and Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,thirteen GERD patients who underwent the endoscopic anterior fundoplication by the MUSETM system were enrolled.The GERD health related quality of life questionnaire (GERD-HRQL) score,satisfaction of symptomatic control,questionnaire for gastroesophageal reflux disease (GERD-Q) score,the degree of esophagitis,condition of gastroesophageal flap valve,medicine administration and side effects were compared before and after the operation.Paired t test and Wilcoxon rank sum test were performed for statistical analysis.Results The total GERD-HRQL score decreased from 23 points (14 to 36 points) before operation when proton pump inhibitor (PPI) was stopped for seven days to 3 points (0 to 21 points) at three months after operation and 1 point (0 to 18 points) at six months after operation;and the differences were statistically significant (Z=-3.111 and -3.183,both P＜0.01).Among 13 patients,the GERD-HRQL score of 11 patients decreased over 50 ％ after operation.The heartburn score decreased from 21 points (13 to 29 points) before operation when PPI was stopped for seven days to 0 point (0 to 17 points) at three months after operation and 0 point (0 to 16 points) at six months after operation;and the differences were statistically significant (Z=-3.113 and -3.182,both P＜0.01).Among 13 patients,assessment of symptom control at three months after operation of seven patients were satisfactory,four patients were mostly satisfactory and two patients were unsatisfactory;assessment of symptom control at six months after operation of nine patients were satisfactory,four patients were mostly satisfactory;and the satisfaction rate were both higher than that before operation,and the differences were statistically significant (x2=16.235 and 25.159,both P＜0.01).The total GERD-Q score reduced from 13 points (8 to 17 points) before operation to 6 points (3 to 11 points) at three months after operation and 6 points (6 to 13 points) at six months after operation (Z=-3.192 and-3.066,both P＜0.01).DeMeester score decreased from 38.40 points (20.20 to 255.30 points) to 11.10 points (1.10 to 46.20 points) at six months after operation;and the percent of total time of esophageal pH＜4 reduced from 10％ (5％ to 75％) to 3％ (0 to 13％) at six months after operation;the difference was statistically significant (Z=-3.181 and-3.180,both P=0.001).There was no significant difference in esophageal motility changes before and after treatment (all P ＞ 0.05).The number of patients without esophagitis increased from three before treatment to eight after treatment.Additionally,the number of patients whose gastroesophageal flap valve was less than grade Ⅱ increased from three before operation to 11 at six months after operation.The patients were followed up for six months,among 13 patients,10 patients were completely deprived of PPI,one patient was reduced over 50％,and two patients were treated with less than 50％ reduction.All 13 patients had mild tolerable abdominal pain and sore throat within 48 hours after operation.No other adverse reactions were observed.Conclusion The endoscopic anterior fundoplication by the MUSETM is a safe and effective treatment for GERD.%目的 评估MUSETM内镜下胃底折叠术治疗GERD的疗效和安全性.方法 纳入2017年3月至11月在北京解放军总医院、上海交通大学附属第一人民医院和上海交通大学医学院附属仁济医院消化科接受MUSETM内镜下胃底折叠术治疗的13例GERD患者,比较其手术治疗前后胃食管反流健康相关生命质量问卷(GERD-HRQL)评分、症状控制满意度、胃食管反流症状诊断问卷(GERD-Q)评分、食管炎程度、阀瓣情况、药物使用和不良反应等.统计学方法采用配对t检验和Wilcoxon秩和检验.结果 GERD-HRQL总评分由术前停用PPI 7 d时的23分(14～36分)降至术后3个月的3分(0～21分)和术后6个月的1分(0～18分),差异均有统计学意义(Z=-3.111、-3.183,P均＜0.01).13例患者中,术后GERD-HRQL总评分下降≥50％者11例.胃灼热症状总分由术前停用PPI 7 d时的21分(13～29分)降至术后3个月的0分(0～17分)和术后6个月的0分(0～16分),差异均有统计学意义(Z=-3.113、-3.182,P均＜0.01).13例患者中,术后3个月的症状控制评价为满意者7例,尚可者4例,不满意者2例;术后6个月的症状控制评价为满意者9例,尚可者4例;满意度均高于术前,差异均有统计学意义(x2=16.235、25.159,P均＜0.01).GERD-Q总评分由术前的13分(8～17分)降至术后3个月的6分(3～11分)和术后6个月的6分(6～l3分),差异均有统计学意义(Z=-3.192、-3.066,P均＜0.01).DeMeester积分由术前的38.40分(20.20～255.30分)降至术后6个月的11.10分(1.10～46.20分);pH值＜4的总时间占比由术前的10％(5％～75％)降至术后6个月的3％(0～13％);差异均有统计学意义(Z=-3.180、-3.181,P均=0.001).手术前后食管动力变化差异均无统计学意义(P均＞0.05).无食管炎的患者由术前的3例增至术后的8例.阀瓣形态≤Ⅱ级的患者由术前的3例增至11例.术后6个月随访,13例患者中完全停用PPI者10例,用药减少＞50％者1例,用药减少≤50％者2例.13例患者术后48 h内均有轻微可耐受的咽痛、上腹隐痛,无其他不良反应.结论 MUSETM内镜下胃底折叠术治疗GERD疗效显著,安全性好.