磁性括约肌增强器治疗胃食管反流病术后不良反应与处理策略

Management strategies of adverse reactions to magnetic sphincter augmentation for gastroesophageal reflux disease

目的拟探讨国产磁性括约肌增强器(MSA)治疗胃食管反流病(GERD)的不良反应与处理策略。方法按照上海市胸科医院-胜杰康公司磁性括约肌增强器(SS-MSA)临床试验的入排标准,2018年8月至2021年10月共纳入43例GERD患者接受MSA治疗,在腹腔镜下完成SS-MSA植入手术。术后主要疗效评价指标包括24 h酸暴露总时间、受试者服用PPI药物情况及GERD健康相关生活质量评分(GERD-Q)。记录并发症发生情况。本试验已在中国临床试验注册中心注册(注册号:ChiCTRONC-16009512)。结果43例接受MSA治疗患者中,23例完成1年的随访,24 h酸暴露总时间术前9%(6.2%~13.4%),术后0.4%(0.1%~2.4%),差异有统计学意义(P<0.001);术前GERD-HRQL评分为11(8~14),术后1年为6(6~11),较术前显著下降,差异有统计学意义(P=0.001)。受试者术前全部服用质子泵抑制剂(PPI)药物,术后持续性服用PPI药物患者为5例(21.7%,5/23)、入组患者可正常嗳气、打嗝。术后最常见的并发症为吞咽困难,发生率为86%(37/43),其中95%(35/37例)为轻中度,均在术后1~3个月缓解。2例患者术后1个月左右出现严重吞咽困难,术中分别植入13、14号MSA,均将装置取出。其余腹泻、腹痛、便秘、恶心等并发症,除1例腹泻患者住院治疗外,其余均对症治疗。术后仍有反酸症状持续者27例,短期缓解者13例,存在症状超过3个月的13例,以轻中度为主。1例因反流严重取出装置。1例因胸痛取出装置。结论SS-MSA手术后并发症主要为吞咽困难,短期内大多数均能缓解。选择好适当型号的MSA装置,良好的术前宣教、术后饮食指导将保证该术式的成功率。

Objective Magnetic sphincter augmentation(MSA)is a new surgical treatment for gastroesophageal reflux disease(GERD).This study aimed to explore the postoperative complications and management strategies of Chinese MSA in the treatment of GERD.Methods According to the enrollment criteria for the SS-MSA clinical trial,43 GERD patients were treated with MSA from August 2018 to October 2021.SSMSA,jointly developed by ShengJieKang Co.and Shanghai Chest Hospital,was implanted via laparoscopy.The primary evaluation index of postoperative efficacy included the total time of acid exposure within 24 h,the average daily dose of PPI medications and GERD-Health Related Quality of Life(GERD-Q)improvement after MSA implantation.The complications were recorded.This trial was registered with the Chinese Clinical Trial Registry(registration number:ChiCTR-ONC-16009512).Results Among the 43 GERD patients undergoing SS-MSA surgery,23 cases were followed up for 1 year.The total time of acid exposure within 24 h[9%(6.2%-13.4%)vs 0.4%(0.1%-2.4%),P<0.001]and GERD-Q score[11(8-14)vs 6(6-11),P=0.001]were improved after operation significantly.All subjects took proton pump inhibitor(PPI)drugs before surgery,while 5 patients(21.7%)needed long-term administration of PPI postoperatively.The patients could belch normally.The most common complication after the operation was dysphagia(37/43,86%),of which 95%(35/37 cases)were mild to moderate and were relieved within 1-3 months.Two patients developed severe dysphagia one month after the operation with the size of MSA 13 and 14,both of which were removed.Other postoperative adverse events included diarrhea,abdominal pain,constipation,and nausea.All patients received symptomatic therapy and were relieved within 3 months,except for one case of diarrhea with readmission.Twenty-seven patients underwent persistent acid reflux symptoms postoperatively.The symptoms disappeared within 3 months in 13 patients and mild to moderate symptoms persisted in 14 patients,with intermittent or continuous use of PPI drugs and one patient had the device removed due to serious reflux.One patient had the device removed due to chest pain.Conclusions The main complication was dysphagia after SS-MSA implantation,which could be relieved in a short time.Proper selection of MSA devices,good preoperative education and postoperative diet guidance will ensure the success rate of the operation.