Zhuang Qian Jun, Tan Nian Di, Chen Song Feng, Zhang Meng Yu, Xiao Ying Lian
Department of Gastroenterology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China.
J Dig Dis. 2021 Dec;22(12):695-705. doi: 10.1111/1751-2980.13063. Epub 2021 Nov 30.
In this systematic review and meta-analysis we aimed to determine the efficacy and safety of magnetic sphincter augmentation (MSA) in the management of refractory gastroesophageal reflux disease (rGERD).
Literature search was conducted in PubMed, the Cochrane Library, EMBASE, Web of Science, OpenGrey and ClincalTrials.gov for single-arm studies evaluating the efficacy and safety of MSA in rGERD or comparative studies with proton pump inhibitor (PPI) or laparoscopic Nissen fundoplication (LNF) serving as the control published until April 2020. Primary outcome was the rate of postoperative PPI use, and secondary outcomes included postoperative GERD-health-related quality of life (GERD-HRQL), normalization of acid exposure time (AET) and incidence of procedure-related adverse events (AE).
Ten single-arm studies, one randomized controlled trial and three cohort studies involving 1138 participants were included. Post-MSA PPI withdrawal, significant GERD-HRQL improvement and AET normalization were achieved in 87.0%, 88.0% and 75.0% of the patients, respectively. The incidence of postoperative dysphagia was 29% and endoscopic dilation was required in 7.4% of patients undergoing MSA. MSA showed a better efficacy in symptom control than PPI (PPI cessation: 91% vs 0%; GERD-HRQL improvement: 81% vs 8%) and similar effectiveness but a lower risk of gas-bloat syndrome (risk ratio [RR] 0.69, 95% confidence interval [CI] 0.51-0.93, P = 0.01) and better reserved ability to belch (RR 1.48, 95% CI 0.76-2.86, P = 0.25) compared with LNF.
MSA was an effective and safe therapy for rGERD. Well-designed randomized trials that compare the efficacy of MSA with other therapies are needed.
在本系统评价和荟萃分析中,我们旨在确定磁括约肌增强术(MSA)治疗难治性胃食管反流病(rGERD)的疗效和安全性。
在PubMed、Cochrane图书馆、EMBASE、Web of Science、OpenGrey和ClincalTrials.gov中进行文献检索,以查找评估MSA治疗rGERD疗效和安全性的单臂研究,或截至2020年4月发表的以质子泵抑制剂(PPI)或腹腔镜尼氏胃底折叠术(LNF)作为对照的比较研究。主要结局是术后使用PPI的比例,次要结局包括术后胃食管反流病健康相关生活质量(GERD-HRQL)、酸暴露时间(AET)正常化以及手术相关不良事件(AE)的发生率。
纳入了10项单臂研究、1项随机对照试验和3项队列研究,共1138名参与者。MSA术后停用PPI、GERD-HRQL显著改善和AET正常化的患者分别占87.0%、88.0%和75.0%。MSA术后吞咽困难的发生率为29%,7.4%接受MSA的患者需要内镜扩张。MSA在症状控制方面比PPI显示出更好的疗效(停用PPI:91%对0%;GERD-HRQL改善:81%对8%),与LNF相比效果相似,但气胀综合征风险较低(风险比[RR]0.69,95%置信区间[CI]0.51-0.9