Stanak Michal, Erdos Judit, Hawlik Katharina, Birsan Tudor
Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria.
St. John of God Hospital, Vienna, Austria.
Gastroenterology Res. 2018 Jun;11(3):161-173. doi: 10.14740/gr1024w. Epub 2018 May 31.
Electric stimulation therapy (EST) and magnetic sphincter augmentation (MSA) represent novel methods for the surgical treatment of gastroesophageal reflux disease (GERD). The aim of this review was to assess the effectiveness and safety of EST and magnetic sphincter augmentation device (MSAD) comapred to laparoscopic fundoplication (LF) and proton pump inhibitor therapy (in case of EST). We performed a systematic literature search without restrictions on publication dates in five electronic databases (MEDLINE, EMBASE, the Cochrane library, PubMed, and Centre for Reviews and Dissemination), complemented by hand search, search in trial registries, and documentation provided by the manufacturers. No study passed inclusion criteria for analyzing EST effectiveness. Concerning safety, lead erosion through the esophagus and trocar perforation of the small bowel occurred in 2.4% of patients (in one study). Only the registry study fulfilled inclusion criteria for effectiveness analysis of MSAD. The crucial outcome of GERD-health-related quality of life (HRQL) score improved from 20 to 3 points in MSAD patients, and from 23 to 3.5 points in LF patients. However, the LF patients were in a more severe stage of the disease. The results yield indefinite conclusions about the use of both MSAD and EST. Clinical effectiveness and safety of both MSAD and EST are not sufficiently proven and are yet to be supported by high quality evidence from randomized controlled trials.
电刺激疗法（EST）和磁括约肌增强术（MSA）是治疗胃食管反流病（GERD）的新型手术方法。本综述的目的是评估与腹腔镜胃底折叠术（LF）和质子泵抑制剂疗法（针对EST）相比，EST和磁括约肌增强装置（MSAD）的有效性和安全性。我们在五个电子数据库（MEDLINE、EMBASE、Cochrane图书馆、PubMed和综述与传播中心）中进行了无出版日期限制的系统文献检索，并辅以手工检索、试验注册库检索以及制造商提供的文献资料。没有研究符合分析EST有效性的纳入标准。关于安全性，2.4%的患者（在一项研究中）出现了食管导联侵蚀和小肠套管针穿孔。只有注册研究符合MSAD有效性分析的纳入标准。GERD健康相关生活质量（HRQL）评分这一关键结果在MSAD患者中从20分改善至3分，在LF患者中从23分改善至3.5分。然而，LF患者处于疾病更严重的阶段。关于MSAD和EST的使用，结果得出了不确定的结论。MSAD和EST的临床有效性和安全性尚未得到充分证实，仍有待高质量随机对照试验证据的支持。
