Madan Atul K, Ternovits Craig A, Tichansky David S
Department of Surgery, University of Tennessee Health Science Center, 956 Court Ave., Room G210, Memphis, TN 38163, USA.
Am J Surg. 2006 Jul;192(1):72-5. doi: 10.1016/j.amjsurg.2006.01.055.
Endoluminal therapies are emerging as a new therapeutic option for the treatment of gastroesophageal reflux disease (GERD). Many of these endoluminal therapies are touted as short outpatient procedures with minimal complications. It is thought that these complications are uncommon and minor. This investigation sought to summarize the adverse events of these endoluminal therapies for the treatment of GERD.
The Manufacturer and User Facility Device Experience Database for the U.S. Food and Drug Administration's Center for Devices and Radiological Health Web site was searched to examine all voluntary adverse events reported on emerging endoluminal therapies. The adverse events can be divided into 3 categories: (1) radiofrequency ablation based, (2) injection based, and (3) suture based.
There were a total of 50 adverse events reported on 4 specific therapies. Half of the complications were found to result from injection-based therapy and 44% of the complications were found to result from radiofrequency ablation-based therapy. There were 8 deaths reported (5 in the injection-based group and 3 in the radiofrequency ablation-based group). Sixty-four percent of the adverse events resulted in hospitalizations and 10% of these patients required surgery.
Physicians must be aware that no endoluminal therapy is truly noninvasive. Complications and even deaths are associated with these treatments for GERD. Patients must be informed of all the potential risks and complications of these new technologies.
腔内治疗正成为治疗胃食管反流病（GERD）的一种新的治疗选择。许多此类腔内治疗被吹捧为门诊短期手术，并发症极少。人们认为这些并发症不常见且轻微。本研究旨在总结这些腔内治疗GERD的不良事件。
检索美国食品药品监督管理局器械与放射健康中心网站的制造商和用户设施器械经验数据库，以检查新兴腔内治疗所报告的所有自愿不良事件。不良事件可分为3类：（1）基于射频消融的，（2）基于注射的，（3）基于缝合的。
4种特定治疗共报告了50起不良事件。发现一半的并发症是由基于注射的治疗引起的，44%的并发症是由基于射频消融的治疗引起的。报告了8例死亡（基于注射的组5例，基于射频消融的组3例）。64%的不良事件导致住院，其中10%的患者需要手术。
医生必须意识到，没有一种腔内治疗是真正无创的。这些GERD治疗会伴有并发症甚至死亡。必须告知患者这些新技术的所有潜在风险和并发症。
