20 12 65438+ 10/01,the consultant group of digestive medicine and urology equipment of the US Food and Drug Administration (FDA) voted on the pre-marketing license of LINX anti-reflux system. Nine members of the group unanimously voted to confirm the efficacy, safety and favorable risk-benefit ratio of the device in treating pathological gastroesophageal reflux disease (GERD) refractory to reflux drugs. The anti-reflux system consists of a series of magnetic beads, and the attraction between the magnetic beads can help the lower esophageal sphincter (LES) to close, thus playing an anti-reflux role. When the patient swallows, food can also spread the beads into the stomach.
■? Clinical problems in controlling symptoms of gastroesophageal reflux: PPI, surgery or something? GERD is one of the most popular gastrointestinal diseases in America. In addition to pain symptoms, GERD can lead to esophageal mucosal injury, Barrett's esophagus, and can also develop into adenocarcinoma. At present, the main drug treatment is taking proton pump inhibitors every day. PPI is very effective for esophagitis, but it is ineffective for controlling reflux symptoms. Although fundoplication can effectively reconstruct the reflux barrier, it permanently changes the anatomical structure of the stomach and will produce many side effects. For many years, people have been exploring new technologies, hoping to enhance the strength of LES and avoid the adverse consequences of fundoplication. These techniques include suturing the relaxed lower esophageal sphincter and injecting polymers to change the compliance of LES. Unfortunately, few of them are approved by the FDA. In this case, LINX anti-reflux system came into being, and doctors can place it above the patient's stomach and near the lower esophageal sphincter through laparoscopy. Because of the short operation time, patients can resume normal diet and activities within one week, and they can be taken out by laparoscopy, which has attracted much attention. ■? The FDA advisory group suggested that there were "hard wounds" in clinical trials, but the defects were not covered up. The feasibility study of LINX system * * * included 44 patients from four research institutions in Europe and America. At 1 and 2 years after operation, 85% and 90% patients reported improvement in symptoms, respectively. 90% and 86% patients reported stopping using PPI completely. 43% patients had dysphagia in the early stage, and most of them disappeared within 90 days after operation. 1 patient took out the anti-reflux system through laparoscopy because of persistent dysphagia. The key study included 100 patients from 14 research institutions. After the operation, 92% patients reported improvement of symptoms, 93% patients used at least half of PPI dose, and 64% patients had normal or improved esophageal acid exposure. The incidence of serious adverse events was 6%: 3 patients had to take out the anti-reflux system because of dysphagia; Two patients were hospitalized again for nausea and vomiting 7 days after operation. He was admitted to hospital with chest pain 1 case 6 months after operation, and the system was taken out 1 year after operation. The FDA advisory group's debate about safety focuses on dysphagia. 68% patients with anti-reflux system reported dysphagia, which is the most common complication. The team's knowledge is that dysphagia symptoms are relatively mild, not a safety hazard. Dr. Gould of Milwaukee Medical College in Wisconsin believes that if we study the Nissen fundoplication cohort, there will be some symptoms that are not common in other treatments, so we should look at its safety as a whole. Dr. Schwaitzberg of Harvard Medical School thinks that there is a "hard injury" in the relevant clinical research design, but he also thinks that "their demonstration of its efficacy and low complication rate is quite good". Schwartzberg stressed: "I want to see the research last at least 10 years after it is approved. As an implantable medical device, we should understand the long-term results. " Dr Affifi, a statistician at UCLA, said he would like to see a case-control study. Dr. Faulx of case western reserve university Medical Center in Ohio commented that compared with the standard treatment which is not perfect at present, the LINX anti-reflux system has proved to be quite useful and the risk is minimal.