AIM: To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication (ELGP) in pa- tients with proton pump inhibitor (PPI)-resistant, non- erosive reflux disease (NERD). METHODS: The su...AIM: To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication (ELGP) in pa- tients with proton pump inhibitor (PPI)-resistant, non- erosive reflux disease (NERD). METHODS: The subjects were NERD patients, diag- nosed by upper endoscopy before PPI use, who had symptoms such as heartburn or reflux sensations two or more times a week even after 8 wk of full-dose PPI treatment. Prior to ELGP, while continuing full-dose PPImedication, patients' symptoms and quality of life (QOL) were assessed using the questionnaire for the diagno- sis of reflux disease, the frequency scale for symptoms of gastro-esophageal reflux disease (FSSG), gastroin- testinal symptoms rating scale, a 36-item short-form. In addition, 24-h esophageal pH monitoring or 24-h in- traesophageal pH/impedance (MII-pH) monitoring was performed. The Bard EndoCinchTM was used for ELGP, and 2 or 3 plications were made. After ELGP, all acid reducers were temporarily discontinued, and medica- tion was resumed depending on the development and severity of symptoms. Three mo after ELGP, symptoms, QOL, pH or MII-pH monitoring, number of plications, and PPI medication were evaluated. Further, symptoms, number of plications, and PPI medication were evalu- ated 12 mo after ELGP to investigate long-term effects. RESULTS: The mean FSSG score decreased signifi- cantly from before ELGP to 3 and 12 mo after ELGP (19.1 :k 10.5 to 10.3 + 7.4 and 9.3 + 9.9, P 〈 0.05, respectively). The total number of plications decreased gradually at 3 and 12 mo after ELGP (2.4 + 0.8 to 1.2 :l: 0.8 and 0.8 :l: 1.0, P 〈 0.05, respectively). The FSSG scores in cases with no remaining plications and in cases with one or more remaining plications were 4.4 and 2.7, respectively, after 3 too, and 2.0 and 2.8, respectively, after 12 mo, showing no correlation to plication loss. On pH monitoring, there was no differ- ence in the percent time pH 〈 4 from before ELGP to 3 mo after. Impedance monitoring revealed no changes in the number of reflux episodes or the symptom index for reflux events from before ELGP to 3 mo after, but the symptom sensitivity index decreased significantly 3 mo after ELGP (16.1:1:12.9 to 3.9 ~ 8.3, P 〈 0.01). At 3 mo after ELGP, 6 patients (31.6%) had reduced their PPI medication by 50% or more, and 11 patients (57.9%) were able to discontinue PPI medication alto- gether. After 12 mo, 3 patients (16.7%) were able toreduce the amount of PPI medication by 50% or more, and 22 patients (66.7%) were able to discontinue PPI medication altogether. A high percentage of cases with remaining plications had discontinued PPIs medication after 3 mo, but there was no difference after 12 mo. No serious complications were observed in this study. CONCLUSION: ELGP was safe, resulted in significant improvement in subjective symptoms, and allowed less medication to be used over the long term in patients with PPI-refractory NERD.展开更多
基金Supported by In Part by a Grant for Medical Research from Aichi Medical University School of Medicine
文摘AIM: To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication (ELGP) in pa- tients with proton pump inhibitor (PPI)-resistant, non- erosive reflux disease (NERD). METHODS: The subjects were NERD patients, diag- nosed by upper endoscopy before PPI use, who had symptoms such as heartburn or reflux sensations two or more times a week even after 8 wk of full-dose PPI treatment. Prior to ELGP, while continuing full-dose PPImedication, patients' symptoms and quality of life (QOL) were assessed using the questionnaire for the diagno- sis of reflux disease, the frequency scale for symptoms of gastro-esophageal reflux disease (FSSG), gastroin- testinal symptoms rating scale, a 36-item short-form. In addition, 24-h esophageal pH monitoring or 24-h in- traesophageal pH/impedance (MII-pH) monitoring was performed. The Bard EndoCinchTM was used for ELGP, and 2 or 3 plications were made. After ELGP, all acid reducers were temporarily discontinued, and medica- tion was resumed depending on the development and severity of symptoms. Three mo after ELGP, symptoms, QOL, pH or MII-pH monitoring, number of plications, and PPI medication were evaluated. Further, symptoms, number of plications, and PPI medication were evalu- ated 12 mo after ELGP to investigate long-term effects. RESULTS: The mean FSSG score decreased signifi- cantly from before ELGP to 3 and 12 mo after ELGP (19.1 :k 10.5 to 10.3 + 7.4 and 9.3 + 9.9, P 〈 0.05, respectively). The total number of plications decreased gradually at 3 and 12 mo after ELGP (2.4 + 0.8 to 1.2 :l: 0.8 and 0.8 :l: 1.0, P 〈 0.05, respectively). The FSSG scores in cases with no remaining plications and in cases with one or more remaining plications were 4.4 and 2.7, respectively, after 3 too, and 2.0 and 2.8, respectively, after 12 mo, showing no correlation to plication loss. On pH monitoring, there was no differ- ence in the percent time pH 〈 4 from before ELGP to 3 mo after. Impedance monitoring revealed no changes in the number of reflux episodes or the symptom index for reflux events from before ELGP to 3 mo after, but the symptom sensitivity index decreased significantly 3 mo after ELGP (16.1:1:12.9 to 3.9 ~ 8.3, P 〈 0.01). At 3 mo after ELGP, 6 patients (31.6%) had reduced their PPI medication by 50% or more, and 11 patients (57.9%) were able to discontinue PPI medication alto- gether. After 12 mo, 3 patients (16.7%) were able toreduce the amount of PPI medication by 50% or more, and 22 patients (66.7%) were able to discontinue PPI medication altogether. A high percentage of cases with remaining plications had discontinued PPIs medication after 3 mo, but there was no difference after 12 mo. No serious complications were observed in this study. CONCLUSION: ELGP was safe, resulted in significant improvement in subjective symptoms, and allowed less medication to be used over the long term in patients with PPI-refractory NERD.