{"title":"一项试点研究,比较不同质子泵抑制剂在治疗侵蚀性食管炎第一周内的初始临床反应","authors":"Min‐Kai Liao, Tsung‐Jung Lin, Hsi‐Chang Lee, Chih‐Lin Lin, Kuan‐Yang Chen, Deng‐Chyang Wu","doi":"10.1002/aid2.13394","DOIUrl":null,"url":null,"abstract":"Gastroesophageal reflux disease (GERD) characterized by heartburn and/or acid regurgitation symptoms is one of the most common gastrointestinal disorders. The rapid onset of proton pump inhibitors (PPIs) to improve annoying symptom is an essential need in treating GERD. There was no report about the short‐term clinical effects comparing lansoprazole 30 mg to rabeprazole 20 mg. This pilot study was designed to compare the initial one‐week clinical response of the two drugs in GERD with erosive esophagitis. Total 44 patients with GERD were enrolled in this study and randomized into two groups. The patients had the symptoms of acid regurgitation, heartburn, or feeling of acidity in the stomach and erosive esophagitis proven by endoscopy. They respectively received once‐daily dose of lansoprazole 30 mg (n = 23) and rabeprazole 20 mg (n = 21) for treatment of GERD. The primary end point was complete symptom resolution (CSR). The CSR rate was evaluated by questionnaire including acid regurgitation, heartburn sensation and epigastric pain at day 1, 3 and 7. Two patients in the arm of rabeprazole had poor compliance of drugs and were excluded from analysis. The final patient numbers were 23 in the arm of lansoprazole and 19 in rabeprazole. The baseline characteristics of two groups were similar in age, gender, body mass index (BMI), Helicobacter pylori infection, GERD severity, smoking, alcohol, coffee, spicy, sweet food and laboratory data. The ingestion of tea was the only one variable with significant difference between the two groups (65.2% and 31.58%, p = .03). At day 1, 3 and 7, the CSR rate of lansoprazole and rabeprazole were 21.74% and 26.32% (p = 1.000), 34.78% and 31.58% (p = .827), 47.83% and 47.37% (p = .976), respectively. The other clinical factors, including age, gender, BMI, Helicobacter pylori infection, smoking, alcohol, coffee, tea, spicy, sweet food and laboratory data, have also no significant influence on CSR rates at day 1, 3, 7. However, the patients with GERD C and D had significantly higher CSR rate than patients with GERD A and B at day 1 and 7 (CSR rate at day 1: 50.00% vs. 15.63, p = .040; day 3: 60.00% vs. 25.00%, p = .059; day 7: 90.00% vs. 34.38%, p = .003). In multivariate regression analysis, the patients with GERD C and D still had significantly higher CSR rate than patients with GERD A and B at day 7 (Odds ratio: 28.27, 95% CI: 2.10–380.03, p = .012). The CSR rates between lansoprazole group and rabeprazole group at day 1, 3, 7 were not significantly different, so the difference of PPIs did not play the role on the initial clinical response within 1 week for the erosive GERD patients. However, the patients with more severe erosive GERD on endoscopy had higher CSR rate at day 7.","PeriodicalId":7278,"journal":{"name":"Advances in Digestive Medicine","volume":"77 S8","pages":""},"PeriodicalIF":0.3000,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A pilot study comparing the initial clinical response to different proton pump inhibitors within first week in treating erosive esophagitis\",\"authors\":\"Min‐Kai Liao, Tsung‐Jung Lin, Hsi‐Chang Lee, Chih‐Lin Lin, Kuan‐Yang Chen, Deng‐Chyang Wu\",\"doi\":\"10.1002/aid2.13394\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Gastroesophageal reflux disease (GERD) characterized by heartburn and/or acid regurgitation symptoms is one of the most common gastrointestinal disorders. The rapid onset of proton pump inhibitors (PPIs) to improve annoying symptom is an essential need in treating GERD. There was no report about the short‐term clinical effects comparing lansoprazole 30 mg to rabeprazole 20 mg. This pilot study was designed to compare the initial one‐week clinical response of the two drugs in GERD with erosive esophagitis. Total 44 patients with GERD were enrolled in this study and randomized into two groups. The patients had the symptoms of acid regurgitation, heartburn, or feeling of acidity in the stomach and erosive esophagitis proven by endoscopy. They respectively received once‐daily dose of lansoprazole 30 mg (n = 23) and rabeprazole 20 mg (n = 21) for treatment of GERD. The primary end point was complete symptom resolution (CSR). The CSR rate was evaluated by questionnaire including acid regurgitation, heartburn sensation and epigastric pain at day 1, 3 and 7. Two patients in the arm of rabeprazole had poor compliance of drugs and were excluded from analysis. The final patient numbers were 23 in the arm of lansoprazole and 19 in rabeprazole. The baseline characteristics of two groups were similar in age, gender, body mass index (BMI), Helicobacter pylori infection, GERD severity, smoking, alcohol, coffee, spicy, sweet food and laboratory data. The ingestion of tea was the only one variable with significant difference between the two groups (65.2% and 31.58%, p = .03). At day 1, 3 and 7, the CSR rate of lansoprazole and rabeprazole were 21.74% and 26.32% (p = 1.000), 34.78% and 31.58% (p = .827), 47.83% and 47.37% (p = .976), respectively. The other clinical factors, including age, gender, BMI, Helicobacter pylori infection, smoking, alcohol, coffee, tea, spicy, sweet food and laboratory data, have also no significant influence on CSR rates at day 1, 3, 7. However, the patients with GERD C and D had significantly higher CSR rate than patients with GERD A and B at day 1 and 7 (CSR rate at day 1: 50.00% vs. 15.63, p = .040; day 3: 60.00% vs. 25.00%, p = .059; day 7: 90.00% vs. 34.38%, p = .003). In multivariate regression analysis, the patients with GERD C and D still had significantly higher CSR rate than patients with GERD A and B at day 7 (Odds ratio: 28.27, 95% CI: 2.10–380.03, p = .012). The CSR rates between lansoprazole group and rabeprazole group at day 1, 3, 7 were not significantly different, so the difference of PPIs did not play the role on the initial clinical response within 1 week for the erosive GERD patients. 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引用次数: 0
摘要
以烧心和/或反酸症状为特征的胃食管反流病(GERD)是最常见的胃肠道疾病之一。质子泵抑制剂(PPIs)起效迅速,可改善恼人的症状,是治疗胃食管反流病的基本需要。目前还没有关于兰索拉唑 30 毫克与雷贝拉唑 20 毫克短期临床效果比较的报告。本试验研究旨在比较两种药物对胃食管反流病合并侵蚀性食管炎患者一周内的初步临床反应。共有 44 名胃食管反流病患者参加了这项研究,并被随机分为两组。这些患者均有反酸、烧心或胃酸过多的症状,并经内镜检查证实患有侵蚀性食管炎。他们分别接受每日一次剂量的兰索拉唑 30 毫克(23 人)和雷贝拉唑 20 毫克(21 人)治疗胃食管反流病。主要终点是症状完全缓解(CSR)。完全症状缓解率通过问卷进行评估,包括第 1、3 和 7 天的反酸、烧心感和上腹痛。雷贝拉唑治疗组中有两名患者服药依从性差,因此被排除在分析之外。兰索拉唑治疗组和雷贝拉唑治疗组的最终患者人数分别为 23 人和 19 人。两组患者在年龄、性别、体重指数(BMI)、幽门螺杆菌感染、胃食管反流严重程度、吸烟、饮酒、喝咖啡、吃辛辣和甜食以及实验室数据方面的基线特征相似。摄入茶水是两组之间唯一存在显著差异的变量(65.2% 和 31.58%,P = 0.03)。在第1天、第3天和第7天,兰索拉唑和雷贝拉唑的CSR率分别为21.74%和26.32%(P = 1.000)、34.78%和31.58%(P = .827)、47.83%和47.37%(P = .976)。其他临床因素,包括年龄、性别、体重指数、幽门螺杆菌感染、吸烟、饮酒、咖啡、茶、辛辣、甜食和实验室数据,对第 1、3、7 天的 CSR 率也没有显著影响。然而,胃食管反流 C 型和 D 型患者在第 1 天和第 7 天的 CSR 率明显高于胃食管反流 A 型和 B 型患者(第 1 天:50.00% vs. 15.63,p = .040;第 3 天:60.00% vs. 25.00%,p = .059;第 7 天:90.00% vs. 34.38%,p = .003)。在多变量回归分析中,胃食管反流病 C 和 D 患者在第 7 天的 CSR 率仍明显高于胃食管反流病 A 和 B 患者(Odds ratio:28.27,95% CI:2.10-380.03,p = .012)。兰索拉唑组和雷贝拉唑组在第 1、3、7 天的 CSR 率没有显著差异,因此 PPIs 的差异对侵蚀性胃食管反流病患者 1 周内的初始临床反应没有影响。然而,内镜检查显示侵蚀性胃食管反流较严重的患者在第 7 天的 CSR 率较高。
A pilot study comparing the initial clinical response to different proton pump inhibitors within first week in treating erosive esophagitis
Gastroesophageal reflux disease (GERD) characterized by heartburn and/or acid regurgitation symptoms is one of the most common gastrointestinal disorders. The rapid onset of proton pump inhibitors (PPIs) to improve annoying symptom is an essential need in treating GERD. There was no report about the short‐term clinical effects comparing lansoprazole 30 mg to rabeprazole 20 mg. This pilot study was designed to compare the initial one‐week clinical response of the two drugs in GERD with erosive esophagitis. Total 44 patients with GERD were enrolled in this study and randomized into two groups. The patients had the symptoms of acid regurgitation, heartburn, or feeling of acidity in the stomach and erosive esophagitis proven by endoscopy. They respectively received once‐daily dose of lansoprazole 30 mg (n = 23) and rabeprazole 20 mg (n = 21) for treatment of GERD. The primary end point was complete symptom resolution (CSR). The CSR rate was evaluated by questionnaire including acid regurgitation, heartburn sensation and epigastric pain at day 1, 3 and 7. Two patients in the arm of rabeprazole had poor compliance of drugs and were excluded from analysis. The final patient numbers were 23 in the arm of lansoprazole and 19 in rabeprazole. The baseline characteristics of two groups were similar in age, gender, body mass index (BMI), Helicobacter pylori infection, GERD severity, smoking, alcohol, coffee, spicy, sweet food and laboratory data. The ingestion of tea was the only one variable with significant difference between the two groups (65.2% and 31.58%, p = .03). At day 1, 3 and 7, the CSR rate of lansoprazole and rabeprazole were 21.74% and 26.32% (p = 1.000), 34.78% and 31.58% (p = .827), 47.83% and 47.37% (p = .976), respectively. The other clinical factors, including age, gender, BMI, Helicobacter pylori infection, smoking, alcohol, coffee, tea, spicy, sweet food and laboratory data, have also no significant influence on CSR rates at day 1, 3, 7. However, the patients with GERD C and D had significantly higher CSR rate than patients with GERD A and B at day 1 and 7 (CSR rate at day 1: 50.00% vs. 15.63, p = .040; day 3: 60.00% vs. 25.00%, p = .059; day 7: 90.00% vs. 34.38%, p = .003). In multivariate regression analysis, the patients with GERD C and D still had significantly higher CSR rate than patients with GERD A and B at day 7 (Odds ratio: 28.27, 95% CI: 2.10–380.03, p = .012). The CSR rates between lansoprazole group and rabeprazole group at day 1, 3, 7 were not significantly different, so the difference of PPIs did not play the role on the initial clinical response within 1 week for the erosive GERD patients. However, the patients with more severe erosive GERD on endoscopy had higher CSR rate at day 7.
期刊介绍:
Advances in Digestive Medicine is the official peer-reviewed journal of GEST, DEST and TASL. Missions of AIDM are to enhance the quality of patient care, to promote researches in gastroenterology, endoscopy and hepatology related fields, and to develop platforms for digestive science. Specific areas of interest are included, but not limited to: • Acid-related disease • Small intestinal disease • Digestive cancer • Diagnostic & therapeutic endoscopy • Enteral nutrition • Innovation in endoscopic technology • Functional GI • Hepatitis • GI images • Liver cirrhosis • Gut hormone • NASH • Helicobacter pylori • Cancer screening • IBD • Laparoscopic surgery • Infectious disease of digestive tract • Genetics and metabolic disorder • Microbiota • Regenerative medicine • Pancreaticobiliary disease • Guideline & consensus.