Yuan Yao Zong, Fang Jing Yuan, Zou Duo Wu, Levinson Nigel, Jenner Bartosz, Wilkinson Joanne
Department of Gastroenterology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China.
J Dig Dis. 2016 Nov;17(11):725-734. doi: 10.1111/1751-2980.12406.
To assess the efficacy of Gaviscon Double Action (DA) alginate antacid chewable tablets for reducing esophageal acid exposure in Chinese patients with gastroesophageal reflux disease (GERD).
Altogether 44 patients reporting moderate to severe heartburn symptoms underwent two pH monitoring visits. The treatment sequence was randomized to patients received DA alginate antacid or placebo at one visit and the alternate treatment 7 days later. After a standardized reflux-provoking meal, patients took four tablets of DA alginate antacid or placebo. Esophageal pH was measured for 4 h post-dosing using an electrode positioned 5 cm above the lower esophageal sphincter. The primary end-point was the percentage of 4-h post-dosing period with pH <4. Secondary end-points were number of acid reflux episodes (pH <4), longest reflux time and DeMeester scores.
All 44 patients completed the study and provided data for analysis. With DA alginate antacid, the mean percentage time with pH <4 was 5.1%, significantly less (P = 0.0003) than with placebo (14.8%). DA alginate antacid was statistically significantly superior (P = 0.0290) to placebo (from at least twofold to threefold better) for all other end-points. Two patients reported two mild adverse events (AEs) that resolved within a month of completing the study. No patients had serious and/or severe AEs and none withdrew due to AEs.
DA alginate antacid was statistically significantly superior to placebo in reducing post-prandial acid exposure without serious clinically relevant health risks. These findings suggest DA alginate antacid tablets are appropriate for treating acid reflux in Chinese GERD patients with heartburn symptoms.
评估胃仙-U双重作用（DA）海藻酸盐抗酸咀嚼片对降低中国胃食管反流病（GERD）患者食管酸暴露的疗效。
共有44名报告有中度至重度烧心症状的患者接受了两次pH监测。治疗顺序随机安排，患者在一次就诊时接受DA海藻酸盐抗酸剂或安慰剂治疗，7天后接受另一种治疗。在一顿标准化的诱发反流餐后，患者服用四片DA海藻酸盐抗酸剂或安慰剂。使用位于食管下括约肌上方5厘米处的电极在给药后4小时测量食管pH值。主要终点是给药后4小时内pH值<4的时间百分比。次要终点是酸反流发作次数（pH值<4）、最长反流时间和DeMeester评分。
所有44名患者均完成研究并提供了分析数据。服用DA海藻酸盐抗酸剂时，pH值<4的平均时间百分比为5.1%，显著低于安慰剂组（14.8%）（P = 0.0003）。对于所有其他终点，DA海藻酸盐抗酸剂在统计学上显著优于安慰剂（P = 0.0290）（至少好两倍至三倍）。两名患者报告了两起轻度不良事件（AE），在完成研究后一个月内缓解。没有患者出现严重和/或重度AE，也没有患者因AE退出研究。
DA海藻酸盐抗酸剂在减少餐后酸暴露方面在统计学上显著优于安慰剂，且无严重的临床相关健康风险。这些发现表明，DA海藻酸盐抗酸咀嚼片适用于治疗有烧心症状的中国GERD患者的酸反流。
