Division of Gastroenterology, Department of Internal Medicine, University of Genoa, 16126 Genoa, Italy.
World J Gastroenterol. 2012 Aug 28;18(32):4371-8. doi: 10.3748/wjg.v18.i32.4371.
To evaluate the effect of a novel alginate-based compound, Faringel, in modifying reflux characteristics and controlling symptoms.
In this prospective, open-label study, 40 patients reporting heartburn and regurgitation with proven reflux disease (i.e., positive impedance-pH test/evidence of erosive esophagitis at upper endoscopy) underwent 2 h impedance-pH testing after eating a refluxogenic meal. They were studied for 1 h under basal conditions and 1 h after taking 10 mL Faringel. In both sessions, measurements were obtained in right lateral and supine decubitus positions. Patients also completed a validated questionnaire consisting of a 2-item 5-point (0-4) Likert scale and a 10-cm visual analogue scale (VAS) in order to evaluate the efficacy of Faringel in symptom relief. Tolerability of the treatment was assessed using a 6-point Likert scale ranging from very good (1) to very poor (6).
Faringel decreased significantly (P < 0.001), in both the right lateral and supine decubitus positions, esophageal acid exposure time [median 10 (25th-75th percentil 6-16) vs 5.8 (4-10) and 16 (11-19) vs 7.5 (5-11), respectively] and acid refluxes [5 (3-8) vs 1 (1-1) and 6 (4-8) vs 2 (1-2), respectively], but increased significantly (P < 0.01) the number of nonacid reflux events compared with baseline [2 (1-3) vs 3 (2-5) and 3 (2-4) vs 6 (3-8), respectively]. Percentage of proximal migration decreased in both decubitus positions (60% vs 32% and 64% vs 35%, respectively; P < 0.001). Faringel was significantly effective in controlling heartburn, based on both the Likert scale [3.1 (range 1-4) vs 0.9 (0-2); P < 0.001] and VAS score [7.1 (3-9.8) vs 2 (0.1-4.8); P < 0.001], but it had less success against regurgitation, based on both the Likert scale [2.6 (1-4) vs 2.2 (1-4); P = not significant (NS)] and VAS score [5.6 (2-9.6) vs 3.9 (1-8.8); P = NS]. Overall, the tolerability of Faringel was very good 5 (2-6), with only two patients reporting modest adverse events (i.e., nausea and bloating).
Our findings demonstrate that Faringel is well-tolerated and effective in reducing heartburn by modifying esophageal acid exposure time, number of acid refluxes and their proximal migration.
评估新型海藻酸盐复合制剂法瑞尔（Faringel）在改善反流特征和控制症状方面的疗效。
本前瞻性、开放标签研究纳入 40 例有烧心和反流症状且证实有反流病（即阻抗-pH 检测阳性/上消化道内镜检查有食管糜烂证据）的患者，在进食反流餐 2 小时后进行阻抗-pH 检测。在基础状态下和服用 10 毫升法瑞尔后 1 小时分别进行右外侧卧位和仰卧位检测。在两次检测中，均同时进行右侧卧位和仰卧位测量。患者还完成了一份有效的问卷，其中包括 2 项 5 分制（0-4 分）李克特量表和 10cm 视觉模拟量表（VAS），以评估法瑞尔在缓解症状方面的疗效。采用 6 分制李克特量表（1 分非常好，6 分非常差）评估治疗的耐受性。
与基线相比，法瑞尔在右外侧卧位和仰卧位均显著降低（P < 0.001）了食管酸暴露时间[中位数分别为 10（25 百分位至 75 百分位 6-16）与 5.8（4-10）和 16（11-19）与 7.5（5-11）]和酸反流[中位数分别为 5（3-8）与 1（1-1）和 6（4-8）与 2（1-2）]，但显著增加了非酸反流事件的数量[中位数分别为 2（1-3）与 3（2-5）和 3（2-4）与 6（3-8）]。两种卧位的近端迁移百分比均降低（60%与 32%和 64%与 35%；P < 0.001）。法瑞尔在控制烧心方面非常有效，基于李克特量表[3.1（范围 1-4）与 0.9（0-2）；P < 0.001]和 VAS 评分[7.1（3-9.8）与 2（0.1-4.8）；P < 0.001]，但在控制反流方面效果较差，基于李克特量表[2.6（1-4）与 2.2（1-4）；P = 无显著差异（NS）]和 VAS 评分[5.6（2-9.6）与 3.9（1-8.8）；P = NS]。总体而言，法瑞尔的耐受性非常好，5 分（2-6 分），只有两名患者报告有轻微不良反应（即恶心和腹胀）。
我们的研究结果表明，法瑞尔耐受性良好，可有效减少烧心，通过改变食管酸暴露时间、酸反流次数及其近端迁移来实现。
