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首页> 外文期刊>World Journal of Gastroenterology >Prospective, randomized, and active controlled study of the efficacy of alginic acid and antacid in the treatment of patients with endoscopy-negative reflux disease.
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Prospective, randomized, and active controlled study of the efficacy of alginic acid and antacid in the treatment of patients with endoscopy-negative reflux disease.

机译：海藻酸和抗酸剂治疗内镜阴性反流病患者的疗效的前瞻性，随机和主动对照研究。

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AIM: To assess the efficacy and safety of a compound containing alginic acid plus antacid (Topaal) compared to equal-strength antacid (Nacid) in patients with endoscopy-negative reflux disease (ENRD). METHODS: A total of 121 patients with ENRD were randomized to receive Topaal (65 patients) or Nacid (56 patients) for 6 weeks, with a consultation every 3 weeks. The primary end-point assessment was the change in the severity of heartburn as evaluated using a visual analog scale (VAS) at 6 weeks. The secondary end-point assessments were the VAS at 3 weeks, the change of frequency of the reflux symptom, the change of quality of life and the adverse effects. RESULTS: Demographics of randomized subjects in each treatment group were comparable except that the Topaal group included more males. The baseline characteristics between the groups were similar. After 6 weeks of treatment, the reduction of VAS of heartburn was more prominent in the Topaal group (-6.29 cm vs -4.11 cm). At the 3rd week, Topaal group showed greater reduction of VAS for heartburn (P=0.0016), regurgitation (P=0.0006), vomiting (P=0.0373), and belching (P<0.0001). The patients of the Topaal group had lower frequency of heartburn (P=0.0015) and pain (P=0.0163) at the end of the 6-week treatment period. From the doctor's point of view, the Topaal group also showed significant reduction in the severity of heartburn (P=0.0020), regurgitation (P=0.0081), vomiting (P=0.0182), and belching (P=0.0018) at the end of the treatment. The improvement of the quality of life was more remarkable in the Topaal group at the end of the 6-week treatment period (P<0.0001). For the adverse effect, there was no difference in both the groups. CONCLUSION: Topaal is more effective than Nacid for the treatment of symptoms presented by patients with ENRD.
机译：目的：评估含海藻酸加抗酸剂（托帕尔）与等强度抗酸剂（Nacid）相比在内镜阴性反流病（ENRD）患者中的疗效和安全性。方法：总共121名ENRD患者被随机分配接受托帕尔（65例）或纳德（56例）治疗，为期6周，每3周进行一次咨询。主要终点评估是在6周时使用视觉模拟量表（VAS）评估的烧心严重程度的变化。次要终点评估为3周时的VAS，反流症状发生频率的变化，生活质量的变化和不良反应。结果：每个治疗组中随机受试者的人口统计学是可比的，只是托帕尔组的男性更多。各组之间的基线特征相似。治疗6周后，托帕尔组胃灼热的VAS降低更为明显（-6.29 cm对-4.11 cm）。在第3周，托帕尔组的胃灼热（P = 0.0016），反流（P = 0.0006），呕吐（P = 0.0373）和，气（P <0.0001）表现出更大的VAS降低。在6周的治疗期结束时，Topaal组的患者有较低的烧心频率（P = 0.0015）和疼痛（P = 0.0163）。从医生的角度来看，托帕尔组还显示出在结束时胃灼热（P = 0.0020），反流（P = 0.0081），呕吐（P = 0.0182）和of气（P = 0.0018）的严重程度明显降低。治疗。在6周治疗期结束时，托帕尔组的生活质量改善更为显着（P <0.0001）。对于不良反应，两组均无差异。结论：托帕尔比Nacid更有效地治疗ENRD患者出现的症状。

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