Prospective,randomized,and active controlled study of the efficacy of alginic acid and antacid in the treatment of patients with endoscopy-negative reflux disease  

作　　者：I-Rue Lai Ming-Shiang Wu Jaw-Town Lin 

机构地区：[1]Department of Surgery,National Taiwan University Hospital,National Taiwan University College of Medicine,Taipei,Taiwan China [2]Division of Gastroenterology,Department of Internal Medicine,National Taiwan University Hospital,National Taiwan University College of Medicine,Taipei,Taiwan,China

出　　处：《World Journal of Gastroenterology》2006年第5期747-754,共8页世界胃肠病学杂志（英文版）

摘　　要：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 3m 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.瞄准：与内视镜检查法否定的倒流疾病(ENRD ) 在病人与相等力量的解酸药(Nacid ) 相比加解酸药(Topaal ) 估计复合包含藻酸的功效和安全。方法：有 ENRD 的 121 个病人的一个总数被使随机化收到 Topaal (65 个病人) 或 Nacid (56 个病人) 6 个星期，与咨询每 3 个星期。主要端点评价是在在 6 个星期用视觉模拟规模(管) 评估了的心痛的严厉的变化。第二等的端点评价是在 3 个星期的 VAS，倒流症状的频率的变化，生命和不利效果的质量的变化。结果：除了 Topaal 组包括了更多的男性之外，在每个治疗组的使随机化的题目的人口分布是可比较的。在这些组之间的基线特征是类似的。在 6 星期治疗以后，心痛的管的减小在 Topaal 组(-6.29 厘米对 -4.11 厘米) 是更突出的。在第三个星期， Topaal 为心痛(P=0.0016 ) 组织管的显示出的更大的减小，流回(P=0.0006 ) ，呕吐(P=0.0373 ) ，并且打嗝(P<0.0001 ) 。Topaal 组的病人在 6 星期的治疗经期的结束有心痛(P=0.0015 ) 和疼痛(P=0.0163 ) 的低频率。从医生的观点， Topaal 组也在心痛(P=0.0020 ) 的严厉显示出重要减小，流回(P=0.0081 ) ，呕吐(P=0.0182 ) ，并且打嗝(P=0.0018 ) 在治疗的结束。生命的质量的改进在在 6 星期的治疗经期(P<0.0001 ) 的结束的 Topaal 组是更显著的。为不利效果，在两个没有差别这些组。结论：Topaal 是比为病人与 ENRD 介绍的症状的治疗的 Nacid 更有效的。

关 键 词：Alginic acid Endoscopy-negative reflux disease 

分 类 号：R571[医药卫生—消化系统]