Madan K, Ahuja V, Kashyap P C, Sharma M P
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
Dis Esophagus. 2004;17(4):274-8. doi: 10.1111/j.1442-2050.2004.00424.x.
The present study aimed to compare the efficacy for the therapy of GERD of pantoprazole alone with a combination of pantoprazole and mosapride. The study was a prospective, randomized trial involving 68 patients suffering heartburn and/or regurgitation at least twice a week for 6 weeks. Sixty-one patients consented to be randomized to receive either pantoprazole 40 mg b.i.d. (n = 33, group A) or pantoprazole 40 mg b.i.d. plus mosapride 5 mg t.d.s. (n = 28, group B) for 8 weeks. Twenty-four-hour esophageal pH-metry and endoscopy were conducted at recruitment and endoscopy was repeated at 8 weeks in all the patients studied. There were no differences in symptomatic responses to therapy between the groups (69.7% vs 89.2%; P = 0.11). The mean symptom score after 8 weeks was significantly lower in group B (3.78 +/- 3.62 vs 1.67 +/- 2.09; P = 0.009). Nonerosive esophagitis was present in 29 patients. In patients with nonerosive GERD there was no significant difference in symptomatic response to either regimen (17/20 in group A and 7/9 in group B responded; P = 0.63). In erosive esophagitis, symptomatic responses occurred more frequently in group B, 18/19 (94.7%), than in group A, 6/13 (46.2%; P = 0.003). However endoscopic healing of esophagitis occurred equally with either regimen (6/11, 54.5% in group A; 12/17, 70.5% in group B; P = 0.44). In nonerosive GERD, the addition of mosapride offers no benefit over pantoprazole alone. A combination of pantoprazole and mosapride is more effective than pantoprazole alone in providing symptomatic relief to patients with erosive GERD.
本研究旨在比较单用泮托拉唑与泮托拉唑联合莫沙必利治疗胃食管反流病（GERD）的疗效。该研究为一项前瞻性随机试验，纳入了68例每周至少出现烧心和/或反流症状两次达6周的患者。61例患者同意随机分组，分别接受泮托拉唑40mg每日两次（n = 33，A组）或泮托拉唑40mg每日两次加莫沙必利5mg每日三次（n = 28，B组）治疗8周。在研究开始时对所有患者进行24小时食管pH监测和内镜检查，并在8周时重复内镜检查。两组间治疗的症状反应无差异（69.7%对89.2%；P = 0.11）。8周后B组的平均症状评分显著更低（3.78±3.62对1.67±2.09；P = 0.009）。29例患者存在非糜烂性食管炎。在非糜烂性GERD患者中，两种治疗方案的症状反应无显著差异（A组20例中有17例有反应，B组9例中有7例有反应；P = 0.63）。在糜烂性食管炎患者中，B组的症状反应比A组更频繁，B组为18/19（94.7%），A组为6/13（46.2%；P = 0.003）。然而，两种治疗方案的食管炎内镜愈合情况相同（A组11例中有6例，54.5%；B组17例中有12例，70.5%；P = 0.44）。在非糜烂性GERD中，加用莫沙必利并不比单用泮托拉唑更有益。泮托拉唑与莫沙必利联合使用比单用泮托拉唑能更有效地缓解糜烂性GERD患者的症状。
