Bate C M, Green J R, Axon A T, Murray F E, Tildesley G, Emmas C E, Taylor M D
Royal Albert Edward Infirmary, Wigan, UK.
Aliment Pharmacol Ther. 1997 Aug;11(4):755-63. doi: 10.1046/j.1365-2036.1997.00198.x.
Previous studies have demonstrated greater efficacy for omeprazole compared with cimetidine in patients with endoscopically verified oesophagitis, but excluded the substantial group of gastro-oesophageal reflux disease (GERD) patients with reflux symptoms but without endoscopic abnormality. This prospective, randomized, double-blind study compared omeprazole and cimetidine in the treatment of GERD-associated heartburn both in patients with symptomatic non-ulcerative oesophagitis and in those with heartburn but without oesophagitis.
A total of 221 patients with heartburn and oesophageal mucosa grade 0 (normal, n = 51), 1 (no macroscopic erosions, n = 52), 2 (isolated erosions, n = 97) or 3 (confluent erosions, n = 21) were randomized to receive double-blind either omeprazole 20 mg daily or cimetidine 400 mg q.d.s. for a period of 4 weeks. Those still symptomatic after 4 weeks of treatment received omeprazole 20 mg daily for a further 4 weeks.
There was no correlation between severity of heartburn and endoscopic grade at entry (correlation coefficient = 0.196). After 4 weeks of treatment, the proportion of patients in whom heartburn was controlled (no more than mild symptoms on no more than 1 day in the previous 7) on omeprazole (66%; 74/112) was more than double that on cimetidine (31%; 34/109) (P < 0.0001). There was no significant difference between the relief of heartburn in the 47% of patients without unequivocal oesophagitis (endoscopic grade 0 or 1) and in the 53% of patients with erosive oesophagitis (grade 2 or 3) (P = 0.31). Only treatment with omeprazole (P < 0.0001) and lower severity of heartburn at entry (P < 0.01) were significant in predicting heartburn relief. Amongst those patients requiring an additional 4 weeks of treatment with omeprazole, 67% (54/81) reported that their heartburn was controlled after 8 weeks of treatment.
We conclude that omeprazole is superior to cimetidine for the relief of all grades of heartburn in GERD, whether or not the patient has unequivocal endoscopic oesophagitis.
既往研究表明，在内镜检查确诊的食管炎患者中，奥美拉唑比西咪替丁疗效更佳，但排除了大量有反流症状但无内镜异常的胃食管反流病（GERD）患者。这项前瞻性、随机、双盲研究比较了奥美拉唑和西咪替丁在治疗GERD相关烧心方面的效果，研究对象包括有症状的非溃疡性食管炎患者以及有烧心症状但无食管炎的患者。
共有221例有烧心症状且食管黏膜分级为0级（正常，n = 51）、1级（无肉眼可见糜烂，n = 52）、2级（孤立性糜烂，n = 97）或3级（融合性糜烂，n = 21）的患者，被随机分为两组，双盲接受每日20 mg奥美拉唑或每日4次、每次400 mg西咪替丁治疗，为期4周。治疗4周后仍有症状的患者再接受4周每日20 mg奥美拉唑的治疗。
烧心严重程度与入组时的内镜分级之间无相关性（相关系数 = 0.196）。治疗4周后，接受奥美拉唑治疗的患者中烧心得到控制（在前7天中不超过1天有不超过轻度症状）的比例为66%（74/112），是接受西咪替丁治疗患者（31%；34/109）的两倍多（P < 0.0001）。47%无明确食管炎（内镜分级为0或1级）的患者与53%有糜烂性食管炎（2或3级）的患者在烧心缓解方面无显著差异（P = 0.31）。仅奥美拉唑治疗（P < 0.0001）和入组时烧心严重程度较低（P < 0.01）对预测烧心缓解有显著意义。在需要额外4周奥美拉唑治疗的患者中，67%（54/81）报告称治疗8周后烧心得到控制。
我们得出结论，对于GERD患者各种程度的烧心缓解，无论患者是否有明确的内镜下食管炎，奥美拉唑均优于西咪替丁。
