Klinkenberg-Knol E C, Jansen J M, Festen H P, Meuwissen S G, Lamers C B
Lancet. 1987 Feb 14;1(8529):349-51. doi: 10.1016/s0140-6736(87)91726-0.
Omeprazole 60 mg once daily was compared with ranitidine 150 mg twice daily in an endoscopically-controlled, double-blind randomised trial in 51 outpatients with erosive or ulcerative reflux oesophagitis (grade 2 or 3). Endoscopy was repeated after 4 weeks and, in the absence of healing, again after 8 weeks. Symptoms were assessed before entry and after 2, 4, and 8 weeks. Patients who were unhealed after 8 weeks were blindly switched to the other drug and treatment was continued for another 4 to 8 weeks. The healing rate (change to grade 0 or 1 oesophagitis) after 4 weeks was 19 of 25 patients treated with omeprazole and 7 of 26 patients treated with ranitidine (p = 0.002). The corresponding figures after 8 weeks were 22 of 25 and 10 of 26 (p = 0.001). The higher healing rate with omeprazole was reflected in a significantly faster and stronger improvement of reflux symptoms. 13 patients, who were unhealed after 8 weeks on ranitidine, were healed after switching treatment. Healing was achieved in 1 of 3 patients who were switched to ranitidine. There were no adverse events or changes in laboratory variables of clinical importance. Omeprazole is superior to ranitidine in the short-term treatment of reflux oesophagitis.
在一项针对51例糜烂性或溃疡性反流性食管炎（2级或3级）门诊患者的内镜对照双盲随机试验中，将每日一次服用60毫克奥美拉唑与每日两次服用150毫克雷尼替丁进行了比较。4周后重复进行内镜检查，若未愈合，则在8周后再次检查。在入组前以及2周、4周和8周后对症状进行评估。8周后未愈合的患者被随机改为服用另一种药物，并继续治疗4至8周。4周后，接受奥美拉唑治疗的25例患者中有19例愈合，接受雷尼替丁治疗的26例患者中有7例愈合（p = 0.002）。8周后的相应数字分别为25例中的22例和26例中的10例（p = 0.001）。奥美拉唑较高的愈合率体现在反流症状改善明显更快且更显著。13例服用雷尼替丁8周后未愈合的患者在换药后愈合。转而服用雷尼替丁的3例患者中有1例愈合。未出现不良事件，临床重要的实验室指标也未发生变化。在反流性食管炎的短期治疗中，奥美拉唑优于雷尼替丁。
