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.

译文

在51例患有糜烂性或溃疡性反流性食管炎 (2级或3级) 的门诊患者的内镜对照,双盲随机试验中,将奥美拉唑60 mg每日一次与雷尼替丁150 mg每日两次进行比较。4周后重复内窥镜检查,在没有愈合的情况下,8周后再次进行内窥镜检查。在进入前,第2、4和8周后评估症状。8周后未愈合的患者盲目改用另一种药物,并继续治疗4至8周。4周后治愈率 (改变为0或1级食管炎) 为奥美拉唑治疗的25例患者中的19例和雷尼替丁治疗的26例患者中的7例 (p = 0.002)。8周后的相应数字是25个中的22个和26个中的10个 (p = 0.001)。奥美拉唑的治愈率较高,反映在反流症状的改善明显更快,更强。13例在接受雷尼替丁治疗8周后未愈合的患者在转换治疗后均治愈。转换为雷尼替丁的3名患者中有1名获得了治愈。没有不良事件或具有临床重要性的实验室变量的变化。在反流性食管炎的短期治疗中,奥美拉唑优于雷尼替丁。

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