Sabbatini F, Lazzaroni M, Petrillo M, Piai G, Mazzacca G, Bianchi Porro G
Institute of Gastroenterology, University of Naples, Italy.
Eur J Clin Pharmacol. 1990;39(5):515-7. doi: 10.1007/BF00280946.
The efficacy and safety of mifentidine 20 mg at night, a new, potent, long-acting H2-receptor antagonist, has been compared with ranitidine 300 mg at night in 60 patients with acute duodenal ulcer, in a randomized double-blind study. Antacid tablets were allowed as additional treatment for pain relief. The treatment lasted for 4 weeks. After 4 weeks of treatment the healing rate was similar; amongst the patients who completed the treatment, healing was 68% for mifentidine, 63% for ranitidine, and on intention-to-treat analysis, healing in both groups was 63%. Pain relief and antacid consumption were similar in both groups. Clinically significant adverse effects were not detected and any changes in laboratory values were minimal, clinically insignificant and reversible. Mifentidine appears to be an effective and safe once-a-day treatment for acute duodenal ulcer disease.
在一项随机双盲研究中,对60例急性十二指肠溃疡患者比较了新型强效长效H2受体拮抗剂米芬替丁夜间服用20毫克与雷尼替丁夜间服用300毫克的疗效和安全性。允许使用抗酸片作为缓解疼痛的辅助治疗。治疗持续4周。治疗4周后,愈合率相似;在完成治疗的患者中,米芬替丁的愈合率为68%,雷尼替丁为63%,在意向性治疗分析中,两组的愈合率均为63%。两组的疼痛缓解和抗酸剂消耗量相似。未检测到具有临床意义的不良反应,实验室值的任何变化均极小,临床意义不大且可逆。米芬替丁似乎是一种治疗急性十二指肠溃疡疾病的安全有效的每日一次治疗药物。