Lauritsen K, Laursen L S, Havelund T, Bytzer P, Svendsen L B, Rask-Madsen J
Br Med J (Clin Res Ed). 1986 Mar 29;292(6524):864-6. doi: 10.1136/bmj.292.6524.864.
One hundred and eighty patients with endoscopically proved duodenal ulcers were allocated at random to double blind treatment with the synthetic dehydroprostaglandin E2 enprostil 35 micrograms twice daily or ranitidine 150 mg twice daily for up to six weeks. Patients completed the study if ulcer healing and pain relief had occurred at two or four weeks. A total of 163 patients completed the trial. The duration of treatment was longer in the enprostil group (p less than 0.005) and the cumulative healing rates at two, four, and six weeks were 51%, 74%, and 85%, respectively. In the ranitidine group the corresponding figures were 65% (p less than 0.04), 89% (p less than 0.02), and 99% (p less than 0.002). More patients treated with ranitidine reported relief of pain (p less than 0.004 at weeks 5 and 6). The observed superiority of ranitidine 150 mg twice daily over enprostil 35 micrograms twice daily questions the clinical relevance of using so called "cytoprotection" as treatment for duodenal ulcer disease in the short term.
180例经内镜证实为十二指肠溃疡的患者被随机分配,接受双盲治疗,一组每日两次服用合成脱氢前列腺素E2恩前列素35微克,另一组每日两次服用雷尼替丁150毫克,疗程最长六周。若在两周或四周时溃疡愈合且疼痛缓解,患者则完成研究。共有163例患者完成了试验。恩前列素组的治疗时间更长(p<0.005),两周、四周和六周时的累积愈合率分别为51%、74%和85%。雷尼替丁组相应的数据分别为65%(p<0.04)、89%(p<0.02)和99%(p<0.002)。更多接受雷尼替丁治疗的患者报告疼痛缓解(在第5周和第6周时p<0.004)。每日两次服用150毫克雷尼替丁相对于每日两次服用35微克恩前列素的观察到的优势,对短期内使用所谓“细胞保护”作为十二指肠溃疡疾病治疗方法的临床相关性提出了质疑。