Bianchi Porro G, Lazzaroni M, Manzionna G, Petrillo M
Gastrointestinal Unit, L Sacco University Hospital, Milan, Italy.
Aliment Pharmacol Ther. 1998 Apr;12(4):355-60. doi: 10.1046/j.1365-2036.1998.00312.x.
To establish the healing efficacy of two drugs, omeprazole and sucralfate, when given to patients who had developed gastric or duodenal ulcer while undergoing chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
Ninety-eight patients with arthritis or arthrosis and NSAID-related gastric or duodenal ulcer were admitted to the endoscopic, single-blind study. They were randomized to receive either omeprazole 20 mg o.m. or sucralfate 2 g b.d. for 4-8 weeks. The patients continued to receive the same NSAID during the trial. Upper gastrointestinal endoscopy was performed at entry and after 4 or 8 weeks.
Eighty-eight patients completed the 4-week study, but only 81 were available for final analysis at 8 weeks. Omeprazole was significantly superior to sucralfate in inducing gastric ulcer healing after both 4 (87 vs. 52%, P = 0.007) and 8 weeks (100 vs. 82%, P = 0.04). No statistically significant difference in duodenal ulcer healing rates emerged between the two groups either at 4 (79 vs. 55%) or 8 weeks (95 vs. 73%). The healing rates in patients with combined gastric and duodenal ulcer were 67 vs. 33% after 4 weeks and 6 7 vs. 6 7% after 8 weeks of treatment. The percentages of asymptomatic patients were similar in the two treatment groups both at 4 (70 vs. 73%) and 8 weeks (70 vs. 75%). H. pylori infection did not influence healing rates, but significantly more H. pylori-positive patients healed with omeprazole.
The results of this study show that omeprazole is superior to sucralfate in healing NSAID-induced gastroduodenal ulcer in patients who continue to take anti-inflammatory drugs. The good results observed were unrelated to H. pylori status.
确定在接受非甾体抗炎药（NSAIDs）慢性治疗期间发生胃溃疡或十二指肠溃疡的患者中，给予奥美拉唑和硫糖铝这两种药物的愈合疗效。
98例患有关节炎或关节病且患有NSAIDs相关胃溃疡或十二指肠溃疡的患者被纳入这项内镜单盲研究。他们被随机分为接受每日口服20mg奥美拉唑或每日两次2g硫糖铝治疗4 - 8周。患者在试验期间继续服用相同的NSAIDs。在入组时以及4周或8周后进行上消化道内镜检查。
88例患者完成了4周的研究，但在8周时仅有81例可用于最终分析。在4周（87%对52%，P = 0.007）和8周（100%对82%，P = 0.04）后，奥美拉唑在诱导胃溃疡愈合方面显著优于硫糖铝。在4周（79%对55%）或8周（95%对73%）时，两组十二指肠溃疡愈合率均未出现统计学上的显著差异。治疗4周后，合并胃溃疡和十二指肠溃疡患者的愈合率分别为67%对33%，治疗8周后为67%对67%。两个治疗组在4周（70%对73%）和8周（70%对75%）时无症状患者的百分比相似。幽门螺杆菌感染不影响愈合率，但接受奥美拉唑治疗的幽门螺杆菌阳性患者愈合的比例显著更高。
本研究结果表明，在继续服用抗炎药的患者中，奥美拉唑在愈合NSAIDs诱导的胃十二指肠溃疡方面优于硫糖铝。观察到的良好结果与幽门螺杆菌状态无关。
