Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan, ROC.
Am J Gastroenterol. 2012 Jul;107(7):1022-9. doi: 10.1038/ajg.2012.87. Epub 2012 Apr 17.
Aspirin-related peptic ulcers are a common disorder. However, whether or not aspirin should be continued during treatment for aspirin-related ulcers remains unclear.
To compare esomeprazole alone with esomeprazole plus aspirin in the treatment of aspirin-related peptic ulcers and to investigate the independent factors associated with the failure of ulcer healing.
From January 2008 to July 2011, patients with aspirin-related peptic ulcers were randomized to receive esomeprazole (40 mg per day) alone or esomeprazole (40 mg per day) plus aspirin (100 mg per day) for 8 weeks. The subjects with Helicobacter pylori infection were treated with standard triple therapy. Follow-up endoscopy was carried out at the end of the 8th week. The primary end point was the healing of peptic ulcers.
In all, 178 patients (89 receiving esomeprazole alone and 89 receiving esomeprazole plus aspirin) were enrolled and underwent follow-up endoscopy. The healing rate of ulcers by modified intention-to-treat analysis was 82.5% (95% confidence interval (CI), 74.2-90.8%) among patients treated with esomeprazole alone and 81.5% (95% CI, 73.0-90.0%) among patients treated with esomeprazole plus aspirin (difference, 1.0%; 95% CI, -11.2 to 12.6%). The per-protocol analysis yielded similar results (healing rate: 83.1% vs. 83.8%, respectively; difference, 0.7%; 95% CI, -11.2 to 12.6%). Multivariate analysis disclosed that use of steroids during treatment (odds ratio: 5.6; 95% CI, 1.1-27.7%) was the only independent factor associated with the failure of ulcer healing.
The observed ulcer healing rates were comparable in the esomeprazole and esomeprazole-plus-aspirin groups, but the wide CIs do not rule out clinically meaningful differences of more than 10%.
阿司匹林相关性消化性溃疡是一种常见疾病。然而，在治疗阿司匹林相关性溃疡期间是否应继续使用阿司匹林仍不清楚。
比较埃索美拉唑单独治疗与埃索美拉唑加阿司匹林治疗阿司匹林相关性消化性溃疡的效果，并探讨与溃疡愈合失败相关的独立因素。
本研究为 2008 年 1 月至 2011 年 7 月的一项随机对照研究，将阿司匹林相关性消化性溃疡患者随机分为埃索美拉唑（每天 40mg）单独治疗组或埃索美拉唑（每天 40mg）加阿司匹林（每天 100mg）治疗组，疗程 8 周。幽门螺杆菌感染者给予标准三联疗法。第 8 周末进行内镜随访。主要终点是消化性溃疡的愈合情况。
共纳入 178 例患者（89 例接受埃索美拉唑单独治疗，89 例接受埃索美拉唑加阿司匹林治疗）并进行内镜随访。意向治疗分析显示，埃索美拉唑单独治疗组溃疡愈合率为 82.5%（95%可信区间[CI]，74.2%90.8%），埃索美拉唑加阿司匹林治疗组为 81.5%（95%CI，73.0%90.0%）（差异为 1.0%；95%CI，-11.2%至 12.6%）。基于方案的分析也得到了类似的结果（愈合率：83.1%对 83.8%；差异为 0.7%；95%CI，-11.2%至 12.6%）。多变量分析显示，治疗期间使用类固醇（比值比：5.6；95%CI，1.1~27.7%）是与溃疡愈合失败相关的唯一独立因素。
埃索美拉唑组和埃索美拉唑加阿司匹林组的观察溃疡愈合率相当，但较宽的置信区间不能排除超过 10%的临床意义差异。
