Institute of Digestive Disease, Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong.
Ann Intern Med. 2010 Jan 5;152(1):1-9. doi: 10.7326/0003-4819-152-1-201001050-00179. Epub 2009 Nov 30.
It is uncertain whether aspirin therapy should be continued after endoscopic hemostatic therapy in patients who develop peptic ulcer bleeding while receiving low-dose aspirin.
To test that continuing aspirin therapy with proton-pump inhibitors after endoscopic control of ulcer bleeding was not inferior to stopping aspirin therapy, in terms of recurrent ulcer bleeding in adults with cardiovascular or cerebrovascular diseases.
A parallel randomized, placebo-controlled noninferiority trial, in which both patients and clinicians were blinded to treatment assignment, was conducted from 2003 to 2006 by using computer-generated numbers in concealed envelopes. (ClinicalTrials.gov registration number: NCT00153725)
A tertiary endoscopy center.
Low-dose aspirin recipients with peptic ulcer bleeding.
78 patients received aspirin, 80 mg/d, and 78 received placebo for 8 weeks immediately after endoscopic therapy. All patients received a 72-hour infusion of pantoprazole followed by oral pantoprazole. All patients completed follow-up.
The primary end point was recurrent ulcer bleeding within 30 days confirmed by endoscopy. Secondary end points were all-cause and specific-cause mortality in 8 weeks.
156 patients were included in an intention-to-treat analysis. Three patients withdrew from the trial before finishing follow-up. Recurrent ulcer bleeding within 30 days was 10.3% in the aspirin group and 5.4% in the placebo group (difference, 4.9 percentage points [95% CI, -3.6 to 13.4 percentage points]). Patients who received aspirin had lower all-cause mortality rates than patients who received placebo (1.3% vs. 12.9%; difference, 11.6 percentage points [CI, 3.7 to 19.5 percentage points]). Patients in the aspirin group had lower mortality rates attributable to cardiovascular, cerebrovascular, or gastrointestinal complications than patients in the placebo group (1.3% vs. 10.3%; difference, 9 percentage points [CI, 1.7 to 16.3 percentage points]).
The sample size is relatively small, and only low-dose aspirin, 80 mg, was used. Two patients with recurrent bleeding in the placebo group did not have further endoscopy.
Among low-dose aspirin recipients who had peptic ulcer bleeding, continuous aspirin therapy may increase the risk for recurrent bleeding but potentially reduces mortality rates. Larger trials are needed to confirm these findings.
对于正在服用小剂量阿司匹林时发生消化性溃疡出血的患者，内镜止血治疗后是否应继续阿司匹林治疗尚不确定。
旨在检验在消化性溃疡出血内镜控制后继续使用质子泵抑制剂联合阿司匹林治疗与停用阿司匹林治疗相比，在心血管或脑血管疾病成年患者中是否不劣于后者，前者用于治疗复发性溃疡出血。
采用平行、随机、安慰剂对照、非劣效性试验，于 2003 年至 2006 年期间开展，采用密封信封中生成的计算机数字进行分组（ClinicalTrials.gov 注册号：NCT00153725）。
三级内镜中心。
接受小剂量阿司匹林治疗且发生消化性溃疡出血的患者。
78 例患者在接受内镜治疗后立即接受阿司匹林 80mg/d 和安慰剂治疗 8 周。所有患者接受泮托拉唑 72 小时输注，然后口服泮托拉唑。所有患者完成随访。
主要终点是通过内镜确认的 30 天内复发性溃疡出血。次要终点是 8 周内的全因死亡率和特定病因死亡率。
156 例患者纳入意向治疗分析。3 例患者在完成随访前退出试验。30 天内复发性溃疡出血的发生率在阿司匹林组为 10.3%，在安慰剂组为 5.4%（差异，4.9 个百分点[95%CI，-3.6 至 13.4 个百分点]）。接受阿司匹林治疗的患者全因死亡率低于接受安慰剂治疗的患者（1.3%比 12.9%；差异，11.6 个百分点[CI，3.7 至 19.5 个百分点]）。阿司匹林组患者心血管、脑血管或胃肠道并发症导致的死亡率低于安慰剂组（1.3%比 10.3%；差异，9 个百分点[CI，1.7 至 16.3 个百分点]）。
样本量相对较小，且仅使用小剂量阿司匹林（80mg）。安慰剂组中 2 例复发性出血患者未进一步行内镜检查。
在接受小剂量阿司匹林治疗且发生消化性溃疡出血的患者中，持续使用阿司匹林治疗可能会增加再次出血的风险，但可能会降低死亡率。需要更大规模的试验来证实这些发现。
