University of Texas Southwestern and VA North Texas Health Care System, Dallas, Texas 75216-7167, USA.
Am J Gastroenterol. 2011 Feb;106(2):272-7. doi: 10.1038/ajg.2010.436. Epub 2010 Nov 16.
Relative contributions of local and systemic mechanisms of upper gastrointestinal (GI) injury following aspirin are unknown. Studies suggest that aspirin's GI risk is age related and that gastroprotection may be needed at therapy initiation. We determined acute gastroduodenal erosion and ulceration following low-dose aspirin and aspirin-phosphatidylcholine complex (PL2200) in subjects at risk of aspirin ulcers.
In a randomized, single blind, multicenter active-controlled study, we compared upper GI damage of aspirin and PL2200 in healthy subjects (n=204, ages 50-74 years) following 7 days of oral 325 mg once daily, immediate release aspirin or PL2200.
Overall, 42.2% of aspirin-treated subjects developed multiple erosions and/or ulcers, whereas 22.2% treated with PL2200 developed such damage (P=0.0027). Gastroduodenal ulcers were observed in 17.6% of aspirin-treated compared with 5.1% of subjects treated with PL2200 (P=0.0069).
Low-dose aspirin induced a surprisingly high incidence of acute gastroduodenal ulcers in at risk subjects, highlighting that aspirin's upper GI risk begins early and may require gastroprotection. Local mechanisms of GI protection are important as aspirin's preassociation with surface-active phospholipids significantly reduced mucosal damage. PL2200 may be an attractive alternative or complement to proton pump inhibitors in older patients who are at risk of aspirin-induced ulceration. Longer-term studies assessing clinical GI events are desirable to confirm the clinical GI safety profile of PL2200.
局部和全身机制对上消化道（GI）损伤的相对贡献尚不清楚。研究表明，阿司匹林的 GI 风险与年龄有关，可能需要在治疗开始时进行胃保护。我们确定了低剂量阿司匹林和阿司匹林-磷脂酰胆碱复合物（PL2200）在有阿司匹林溃疡风险的受试者中的急性胃十二指肠糜烂和溃疡。
在一项随机、单盲、多中心活性对照研究中，我们比较了健康受试者（年龄 50-74 岁）在接受 7 天口服 325mg 每日一次，速释阿司匹林或 PL2200 后，阿司匹林和 PL2200 对上消化道损伤的影响。
总体而言，42.2%接受阿司匹林治疗的受试者出现多个糜烂和/或溃疡，而 22.2%接受 PL2200 治疗的受试者出现这种损伤（P=0.0027）。与接受 PL2200 治疗的受试者（P=0.0069）相比，接受阿司匹林治疗的受试者中观察到胃十二指肠溃疡发生率为 17.6%。
低剂量阿司匹林在高危受试者中引起了令人惊讶的高发生率的急性胃十二指肠溃疡，突出表明阿司匹林的上消化道风险很早就开始了，可能需要胃保护。局部胃肠保护机制很重要，因为阿司匹林与表面活性磷脂的预结合显著减少了黏膜损伤。PL2200 可能是一种有吸引力的替代或补充质子泵抑制剂，用于有阿司匹林诱导溃疡风险的老年患者。需要进行更长时间的研究来评估临床胃肠道事件，以确认 PL2200 的临床胃肠道安全性。
