Chitapanarux Taned, Lertprasertsuke Nirush, Kongnak Acharaporn
Gastrohepatology Unit, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Northern Thai Research Group of Radiation Oncology (NTRG-RO), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Scand J Gastroenterol. 2019 Oct;54(10):1199-1204. doi: 10.1080/00365521.2019.1672781. Epub 2019 Oct 8.
Low-dose aspirin is the standard treatment for the prevention of cardiovascular events in at-risk patients. We performed a randomized, placebo-controlled study to determine the efficacy of teprenone for primary prevention of gastrointestinal injury in patients taking LDA for vascular protection. Patients were eligible for enrollment if they required aspirin 100 mg/day. Aspirin- naïve patients without gastroduodenal ulcer and infection were randomized to receive teprenone 150 mg/day or placebo for 12 weeks. Primary outcome was assessed by the incidence rate of gastroduodenal ulcer. Secondary outcomes were assessed by the incidence rate of gastric mucosal injury, the improvement in modified Lanza score (MLS), gastrointestinal symptom rating scale (GSRS) and the change of gastric immunohistochemical expression for COX-1. Total of 130 patients were randomized, 64 in teprenone group and 66 in placebo group. There was no incidence of ulcer after 12 weeks in both groups. Incidence of gastric mucosal injury was higher in placebo group than in teprenone group (40.0 vs. 13.38%, = .039). Mean change of MLS was higher in placebo group than in teprenone group (0.767 ± 0.467 vs. 0.271 ± 0.158, = .003). Scores of mucosal edema, hyperemia and hemorrhage and the change of GSRS were not different between the two groups. Change of COX-1 immunoreactive score was higher in placebo group than in teprenone group (2.433 ± 1.476 vs. 1.233 ± 0.955, = .001). There were no treatment-related adverse events. Teprenone is effective in preventing gastric mucosal injury in patients taking LDA. Preventive effects of teprenone on LDA-related gastroduodenal ulcers require further investigation.
低剂量阿司匹林是预防高危患者心血管事件的标准治疗方法。我们进行了一项随机、安慰剂对照研究，以确定替普瑞酮对服用低剂量阿司匹林进行血管保护的患者预防胃肠道损伤的疗效。如果患者需要每天服用100毫克阿司匹林，则符合入组条件。未服用过阿司匹林且无胃十二指肠溃疡和感染的患者被随机分为两组，一组每天服用150毫克替普瑞酮，另一组服用安慰剂，为期12周。主要结局通过胃十二指肠溃疡的发病率进行评估。次要结局通过胃黏膜损伤的发病率、改良兰扎评分（MLS）的改善情况、胃肠道症状评分量表（GSRS）以及COX-1胃免疫组化表达的变化进行评估。共有130名患者被随机分组，替普瑞酮组64例，安慰剂组66例。两组在12周后均无溃疡发生。安慰剂组胃黏膜损伤的发生率高于替普瑞酮组（40.0%对13.38%，P = 0.039）。安慰剂组MLS的平均变化高于替普瑞酮组（0.767±0.467对0.271±0.158，P = 0.003）。两组间黏膜水肿、充血和出血的评分以及GSRS的变化无差异。安慰剂组COX-1免疫反应评分的变化高于替普瑞酮组（2.433±1.476对1.233±0.955，P = 0.001）。未发生与治疗相关的不良事件。替普瑞酮对服用低剂量阿司匹林的患者预防胃黏膜损伤有效。替普瑞酮对低剂量阿司匹林相关胃十二指肠溃疡的预防作用需要进一步研究。
