近年來科學發展進步飛快, 人們的生活經歷著難以想像的變化。隨著經濟越加繁榮與國際交流頻繁, 現代人的生活早已沒有姜太公釣魚的雅致, 而是更加習慣高效率的「衝衝衝」, 也因此造就了消化不良、胃痛胃潰瘍等文明病。不只如此, 部分患者在潰瘍治療好後, 還需擔心容易覆發的潰瘍後再出血問題。
臨床常見的潰瘍後再出血(無論有無胃幽門螺旋桿菌(H.pylori)感染), 治療選項常包含質子幫浦抑制劑(PPIs), 但對於組織胺阻斷劑(H2-block)在之中的角色尚未充分討論。而在肝膽腸胃科響負盛名之GUT Journal 今年發表的研究發現, Famotidine預防潰瘍再出血與PPI類療效相當 (持續使用2年)。此結果可應用於類似患者之治療, 藉此減低醫療花費支出。
試驗方法
設計採用隨機分配、無廠商介入的雙盲試驗, 收錄非H.pylori感染之特異性胃腸道出血患者, 在潰瘍治療結束後隨機分配到以下兩組別, 持續治療2年的時間: (1) Lansoprazole, 每天服用30mg、(2) Famotidine, 每天服用40mg。主要監測終點為在24個月中反覆發生的腸胃出血比例。
試驗結果
在2010 – 2018年間持續收錄了共228位患者(兩組皆分別分配了114位), 在後續治療期間發生腸胃再出血比率, 在Lansoprazole組為0.88%, Famotidine組為2.63% (p=0.313, 無顯著差異)。發生再出血的原因並非使用Aspirin, NSAIDs, 或抗血栓藥。
試驗結論
經此次高證據力之2年、雙盲隨機分配試驗顯示, 在非H.pylori感染之再出血患者上使用Famotidine預防再出血效果與Lansoprazole相當。此結果可提供未來臨床治療準則之制定, 用以符合非特異性再出血患者的治療。
References
----------其他文章--------------------
Objective
Patients with a history of Helicobacter pylori-negative idiopathic bleeding ulcers have a considerable risk of recurrent ulcer complications. We hypothesised that a proton pump inhibitor (lansoprazole) is superior
to a histamine 2 receptor antagonist (famotidine) for the prevention of recurrent ulcer bleeding in such patients.
Design
In this industry-independent, double-blind, randomised trial, we recruited patients with a history of idiopathic bleeding ulcers. After ulcer healing, we randomly assigned (1:1) patients to receive oral lansoprazole 30 mg or famotidine 40 mg daily for 24 months. The primary endpoint was recurrent upper GI bleeding within 24 months, analysed in the intentionto- treat population as determined by an independent adjudication committee.
Results
Between 2010 and 2018, we enrolled 228 patients (114 patients in each study group). Recurrent upper GI bleeding occurred in one patient receiving lansoprazole (duodenal ulcer) and three receiving famotidine (two gastric ulcers and one duodenal ulcer). The cumulative incidence of recurrent upper GI bleeding in 24 months was 0.88% (95% CI 0.08% to 4.37%) in the lansoprazole arm and 2.63% (95% CI 0.71% to 6.91%) in the famotidine arm (p=0.313; crude HR 0.33, 95% CI 0.03 to 3.16, p=0.336). None of the patients who rebled used aspirin, non-steroidal anti-inflammatory drugs or other antithrombotic drugs.
Conclusion
This 2-year, double-blind randomised trial showed that among patients with a history of H. pylorinegative idiopathic ulcer bleeding, recurrent bleeding rates were comparable between users of lansoprazole and famotidine, although a small difference in efficacy cannot be excluded.
留言列表
