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首页> 外文期刊>Hepato-gastroenterology. >Combination of enprostil and cimetidine is more effective than cimetidine alone in treating gastric ulcer: prospective multicenter randomized controlled trial.
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Combination of enprostil and cimetidine is more effective than cimetidine alone in treating gastric ulcer: prospective multicenter randomized controlled trial.

机译：恩普列汀和西咪替丁联合治疗比单独使用西咪替丁治疗胃溃疡更有效：一项前瞻性多中心随机对照试验。

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BACKGROUND/AIMS: Little is known about the clinical efficacy of co-therapy of enprostil, a prostaglandin E2 analogue, with a histamine H2-receptor antagonist. We aimed to assess the additive benefit of enprostil in combination with cimetidine for treating gastric ulcer in a prospective multicenter randomized controlled trial. METHODOLOGY: In 43 hospitals 171 intention-to-treat (ITT) patients, diagnosed as having gastric ulcer by endoscopy, were randomly allocated to receive either enprostil 25microg b.i.d. and cimetidine 400mg b.i.d. (Group E=85), or cimetidine 400mg b.i.d. alone (Group C=86) for 8 weeks. Healing was examined by endoscopy at 4 and 8 weeks. RESULTS: Per protocol (PP) analysis comprised 166 patients (E=82, C=84). Despite no significant advantage at 4 weeks (E=55.3%, C=42.2%), the combination yielded higher healing rates at 8 weeks by ITT (E=89.4%, C=68.6%; p<0.001) and PP analysis (E=92.7%, C=70.2%; p<0.001). Symptom relief rates [E, C] at 2, 4, and 8 weeks were [80.2%, 68.3%] (not significant), [97.4%, 88.3%] (p<0.05), and [95.6%, 87.0%] (p<0.05), respectively. Significant advantage was observed in the patients aged 40 or older, with solitary ulcer (>5mm in diameter), and without smoking or drinking habits. No adverse effects were critical. CONCLUSIONS: Enprostil safely and significantly augmented gastric ulcer healing and symptom relief by cimetidine.
机译：背景/目的：关于恩普列斯（prostaglandin E2类似物）与组胺H2受体拮抗剂联合治疗的临床疗效知之甚少。我们的目的是在一项前瞻性多中心随机对照试验中评估恩普曲与西咪替丁联合治疗胃溃疡的附加益处。方法：在43家医院中，随机分配了171例经内窥镜检查诊断患有胃溃疡的意向性治疗（ITT）患者，接受25毫克/天的enprostil治疗。和西咪替丁400 mg b.i.d. （组E = 85）或西咪替丁400 mg b.i.d.独自（C = 86组）持续8周。在第4和8周时通过内窥镜检查愈合情况。结果：按方案（PP）分析包括166例患者（E = 82，C = 84）。尽管在4周时无显着优势（E = 55.3％，C = 42.2％），但通过ITT（E = 89.4％，C = 68.6％; p <0.001）和PP分析（E），该组合在8周时产生了更高的治愈率＝ 92.7％，C ＝ 70.2％; p ＜0.001）。第2、4和8周的症状缓解率[E，C]分别为[80.2％，68.3％]（不显着），[97.4％，88.3％]（p <0.05）和[95.6％，87.0％] （p ＜0.05）。在患有孤独性溃疡（直径> 5mm）且没有吸烟或饮酒习惯的40岁或40岁以上患者中观察到了显着的优势。没有不利影响是关键的。结论：Enprostil安全且显着增强了西咪替丁的胃溃疡愈合和症状缓解。

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