吉法酯对伴有消化不良症状慢性胃炎的临床研究

背景 胃黏膜保护剂对伴有症状的慢性胃炎的作用尚不明确。本研究是一项多中心、开放、随机试验，比较吉法酯和硫糖铝对伴消化不良症状的慢性胃炎的综合疗效。 方法 共有来自国内6家中心的253例证实有慢性胃炎的消化不良患者进入研究，被随机分为两组，分别接受6周的300mg/d吉法酯或3.0/d的硫糖铝治疗。研究终点是6周的内镜学改变。 结果 吉法酯对于内镜下评分和症状改善的有效率分别为72%和67%，显著高于硫糖铝组（40.1%和39.3%，P<0.001，ITT）。在组织学评价上，吉法酯和硫糖铝相比，对减轻黏膜的慢性炎症（57.7% vs 24.8%, P<0.001）和炎症活动（36.4% vs 23.1%, P<0.05）都有效。同时，吉法酯可以显著增加黏膜的前列腺素水平，降低MPO水平。黏膜糜烂的程度与症状无关，但Hp的状态影响到吉法酯的疗效。 结论 吉法酯对慢性糜烂性胃炎的黏膜炎症有显著疗效，内镜和炎症评分应该作为胃炎相关临床研究的主要评价指标。

Gastro- protecting effect of gefarnate on chronic erosive gastritis with dyspeptic symptoms

Background The role of gastro-protecting agents on symptomatic chronic gastritis is unclear. This multicenter, open, randomized trial was designed to compare the comprehensive effects of gefarnate with sucralfate on erosive gastritis with dyspeptic symptoms. Methods Totally 253 dyspepsia patients confirmed with erosive gastritis were enrolled from six centers in China. They randomly received either daily 300mg gefarnate or 3g sucralfate for six weeks. The primary endpoint was the effective rate of both treatments on endoscopic erosion at week six. Results Gefarnate showed an effective rate of 72% and 67% on endoscopic score and dyspeptic symptom release, which is statistically higher than sucralfate (40.1% and 39.3%, P<0.001, intension-to-treat). For histological improvement, gefarnate showed both effective in decrease mucosal chronic inflammation (57.7% vs 24.8%, P<0.001, intension-to-treat) and active inflammation (36.4% vs 23.1%, P<0.05, intension-to-treat) than the control. A significant increase of prostaglandins and decrease of myeloperoxidase in mucosa were observed in gefarnate group. Severity of erosion is non-relevant to symptoms but H. pylori status does affect the outcome of therapy. Conclusions Gefarnate demonstrates an effective outcome on the mucosal inflammation in patients with chronic erosive gastritis. Endoscopic and inflammation score should be the major indexes used in gastritis-related trials.