瑞巴派特治疗慢性非萎缩性胃炎的随机、对照、多中心临床研究

目的 评价瑞巴派特治疗伴糜烂的非萎缩性胃炎的疗效及其对幽门螺杆菌(Hp)相关胃黏膜损伤的保护作用.方法 共选取来自11个中心的452例经内镜确诊的非萎缩性胃炎伴糜烂患者,随机分为瑞巴派特组(300 mg/d)和硫糖铝组(3.0 g/d),疗程8周,其中半数Hp阳性病例在随机化前行Hp根除治疗.观察所有病例治疗前后的症状、内镜评分和病理改变,部分进行胃黏膜中前列腺素PGE2以及氧自由基产物丙二醛(MDA)检测.结果 符合方案集分析(n=415)显示瑞巴派特组的消化不良症状积分在治疗8周后显著下降,且内镜下炎症积分从治疗前的2.65±0.09下降至0.60±0.10(P<0.001),与硫糖铝相比差异有统计学意义(P<0.001),胃黏膜病理与内镜评判的趋势相符.同时,瑞巴派特组的胃黏膜PGE2含量由治疗前的(225.4 ±18.3)pg/g升至(266.7±14.7)pg/g,MDA含量由(325.9±65.6)mmol/g降至(216.5±61.5)mmol/g,与硫糖铝组相比差异有统计学意义(P=0.046).分层分析未发现瑞巴派特的疗效在HP阳性根除组、Hp阳性和Hp阴性组之间差异有统计学意义.结论 瑞巴派特对慢性非萎缩性胃炎的消化不良症状和内镜表现的改善优于硫糖铝,并且其对胃黏膜的保护作用不受Hp感染的影响.

A randomized controlled multicenter trial of Rebamipide on chronic non-atrophic gastritis

Objective To investigate the effect of rebamipide on chronic non-atrophic gastritis (NAG) with erosion and its protection of gastric mucosa from Helicobacter priori(Hp) associated lesions.Methods Patients(n=452)with endoscopically confirmed NAG with erosion from 11 hospitals in China were enrolled and randomly assigned at a ratio of 3:1 to receive either rebamipide(100 mg t.i.d.)or sucralfate(1.0 t.i.d.)for 8 weeks.Hp infected patients received eradication treatment before randomization.Symptoms,endoscopic scores and histological changes were recorded before and after therapy.Concentrations of serum prostaglandin E(PGE:)and oxygen free radical(MDA)were measured in patients from 2 centers.Results Per-protocol analysis(n=415)showed that the dyspeptic symptom score in rebamipide group decreased significantly after eight weeks of treatment. The endoscopic inflammation score in rebamipide group also decreased from 2.65 ±0.09 to 0.60±0.10(P<0.001),which was,significantly better than that of sucralfate group(P<0.001).Histological findings were consistent with the endoscopic findings.There Was a significant elevation(P=0.002)in PGE2 concentration in mucesa from rebamipide-treated subjects [(225.4±18.3) pg/g vs.(266.7±14.7)Pg/g] compared with that in sucralfate group.The concentration of MDA significantly decreased from(325.9±65.6)mmoL/g to(216.5±61.5)mmol/g,which is markedly different from that of sucralfate group(P=0.046).No statistical difference was found between Hp eradication group,Hp infection group and Hp negative group,regarding the effect of Rebamipide.Conclusion Compared to sucralfate,Rebamipide demonstrates a superior effect on improvement of dyspepsia symptom and endoscopic findings in erosive NAG,which is not influenced by Hp infection.