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
서파파특치료만성비위축성위염적수궤、대조、다중심림상연구
A randomized controlled multicenter trial of Rebamipide on chronic non-atrophic gastritis
  • 万方数据
    中华消化内镜杂志 중화소화내경잡지
    CHINESE JOURNAL OF DIGESTIVE ENDOSCOPY
    2008年 7期 353-358 ,共6页

    杜奕奇%李兆申%湛先保%邹多武%陈洁%龚燕芳%任建林%何利平%张志坚%郭晓钟%吴建胜%田字彬%施瑞华%姜泊%房殿春%厉有名

    두혁기%리조신%담선보%추다무%진길%공연방%임건림%하리평%장지견%곽효종%오건성%전자빈%시서화%강박%방전춘%려유명

    瑞巴派特%慢性非萎缩性胃炎%幽门螺杆菌 瑞巴派特%慢性非萎縮性胃炎%幽門螺桿菌
    서파파특%만성비위축성위염%유문라간균
    Rebamipide%Chronic non-atrophic gastritis%Helieobacter pylori
    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.
    목적 평개서파파특치료반미란적비위축성위염적료효급기대유문라간균(Hp)상관위점막손상적보호작용.방법 공선취래자11개중심적452례경내경학진적비위축성위염반미란환자,수궤분위서파파특조(300 mg/d)화류당려조(3.0 g/d),료정8주,기중반수Hp양성병례재수궤화전행Hp근제치료.관찰소유병례치료전후적증상、내경평분화병리개변,부분진행위점막중전렬선소PGE2이급양자유기산물병이철(MDA)검측.결과 부합방안집분석(n=415)현시서파파특조적소화불량증상적분재치료8주후현저하강,차내경하염증적분종치료전적2.65±0.09하강지0.60±0.10(P<0.001),여류당려상비차이유통계학의의(P<0.001),위점막병리여내경평판적추세상부.동시,서파파특조적위점막PGE2함량유치료전적(225.4 ±18.3)pg/g승지(266.7±14.7)pg/g,MDA함량유(325.9±65.6)mmol/g강지(216.5±61.5)mmol/g,여류당려조상비차이유통계학의의(P=0.046).분층분석미발현서파파특적료효재HP양성근제조、Hp양성화Hp음성조지간차이유통계학의의.결론 서파파특대만성비위축성위염적소화불량증상화내경표현적개선우우류당려,병차기대위점막적보호작용불수Hp감염적영향.
    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.
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