健康人口服单一剂量的雷贝拉唑与埃索美拉唑对胃酸抑制作用的比较(英文)  

Comparison of the inhibitive effect on gastric acid between single dose rabeprazole and esomeprazole in healthy volunteers

作　　者：郭建强[1] 张澍田[2] 刘斌[1] 高庆岭[3] 许伟华[1] 栗华[1] 王洪波[1] 

机构地区：[1]山东大学第二医院消化科,济南250033 [2]北京首都医科大学附属北京友谊医院消化科,北京100050 [3]山东大学护理学院试验中心,济南250012

出　　处：《中国临床药学杂志》2005年第1期1-5,共5页Chinese Journal of Clinical Pharmacy

摘　　要：目的　比较健康人口服雷贝拉唑10、2 0mg和埃索美拉唑2 0、4 0mg对胃酸的抑制作用。方法　本研究为多中心、单一剂量、多种用法、开放、随机自身对照性研究,10例HP感染阴性的健康志愿者,按随机顺序分别服用雷贝拉唑10和2 0mg及埃索美拉唑2 0和4 0mg,同步检测2 4hpH值,清洗期为14d。结果　服药前胃内pH基础值和服药后胃内pH的中位数之间均无显著性差异(P >0 . 0 5 ) ;各组单一剂量的雷贝拉唑和埃索美拉唑均能在3h内出现抑酸作用,但雷贝拉唑10和2 0mgpH >4开始时间显著快于埃索美拉唑2 0和4 0mg(P <0 .0 5 ) ;胃内pH >4总时间的中位数,除雷贝拉唑2 0mg和埃索美拉唑4 0mg显著长于埃索美拉唑2 0mg外(P <0 .0 5 ) ,其他剂量间相比较未见显著差别(P >0 .0 5 ) ;白天pH >4的持续时间雷贝拉唑10和2 0mg与埃索美拉唑2 0和4 0mg之间无显著差别,而夜间pH >4的持续时间雷贝拉唑2 0mg显著长于埃索美拉唑2 0mg(P <0 . 0 1)和4 0mg(P <0 . 0 5 ) ,并且雷贝拉唑10mg夜间pH >4的时间也长于埃索美拉唑2 0mg(P <0 . 0 5 ) ;NAB的持续时间雷贝拉唑2 0mg显著短于埃索美拉唑2 0mg (P <0 . 0 1)和4 0mg(P <0 .0 5 ) ,并且雷贝拉唑10mg和埃索美拉唑4 0mg夜间酸突破的时间也显著较埃索美拉唑2 0mg为短(P <0 . 0 5 )。结论　HP?AIM To compare the inhibitive effect on gastric acid after a single dose of rabeprazole 10,20 mg, esomeprazole 20,40 mg in healthy H.pylori(Hp)-negative subjects. METHODS This was a randomized, multi-center, open-label, single-dose, four-way crossover study. Each subject received a single dose of rabeprazole 10 mg and 20 mg, esomeprazole 20 mg and 40 mg,respectively. 24-h intragastric pH was monitored simultaneously. There were 14 d washout time before taking the medication. Parameters included basic pH, the onset time of pH>4 after the medication, daytime recording time (09:00-22:00) and nighttime recording time(22:00-8:00), the median value and the time spent of pH>4 in daytime recording and night time recording, acid breakthrough time (pH<4) during the night time.RESULTS There were no difference of the median values of intragastric pH before and after drug administration. Both rabeprazole and esomeprazole in different single dosages can take inhibitive effect in 3 h. The onset time of rabeprazole in 10 mg and 20 mg was significantly faster than that of esomeprazole in 20 mg and 40 mg (P<0.05) respectively. Except the median value of rabeprazole 20 mg and esomeprazole 40 mg was longer than that in esomeprazole 20 mg, there was no significant difference of intragastric pH>4 in any other dosage. There was no significant difference of the time spent of pH>4 in daytime among all drug administrations of rabeprazole and esomeprazole. However, the time spent of pH>4 in nighttime of rabeprazole 20 mg was significantly longer than that of esomeprazole 20 mg (P<0.01) and 40 mg (P<0.05). It was found that the time spent of pH>4 in nighttime of rabeprazole 10 mg was significantly longer than that of esomeprazole 20 mg (P<0.01). The nocturnal acid breakthrough (NAB) time of rabeprazole 20 mg was significantly shorter than that of esomeprazole 20 mg (P<0.01) and 40 mg(P<0.05). The acid breakthrough time during the nighttime in rabeprazole 10 mg and esomeprazole 40 mg was significantly shorter than that in esomeprazole 2

关 键 词：24h PH检测 雷贝拉唑 埃索美拉唑 

分 类 号：R96[医药卫生—药理学]