注射用兰索拉唑治疗十二指肠溃疡24小时pH监测的临床试验研究  

The Clinical Study on 24 Hour pH Monitoring of Lansoprazole for Injection in Treatment of Duodenal Ulcer

作　　者：李晓昕[1] 张宜山[1] 张振玉[2] 

机构地区：[1]江苏奥赛康药业有限公司,南京211112 [2]南京市第一医院消化科,南京210016

出　　处：《中国医药导刊》2008年第6期870-871,共2页Chinese Journal of Medicinal Guide

摘　　要：目的:客观评价注射用兰索拉唑治疗十二指肠溃疡时对胃酸的抑制作用及安全性研究。方法:本研究采用随机、盲法、阳性药物、平行对照、多中心的临床试验。结果:从2005年10月至2005年12月共有35例患者入组,经监测结果:两组pH监测总时间、pH上升至4的时间、pH上升至6的时间、pH上升>4的时间所占百分比、pH上升>6的时间所占百分比均无统计学意义(P>0.05)。结论:注射用兰索拉唑用于治疗十二指肠溃疡胃酸抑制是有效而安全药物。Objective： To evaluate acid-secretion inhibition and safety during treatment of duodenal ulcer patients by Lansoprazole for Injection. Method： A multi-center, parallel-controlled, randomized, blind, and positive drug clinical trial was conducted. Results： From Oct. 2005 to Dec. 2005, total 35 patients were enrolled in the clinical trial. The data shows that there is no statistically significant difference between two groups on monitoring time, ratios of times up to pH 4, up to PH 6, up to above pH 4, and up to above pH 6, respectively （P〉0.05）. Conclusions： The clinical trial result shows that it is effective in acid-secretion.

关 键 词：注射用兰索拉唑 十二指肠溃疡 24小时PH监测 

分 类 号：R573.1[医药卫生—消化系统]