摘要
目的比较健康人静脉输注艾司奥美拉唑国产制剂(商品名:艾速平)与其进口制剂(商品名:耐信)对胃酸的抑制作用。方法采用单中心、随机、交叉、对照性研究。19例健康志愿者,按随机顺序分成试验组和对照组,分别予以耐信或艾速平40 mg输注,通过胃内pH监测比较两者用药后0～24 h及96～120 h的抑酸效果,洗脱期为14 d。结果用药后第1天胃内pH>4.0和pH>6.0的总时间百分比试验组和对照组之间差异均无统计学意义(79.6%vs 77.1%,P=0.55; 41.5%vs 42.8%,P=0.76)。用药后第5天胃内pH>4.0和pH>6.0的总时间百分比试验组和对照组之间差异也无统计学意义(88.2%vs 88.9%,P=0.74;44.3%vs 41.8%,P=0.57)。此外,用药后第1天胃内pH达到4.0和6.0的平均时间、用药后胃内pH的平均值、中位值和每小时胃内平均值等指标,2组间差异均无统计学意义(P>0.05)。结论相同剂量的耐信与艾速平都能有效地控制胃内酸度,两者疗效相当。
AIM To compare the inhibitive effect on gastric acid after a single dose of domestic agents of esomeprazole and import agents of esomeprazole by intravenous infusion. METHODS This was a randomized, single-center, controlled crossover study. Totally 19 healthy volunteers successfully completed the trial. The subjects were randomly divided into the control group(import agents of esomeprazole) and the trial group(domestic agents of esomeprazole), respectively.Twenty-four hours intragastric pH was monitored 0-24 h and 96-120 h after medication to compare the inhibitive effect on gastric acid.There was 14 days washout time before taking the medication. RESULTS On the first day of treatment, the percentages of pH>4.0 time of trail group and control group were 79.6 % and 77.1 %, respectively; and there was no statistical differences between 2 groups(P=0.55). On the first day of treatment, the percentages of pH>6.0 time of trial group and control group were 41.5 % and 42.8 %, respectively; and there was no statistical differences between 2 groups(P=0.76). On the fifth day of treatment, the percentages of pH>4.0 time of trial group and control group were 88.2 % and 88.9 %, respectively; and there was no statistical differences between 2 groups(P=0.74). On the fifth day of treatment, the percentages of pH>6.0 time of trial group and control group were 44.3 % and 41.8 %, respectively; and there was no statistical differences between 2 groups(P=0.57). Moreover, there were no significant differences for the time spent of pH>4.0 and pH>6.0, the average pH value and the median pH value and so on(P>0.05). CONCLUSION Domestic agents of esomeprazole and import agents of esomeprazole both can effectively inhibit gastric acid, and the efficacy of the two drugs is comparable.
作者
张玲
陆建萍
沈振
龚燕芳
庄海花
童倩
钱维
沈娇娇
李家琪
邹多武
ZHANG Ling;LU Jianping;SHEN Zhen;GONG Yanfang;ZHUANG Haihua;TONG Qian;QIAN Wei;SHEN Jiaojiao;LI Jiaqi;ZOU Duowu(Gastroenterology Department of Changhai Hospital,Second Military Medical University,Shanghai 200433,China;CHIA TAI TIANQING Pharmaceutical Group CO.,Nanjing 210023,China)
出处
《中国临床药学杂志》
CAS
2019年第1期1-4,共4页
Chinese Journal of Clinical Pharmacy
关键词
艾司奥美拉唑
抑酸效果
临床疗效
随机
交叉
对照试验
esomeprazole
inhibitive effect on gastric acid
curative effect
randomized controlled crossover trial
