注射用雷贝拉唑钠与注射用奥美拉唑钠对健康人胃内24小时pH值的影响

中国临床药理学与治疗学 ›› 2010, Vol. 15 ›› Issue (2): 180-184.

注射用雷贝拉唑钠与注射用奥美拉唑钠对健康人胃内24小时pH值的影响

王瑾¹, 晁阳², 王永庆³, 于锋¹

¹中国药科大学药学院,南京 210009,江苏;
²南京长澳医药科技有限公司,南京 210038,江苏;
³南京医科大学第一附属医院临床药物研究室,南京 210029,江苏

收稿日期:2009-12-01 修回日期:2009-12-24 出版日期:2010-02-26 发布日期:2020-09-18
通讯作者: 于锋,男,教授,硕士生导师,研究方向:临床药学。Tel: 025-83271262 E-mail: yufengcpu@163.com
作者简介:王瑾,女,硕士,研究方向:临床药学。Tel: 025-83271262 E-mail: wjibicf@163.com

Comparison of the efficacy between rabeprazole sodium and omeprazole sodium for injection on 24-hour intragastric pH in healthy volunteers

WANG Jin¹, CHAO Yang², WANG Yong-qing³, YU Feng¹

¹ Collega of Pharmacy, China Pharmaceutical University, Nanjing 210009, Jiangsu, China;
² Chang'ao Pharmaceutical Technology Ltd, Nanjing 210038, Jiangsu, China;
³ Department of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China

Received:2009-12-01 Revised:2009-12-24 Online:2010-02-26 Published:2020-09-18

摘要/Abstract

摘要： 目的:比较不同剂量的注射用雷贝拉唑钠与注射用奥美拉唑钠 40 mg 对健康受试者胃内24 h pH值的影响。方法:采用开放、对照、多中心的临床试验方法,84名健康受试者分为4组,分别静脉滴注雷贝拉唑 10 mg(A组)、20 mg(B组)、40 mg(C组)和奥美拉唑 40 mg(D组),每日1次,连续 5 d 用药,并在第1天和第5天进行胃内24 h pH值监测。结果:24 h pH中值:四组用药第5天的pH中值均显著高于第1天用药后的pH中值(P<0.05);pH>4和pH>6时间百分数:四组用药第5天均比用药第1天后有显著性增高(P<0.05);第1天,C组胃内pH>4时间百分比显著高于A组(P<0.05);第5天,D组胃内pH>6的时间百分比显著高于A组、B组(P<0.05)。结论:注射用雷贝拉唑钠和注射用奥美拉唑钠均可显著抑制胃酸分泌,且连续用药比单次用药有更明显的胃酸抑制作用。雷贝拉唑 20 mg 与 40 mg 的作用强度和有效性相似。单次给药,雷贝拉唑钠三个剂量组与奥美拉唑钠抑酸能力相当;连续多次给药,雷贝拉唑钠三组不同剂量有相近的抑酸作用。此外,性别不会对药物作用产生影响。

关键词: 注射用雷贝拉唑钠, 注射用奥美拉唑钠, 24 h pH值

Abstract: AIM: To compare the effects between different doses of rabeprazole(RAB) sodium for injection and 40 mg of omeprazole(OME) sodium for injection on 24-hour intragastric pH in healthy subjects. METHODS: In this open, paralleled, multi-center study, 84 healthy volunteers were divided into 4 groups. They were administered with intravenous dripping of 10 mg(Group A),20 mg(Group B) and 40 mg(Group C) per day of RAB and 40 mg(Group D) per day of OME respectively for 5 days. The values of intragastric pH of each subject were monitored for 24 h on the first day and the last day. RESULTS: The median 24 h intragastric pH values: the pH values on day 5 were significantly increased compared with those on day 1 (P<0.05). The mean percentage of the gastric pH>4 and pH>6 on day 5 were significantly increased compared with those on day 1 (P<0.05). The mean percentage of the gastric pH>4 in Group C were higher than those in Group A on day 1(P<0.05); and the mean percentage of the gastric pH>6 in Group D was higher than those in Groups A and B on day 5(P<0.05). CONCLUSION: Both RAB and OME sodium for injection have great inhibitory effect on gastric acid secretion. Continuous administration can more significantly inhibit the gastric acid than that of single-dose. The efficacy and drug potency of RAB 20 mg in gastric acid inhibition are similar to those of RAB 40 mg. The acid suppression is similar with single dose of RAB 10 mg, 20 mg, 40 mg and OME 40 mg. The roles of acid suppression are similar with continuous administration of three different doses of RAB. Besides, gender does not affect the pharmacodynamic action of the drugs.

Key words: Rabeprazole sodium for injection, Omeprazole sodium for injection, 24 h intragastric pH

中图分类号:

王瑾, 晁阳, 王永庆, 于锋. 注射用雷贝拉唑钠与注射用奥美拉唑钠对健康人胃内24小时pH值的影响[J]. 中国临床药理学与治疗学, 2010, 15(2): 180-184.

WANG Jin, CHAO Yang, WANG Yong-qing, YU Feng. Comparison of the efficacy between rabeprazole sodium and omeprazole sodium for injection on 24-hour intragastric pH in healthy volunteers[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(2): 180-184.

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