Bell N, Karol M D, Sachs G, Greski-Rose P, Jennings D E, Hunt R H
McMaster University Medical Center, Hamilton, Ontario, Canada.
Aliment Pharmacol Ther. 2001 Jan;15(1):105-13. doi: 10.1046/j.1365-2036.2001.00831.x.
A double-blind, placebo-controlled study to assess the duration of effect of lansoprazole 30 mg o.m. on intragastric pH, acid secretion, gastrin levels, the potential for rebound acidity, and the relationship between gastric acid and drug pharmacokinetic parameters.
Sixteen subjects were treated with lansoprazole 30 mg daily or placebo for 14 days, followed by a 7-day post-dosing period and a post-study evaluation on day 28. Ambulatory 24-h pH was recorded and pentagastrin-stimulated acid secretion measured. Plasma kinetics of lansoprazole were determined.
Mean intragastric pH in the lansoprazole group increased significantly (P < 0.05) from baseline to day 14 compared to placebo. After cessation of treatment, secretory activity, as measured by intragastric pH, basal acid output and stimulated acid output, returned to baseline in 2 to 4 days without any overshoot, indicating the absence of acid rebound. Lansoprazole's terminal disposition half-life was 1.11 h. Mean pH and serum gastrin returned to baseline with half-lives of 22 and 19 h, respectively.
Lansoprazole 30 mg daily significantly increases mean intragastric pH without producing acid rebound. Regeneration of acid production depends primarily on de novo synthesis of the acid pump.
一项双盲、安慰剂对照研究，旨在评估口服30毫克兰索拉唑对胃内pH值、胃酸分泌、胃泌素水平、胃酸反跳可能性以及胃酸与药物药代动力学参数之间关系的作用持续时间。
16名受试者每日接受30毫克兰索拉唑或安慰剂治疗14天，随后是7天的给药后观察期，并在第28天进行研究后评估。记录动态24小时pH值，并测量五肽胃泌素刺激的胃酸分泌。测定兰索拉唑的血浆动力学。
与安慰剂相比，兰索拉唑组从基线到第14天胃内平均pH值显著升高（P<0.05）。治疗停止后，通过胃内pH值、基础胃酸分泌量和刺激胃酸分泌量测量的分泌活性在2至4天内恢复到基线水平，没有任何过冲现象，表明不存在胃酸反跳。兰索拉唑的终末处置半衰期为1.11小时。平均pH值和血清胃泌素分别以22小时和19小时的半衰期恢复到基线水平。
每日30毫克兰索拉唑可显著提高胃内平均pH值，且不会产生胃酸反跳。胃酸分泌的恢复主要取决于酸泵的重新合成。
