Dammann H G, Burkhardt F
Klinische Forschung Hamburg, Wissenschaftliches Institut, Germany.
Eur J Gastroenterol Hepatol. 1999 Nov;11(11):1277-82.
To determine the influence of recommended therapeutic doses of pantoprazole and omeprazole on meal-stimulated acid secretion.
In this double-blind, placebo-controlled, three-period crossover study, 12 healthy male volunteers received 40 mg pantoprazole od, 20 mg omeprazole od or placebo at 08:00 h for 5 days in a randomized order. Meal-stimulated acid secretion was determined by means of a homogenized test meal, and intragastric titration on day 1, 4-6 h, 8-10 h, 16-18 h, and 24-26 h, and on days 3 and 5, 4-6 h after oral drug administration.
On day 1 (4-6 h after oral drug administration), meal-stimulated acid secretion was decreased by 36% and 24% after administration of 40 mg pantoprazole or 20 mg omeprazole, respectively. After 3 and 5 days of dosing, the decreases were 88% and 85% with 40 mg pantoprazole, and 70% and 74% with 20 mg omeprazole. At all measuring points during the 5-day dosing periods, 40 mg pantoprazole proved superior to 20 mg omeprazole in inhibiting meal-stimulated gastric acid secretion. The differences were statistically significant for pantoprazole on day 1, 24-26 h after oral drug administration and on day 3 (P = 0.0425 and P = 0.0244, respectively). On day 1, only pantoprazole was significantly better than placebo (P = 0.0210, 4-6 h after dosing; P = 0.0093, 8-10 h after dosing and P = 0.0068, 16-18 h after dosing).
Pantoprazole 40 mg is significantly more effective than omeprazole 20 mg in inhibiting meal-stimulated acid secretion. In addition, pantoprazole exhibits a more rapid onset of action.
确定泮托拉唑和奥美拉唑的推荐治疗剂量对进餐刺激胃酸分泌的影响。
在这项双盲、安慰剂对照、三阶段交叉研究中,12名健康男性志愿者按随机顺序于08:00时服用40毫克泮托拉唑每日一次、20毫克奥美拉唑每日一次或安慰剂,持续5天。通过均质试验餐和胃内滴定法测定第1天、4 - 6小时、8 - 10小时、16 - 18小时和24 - 26小时以及第3天和第5天口服药物后4 - 6小时的进餐刺激胃酸分泌。
在第1天(口服药物后4 - 6小时),服用40毫克泮托拉唑和20毫克奥美拉唑后,进餐刺激胃酸分泌分别下降了36%和24%。给药3天和5天后,40毫克泮托拉唑导致的下降分别为88%和85%,20毫克奥美拉唑导致的下降分别为70%和74%。在5天给药期的所有测量点,40毫克泮托拉唑在抑制进餐刺激胃酸分泌方面优于20毫克奥美拉唑。泮托拉唑在口服药物后第1天、24 - 26小时和第3天的差异具有统计学意义(分别为P = 0.0425和P = 0.0244)。在第1天,只有泮托拉唑显著优于安慰剂(给药后4 - 6小时P = 0.0210;给药后8 - 10小时P = 0.0093;给药后16 - 18小时P = 0.0068)。
40毫克泮托拉唑在抑制进餐刺激胃酸分泌方面比20毫克奥美拉唑显著更有效。此外,泮托拉唑起效更快。