一项关于 10 毫克奥美拉唑胶囊对健康犬胃 pH 值影响的前瞻性、随机、双盲、安慰剂对照交叉研究。
A prospective, randomized, masked, placebo-controlled crossover study for the effect of 10 mg omeprazole capsules on gastric pH in healthy dogs.
机构信息
North Carolina State University, College of Veterinary Medicine, Raleigh, North Carolina, USA.
Department of Small Animal, Clinical Sciences, University of Tennessee, College of Veterinary Medicine, Knoxville, Tennessee, USA.
出版信息
J Vet Intern Med. 2021 Mar;35(2):887-891. doi: 10.1111/jvim.16061. Epub 2021 Feb 15.
BACKGROUND
Enteric-coated omeprazole capsules are commonly used as a gastric acid suppressant in dogs. However, the efficacy of this formulation has not been evaluated for clinical use in dogs.
HYPOTHESIS/OBJECTIVES: To evaluate the efficacy of a 10 mg PO omeprazole capsule (TriviumVet) undergoing FDA approval to increase gastric pH in dogs. We hypothesized that encapsulated omeprazole would significantly increase the gastric pH compared to placebo and reach pH goals extrapolated from people for the treatment of esophagitis and duodenal ulceration.
ANIMALS
Six healthy research dogs.
METHODS
Randomized, blinded, 2-way crossover study. Dogs were PO administered omeprazole at 0.5 to 1.0 mg/kg or placebo (empty gelatin capsules) twice-daily for 5 days. The intragastric pH was recorded on days 2 to 5 of treatment. Mean pH and the mean percentage time (MPT) intragastric pH was ≥3 or ≥4 were compared between and within treatment groups.
RESULTS
Dogs treated with omeprazole had a significantly higher MPT ± SD intragastric pH ≥3 (91.2% ± 11.0%), ≥4 (86.9% ± 13.7%) and mean ± SD pH (5.4 ± 0.8) than dogs treated with placebo (19.7% ± 15.5%, 28.3 ± 20.7, and 2.4 ± 1.0, respectively) (P < .001 for all).
CONCLUSIONS AND CLINICAL IMPORTANCE
The 10 mg enteric-coated omeprazole capsule PO administered evaluated in this study is an effective gastric acid suppressant in healthy dogs.
背景
肠溶包衣奥美拉唑胶囊常用于抑制犬的胃酸。然而，这种制剂在犬中的临床应用效果尚未得到评估。
假设/目的：评估一种正在接受美国食品药品监督管理局（FDA）批准的用于增加犬胃内 pH 值的 10 mg PO 奥美拉唑胶囊（TriviumVet）的疗效。我们假设与安慰剂相比，包衣奥美拉唑能显著增加胃内 pH 值，并达到从治疗食管炎和十二指肠溃疡的人群中推断出的 pH 目标。
动物
6 只健康的研究犬。
方法
随机、双盲、2 向交叉研究。犬 PO 给予奥美拉唑 0.5 至 1.0 mg/kg 或安慰剂（空明胶胶囊），每天 2 次，连续 5 天。在治疗的第 2 至 5 天记录胃内 pH 值。比较治疗组间和组内的平均 pH 值和胃内 pH 值≥3 或≥4 的平均时间（MPT）。
结果
接受奥美拉唑治疗的犬胃内 pH 值≥3 的 MPT±SD 显著较高（91.2%±11.0%）、≥4（86.9%±13.7%）和平均 pH 值（5.4±0.8），而接受安慰剂治疗的犬胃内 pH 值分别为 19.7%±15.5%、28.3%±20.7%和 2.4±1.0%（均 P<.001）。
结论和临床意义
本研究评估的 PO 给予的 10 mg 肠溶包衣奥美拉唑胶囊是一种有效的犬胃酸抑制剂。
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