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三种剂量奥美拉唑治疗马胃溃疡综合征的比较:一项双盲、随机、剂量反应临床试验。

A comparison of three doses of omeprazole in the treatment of equine gastric ulcer syndrome: A blinded, randomised, dose-response clinical trial.

作者信息

Sykes B W, Sykes K M, Hallowell G D

机构信息

BW Sykes Consultancy, Upper Orara, New South Wales, Australia.

出版信息

Equine Vet J. 2015 May;47(3):285-90. doi: 10.1111/evj.12287. Epub 2014 May 29.

Abstract

REASONS FOR PERFORMING THE STUDY

A previous study demonstrated that a dose effect between 1.6 and 4.0 mg/kg bwt of omeprazole per os s.i.d. is present in the treatment of equine gastric ulceration. In the same study, healing of glandular ulceration appeared inferior to healing of squamous ulceration. However, several limitations were recognised in that study and further investigation is warranted.

OBJECTIVES

To further investigate the presence of a dose relationship in the treatment of gastric ulceration under conditions that may favour omeprazole efficacy such as administration prior to exercise and after a brief fast, and potential differences between the response of squamous and glandular ulceration to omeprazole therapy.

STUDY DESIGN

A blinded, randomised, dose-response clinical trial.

METHODS

Sixty Thoroughbred racehorses with grade ≥2/4 squamous and/or glandular ulceration were identified by gastroscopy. Horses were randomly assigned to receive either 1.0, 2.0 or 4.0 mg/kg bwt of enteric coated omeprazole per os s.i.d. 1-4 h prior to exercise. Gastroscopy was repeated at approximately 28 days.

RESULTS

The lower doses studied (1.0 and 2.0 mg/kg bwt) were noninferior to the reference dose (4.0 mg/kg bwt) in the treatment of squamous ulceration. Healing was greater in squamous ulceration than glandular ulceration (86% vs. 14%; P<0.0001). Improvement in ulcer grade was more likely in squamous lesions than glandular lesions (96% vs. 34%; P<0.0001). Worsening of the glandular ulcer grade was observed in 36% of horses.

CONCLUSIONS

The results of this study suggest that, under the conditions studied, where omeprazole is administered before exercise and following a brief fast, doses of omeprazole as low as 1 mg/kg bwt per os s.i.d. may be as effective as higher doses. The proportion of glandular ulceration that heals with 28 days of omeprazole therapy is less than that of squamous ulceration.

摘要

开展本研究的原因

先前的一项研究表明,口服奥美拉唑剂量为1.6至4.0毫克/千克体重,每日一次,在治疗马胃溃疡时存在剂量效应。在同一研究中,腺性溃疡的愈合似乎不如鳞状溃疡的愈合。然而,该研究存在一些局限性,因此有必要进行进一步调查。

目的

在可能有利于奥美拉唑疗效的条件下,如运动前给药和短暂禁食后给药,进一步研究胃溃疡治疗中剂量关系的存在,以及鳞状和腺性溃疡对奥美拉唑治疗反应的潜在差异。

研究设计

一项双盲、随机、剂量反应临床试验。

方法

通过胃镜检查确定60匹纯种赛马患有≥2/4级鳞状和/或腺性溃疡。马匹被随机分配,在运动前1至4小时口服1.0、2.0或4.0毫克/千克体重的肠溶包衣奥美拉唑,每日一次。大约28天后重复胃镜检查。

结果

在鳞状溃疡的治疗中,所研究的较低剂量(1.0和2.0毫克/千克体重)不劣于参考剂量(4.0毫克/千克体重)。鳞状溃疡的愈合情况优于腺性溃疡(86%对14%;P<0.0001)。鳞状病变溃疡分级的改善比腺性病变更有可能(96%对34%;P<0.0001)。36%的马匹腺性溃疡分级恶化。

结论

本研究结果表明,在所研究的条件下,即在运动前和短暂禁食后给予奥美拉唑,口服剂量低至1毫克/千克体重、每日一次的奥美拉唑可能与较高剂量一样有效。接受28天奥美拉唑治疗后愈合的腺性溃疡比例低于鳞状溃疡。

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