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美国食品药品监督管理局报告的在使用奥美拉唑、兰索拉唑和泮托拉唑治疗期间发生的不良事件及药物相互作用总结。

A summary of Food and Drug Administration-reported adverse events and drug interactions occurring during therapy with omeprazole, lansoprazole and pantoprazole.

作者信息

Labenz J, Petersen K U, Rösch W, Koelz H R

机构信息

Department of Medicine, Jung-Stilling Hospital, Siegen, Germany.

出版信息

Aliment Pharmacol Ther. 2003 Apr;17(8):1015-9. doi: 10.1046/j.1365-2036.2003.01550.x.

Abstract

BACKGROUND

Pantoprazole is claimed to have a lower potential for drug interaction than other proton pump inhibitors.

AIM

To estimate the frequency of adverse events and drug interactions reported to the Food and Drug Administration in patients receiving omeprazole, lansoprazole or pantoprazole.

METHODS

The study involved a search of the Food and Drug Administration's database for adverse events and drug interactions with omeprazole, lansoprazole or pantoprazole as primary or secondary suspect drug. An estimate of the amount of drug dispensed during the adverse event collection period (from US drug launch) was obtained from the International Medical Statistics health database.

RESULTS

Of the suspected drug interactions recorded, vitamin K antagonist interactions, although rare, were the most common. The frequency of vitamin K antagonist interactions was 0.09 per million packages for omeprazole and 0.11 per million packages for lansoprazole and pantoprazole. Interactions with benzodiazepines or phenytoin were even rarer, being reported in less than 10 patients on each proton pump inhibitor.

CONCLUSION

The frequency of reported drug interactions was low for omeprazole, lansoprazole and pantoprazole and vitamin K antagonist interactions were by far the most common. These potentially important drug interactions, although rare, were no less frequent on pantoprazole than on omeprazole or lansoprazole, suggesting a class effect.

摘要

背景

泮托拉唑被认为与其他质子泵抑制剂相比,药物相互作用的可能性更低。

目的

评估向美国食品药品监督管理局报告的接受奥美拉唑、兰索拉唑或泮托拉唑治疗的患者中不良事件和药物相互作用的发生频率。

方法

该研究通过检索美国食品药品监督管理局数据库,查找以奥美拉唑、兰索拉唑或泮托拉唑作为主要或次要可疑药物的不良事件和药物相互作用。不良事件收集期间(自美国药品上市起)的药物配给量估计值来自国际医学统计健康数据库。

结果

在记录的可疑药物相互作用中,维生素K拮抗剂相互作用虽罕见,但最为常见。奥美拉唑的维生素K拮抗剂相互作用频率为每百万包装0.09次,兰索拉唑和泮托拉唑为每百万包装0.11次。与苯二氮䓬类药物或苯妥英的相互作用更为罕见,每种质子泵抑制剂报告的患者少于10例。

结论

奥美拉唑、兰索拉唑和泮托拉唑报告的药物相互作用频率较低,维生素K拮抗剂相互作用是迄今为止最常见的。这些潜在的重要药物相互作用虽罕见,但泮托拉唑的发生频率并不低于奥美拉唑或兰索拉唑,提示存在类效应。

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