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兰索拉唑口腔崩解片:在酸相关性疾病中的药代动力学及治疗应用

Lansoprazole oro-dispersible tablet : pharmacokinetics and therapeutic use in acid-related disorders.

作者信息

Baldi Fabio

机构信息

Department of Gastroenterology, S. Orsola Malpighi Hospital, Bologna, Italy.

出版信息

Drugs. 2005;65(10):1419-26. doi: 10.2165/00003495-200565100-00007.

Abstract

Lansoprazole is an H+, K+-adenosine triphosphatase proton pump inhibitor (PPI) used for management of acid-related disorders. Lansoprazole has been reformulated as an oro-dispersible tablet (LODT) that quickly dissolves in the mouth without water. In healthy adults the safety and bioavailability of LODT 15-30 mg, taken without water or dispersed in water, were found to be comparable with those of lansoprazole 15-30 mg capsules. Moreover, the bioavailability of LODT administered without water has been found to be similar to that of water-dispersed LODT given via a nasogastric tube. In a clinical study, the vast majority of patients found the mouth feel of LODT acceptable and almost all found it easy to take. A comparison of LODT with esomeprazole in a small group of patients with non-erosive reflux disease showed similar decreases in symptoms from baseline and no significant difference between groups. In conclusion, LODT is effective, bioequivalent to the capsule formulation and acceptable to patients. LODT offers an alternative dose administration method to all patients requiring a PPI, especially those who have difficulty swallowing, and may increase patient convenience and compliance.

摘要

兰索拉唑是一种H⁺,K⁺ - 腺苷三磷酸酶质子泵抑制剂(PPI),用于治疗酸相关性疾病。兰索拉唑已被重新制成口腔崩解片(LODT),无需用水即可在口腔中迅速溶解。在健康成年人中,发现无水服用或分散于水中服用的15 - 30毫克LODT的安全性和生物利用度与15 - 30毫克兰索拉唑胶囊相当。此外,发现无水服用的LODT的生物利用度与通过鼻胃管给予的水分散LODT相似。在一项临床研究中,绝大多数患者认为LODT的口感可以接受,几乎所有人都觉得服用方便。在一小群非糜烂性反流病患者中对LODT与埃索美拉唑进行比较,结果显示两组从基线开始症状的减轻程度相似,且两组之间无显著差异。总之,LODT有效,与胶囊制剂生物等效且患者可接受。LODT为所有需要PPI的患者提供了一种替代给药方法,尤其是那些吞咽困难的患者,并且可能会提高患者的便利性和依从性。

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