阿司匹林和质子泵抑制剂固定复方制剂的立题合理性探讨  

Rationality of developing fixed-dose combination of aspirin and proton pump inhibitor

作　　者：徐伟仙[1] 陈颖[2] 华尉利[2] 谢松梅[2] 王涛[2] 王水强[2] 

机构地区：[1]北京大学第三医院心血管内科,北京100191 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国临床药理学杂志》2016年第5期466-468,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：小剂量阿司匹林(75~150 mg·d^(-1))广泛用于缺血性心脑血管疾病,其主要不良反应是消化道黏膜损伤、溃疡形成和出血等。质子泵抑制剂(PPI)具有强而持久的抑制胃酸分泌的作用。对于长期服用小剂量阿司匹林的患者,在出现严重上消化道不良反应时,可根据病情需要短期加用PPI。本文对研发"阿司匹林和PPI固定复方制剂"的合理性问题进行了较为全面的阐述。基于可能的获益/风险综合考虑,开发阿司匹林与PPI固定剂量复方制剂的依据不足。Low-dose aspirin（ 75-150 mg·d^-1） is widely used in the management of ischemic cardiovascular and cerebrovascular diseases. Aspirin can cause gastrointestinal mucosal damage,ulceration and bleeding. Proton pump inhibitor（ PPI） is a strong and long-last inhibitor of gastric acid secretion. In patients with long-term use of low-dose aspirin,PPI can be added for short time in the event of serious upper gastrointestinal adverse reactions according to the clinical conditions. The rationality of developing fixed-dose combination of aspirin and PPI is discussed in this paper. When the possible benefit / risk is taken into account,the basis for the developing fixed-dose combination of aspirin and PPI is insufficient.

关 键 词：阿司匹林 质子泵抑制剂 固定剂量复方 获益/风险 

分 类 号：R954[医药卫生—药学] R714.252