国内外阿司匹林肠溶片说明书的分析与比较

Comparison and Analysis on Instructions for Foreign and Domestic Aspirin Enteric-coated Tablets

目的系统总结阿司匹林肠溶片说明书条目的规范性与内容的准确性,为进一步管理与完善说明书提供依据。方法检索国内外相关药品网站或数据库,纳入2002-2013年各药品市场存在的非处方阿司匹林肠溶片说明书进行汇总分析。结果共纳入说明书82份,按规格和用法用量划分为大、小剂量两类。分析发现国产说明书基本条目标注不正确情况多在非安全性信息和禁忌、注意事项部分,国产小剂量肠溶片适应证、用法用量等内容尚未统一。此外,国内外说明书适应证、用法用量和适用人群等安全性信息存在不一致,小剂量组差异较大剂量组明显。结论现行国产阿司匹林肠溶片说明书条目规范情况尚可,但小剂量肠溶片安全性信息规范较差。与国外及国内进口肠溶片说明书相比,国产的安全性信息缺乏本地研究的结果,儿童用药急需重视。

Objective To improve the domestic instructions by summarizing evidence of the criterion and accuracy of aspirin enteric-coated tablet instructions. Methods Systematic review was applied to identify instructions through foreign and domestic web/databases. Aspirin enteric-coated tablet instructions classified as OTC and produced during 2002-2013 were included. Results 82 copies were eligible and divided into low or high dose type according to the usage and specifications. In terms of domestic instructions, incorrect label of basic items was mainly in the non-safety information, contraindications and precautions, and low-dose instructions were not unified in indications, usage and dosage, etc. As for safety information, we found that two types all had inconsistency in indications, dosage and suitable crowd, and the difference in low dose was more obvious. Conclusion The quality of basic items in domestic instructions was acceptable, but the low-dose safety information was poorly administrated. Compared with others, domestic instructions lacked local researches and we should attach more importance to pediatric use.