92张药品说明书皮肤敏感试验内容调查

Analysis on Skin Sensitive Test Described in 92 Drug Instructions

目的:调查临床常用药品说明书中皮肤敏感试验(简称皮试)相关信息,为规范药品说明书中皮试内容提供参考。方法:参照《中国药典临床用药须知》2010年版规定,在河南省医药采购服务中心平台上检索需要进行皮试的药品说明书并做统计分析。结果:共调查药品说明书共92张;存在皮试警示语表述欠科学、不规范,警示语位置不统一;有皮试方法和皮试液浓度的说明书25张(27.2%),有皮试液配制方法的说明书11张(12.0%),有阳性判定方法的说明书9张(9.8%),有过敏处置要求的说明书30张(32.6%),有皮试结果观察时间的说明书13张(14.1%)。结论:皮试药品说明书有关皮试内容不规范、不统一或缺失,不利于药物合理应用和患者用药安全。国家药品监督管理部门应建立并完善药品说明书皮试相关信息书写规范或标准。

Objective：To survey related information on skin sensitive test （skin test） in common clinical drug instructions to provide reference for the standardization of drug instructions.Methods：According to the clinical medication notice in China pharmacopoeia （2010 edition）,the common clinical skin test described in drug instructions were retrieved and analyzed on the platform of Henan pharmaceutical procurement service center.Results：Totally 92 instructions were surveyed.Some warning statement on skin test was not scientific and standardized with various locations in the instructions.Totally 25 instructions （27.2％） had the description of skin test method and relative solution concentration,11 ones （12.0％） were with preparation method of skin test solution,9 ones （9.8％） showed positive judgment method,30 ones （32.6％） were with allergy treatment requirements,and 13 ones （14.1％） exhibited result observation time.Conclusion：Skin test information is not standardized and unified,even is deficient,which is harmful to the rational drug use and medication safety.State drug administration should establish and improve the standards for skin test information in drug instructions.