基于药品说明书的32种头孢菌素类抗菌药物皮肤过敏试验、交叉过敏警示标志的调查与分析  

Investigation and Analysis of Skin Allergy Tests and Cross Allergy Warning of 32 Cephalosporin Antibacterial Drugs Based on Drug Package Inserts

作　　者：朱意妹 吴光铭 李淼 黎琳 ZHU Yi-mei;WU Guang-ming;LI Miao;LI Lin(Guidong Health School,Hezhou 542899,China;Wuzhou Workers'Hospital,Wuzhou 543001,China)

机构地区：[1]桂东卫生学校,贺州542899 [2]梧州市工人医院,梧州543001

出　　处：《中国合理用药探索》2024年第4期110-116,共7页Chinese Journal of Rational Drug Use

摘　　要：目的:收集在我国上市的头孢菌素类抗菌药物药品说明书,探索其在使用过程中存在的问题。方法:通过查阅国家药品监督管理局(NMPA)官方网站获取已上市的头孢菌素类抗菌药物目录,利用MCDEX软件(网络版)、用药助手软件(手机版)以及药智数据等数据库收集目标药物的药品说明书,对其中涉及皮肤过敏试验要求、交叉过敏警示标志的内容进行分类汇总分析。结果:符合纳排标准的32种头孢菌素类抗菌药物涉及267个品规,共计3579份药品说明书;311份药品说明书强调在使用前要求或建议进行皮肤过敏试验;每份药品说明书均有交叉过敏警示标志,但描述各不相同;绝大多数药品说明书的禁忌项将头孢过敏史列为禁用情形,少数药品说明书中明确规定了青霉素过敏为禁用的条件。结论:目前我国头孢菌素类抗菌药物的药品说明书对皮肤过敏试验的标注仍存在分歧;药品说明书中禁忌项的描述对于交叉过敏过度夸大,一定程度上可能造成部分患者不能再接受青霉素和头孢菌素类抗菌药物治疗,有待进一步规范。Objective:To collect the drug package inserts of cephalosporins marketed in China,and explore the problems currently existing in the use of cephalosporin antibacterial drugs.Methods:The catalogue of cephalosporin antibacterial drugs marketed in China was obtained from the official website of the National Medical Products Administration(NMPA),and the drug package inserts listed in the target drug catalogue were collected from the database of MCDEX software(web version),medication assistant software(mobile version)and yaoZh data,etc.,and the contents involved the skin allergy test requirement and cross allergy warning were classified and summarized for analysis.Results:A total of 3579 package inserts for 267 products of 32 cephalosporin antibacterials that met the inclusion criteria were collected;311 package inserts emphasized the requirement or recommendation of skin allergy test before use;each package insert contained a warning of cross-allergy,but the descriptions were different.Most of the drugs had history of cephalosporin allergy as a prohibited condition in the contraindication section,while some cephalosporins had penicillin allergy as a prohibited condition in the package inserts.Conclusion:At present,there are still divergence in the labelling of skin tests in the package inserts of cephalosporin antibacterial drugs in China;the description of[Contraindication]is over-exaggerated for cross-allergy,which,to a certain extent,may cause some patients to lost the chance to receive penicillin and cephalosporins,which needs to be further standardized.

关 键 词：头孢菌素 皮肤过敏试验 交叉过敏 药品说明书 青霉素 

分 类 号：R969.3[医药卫生—药理学]