基于3938份药品说明书探讨头孢菌素类药品皮肤过敏试验的规范

Evaluation on the Specification of Skin Test Based on 3938 Cephalosporin Antibacterial Package Inserts

目的收集头孢菌素类药品说明书并汇总分析,结合相关文献并提出具体的修订意见,为药品说明书的修订更新以及头孢菌素类药品皮肤过敏试验(皮试)的规范提供参考。方法收集整理38种头孢菌素类药品说明书共3938份,对说明书中皮试要求、过敏警示语等内容通过Excel汇总分析。结果12种头孢菌素类抗菌药品共450份说明书要求在用药前进行皮试,不同厂家对于药品在皮试要求、过敏注意事项及禁忌描述存在差异,大部分要求皮试的说明书缺少具体的皮试液配制、皮试操作以及皮试结果判读等内容。结论头孢菌素类药品说明书关于皮试与过敏的相关内容缺乏科学性与规范性。头孢菌素类药品生产厂家在药品说明书中应普遍取消常规对皮试的要求,第3代头孢菌素变态反应相对较高,应新增补充条项以重点警示变态反应发生的可能,以及需要详细询问过敏史并随时做好过敏性休克抢救的准备。

Objective To collect and summarize the package inserts of cephalosporins,to put forward specific revision comments in combination with relevant literatures,and to provide reference for the revision and update of package inserts and the specification of cephalosporin skin test.Methods A total of 3938 package inserts of 38 cephalosporins were collected and collated,and the skin test requirements and allergic warnings in the package inserts were summarized and analyzed by Excel.Results A total of 450 package inserts of 12 cephalosporin antibiotics required skin allergy test before medication.There were differences in the requirements for skin test,allergic precautions and contraindications of drugs by different manufacturers.Most of the package inserts requiring skin test lacked specific skin test solution preparation,skin test operation and interpretation of skin test results.Conclusion At present,there is still a lack of scientificity and standardization in the relevant contents of skin test and allergy in the package inserts of cephalosporins.The manufacturers of cephalosporins should generally cancel the requirements for routine skin test in the package inserts.For the drugs with relatively high incidence of allergic reactions such as third-generation cephalosporins,supplementary items should be added to focus on warning the possibility of allergic reactions,as well as the need to inquire the history of allergy in detail and prepare for the rescue of anaphylactic shock at any time.