Systematic review on the necessity of skin testing and retesting for benzathine benzylpenicillin for injection
Objective To provide evidence-based support for the clinical management of skin testing and retesting for benzathine benzylpenicillin,improving diagnostic and treatment efficiency while ensuring patient medication safety.Methods Instructions for benzathine benzylpenicillin were retrieved from the official websites of the China National Medical Products Administration(NMPA)and the FDA.PubMed,Embase,the Cochrane Library,CNKI,Wanfang data,and SinoMed databas-es were searched for guidelines/consensus/guidance on β-lactam antibiotics,penicillin,and benzathine benzylpenicillin skin testing,as well as pharmacokinetic and clinical research literature on benzathine benzylpenicillin and its skin tests.Results The benzathine benzylpenicillin package inserts from the NMPA and FDA were obtained,along with the"Guidelines for Skin Testing of β-lactam Antibiotics(2021)","Expert Consensus on Clinical Operation of Penicillin Skin Test(2022)"and"Instruc-tions for Clinical Use of the Pharmacopoeia of the People's Republic of China(2020 Edition)".Twelve articles related to the pharmacokinetics of benzathine benzylpenicillin and other relevant topics were included.The Chinese drug information sheet requires a skin test before the initial use of benzathine benzylpenicillin,whereas the FDA sheet does not mandate it.However,both emphasize the preparedness for managing severe allergic reactions.Pharmacokinetic studies revealed that benzathine ben-zylpenicillin concentrations remain in the body up to the fourth week post-injection.Conclusion This study through a system-atic review,confirms the Chinese stipulation requiring a skin test prior to the initial administration of benzathine benzylpenicil-lin.Drawing upon pharmacokinetic evidence,it suggests that retesting within four weeks may not be necessary.It is recom-mended that multidisciplinary experts reach a consensus,grounded in evidence,to formulate clear guidelines for the retesting of benzathine benzylpenicillin,thereby facilitating standardized implementation by frontline healthcare practitioners.Neverthe-less,the paramount importance lies in being fully prepared for managing severe allergic reactions,regardless of whether a skin test or retest is conducted.
benzathine benzylpenicillinskin testmanagement of anaphylaxispackage insertssystematic review
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