关键词: 辅酶Q10注射液, 辅酶Q10氯化钠注射液, 过敏反应, 说明书, 监管措施, 药品不良反应/事件, 安全性, 风险

Abstract: Objective To analyze the data on monitoring of safety of coenzyme Q10 injection and provide reference for clinical rational drug use. Methods Reports of adverse drug reactions/events of coenzyme Q10 injection between January 1, 2004 and September 30, 2020 were retrieved from China adverse drug reaction monitoring database and from domestic literature database between inception to June 30, 2021. And the domestic labeling on Q10 injection were analyzed. Results The national adverse drug reaction monitoring database received 3 097 case reports of adverse reactions/events related to coenzyme Q10 injection, including 320 reports of serious cases(10.4%). Systemic injury, injury to the respiratory system, immune disorders and infections among the severe cases were more serious than among the common cases. Severe allergic reactions to coenzyme Q10 injection deserved more attention. Instructions on safety in the labeling were implicit. Conclusion Medical institutions should keep updated on the safety information in revised instructions and comply with the instructions. Drug manufacturers should be committed to pharmacovigilance and take effective measures to reduce drug risks.

Key words: coenzyme Q10 injection, coenzyme Q10 and sodium chloride injection, allergic reaction, labeling, regulatory measures, adverse drug reaction/event, safety, risk