关键词: 吡拉西坦, 药品不良反应, 风险, 监管措施, 安全性, 说明书

Abstract: Objective To analyze the risk of piracetam preparations in order to provide reference for clinical rational drug use. Methods Individual cases of adverse drug reactions reported in China adverse drug reaction (ADR) database between January 1, 2004 and March 31, 2023, domestic literature published from January 1, 2000 to March 31, 2023 and risk control measures taken in China were analyzed. Results Between January 1, 2004 and March 31, 2023, there were a total of 40 675 ADR reports of piracetam preparations in the database, involving 1 922 serious cases (4.7%). There were 5 360 ADR reports of oral preparations, including 55 serious adverse reactions and 429 unexpected adverse reactions. There were 35 315 cases of ADR reports of injection preparations, including 1 865 serious cases (5.3%). Conclusion Piracetam preparations can cause serious adverse reactions such as anaphylactic shock. Clinicians should be alert to these serious adverse reactions and take preventions when prescribing piracetam preparations. Marketing authorization holders should assume more responsibility for monitoring and evaluation of adverse drug reactions and update the information on safety in drug labels in time.

Key words: piracetam, adverse drug reaction, risk, regulatory measures, safety, instruction