关键词: 药品不良反应/事件, 监测, 抗感染, 心血管, 抗变态反应, 儿童, 风险控制, 年度报告

Abstract: Objective To analyze the amount of monitoring of adverse drug reactions/events(ADR/AE) in depth in China in 2022, and to remind the public of the need to use drugs safely and properly. Methods Work related to nation-wide monitoring of adverse drug reactions in 2022 was summarized. Reports of ADRs/AEs received by the National Adverse Drug Reaction Monitoring System in 2022 were statistically analyzed and interpreted. Results A total of 2.023 million reports of ADR/AE were received in 2022, 642 000 of which were new and serious reports. 2.185 million reports involved suspected drugs, 82.3% of which were chemical drugs, 2.6% were biological products, and 12.8% were Chinese medicines. There were 942 000 reports of ADR/AE that involved essential drugs. The risks of adverse reactions of anti-infective drugs, cardiovascular system drugs, anti-metabolic drugs, and drugs for children were given much attention. Conclusion Adverse drug reaction monitoring should continue to be strengthened to ensure safe use of drugs and offer better protection for the public.

Key words: adverse drug reactions/events(ADR/AE), monitor, anti-infective, cardiovascular system, anti-metabolic, children, risk control, annual report