OBJECTIVE To analyze the occurrence regularity and characteristics of anaphylactic shock caused by remimazolam besylate based on the case report of real world data, study its influencing factors and drug risk, and provide references for the improvement of drug instructions and clinical anesthesia medication.

METHODS The National Adverse Drug Reaction Monitoring System Haikou Database(hereinafter referred to as monitoring system) from 2020 to 2024 was searched, combining with foreign literature reports and the FDA Adverse Event Reporting System(FAERS), 7 cases of severe adverse drug reaction(ADR) reports of anaphylactic shock caused by remimazolam besylate received from monitoring system were retrospectively analyzed. Risk signal mining was carried out using the reporting odds ratio(ROR) method and the comprehensive standards method of the UK Medicines and Healthcare Products Regulatory Agency(MHRA).

RESULTS The 7 cases of anaphylactic shock ADR reports in the real world occurred within 30 min, all of which were immediate hypersensitivity reactions. The clinical manifestations were as follows: lowered blood pressure, accelerated heart rate, flushed skin, oxygen desaturation, cyanosis, cardiac respiratory arrest, etc. Severe hypotension was the common clinical manifestation of 7 cases of anaphylactic shock, as well as the initial and main evidence of anaphylactic shock. There were 6 cases of adverse drug events(ADE) of anaphylactic shock received by the FAERS database, accounting for 9.8% of the total number of reports during the same period. Both ROR method and MHRA comprehensive standards method identified the risk signal of anaphylactic shock, ranking fourth among the strength of signals.

CONCLUSION During anesthesia with remimazolam besylate, it is essential to closely monitor patient parameters including skin appearance, hemodynamics, and airway patency to minimize the risk of anaphylactic shock.