Abstract: Objective To efficiently obtain such real-world risk data as the incidence of cefoperazone sodium and sulbactam sodium-related thrombocytopenia in a large sample of drug users.Methods A retrospective study was conducted to automatically monitor inpatients using cefoperazone sodium and sulbactam sodium for injection in our hospital between July 2013 and June 2018 using ADE-ASAS. The incidence and characteristics of cefoperazone sodium and sulbactam sodium-related thrombocytopenia were obtained via the double evaluation system. Case-control study was conducted to analyze the risk factors.Results The incidence of thrombocytopenia among 17 569 patients was 2.73%. Severe thrombocytopenia was more common in patients with liver diseases. Multivariate logistic regression analysis showed that the basic platelet value, creatinine clearance rate, BMI and duration of treatment were the risk factors for thrombocytopenia induced by cefoperazone sodium and sulbactam sodium.Conclusion The incidence of cefoperazone sodium and sulbactam sodium-related thrombocytopenia is high, which is consistent with the results of the team's previous study (3.0%). Monitoring platelet values from the beginning of treatment can detect and avoid risks in time. Patients with complex conditions should be more vigilant about the occurrence of severe ADRs. Proper control of the duration of treatment and focus on patients with renal insufficiency and low BMI can reduce the risk of ADR.

Key words: cefoperazone sodium and sulbactam sodium, adverse drug reaction, automatic surveillance, thrombocytopenia, ADE-ASAS