| ABSTRACT Objective: Through the cefoperazone sodium/sulbactam sodium for injection, the adverse drug reaction (ADR) signal was excavated and evaluated, which provided a reference for clinical rational drug use. Methods:Using the reported odds ratio method (ROR) to conduct adverse reaction signal mining on the data reported by the Yantai ADR Monitoring Center from January 1st, 2015 to December 31st, 2017. The lower limit of ROR 95% confidence interval (CI) > 1 indicates an alarm signal. Results: A total of 38 324 ADR report information were extracted from the database, and 31 954 were excluded from the analysis after repeated and concomitant drug reports. 518 adverse reactions in 392 reports were suspected by cefoperazone sodium/sulbactam sodium to induce(one patient’s report may contain multiple adverse reactions), the first of which was rash, 163 cases, followed by itching, 122 cases. A total of 10 adverse reaction signals were detected by ROR method, among which 3 were not mentioned in the specification, indicating high risk signals. Conclusion:Cefoperazone sodium/sulbactam sodium related rash and itching were worthy of attention. The detection and analysis of adverse reaction signals in the spontaneous reporting system database could provide a reference for clinical drug use. |
