| ABSTRACT Objective: To investigate the occurrence and characteristics of adverse drug reactions (ADRs) caused by fibrinogenase injection, so as to provide reference for safety medication in the clinic. Methods:The retrospective study method was used to analyze 121 cases of ADRs caused by fibrinogenase injection. These ADRs were collected by Zhejiang ADRs monitoring system from January 2010 to April 2018. The analysis includes the type of reports, the case of gender, age, medication situation , adverse drug reactions and occurrence time. Results:95.04% cases were new ADR reports. ADRs caused by fibrinogenase injection mostly occurred in the patients aged above 45 years old (94.2%). The SOCs mostly involved in ADRs were systemic reaction. The main clinical manifestations of serious ADRs are chest distress,rigors,anaphylactoid reaction,fever,dyspnea, etc. Adverse reactions mainly occur in the course of medication. Conclusion:More attention should be paid to ADRs caused by Fibrinogenase injection in clinic, especially the serious allergic reaction. Drug manufacturers should promptly improve the safety information of drug instructions.,so as to guide the clinical safety medication. |
