Investigation and Analysis of Adverse Reactions of Danshen Injection Based on Real-World Data
Objective To investigate and analyze the adverse reactions of Danshen injection based on real-world data.Methods Clinical data of 463 patients who received Danshen injection at the Affiliated Hospital of Jiaozuo Health School from June 2021 to June 2023 were retrospectively analyzed.Adverse reactions were statistically analyzed.Patients were divided into adverse reaction occurrence group and non-occurrence group,and the data between the two groups were compared.Logistic regression analysis was performed to identify the influencing factors of adverse reactions.Results The incidence of adverse reactions in patients using Danshen injection was 9.72%,with skin and appendage damage having the highest incidence followed by gastrointestinal damage.Age(OR=1.896,95%CI:1.262~2.851),primary disease of cardiovascular and cerebrovascular diseases(OR=1.842,95%CI:1.081~3.140),dosage(OR=1.573,95%CI:1.159~2.136),duration of medication(OR=1.737,95%CI:1.245~2.423),and history of allergies(OR=1.813,95%CI:1.367~2.404)were identified as influencing factors of adverse reactions to Danshen injection.Conclusion Danshen injection can cause adverse reactions of varying degrees.Age,primary disease of cardiovascular and cerebrovascular diseases,dosage,duration of medication,and history of allergies are influencing factors of adverse reactions to Danshen injection.Clinical application should be standardized,and adverse reaction monitoring should be strengthened to reduce adverse reactions.