Study on Utilization Safety and Rationality of Sodium Tanshinone ⅡA Sulfonate Injection Based on “Real World ” / 中国药房

ABSTRACT

OBJECTIVE：To provide reference for safe and rational use of Sodium tanshinone ⅡA sulfonate（STS）injection in the clinic. METHODS ：The information of the patients who received STS injection from Jan. 2016 to Dec. 2017 were collected from a Grade 3 hospital. According to relevant suggestions in drug package inserts ，drug utilization rationality was evaluated ，and single-factor and multi-factor analysis on the risk and influential factors for ADR/ADE were performed by group design and individual matching to examine their correlation. RESULTS ：Totally 3 283 patients were included in the study. The drug use frequency were less than 1.5，and the drug utilization indexes were less than 1.0，suggesting that the hospital using STS injection was basically reasonable. Irrational use of drugs mainly included that inappropriate indications （46.48％），unreasonable solvent selection（15.84％），and excessive concentration （2.71％）. Patients with renal insufficiency received STS injection ，and then the risk of ADR/ADE increased by correlation analysis （P＜0.05）. CONCLUSIONS ：Irrational use of STS injection in clinics existed ， mainly like off-label drug use ，excessive concentration ，irrational solvent selection. Drug use evaluation and monitoring should be strengthened. For patients with renal insufficiency ，it is necessary to prevent the occurrence of ADR/ADE ．