Safety evaluation of 4476 cases of sofren injection
ZHANG Xin-ru
SUN Xiu-bo
XIE Li-na
FU Xiu-juan
Abstract：Objective: To reevaluate the post-marketing safety of sofren injection. Methods: Inpatients using sofren injection in the department of cardiovascular disease in our hospital were collected from November 2013 to August 2016. The adverse drug reactions/adverse drug events (ADR/ADE) of the sofren injection were analyzed by the non-prospective centralized monitoring method. Results: A total of 4476 patients were enrolled in the study. Among them, 37 patients had ADR/ADE induced by sofren injection. The incidence of ADR/ADE in women of all age groups except the 70 – 79 age group was significantly higher than that of men (χ2= 0.79, P = 0.02). Patients with allergic history also had a significant higher incidence of ADR/ADE compared with those without allergies. The incidence of ADR/ADE were lower in patients using 0.9% sodium chloride injection (0.80%) as solvent than those using 5% glucose injection (1.39%) as solvent. The heart rate was significant higher in the case group than that in the control group (t = 2.34, P = 0.02). Hematopoiesis, coagulation, liver and kidney function and ion disturbance were not involved in ADR/ADE associated with sofren injection. Conclusion: In clinic, sofren injection is comparatively safe. However, we need to be wary of the heart rate acceleration caused by sofren injection. In addition, our results showed that 0.9% sodium chloride injection was a suitalble solvent while 5% glucose injection was a recommended solvent in the instruction, which deserved more attentions.
Keywords：Sofren injectionAdverse drug reactionAdverse drug eventDrug evaluation
Publication Date：2018-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 286-290 )