Category: Professional Posters
Purpose: Cefazolin sodium pentahydrate for injection is an antibiotics commonly used perioperative prophylaxis and therapy, but it lacks accurate safety data, which has been available since 2004 in China. The purpose of the study is in order to obtain the clinical application and safety status of cefazolin sodium for injection as a whole, and provide more data for its rational and safe application in clinical use.
Methods: The hospital that led the study passed an ethical audit of medical research. In order to investigate the incidence of ADR above 0.1%, and including the rate of loss of follow-up in the study was also considered, an at least 3,600 cases real-world small-scale prospective clinical observation and an embedded case-control study was conducted to evaluate the use of cefazolin sodium pentahydrate for injection and adverse events in a short-term time frame (6 months) without any intervention. Through the two-stage cluster sampling method, 5 hospitals in 2 to 3 provinces and municipalities were randomly selected, and a total of 50 clinical departments were included. From March 1, 2018, inpatients using cefazolin sodium for injection were included, including both prophylactic and therapeutic use. For inpatients with adverse reactions/events found in the study, the doctors provided preliminary comments, which were reviewed by the specialist team. Put gender, age and clinical department as the matching condition for cases group, the control group were selected in a ratio of 4:1 to cases group as nested case-control study method to determine the difference in exposure between the two groups. Data are expressed as means with 95 percent confidence intervals, and evaluation of Positive and control group counts data utilized analysis of variance and measurement data utilized analysis of t test.
Results: A total of 15 effective ADR/E were collected from 3641 valid cases. The incidence of ADR/E was 4.12‰. The Poisson distribution was used to estimate the injection of cefazolin sodium ADR/E for injection. The 95% confidence interval for the incidence rate was (2.31‰, 6.78‰). In the study, 3641 patients who used cefazolin sodium pentahydrate for injection, 3220 of them were used according to the instructions and the guidelines for the treatment, and 14 of the 15 cases with ADR/E were used according to the instructions. The incidence of adverse drug reactions was 4.35 ‰. The clinical symptoms of ADR/E occurred were rash (7 cases), itching (4 cases), vomiting (3 cases), maculopapular rash (2 cases), palpitations (2 cases), dizziness (2 cases) and etc. Adverse reactions / event status are average. The relevance evaluation was "very likely to be related" in 9 cases and "probably related" in 6 cases. After treatment, they with ADR/E all improved or healed.
Conclusion: This study found that the overall adverse reaction rate of cefazolin sodium pentahydrate for injection was "occasional" which is similar to normal cefazolin sodium. Symptom of ADR/E status were general, and ADR/E can be improved or cured within 8 days after stopping, changing or not processing.The study also found that there are some unreasonable medications in the clinic, including long medication courses, preventive administration time, unreasonable frequency, less frequent administration of daily doses, more single dosages, and less reasonable delivery ways, and the most prominent one is the unreasonable volume of infusion.