Analysis of Ornidazole Injection in Clinical Use at Post-marketing Stage by Centralized Hospital Monitoring System

Abstract

This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method, and investigate its widespread use in patients, in order to regulate and guide the rational drug use, improve the drug specificity and provide a basis for drug therapy. The study adopts a prospective, multi-center, large sample size, centralized hospital monitoring system. We selected five leading hospitals in Hubei province, and observed the inpatients who received the ornidazole injection from July 1, 2015 to October 31, 2015. The basic information of patients was recorded, as well as the drug use and adverse events. The statistical analysis was performed based on these data. A total of 4396 individuals were enrolled in this study, most of them were middle-aged female patients and the ornidazole injection was mainly used as prophylactic prior to surgery to prevent the infections, and surgical treatment of anaerobic infections, abdominal infections and pelvic infections. The irrational drug use existed mainly in the prescribing and administration process, including unreasonable dosing frequency, rapid intravenous drip speed and extended duration of drug use. Eleven cases of adverse reactions were collected during the monitoring, incidence rate of adverse reactions was 2.5‰; adverse drug reactions occurred within 30 min. The study results fully reflected the usage of ornidazole injection in the real world. Based on the study, we calculated the adverse reaction incidence of ornidazole and identified the risk factors which may affect the safety of ornidazole injection. Study results strongly recommend that the manufacturers should publish standards for inpatient use and doctors should prescribe with caution accordingly.

Keywords

ornidazole injection / centralized hospital monitoring system / post-marketing reassessment / clinical use / adverse reaction

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