Clinical use by the post-marketing hospital centralized monitoring of 4 396 clinical cases of ornidazole injection / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate the clinical use of ornidazole injection in a wide patient population by the post-marketing hospital centralized monitoring method in order to regulate and guide its rational use, improve the drug specification, and provide a basis for the drug therapy. METHODS: A prospective, multi-center, large sample hospital centralized monitoring method was adopted. Five sentinel hospitals in Hubei Province were selected, and hospitalized patients who received ornidazole injection treatment from July 1, 2015 to October 31, 2015 were observed. The basic information of the patients was recorded, as well as the drug use and adverse events, and then statistical analysis was made. RESULTS: A total of 4396 cases were enrolled in this study, most of them were middle-aged female patients. Ornidazole injection was mainly used before surgeries to prevent infections and after surgeries for treatment of anaerobic infections, abdominal infections and pelvic infections. Irrational drug use existed in clinic, mainly concentrating at unreasonable dosing frequency, excessive dripping speed, and long duration of use. Eleven cases of adverse reactions were collected during the monitoring, indicating an incidence of adverse drug reactions of 2.5‰, and most of the adverse drug reactions occurred within 30 min post drug administration. CONCLUSION: The manufacturers should make further investigation on the dripping speed and quality standard of ornidazole injection to further improve the information in the package insert and regulate the clinical use.