ABSTRACT
Andrographolide total ester sulfonate (ATES) injection is one of the products of traditional Chinese medicine (TCM) currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-word clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86％ were contraindicated.Irregular medication of adults and children accounted for 1.91％ and 23.38％,respectively.Improper choice of solvent accounted for 3.18％.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events (AEs) was observed in the monitoring period,and the incidence of adverse drug reaction (ADR) of ATES injection was 0.12％.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.
ABSTRACT
To assess the clinical use and occurrence of adverse reactions of Xiyanping injection, and to provide reference for rational drug use in the clinic. Based on hospital central monitoring method, the clinical data of Xiyanping injection in our hospital in 2014 was tracked and analyzed. A total of 848 inpatients were enrolled in this study. Among them, 39.9% were not in accordance with the medication purpose. In practice, the dose more than the limits prescribed by the instructions of child and adult were accounted for 1.72% and 6.62%, respectively; improper choice of solvent, accounting for 3.18%; both the choice of versus intravenous drip and aerosol inhalati administration route were reasonable; mixed with other drug, accounting for 2.24%. The incidence of ADR of Xiyanping injection was 0.12%, which showed good safety. Irrational use of Xiyanping injection existed in clinics, and the use should be strengthened and regulated. The manufacturer should improve the drug instruction of usage and dosage.
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.