ABSTRACT
OBJECTIVE:To explore and analyze signals of Xiyanping injection-induced urticaria from spontaneous reporting system database of Jiangxi province. METHODS:The continuous ADR report monitoring data were collected from spontaneous re-porting system of Jiangxi province,and established database. Bayesian confidence propagation neural network(BCPNN) method was used to calculate information component,IC value of Xiyanping injection-induced urticaria. The year-to-year changes of IC val-ue and its interval were analyzed. RESULTS:A total of 328324 ADR reports were collected in Jiangxi province during 2004-2016. The IC value of Xiyanping injection-induced urticaria detected by BCPNN method was 1.10(the lower limit of IC value was 0.65, and upper limit was 1.54),i.e. there was signal and the IC value ranged from-0.87 to 1.65. CONCLUSIONS:The results of BCPNN method suggest that urticaria is a warning signal of Xiyanping injection. The risk is increasing gradually,and prediction precision increase with the addition of report quantity.
ABSTRACT
OBJECTIVE:To investigate general regularity and characteristics of tetanus antitoxin (TAT) induced by ADRs,in order to provide reference for rational drug use in the clinic.METHODS:Domestic and foreign literatures on ADRs induced by TAT were retrieved,and related information of 2 636 case of ADR were analyzed statistically.RESULTS:Among patients whose gender and age were recorded,male with ADR induced by TAT was more than female,mainly aged 15-35 years old,accounting for 70.32 ％ (289/411);28.28 ％ (56/198) used water for injection;ADR occurred within 30 min after medication in 5.84％ (154/2 636)cases;main ADR were lesion of skin and its appendents,circulatory system damage,systemic reaction damage.Main clinical manifestations were urticaria,rash,chest tightness and anaphylaetic shock,etc.Ten cases died and 7 cases had sequelae;the rest were all recovered and cured after symptomatic treatment.CONCLUSIONS:TAT has a higher proportion of allergic reactions,especially anaphylactic shock,but great importance should be attached to rare auditory and vestibular dysfunction,visual impairment,elevated white blood cell count and other ADR.It is suggested to strengthen medication monitoring and used drugs strictly in accordance with drug package inserts so as to promote rational drug use.