ABSTRACT
Objective To recognize the characteristics and causes of the adverse drug reaction (ADR)of traditional Chinese patent medicine,and promote the clinical safe drug use.Methods By retrospective study,ADR reports about Chinese patent medicine collected by Shouguang adverse drug reaction monitoring center from January 1,2012 to December 31,2014 were analyzed statistically.Results A total of 479 reports in accordance with the inclusion criteria were collected,which comprised 479 patients.Of them,224 were male and 255 were female,often occurs in patients over 50 years old[53.0%(254 /479)].Chinese patent medicine involved in these reports were mainly blood -regulating formula,heat agent and formula for resuscitation,respectively 278 cases(58.0%),64 cases (13.4%),51 cases (10.6%).Intravenous administration was an important way to trigger ADR [78.5%(376 /479)],78.5% injection had adverse effects and suitability of medicine were 55.9%.Main clinical manifesta-tions were lesion of skin and its appendages[35.1%(183 /522)]and digestive system damage[18.4%(96 /522)]. Conclusion The application of traditional Chinese medicine syndrome differentiation as the primary principle,atten-tion to individual differences of patients,improve the level of rational use drugs,strengthen the proprietary Chinese medicine preparation process and improve the drug instructions can reduce the adverse reaction occurred to some extent of Chinese patent medicine.