Medical Records Database and Epidemiological Characteristics of Adverse Reaction Caused by Compound Salviae Miltiorrhizae Injection / 中药新药与临床药理

ABSTRACT

Objective To investigate the epidemiological characteristics of adverse reaction(ADR) caused by compound Salviae miltiorrhizae injection.Methods By searching domestic medical periodicals issued in the years of 1978～2006,115 cases of ADR detailed records of compound salviae miltiorrhizae injection were collected and database of ADR cases was established by ACCESS.On the basis of database,epidemiological characteristics of the cases were analyzed by statistic methods.Results The incidence of ADR was the highest(70.43 %)in the middle-aged and old sufferers,and was 50.43 %(58) in the male and 49.57 %(57) in the female.In the primary diseases,coronary artery disease shared the highest of incidence(32.00 %).The incidence of generalized lesion(37.40 %) and that of lesion of skin and its appendages(25.95 %)dominated in ADRs,and ADRs usually occurred within 30 min after first injection(64.37 %).Conclusion The establishment of ADR database is beneficial to the storage and analysis of ADR information.Compound Salviae miltiorrhizae injection can induce multi-systemic lesion,and its mechanism is complicated.Therefore,clinician should pay more attention to the prevention of ADR of compound Salviae miltiorrhizae injection.