Literature analysis of adverse reactions induced by Shenmai injection

GUO Sheng-cai

Abstract：Objective: To explore the general pattern and characteristics of adverse drug reactions (ADRs) induced by Shenmai injection, and provide references for the safety of drug use in clinic. Methods:The domestic reports of ADRs caused by Shenmai injection from 1994 to 2012 were retrieved and analyzed in respect of the distribution of gender and age, occurrence time of ADRs, allergic history of the patients, the primary diseases, utilization of drugs, organs or systems involved in ADRs, main clinical manifestations, rescuing measures and prognosis, etc. Results: Among the 86 ADR cases, there were 37 male patients accounting for 43.02%, and there were 49 female patients accounting for 56.98%. Most of the ADRs induced by Shenmai injection occurred within 30 minutes after injection. Clinical symptoms of ADRs were complex and diversiform. These ADRs involved in multi-organs and systems, including nervous system, respiratory system, skin and appendix, etc. The allergic shock was the most common in all ADRs. Conclusion:There were many related factors of ADRs induced by Shenmai injection, while the mechanism was complex. The drug quality should be strictly controlled. The process of drug use should be strictly monitored in order to reduce the incidence of ADR caused by Shenmai injection and ensure the rational drug use.