Objective: To investigate the clinical application and adverse reactions of shengmai injection and their related factors.
Methods: China National Knowledge Infrastructure (CNKI) database was searched with the key word of "Shengmai Injection" from January 1983 to March 2009 to collect the literature regarding clinical study on shengmai injection, and the dose, indication, medicating path and method, solvent of the drug used, as well as the duration of treatment course and adverse reaction occurred were analysed.
Results: Finally, 647 documents involving 28,305 patients were included. Adverse reactions occurred in 215 patients, including anaphylactic response (anaphylactic shock, systemic anaphylaxis and skin rash) in 56 patients, and the adverse reactions on various systems, organs and tissues in 159 patients among whom there were a case of acute severe liver damage and a case of heart damage with severe sinus arrest. All patients were improved after treatment with no report of dead case.
Conclusion: Shengmai injection has been widely applied in clinical practice since it came into the market in 1983, and its chief adverse reaction is the anaphylactic reaction. Excepting the relation with individual constitution, the occurrence of the adverse reaction is also related to its improper clinical application, such as incorrect combination with other drugs, over-high dosage used and age factor, etc. The prevention, monitoring and in time treatment of the adverse reactions and standardized rational medication of the drug should be stressed in the application of Shengmai Injection by clinical physicians.