Postmarketing studies on safety of Dengfeng® shenmai injection

Lianxin Wang, Wen Zhang, Yanming Xie, Yang Bai, Mulan Wang, Qinghua Ai
2013 Journal of Traditional Chinese Medicine  
OBJECTIVE: To systematically research the postmarketing safety of Dengfeng® shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS: We investigated a comprehensive series of studies on the production process, quality standards, pharmacology, postmarketing clinical studies, and safety evaluation of Shenmai injection, including literature analysis of adverse drug reaction (ADR) case analysis and systematic review. Data from the hospital information system
more » ... and spontaneous reporting system (SRS) were also analyzed. RESULTS: The approximate dosage leading to death in dogs is 45.0-67.5 g raw drug/kg and the toxic reactions are restlessness, skin irritation, salivation, and vomiting. The results of chronic toxicity tests in mice and dogs, and the other tests such as CONCLUSION: This study includes complete information on Shenmai injection ADR incidence rate. We found that Shenmai injection is safe and this study can provide clinical, research, and production institutions with an objective, reliable, and scientific basis for use of Shenmai injection.
doi:10.1016/s0254-6272(14)60019-4 pmid:24660618 fatcat:etidnuds3nefngejmexsww6ex4