title: Postmarketing studies on safety of Dengfeng shenmai injection.
abstract: 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 (HIS) 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 6-month toxicity, drug safety, genetic toxicity, and reproductive toxicity of rats and dogs, were positive or qualified. Patient ADR history and ADR family history were closely associated with itching based on the data analysis from SRS. There was no damage to renal function from Shenmai injection use at a dosage and a treatment course outside the recommended dosage and treatment course as specified based on data analysis from HIS. The most common ADR from Shenmai injection are difficulty breathing, facial flushing, nausea, vomiting, chest tightness, skin itching, rash, and back pain.
  
  
  CONCLUSIONS
  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.
authors.forename: Lianxin
authors.initials: L
authors.lastname: Wang
authors.forename: Wen
authors.initials: W
authors.lastname: Zhang
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
authors.forename: Yang
authors.initials: Y
authors.lastname: Bai
authors.forename: Mulan
authors.initials: M
authors.lastname: Wang
authors.forename: Qinghua
authors.initials: Q
authors.lastname: Ai
mesh_terms: D000818:Animals; D004285:Dogs; D004358:Drug Therapy; D004365:Drugs, Chinese Herbal / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D051379:Mice; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D051381:Rats
chemical_list: D004365:Drugs, Chinese Herbal