title: [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].
abstract: OBJECTIVE
  To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection.
  
  
  METHODS
  Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis.
  
  
  RESULTS
  Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions.
  
  
  CONCLUSIONS
  The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.
authors.affiliation: The First Affiliated Hospital of Henan College of Pharmacy, Zhengzhou 450000, China. lixuelin450000@163.com
authors.forename: Xuelin
authors.initials: X
authors.lastname: Li
authors.forename: Jinfa
authors.initials: J
authors.lastname: Tang
authors.forename: Fei
authors.initials: F
authors.lastname: Meng
authors.forename: Chunxiao
authors.initials: C
authors.lastname: Li
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000009:adverse effects*; D006801:Humans; D007267:Injections; D011358:Product Surveillance, Postmarketing / Q000379:methods*
chemical_list: D004365:Drugs, Chinese Herbal; C540581:danhong