[Comparison and analysis of clinical safety evaluation methods for parenterally administered Chinese medicine].
Parenterally administered Chinese medicine is widely applied in clinic. It particularly plays an important role in the treatment of cardiovascular and cerebrovascular disease, acute infectious diseases and malignant tumors. With the expansion of the scope of the clinical application of parenterally administered Chinese medicine adverse event reports also increase day by day. Thus, parenterally administered Chinese medicine has come to the attention of management departments, medical staff and the public. By the end of 2012, the national adverse drug reaction monitoring database has collected more than 5 million adverse drug reactions/events reports. Parenterally administered Chinese medicine accounted for more than half of the total number of adverse reactions to Chinese medicine. Therefore, it is essential that epidemiological methods are used to analyze the national database for all references to parenterally administered Chinese medicine. Our research aims to analyze the advantages and disadvantages of various safety monitoring methods for parenterally administered Chinese medicine and offer guidance in safety evaluation analysis.
Traditional Chinese Medicine Clinical Basic Medical Research Institute, China Academy of Traditional Chinese Medicine, Beijing 100700, China. ybh612003@163.com
Bo-Hua
BH
Yan
Chengdu University of Traditional Chinese Medicine, Chengdu 610075, China.
Cheng
C
Peng
Traditional Chinese Medicine Clinical Basic Medical Research Institute, China Academy of Traditional Chinese Medicine, Beijing 100700, China.
Yan-Ming
YM
Xie
Traditional Chinese Medicine Clinical Basic Medical Research Institute, China Academy of Traditional Chinese Medicine, Beijing 100700, China.
Yong-Yan
YY
Wang
D002681:China / Q000453:epidemiology; D002986:Clinical Trials as Topic; D016903:Drug Monitoring / Q000379:methods*; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007263:Infusions, Parenteral
D004365:Drugs, Chinese Herbal