Postmarketing studies on safety of Dengfeng~ shenmai injection  

作　　者：Lianxin Wang Wen Zhang Yanming Xie Yang Bai Mulan Wang Qinghua Ai 

机构地区：[1]Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences [2]Marketing Department, Research Department of Chiatai Qingchunbao Pharmaceutical Company, Ltd.

出　　处：《Journal of Traditional Chinese Medicine》2013年第6期827-831,共5页中医杂志（英文版）

基　　金：Supported by National Science and Technology Major Projects for "Major New Drugs Innovation and Development":Study on Key Technologies of Postmarketing Evaluation for Chinese Medicine(No.2009ZX09502-030)

摘　　要：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. 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.OBJECTIVE： To systematically research the post- marketing safety of Dengfeng shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS： We investigated a comprehensive se- ries of studies on the production process, quality standards, pharmacology, postmarketing clinical studies, and safety evaluation of Shenmai injection, including literature analysis of adverse drug reac- tion （ADR） case analysis and systematic review. Da- ta from the hospital information system （HIS） and spontaneous reporting system （SRS） were also ana- lyzed. 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, sali- vation, and vomiting. The results of chronic toxicity tests in mice and dogs, and the other tests such as6-month toxicity, drug safety, genetic toxicity, and reproductive toxicity of rats and dogs, were posi- tive or qualified. Patient ADR history and ADR fami- ly 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. CONCLUSION： This study includes complete infor- mation 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 scientif- ic basis for use of Shenmai injection.

关 键 词：Product surveillance  postmarketing Medicine  Chinese traditional SAFETY Shenmai in-jection 

分 类 号：R286[医药卫生—中药学]