Postmarketing studies on safety of Dengfeng shenmai injection

• Published in: Journal of traditional Chinese medicine Vol. 33; no. 6; pp. 827 - 831
• Main Authors: Wang, Lianxin, Zhang, Wen, Xie, Yanming, Bai, Yang, Wang, Mulan, Ai, Qinghua
• Format: Journal Article
• Language: English
• Published: China 01.12.2013
• Subjects: Animals; Dogs; Drug Therapy; Drugs, Chinese Herbal - adverse effects; Drugs, Chinese Herbal - therapeutic use; Humans; Mice; Product Surveillance, Postmarketing - statistics & numerical data; Rats; 上市; 临床安全性; 医院信息系统; 参麦注射液; 安全性评价; 慢性毒性试验; 报告系统; 药品不良反应
• ISSN: 0255-2922
• DOI: 10.1016/S0254-6272(14)60019-4

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.