Postmarketing evaluation on the safety and effectiveness of Dengzhanxixin injection made from Dengzhanxixin (Herba Erigerontis Breviscapi)

作者：Li Yuanyuan; Lin Gufeng; Xie Yanming^*; Zhang Wen; Guo Ting

来源：Journal of Traditional Chinese Medicine, 2015, 35(1): 99-103.

DOI：10.1016/s0254-6272(15)30015-7

• Product surveillance
• postmarketing
• Safety
• Treatment outcome
• Erigeron
• Dengzhanxixin injection

OBJECTIVE: To assess the safety and effectiveness of Dengzhanxixin injection (DZI) extracted from Dengzhanxixin (Herba Erigerontis Breviscapi) and identify its potential risks.
METHODS: A series of studies were conducted on the production process, quality standards, and pharmacology. Postmarketing clinical studies and literature reviews including adverse reactions (ADR),adverse events (ADE), case analysis and systematic reviews were also conducted. Data from the hospital information system and spontaneous reporting system were analyzed.
RESULTS: The acute toxicity test indicated that the Lethal Dose 50 test ( LD 50) dosage was 250 times more than the clinical maximum daily dosage (6 mg/kg). In long-term toxicity tests, rats experienced renal tubular damage at 480 mg/kg. However, the dose of 120 mg/kg is safe and non-toxic, which is 40 times above the clinical daily maximum. Beagles had increased serum creatinine at 160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was 0.1002%. ADR symptoms included rash (16.00%), chills (16.00%), and fever (16.00%).
CONCLUSION: There is significant evidence that DZI is safe and effective in a clinical setting.

• 出版日期2015-2-1
• 单位中国中医科学院