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

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 c...

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Bibliographic Details
Published in中医杂志：英文版 no. 1; pp. 99 - 103
Main Author Li Yuanyuan Lin Gufeng Xie Yanming Zhang Wen Guo Ting
Format Journal Article
LanguageEnglish
Published 2015
Subjects
上市
医院信息系统
安全性
急性毒性试验
有效性评价
注射液
灯盏细辛
长期毒性试验
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Summary: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 sys- tematic 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 experi-enced 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.
Bibliography:11-2167/R
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 sys- tematic 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 experi-enced 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.
ISSN:0255-2922