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...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(6mg/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 at160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was0.1002%. 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.展开更多
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...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.展开更多
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)
文摘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(6mg/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 at160 mg/kg. In a prospective study, 15 962 cases experienced 16 ADR/ADE. The rate of ADR/ADE was0.1002%. 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.
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)
文摘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.
