Background:Dengzhanxixin Injection(DZXXI)has been widely used to treat Coronary heart disease with angina pectoris patients.Therefore,the study aimed to evaluate the therapeutic efficacy and safety of DZXXI in treatin...Background:Dengzhanxixin Injection(DZXXI)has been widely used to treat Coronary heart disease with angina pectoris patients.Therefore,the study aimed to evaluate the therapeutic efficacy and safety of DZXXI in treating Coronary heart disease with angina pectoris.Methods:The Cochrane Library,the China National Knowledge Infrastructure database,the Wanfang database,the VIP database,the PubMed database,the Medline database,the EMBASE database,and Clinical Trial were used to search literatures up to August 2022.Results:The results showed that DZXXI combined with conventional therapy were significant in clinical efficacy(relative risk(RR)=1.23,95%cerebral infarction(CI):1.18,1.29;P<0.01)and electrocardiogram curative effect(RR=1.35,95%CI:1.24-1.47;P<0.01),even the subgroup of the DZXXI≤20 ml showed the largest difference.In addition,DZXXI combined with conventional therapy could lower the level of triacylglycerol(mean difference(MD)=−0.63,95%CI:−0.72,−0.55;P<0.01),total cholesterol(MD=−1.18,95%CI:−1.28,−1.09;P<0.01)and low density lipoprotein-cholesterol(MD=−0.98,95%CI:−1.08,−0.88;P<0.01),improve the level of high density lipoprotein-cholesterol(MD=0.41,95%CI:0.33,0.49;P<0.01),blood viscosity(MD=−1.09,95%CI:−1.32,−1.86,P<0.01),plasma viscosity(MD=−0.11,95%CI:−0.11,−0.11,P<0.01)and fibrin(MD=−1.50,95%CI:−1.53,−1.47,P<0.01).Conclusion:These findings revealed that there was more efficacious in DZXXI combined with conventional therapy than that in conventional therapy for the Coronary heart disease with angina pectoris and low dose of DZXXI might be suggested.展开更多
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
目的:通过动物实验观察4种去大分子中药注射液的主要疗效变化。方法:用孔径为10K的纤维滤器去除清开灵注射液、双黄连注射液、丹参注射液和灯盏细辛注射液中的大分子物质。用家兔脂多糖(1μg/kg)发热模型证实高(3.0 m L/kg)、中(1.5 m L...目的:通过动物实验观察4种去大分子中药注射液的主要疗效变化。方法:用孔径为10K的纤维滤器去除清开灵注射液、双黄连注射液、丹参注射液和灯盏细辛注射液中的大分子物质。用家兔脂多糖(1μg/kg)发热模型证实高(3.0 m L/kg)、中(1.5 m L/kg)、低(0.75 m L/kg)剂量的清开灵注射液和双黄连注射液的清热疗效变化;用高分子右旋糖酐复制家兔血瘀模型,观察高中低剂量的丹参注射液(1.2 m L/kg、0.6 m L/kg、0.3 m L/kg)和灯盏细辛注射液(6.0 m L/kg、3.0m L/kg、1.5m L/kg)的活血化瘀作用。结果:去大分子清开灵注射液和双黄连注射液与对应的注射剂原液均能不同程度地降低发热家兔的体温,去大分子丹参注射液和灯盏细辛注射液与对应的注射剂原液均能不同程度地改善血瘀证家兔的血液流变学指标;且同等剂量的去大分子注射液与原液无明显差异。结论:清开灵注射液、双黄连注射液、丹参注射液和灯盏细辛注射液去除大分子物质后,其主要疗效无明显改变。展开更多
基金supported by Wuxi Municipal Health Commission(M202027)Wuxi Science and Technology Bureau(N20202022).
文摘Background:Dengzhanxixin Injection(DZXXI)has been widely used to treat Coronary heart disease with angina pectoris patients.Therefore,the study aimed to evaluate the therapeutic efficacy and safety of DZXXI in treating Coronary heart disease with angina pectoris.Methods:The Cochrane Library,the China National Knowledge Infrastructure database,the Wanfang database,the VIP database,the PubMed database,the Medline database,the EMBASE database,and Clinical Trial were used to search literatures up to August 2022.Results:The results showed that DZXXI combined with conventional therapy were significant in clinical efficacy(relative risk(RR)=1.23,95%cerebral infarction(CI):1.18,1.29;P<0.01)and electrocardiogram curative effect(RR=1.35,95%CI:1.24-1.47;P<0.01),even the subgroup of the DZXXI≤20 ml showed the largest difference.In addition,DZXXI combined with conventional therapy could lower the level of triacylglycerol(mean difference(MD)=−0.63,95%CI:−0.72,−0.55;P<0.01),total cholesterol(MD=−1.18,95%CI:−1.28,−1.09;P<0.01)and low density lipoprotein-cholesterol(MD=−0.98,95%CI:−1.08,−0.88;P<0.01),improve the level of high density lipoprotein-cholesterol(MD=0.41,95%CI:0.33,0.49;P<0.01),blood viscosity(MD=−1.09,95%CI:−1.32,−1.86,P<0.01),plasma viscosity(MD=−0.11,95%CI:−0.11,−0.11,P<0.01)and fibrin(MD=−1.50,95%CI:−1.53,−1.47,P<0.01).Conclusion:These findings revealed that there was more efficacious in DZXXI combined with conventional therapy than that in conventional therapy for the Coronary heart disease with angina pectoris and low dose of DZXXI might be suggested.
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.
文摘目的:通过动物实验观察4种去大分子中药注射液的主要疗效变化。方法:用孔径为10K的纤维滤器去除清开灵注射液、双黄连注射液、丹参注射液和灯盏细辛注射液中的大分子物质。用家兔脂多糖(1μg/kg)发热模型证实高(3.0 m L/kg)、中(1.5 m L/kg)、低(0.75 m L/kg)剂量的清开灵注射液和双黄连注射液的清热疗效变化;用高分子右旋糖酐复制家兔血瘀模型,观察高中低剂量的丹参注射液(1.2 m L/kg、0.6 m L/kg、0.3 m L/kg)和灯盏细辛注射液(6.0 m L/kg、3.0m L/kg、1.5m L/kg)的活血化瘀作用。结果:去大分子清开灵注射液和双黄连注射液与对应的注射剂原液均能不同程度地降低发热家兔的体温,去大分子丹参注射液和灯盏细辛注射液与对应的注射剂原液均能不同程度地改善血瘀证家兔的血液流变学指标;且同等剂量的去大分子注射液与原液无明显差异。结论:清开灵注射液、双黄连注射液、丹参注射液和灯盏细辛注射液去除大分子物质后,其主要疗效无明显改变。
