目的:为解决传统药品不良反应(adverse drug reaction,ADR)监测方式存在的问题,设计药品不良反应智能监测平台。方法:药品不良反应智能监测平台基于人工智能、大数据等技术设计,采用浏览器/服务器(Browser/Server,B/S)架构,使用C#语言...目的:为解决传统药品不良反应(adverse drug reaction,ADR)监测方式存在的问题,设计药品不良反应智能监测平台。方法:药品不良反应智能监测平台基于人工智能、大数据等技术设计,采用浏览器/服务器(Browser/Server,B/S)架构,使用C#语言、基于.NET平台开发。整个平台包括ADR知识库、监测规则设置、智能监测、报告管理、统计分析5个功能模块。结果:该平台实现了ADR智能监测、上报、审核、统计分析全流程管理,有效提高了ADR报告的数量、质量和时效性。结论:该平台有利于提高ADR监测能力,提升患者的用药安全监管水平。展开更多
Background:Reliable animal models are crucial to drug development for focal segmental glomerulosclerosis(FSGS),a rare kidney disease.Variability in success rates in literature and significant ethical concerns with ani...Background:Reliable animal models are crucial to drug development for focal segmental glomerulosclerosis(FSGS),a rare kidney disease.Variability in success rates in literature and significant ethical concerns with animal welfare necessitate further optimization of adriamycin(ADR)-induced FSGS model developed on BALB/c mice.Methods:High-performance liquid chromatography(HPLC)was used to assess ADR stability in water and upon light exposure.To identify the optimal ADR level,single intravenous ADR injections with dosing levels from 10 to 17 mg/kg body weight were administered to BALB/c mice to induce FSGS-like pathology.Body weight and proteinuria of FSGS mice were monitored and analyzed for FSGS model-associated morbidity.Animals were euthanized for hematological and kidney histological assessments 8 weeks post induction.To identify the suitable experiment time frame of the ADR-induced FSGS mouse model,a longitudinal study was performed,with an 11-week continuous monitoring of the symptoms.Results:ADR was found to be unstable in aqueous media and light sensitive.A dosing level of 10.5 mg/kg of ADR was optimal for consistent FSGS mouse model induction on BALB/c strain,characterized by minimal mortality and sustained FSGS-like symptoms.Findings from the longitudinal study suggest that 6 weeks post ADR induction may represent the peak of FSGS pathology severity in this mouse model.This time frame may be used for FSGS drug development projects.Conclusion:Based on the outcome from this study,we identified the optimal ADR dosing level and model testing duration.A standard operating procedure(SOP)for the ADR-induced FSGS mouse model was established to facilitate FSGS basic research and drug development.展开更多
Objective To analyze adverse drug reactions(ADR)caused by sunitinib and provide reference for clinical safety.Methods The case reports of ADR related to sunitinib in six Chinese and English databases from 2006 to 2021...Objective To analyze adverse drug reactions(ADR)caused by sunitinib and provide reference for clinical safety.Methods The case reports of ADR related to sunitinib in six Chinese and English databases from 2006 to 2021 were searched to extract relevant data,and then statistical analysis was performed.Results and Conclusion A total of 147 articles were included,involving 156 cases and 283 adverse events.Adverse reactions occurred at the highest rate after 31 to 180 days of drug administration,and ADR involved organs/systems mainly in blood and lymphatic disorders(17.67%),gastrointestinal disorders(15.55%),and skin and subcutaneous tissue disorders(10.60%).The adverse effects caused by sunitinib involve multiple organs/systems throughout the body.Besides,there are many severe fatal cases.During clinical medication,patients should be monitored regularly,and drugs should be reduced or stopped timely when adverse reactions occur to reduce the risk of clinical medication.展开更多
文摘目的:为解决传统药品不良反应(adverse drug reaction,ADR)监测方式存在的问题,设计药品不良反应智能监测平台。方法:药品不良反应智能监测平台基于人工智能、大数据等技术设计,采用浏览器/服务器(Browser/Server,B/S)架构,使用C#语言、基于.NET平台开发。整个平台包括ADR知识库、监测规则设置、智能监测、报告管理、统计分析5个功能模块。结果:该平台实现了ADR智能监测、上报、审核、统计分析全流程管理,有效提高了ADR报告的数量、质量和时效性。结论:该平台有利于提高ADR监测能力,提升患者的用药安全监管水平。
基金United States Department of Defense Office of the Congressionally Directed Medical Research Programs(CDMRP),Grant/Award Number:W81XWH-22-1-0176。
文摘Background:Reliable animal models are crucial to drug development for focal segmental glomerulosclerosis(FSGS),a rare kidney disease.Variability in success rates in literature and significant ethical concerns with animal welfare necessitate further optimization of adriamycin(ADR)-induced FSGS model developed on BALB/c mice.Methods:High-performance liquid chromatography(HPLC)was used to assess ADR stability in water and upon light exposure.To identify the optimal ADR level,single intravenous ADR injections with dosing levels from 10 to 17 mg/kg body weight were administered to BALB/c mice to induce FSGS-like pathology.Body weight and proteinuria of FSGS mice were monitored and analyzed for FSGS model-associated morbidity.Animals were euthanized for hematological and kidney histological assessments 8 weeks post induction.To identify the suitable experiment time frame of the ADR-induced FSGS mouse model,a longitudinal study was performed,with an 11-week continuous monitoring of the symptoms.Results:ADR was found to be unstable in aqueous media and light sensitive.A dosing level of 10.5 mg/kg of ADR was optimal for consistent FSGS mouse model induction on BALB/c strain,characterized by minimal mortality and sustained FSGS-like symptoms.Findings from the longitudinal study suggest that 6 weeks post ADR induction may represent the peak of FSGS pathology severity in this mouse model.This time frame may be used for FSGS drug development projects.Conclusion:Based on the outcome from this study,we identified the optimal ADR dosing level and model testing duration.A standard operating procedure(SOP)for the ADR-induced FSGS mouse model was established to facilitate FSGS basic research and drug development.
文摘Objective To analyze adverse drug reactions(ADR)caused by sunitinib and provide reference for clinical safety.Methods The case reports of ADR related to sunitinib in six Chinese and English databases from 2006 to 2021 were searched to extract relevant data,and then statistical analysis was performed.Results and Conclusion A total of 147 articles were included,involving 156 cases and 283 adverse events.Adverse reactions occurred at the highest rate after 31 to 180 days of drug administration,and ADR involved organs/systems mainly in blood and lymphatic disorders(17.67%),gastrointestinal disorders(15.55%),and skin and subcutaneous tissue disorders(10.60%).The adverse effects caused by sunitinib involve multiple organs/systems throughout the body.Besides,there are many severe fatal cases.During clinical medication,patients should be monitored regularly,and drugs should be reduced or stopped timely when adverse reactions occur to reduce the risk of clinical medication.
