世界中医药Issue(9)：1128-1131,1136,5.DOI:10.3969/j.issn.1673-7202.2014.09.005
舒血宁注射液安全性研究及其药品风险最小化行动计划的制定
Safety Researches and Risk Minimization Action Plan of Shuxuening Injection
摘要
Abstract
Objective:To ensure drug safety of Xingxue Shuxuening injection by optimizing the risk management plan based on the drug’s manufacture,preclinical safety and post-marketing safety researches.Methods:strict quality control was applied to original me-dicinal materials selection and production,conducted toxicology and safety research on Xingxue Shuxuening injection,analyzed adverse drug reaction (ADR)data collected from spontaneous reporting system (SRS),clinical drug administration data from hospital informa-tion system (HIS),large-scale prospective clinical safety research,briefly introduced drug risk management plan and implementation. Results:The post-marketing randomized controlled trials did not have ADR related to organs and blood system reported;published study reports and SRS suggested the drug may cause skin rashes,itching,dizziness,vomiting,phlebitis,etc;HIS data showed that Shuxuen-ing injection (including other varieties of data)and blood urea nitrogen (BUN)changes may be co-related which still need further vali-dation.Moreover,patients who has allergies history were more likely to have allergic reaction after taken Shuxuening injection (P <0. 001 );an ongoing proactive safety research will eventually reveal ADR occurrence and influencing factors.Conclusion:Xingxue Shux-uening injection can be safely applied in clinical under proper drug risk management.关键词
杏雪®舒血宁注射液/中成药/质量控制/安全性研究/真实世界/药品风险最小化行动计划Key words
Xingxue®Shuxuening injection/Chinese patent medicine/Quality control/Safety studies/real world/Drug risk minimi-zation action plans分类
医药卫生引用本文复制引用
杨薇,谢雁鸣..舒血宁注射液安全性研究及其药品风险最小化行动计划的制定[J].世界中医药,2014,(9):1128-1131,1136,5.基金项目
国家重大新药创制科技重大专项（编号2009ZX09502030）；中国中医科学院科技创新团队建设项目（编号PY1303）；中国中医科学院博士研究生创新人才培养基金项目资助 （）
