| 引用本文: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(09):. |
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| 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 |
| 投稿时间：2014-08-06 |
| DOI：10.3969/j.issn.1673-7202.2014.09.005 |
| 中文关键词: 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 |
| English Keywords:Xingxue Shuxuening injection Chinese patent medicine Quality control Safety studies real world Drug risk minimization action plans |
| 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 |
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| 中文摘要: |
| 目的：系统梳理杏雪舒血宁注射液药品生产、临床前安全性研究、药品上市后安全性研究，为完善风险管理计划，保证百姓安全用药提供依据。方法：在原药材选择及生产全过程采取严格质量控制标准的基础上，对杏雪舒血宁注射液的毒理学研究、安全性文献进行梳理，对药品上市后的自发呈报系统（SRS）的药品不良反应（ADR）数据分析、医院信息系统（HIS）数据临床用药特征分析、大规模前瞻性安全性监测研究等多项安全性研究结果进行梳理与汇总，以及简要介绍药品风险管理计划的制定与实施。结果：药品上市后随机对照试验中未发现对脏器及血液系统有影响；文献个案报道及SRS研究中提示患者有皮疹、瘙痒、头晕、呕吐、静脉炎等ADR表现；HIS数据分析显示舒血宁注射液（含其他品种数据）与血尿素氮（BUN）的异常变化可能有关，但还需进一步验证，对疑似过敏反应病例研究发现有过敏史者使用舒血宁注射液更易发生过敏反应（P<0.001）；前瞻性的安全性主动监测研究正在进行中，最终将获得药品ADR发生率及影响因素。结论：杏雪舒血宁注射液药品质量可靠，在药品风险管理下可安全有效的应用于临床。 |
| English Summary: |
| 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 medicinal 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 information 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 Shuxuening injection (including other varieties of data) and blood urea nitrogen (BUN) changes may be co-related which still need further validation. 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 Shuxuening injection can be safely applied in clinical under proper drug risk management. |
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