摘要
目的介绍目前定量药品获益-风险评价方法的基本原理和最新进展。方法查阅目前药品获益-风险评价相关指导原则和系统检索中外有关定量药品获益-风险评价方法文献进行综述。结果简要介绍几种理论依据较为充分的不同类别的定量药品获益-风险评价方法,分析和讨论定量药品获益-风险评价方法的应用现状和发展趋势。结论目前在定量药品获益-风险评价方法的选择与使用上尚未形成统一共识,较为新颖的方法尚未得到广泛应用,仍需真实世界药品评价的进一步检验。
Objective To introduce the basic principles and latest developments of current quantitative drug benefit-risk assessment methods.Methods Current guidelines for drug benefit-risk assessment were consulted while domestic and foreign literature on quantitative drug benefit-risk assessment methods was retrieved to conduct a literature review.Results Several well-grounded quantitative benefit-risk assessment methods were outlined.The current applications of quantitative benefit-risk assessment methods of drugs were analyzed and the developments of quantitative assessment methods were explored.Conclusion There is no specific consensus on the selection and use of quantitative drug benefit-risk assessment methods.The relatively novel methods have not been widely used and need to be verified and confirmed in the real drug benefit-risk assessment context.
作者
郭志坚
胡方圆
郑轶
梁际洲
许金芳
郭晓晶
叶小飞
贺佳
GUO Zhijian;HU Fangyuan;ZHENG Yi;LIANG Jizhou;XU Jinfang;GUO Xiaojing;YE Xiaofei;HE Jia(Department of Medical Statistics,Faculty of Medical Services,Naval Medical University,Shanghai 200433,China)
出处
《中国药物警戒》
2021年第7期649-654,共6页
Chinese Journal of Pharmacovigilance
基金
国家自然科学基金资助项目(82073671)
上海市自然科学基金资助项目(18ZR1449500)
上海市第四轮公共卫生三年行动计划重点学科建设项目循证公共卫生与卫生经济学(15GWZK0901)
上海市卫计委优秀青年医学人才培养计划(2018YQ47)
上海市公共卫生学科带头人(GWV-10.2-XD22)
上海市公共卫生优青计划(GWV-10.2-YQ33)。
关键词
药品
定量
获益-风险评价
方法
药品不良反应
drug
quantitative
benefit-risk assessment
method
adverse drug reaction