摘要
目的开展毒性中药风险效益“阈”研究,为该类中药的应用提供客观参考依据。方法以辛热类毒性中药川(草)乌用药为示例,综合多准则决策、Meta分析、熵权法等手段,建立契合中药复杂用药特点的效益-风险评价(benefit-risk assessment,BRA)模型,开展基于评价结果的“阈”探索,发现影响毒性中药效-毒表达的关键因素,并量化区间范围。结果建立了较为稳定的示例药在其优势治疗领域应用的BRA模型,基于纳入的随机对照试验评价不同“阈”条件及区间范围对示例药效益-风险表达的影响,进而筛选到证候是影响示例药临床应用的关键核心条件。结论基于BRA开展的风险效益“阈”研究,可为临床提供合理使用毒性中药的客观依据,并开展针对性的预警防范。
Objective To study the"risk-benefit threshold"of toxic herbs and provide objective reference for their application.Method Taking Radix aconiti Sinensis and Radix aconiti Kusneziffii(Chuanwu and Caowu)with acrid,hot and toxic properties as an example,a benefit-risk assessment(BRA)model was established by integrating multi criteria decision-making,meta analysis and entropy weight method.The"threshold"exploration based on the evaluation results was carried out,and the key factors affecting the expression of efficacy and toxicity in toxicity were found and the range of interval was quantified.Result A relatively stable BRA model was established to evaluate the effect of different"threshold"conditions and intervals on the benefit risk expression of sample drugs based on the included randomized controlled trials.Conclusion"risk-benefit threshold"could provide objective basis for the rational use of toxic herbs,and also could carry out targeted early warning and prevention.
作者
张晓朦
张冰
张丹
林志健
ZHANG Xiaomeng;ZHANG Bing;ZHANG Dan;LIN Zhijian(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Center for Pharmacovigilance and Rational Use of Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China)
出处
《中国药物警戒》
2021年第6期514-519,524,共7页
Chinese Journal of Pharmacovigilance
基金
国家自然科学基金资助项目(81874349)
国家中医药领军人才支持计划“岐黄学者”项目
第三批国家高层次人才特殊支持计划(万人计划)教学名师项目
北京中医药大学基本科研业务经费重点攻关计划(课题级)(2020-JYB-ZDGG-047)。
关键词
风险-效益
阈
辛热类毒性中药
川乌
草乌
risk-benefit
threshold
herbs with acrid,hot and toxic properties
Radix Aconiti Sinensis
Radix Aconiti Kusneziffii