辛热类毒性中药临床应用的风险效益“阈”探索

Exploration the"Risk-Benefit Threshold"of Chinese herbs with Acrid,Hot and Toxic Properties

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.