辛热类有毒示例药致肾损伤风险分级与警戒思考

doi:10.19803/j.1672-8629.2022.05.03

摘要/Abstract

摘要： 目的以肾脏靶器官为切入点,以辛热类有毒中药为示例建立致肾损伤风险分级模型,并开展相应的药物警戒。方法通过收集建库至2021年12月31日中国知网、万方数据、维普网中辛热类有毒示例药不良反应个案报道共纳入17例,从药物、患者和临床用药三维角度,采用空间距离模型建立半定性定量的致肾损伤三维矩阵风险分级模型。结果初步建立中药致肾损伤的风险分级模型。基于本文纳入的辛热类有毒示例中药草乌、斑蝥、雄黄、蜈蚣和苍耳子的相关个案报道,从药物自身毒性、患者原患肾脏相关疾病和患者临床用药过程中的炮制方式、用药剂量、用药依从性、药物联用情况和给药途径三维角度评价,对不同的案例赋予风险等级评判,根据风险评价等级可分别采用忌用和禁用的警戒措施。结论有毒中药致肾损伤的风险分级体系实现了风险的评估和级别化,为临床用药评判提供参考,实现有针对性的药物警戒措施。

关键词: 肾损伤, 风险分级, 辛热类毒性中药, 药物警戒, 草乌, 斑蝥, 雄黄, 蜈蚣, 苍耳子

Abstract: Objective Taking the renal target organs as the entry point, to establish a graded model of renal injury risk with the example of traditional Chinese medicine with acrid, hot and toxic properties. And corresponding pharmacovigilance was carried out according to this model. Methods A semi-qualitative and quantitative three-dimensional matrix risk ranking model for renal injury was established by collecting case reports of adverse drug reactions (ADR) induced by traditional Chinese medicine with acrid, hot and toxic properties from CNKI, VIP and WanFang database from construction to December 31, 2021, and using a spatial distance model from the three-dimensional perspective of drugs, patients and clinical medication. Results Based on the case reports of traditional Chinese medicine with acrid, hot and toxic properties Caowu (Aconiti Kusnezoffii Radix), Banmao (Mylabris), Xionghuang (Realgar), Wugong (Scolopendra) and Cangerzi (Xanthii Fructus) included in this paper, a three-dimensional evaluation of the toxicity of drug toxicity, the patient's original kidney-related disease and the patient's clinical use of the drug preparation, dose, medication compliance, drug combination and route of administration was conducted to assign a risk rating to different cases, and cautionary measures of contraindication and prohibition could be applied respectively according to the risk evaluation level. Conclusion The risk ranking system of kidney injury induced by toxic Chinese medicine realizes the assessment and rank, which can provide reference for clinical drug evaluation, and realize targeted pharmacovigilance measures.

Key words: kidney injury, risk ranking, herbs with acrid,hot and toxic properties, pharmacovigilance, Caowu (Aconiti Kusnezoffii Radix), Banmao (Mylabris), Xionghuang (Realgar), Wugong (Scolopendra), Cangerzi (Xanthii Fructus)

中图分类号:

吴焕章, 张晓朦, 张冰, 林志健, 章之琪, 张永强. 辛热类有毒示例药致肾损伤风险分级与警戒思考[J]. 中国药物警戒, 2022, 19(5): 481-485.

WU Huanzhang, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian, ZHANG Zhiqi1, ZHANG Yongqiang. Risk ranking and pharmacovigilance thinking of renal injury induced by traditional Chinese medicine with acrid, hot and toxic properties[J]. Chinese Journal of Pharmacovigilance, 2022, 19(5): 481-485.

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