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中药轻粉临床外用的风险评估

Keywords: 轻粉,外用,风险评估

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Abstract:

轻粉是一种常见的临床外用含汞中药,其毒性一直是临床关注的重点,然而,目前含轻粉中药临床外用,尚没有统一的限量标准。危险度评价是一种评估有害物质潜在健康效应的安全性评价方法,该研究尝试应用基于毒性数据的危险度评价,分析轻粉临床外用的风险,以指导含轻粉中药的临床合理应用。通过收集国内外有关轻粉(或氯化亚汞)经皮毒性相关文献资料,按照危险度评价的4个步骤,以安全范围(marginofsafety,MOS)作为评价指标,根据MOS=1时,推算其外用每日最大暴露量。已有轻粉单次外用剂量为1.5g可致人死亡的报道;根据大鼠破损皮肤长期接触(1个月)轻粉的LOAEL为0.096g·kg-1·d-1,推算得到临床疗程2周内每日外用轻粉的NOAEL为1.46mg·kg-1·d-1(体重60kg的患者),当MOS=1时,其外用每日最大暴露量为1.1g。建议成年患者,临床单次外用轻粉低于1.5g;2周内每日轻粉用药量超过1.1g时,应该监测肝肾功能的变化。

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