中药轻粉临床外用的风险评估.docVIP

中药轻粉临床外用的风险评估 　　[摘要]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（margin of safety，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1.5 g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0.096 g?kg-1?d-1，推算得到临床疗程2周内每日外用轻粉的NOAEL为1.46 mg?kg-1?d-1（体重60 kg的患者），当MOS=1时，其外用每日最大暴露量为1.1 g。建议成年患者，临床单次外用轻粉低于1.5 g;2周内每日轻粉用药量超过1.1 g时，应该监测肝肾功能的变化。 　　[关键词]轻粉;外用;风险评估 　　Risk assessment for clinical external application of calomel 　　QIU Heng1， WANG Qi1，2* 　　（1. Department of Toxicology， School of Public Health， Peking University， Beijing 100191， China; 　　2. Key Laboratory of State Administration of Traditional Chinese Medicine for Compatibility Toxicology， Beijing 100191， China） 　　[Abstract]Calomel is a common traditional Chinese medicine（TCM）containing mercury in clinical external application. Although the toxicity of calomel has attracted concern， there is no unified standard yet in clinical external application. Risk assessment is used for evaluating the potential health effects of hazardous substances. The purpose of this article was to evaluate the health risk of calomel in clinical external application on the basis of toxicity data， to ensure safe and rational application of TCM containing calomel. The toxicity data of transdermal administration of calomel or mercurous chloride were collected by searching the literature. The daily maximum exposure dosage of calomel in clinical external application was estimated by following the four procedures of risk assessment， and Margin of Safety （MOS） as an evaluation indicator was then calculated to evaluate the safety of calomel on clinical application. It has been reported that the adult in single transdermal administration of calomel at 1.5 g was lethal. Based on the LOAEL of calomel for long-term transdermal exposure （1 month） in rats was 0.096 g?kg-1?d-1， the NOAEL of calomel for patients （about 60 kg） by exter