基于整合证据链的白鲜皮粉末致肝损伤病例实验研究(1)
[摘要]针对白鲜皮可能导致肝损伤的问题，该文对1例典型的单独服食白鲜皮粉末导致肝损伤病例进行临床和实验室系统研究。按照《中草药相关肝损伤临床诊疗指南》推荐的整合证据链方法对该病例进行诊断研究。通过临床病史、生化学和影像学等检查，排除基础疾病以及病毒性、自身免疫性、酒精性等易混淆肝病对诊断的影响；通过服药史调查，排除其他药物对诊断的影响，该患者仅服食1种药物，怀疑该患者为“白鲜皮粉末”导致药物性肝损伤。进一步按照《中国药典》对患者服食药物进行质量检查，符合白鲜皮项下规定；采用DNA条形码鉴定，ITS2序列BLAST比对，与植物白鲜Dictamnus dasycarpus相似度为100%；检测外源性有害物质，重金属、农残、微生物毒素均未超过相关标准的规定；采用液相高分辨质谱联用仪及Agilent Fake TCM-Drugs数据库检查，未发现化学药物添加。综上，确定该病例为单独服用白鲜皮粉末(15 g/日，超过药典规定用量)导致药物性肝损伤。该文按照《中草药相关肝损伤临床诊疗指南》，从临床到实验室系统检查，确认了1例单独服食白鲜皮粉末致药物性肝损伤的典型病例，为后续研究白鲜皮及其相关制剂的肝损伤风险提供了直接和可靠证据。
, http://www.100md.com
[关键词]中草药； 肝损伤； 白鲜皮； 整合证据链； 生药学鉴定
[Abstract]A typical clinical case of taking Dictamni Cortex(Baixianpi) powder was analyzed to study liver damage caused by Dictamni Cortex. Liver damage was diagnosed according to the integrated evidence chain method recommended by the Guideline for Diagnosis and Treatment of Herb-Induced Liver Injury. By analyzing clinical history and biochemistry and imaging examinations， underlying diseases， such as viral hepatitis， autoimmune liver disease and alcoholic liver disease， were excluded. Through the investigation of medication history， we made it clear that the patient only took Dictamni Cortex powder during the period， and thus suspected that the liver injury was induced by Dictamni Cortex. Furthermore， the quality of the drug was tested， and the results showed it was consistent with the quality standard of Chinese Pharmacopoeia. DNA barcoding showed that the drug was 100% similar with Dictamnus dasycarpus. Moreover， exogenous harmful substances and chemical drug additions were tested， and the results showed that the content of heavy metal， pesticide residues and microbial toxin were consistent with the required standards， and no chemical drug additions were found in Agilent Fake TCM-Drugs database. In summary， we confirmed that the clinical case of drug-induced liver injury was induced by D. dasycarpus with the dose of 15 g·d-1， which exceeded the prescribed amount of Chinese Pharmacopoeia. According to the Guideline for Diagnosis and Treatment of Herb-Induced Liver Injury， the case of drug-induced liver injury induced by D. dasycarpus was confirmed， which provided a direct and reliable evidence for the study of risk of liver injury induced by D. dasycarpus and its relevant preparations.
, 百拇医药
[Key words]Chinese herbal medicine； liver injury； Dictamni Cortex； integrated evidence chain； pharmacognostical identification
白鮮皮为芸香科植物白鲜Dictamnus dasycarpus Turcz.的干燥根皮，为临床常用清热燥湿、祛风解毒中药，含有白鲜皮的中成药常用于治疗湿热疮毒、湿疹疥癣、湿热黄疸、风湿热痹等。然而，调研发现有较多文献报道含有白鲜皮的中成药或复方制剂导致肝损伤，如复方青黛丸[1]、消银片[2]、克银丸[3]、白癜风胶囊[4]和痔血胶囊[5]等。其中，国家药品不良反应监测中心发布了“关注痔血胶囊引起的肝损害”信息通报[6]，指出痔血胶囊引起肝损伤风险。痔血胶囊由白鲜皮和苦参2味中药组成，其中苦参导致肝损伤的报道很少，而且苦参及其所含生物碱如氧化苦参碱等在临床上还可用于慢性肝炎等疾病的治疗，提示苦参可能不是痔血胶囊导致肝损伤的主要原因。那么，白鲜皮是否是痔血胶囊导致肝损伤的主要原因，值得深入研究。一些临床医生和学者怀疑白鲜皮为上述中成药或复方制剂中导致肝损伤的主要原因，但检索国内外文献数据库，至今还没有单味白鲜皮致药物性肝损伤的研究报道，已有的报道都是与白鲜皮复方制剂有关，影响因素难以排除。白鲜皮致肝损伤还缺少直接和可靠的研究证据。, 百拇医药(黄奕雪 郭玉明 周永峰 章从恩 景静 刘士敬 张娜娜 宋经元 肖小河 王伽伯)
, http://www.100md.com
[关键词]中草药； 肝损伤； 白鲜皮； 整合证据链； 生药学鉴定
[Abstract]A typical clinical case of taking Dictamni Cortex(Baixianpi) powder was analyzed to study liver damage caused by Dictamni Cortex. Liver damage was diagnosed according to the integrated evidence chain method recommended by the Guideline for Diagnosis and Treatment of Herb-Induced Liver Injury. By analyzing clinical history and biochemistry and imaging examinations， underlying diseases， such as viral hepatitis， autoimmune liver disease and alcoholic liver disease， were excluded. Through the investigation of medication history， we made it clear that the patient only took Dictamni Cortex powder during the period， and thus suspected that the liver injury was induced by Dictamni Cortex. Furthermore， the quality of the drug was tested， and the results showed it was consistent with the quality standard of Chinese Pharmacopoeia. DNA barcoding showed that the drug was 100% similar with Dictamnus dasycarpus. Moreover， exogenous harmful substances and chemical drug additions were tested， and the results showed that the content of heavy metal， pesticide residues and microbial toxin were consistent with the required standards， and no chemical drug additions were found in Agilent Fake TCM-Drugs database. In summary， we confirmed that the clinical case of drug-induced liver injury was induced by D. dasycarpus with the dose of 15 g·d-1， which exceeded the prescribed amount of Chinese Pharmacopoeia. According to the Guideline for Diagnosis and Treatment of Herb-Induced Liver Injury， the case of drug-induced liver injury induced by D. dasycarpus was confirmed， which provided a direct and reliable evidence for the study of risk of liver injury induced by D. dasycarpus and its relevant preparations.
, 百拇医药
[Key words]Chinese herbal medicine； liver injury； Dictamni Cortex； integrated evidence chain； pharmacognostical identification
白鮮皮为芸香科植物白鲜Dictamnus dasycarpus Turcz.的干燥根皮，为临床常用清热燥湿、祛风解毒中药，含有白鲜皮的中成药常用于治疗湿热疮毒、湿疹疥癣、湿热黄疸、风湿热痹等。然而，调研发现有较多文献报道含有白鲜皮的中成药或复方制剂导致肝损伤，如复方青黛丸[1]、消银片[2]、克银丸[3]、白癜风胶囊[4]和痔血胶囊[5]等。其中，国家药品不良反应监测中心发布了“关注痔血胶囊引起的肝损害”信息通报[6]，指出痔血胶囊引起肝损伤风险。痔血胶囊由白鲜皮和苦参2味中药组成，其中苦参导致肝损伤的报道很少，而且苦参及其所含生物碱如氧化苦参碱等在临床上还可用于慢性肝炎等疾病的治疗，提示苦参可能不是痔血胶囊导致肝损伤的主要原因。那么，白鲜皮是否是痔血胶囊导致肝损伤的主要原因，值得深入研究。一些临床医生和学者怀疑白鲜皮为上述中成药或复方制剂中导致肝损伤的主要原因，但检索国内外文献数据库，至今还没有单味白鲜皮致药物性肝损伤的研究报道，已有的报道都是与白鲜皮复方制剂有关，影响因素难以排除。白鲜皮致肝损伤还缺少直接和可靠的研究证据。, 百拇医药(黄奕雪 郭玉明 周永峰 章从恩 景静 刘士敬 张娜娜 宋经元 肖小河 王伽伯)