山豆根安全性评价与风险控制措施探讨.docVIP

山豆根安全性评价与风险控制措施探讨 　　[摘要]该文从本草溯源及考证、现代文献毒性记载及近年来相关毒性实验研究等方面对山豆根的安全性文献进行了系统回顾和分析。研究提示，山豆根的毒性主要累及神经系统、消化系统和呼吸系统，且呼吸衰竭可能是致死的直接原因。主要症状为：头痛、头晕、呕吐、恶心、腹痛、四肢无力、心悸、胸闷；重者表现为面色苍白、四肢颤抖、抽搐、发冷、心跳加快、血压下降、休克、呼吸衰竭而死亡。若患者大量、长时间服用，可能造成严重的脑损害，尤其是青少年及儿童病例较多。笔者提出规范临床用药，避免患者轻信偏方、验方随意用于预防感冒和治疗咽喉疼痛，临床医师严格按照药典推荐用法用量处方，是充分发挥疗效规避用药风险的重要措施。并建议今后应注重山豆根中毒后常规救治方法的探讨，同时加强毒性物质基础、毒性机制和增效减毒等研究，以期使山豆根充分发挥疗效的同时减少临床不良反应。 　　[关键词]山豆根； 安全性评价； 不良反应； 风险控制 　　[Abstract]The aim is to systemically review and evaluate the safety of Sophora tonkinensisfrom the literature on the herbal origin， toxicity record in modern literature and toxicological studies and publications in recent years By systematic review and analysis， the results showed that its toxicity mainly involved the nervous system， the digestive system and the respiratory system， and respiratory failure may be the direct cause of death The main symptoms included headache， dizziness， vomiting， nausea， abdominal pain， limbs weakness， palpitation， and chest distress； as well as pale complexion， limbs trembling， convulsions， chills， high heart rate， fall of blood pressure， shock， and respiratory failure to death in severe cases High dose and long term medication may cause serious brain damage， especially in adolescents and children The authors have proposed to use rationally under guidance of physician and strictly according to the dosage recommended by pharmacopoeia The patients shall not be credulous about the folk prescriptions and test recipes to use it for，prevention of colds and treatment of sore throat at will In addition， the researches on the conventional treatment methods for S. tonkinensis poisoning， the toxic substance basis， and toxicity mechanism shall be strengthened in further studies These efforts will play important role in exerting the drug effect and avoiding side effect. 　　[Key words]Sophora tonkinensis； safety evaluation； adverse drug reaction； risk control 　　山豆根?槎箍浦参镌侥匣?Sophora tonkinensis Gagnep的干燥根和根茎。《中国药典》2015年版[1]载山豆根苦、寒，有毒，具