中药安君宁的临床耐受性评价

The Study of Suffertibility of Anjunnin for Volunteer

为了考察安君宁在健康人体的耐受性 ,采用与安慰剂的随机双盲对照研究 ,征集 40名健康自愿受试者 ,随机分为 10组 ,接受安君宁和安慰剂的单剂量空腹顿服 ,结果发现安君宁的安全单剂量范围为 6～ 2 4克。主要不良反应为恶心呕吐 ,腹泻和嗜睡 ,头晕头痛、口干 ,其中恶心呕吐和头痛的发生率明显高于安慰剂 (P <0 .0 5 ) ,未发现谵妄、晕厥等不良反应。多为轻度表现 ,部分为中度 ,无重度反应。均未经处理自行消失。对服药前后血压、体温、呼吸、脉搏和肝肾功能、心电图、血、小便常规做监测 ,发现各剂量组与安慰剂类似 ,均在正常范围波动。结果表明安君宁对健康个体耐受性较高 ,短期用药对人体正常生理代谢无明显影响。

In order to study the suffertibility and safety of a traditional chinese medicine An junning,single dosage of An junning or placebo was administrated to 40 cases of healthy volunteers,who were randomly divided into10 groups.The result showed that the range of single dosage was from 6 grams to 24 grams,with mild to medium side effect such as nausea,vomiting,diarrhea,dizziness,swirl,headache,dry mouth.All of these symptoms needed on treatment and alleviated spontaneously.There found no distinet change of temperature,pulse,blood pressure and routine chemical examinations after takd An junning.The result indicted that An junning possessed highly suffertibility and safety.