论文部分内容阅读
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 investigate the safety of Anjuning in healthy volunteers, a randomized, double-blind, placebo-controlled study was conducted in which 40 healthy volunteers were enrolled and randomized to 10 groups to receive a single dose of beraudine and placebo for fasting Dayton clothing, the results found safe safety single dose range of 6 to 24 grams. The main adverse reactions were nausea and vomiting, diarrhea and drowsiness, dizziness, headache and dry mouth. The incidence of nausea and vomiting and headache was significantly higher than that of placebo (P <0.05). No adverse reactions such as delirium and syncope were found. Mostly mild performance, some moderate, no severe reaction. All disappeared without treatment. Before and after taking medication blood pressure, body temperature, respiration, pulse and liver and kidney function, ECG, blood, urinary routine monitoring, found that each dose group and placebo similar to the normal range fluctuations. The results show that An Jun Ning high tolerance to healthy individuals, short-term use of drugs on human normal metabolism had no significant effect.