爱康胶囊I期临床试验研究

PHASE I CLINICAL TRIAL OF AIKANG CAPSULE A PREPARATION OF TRADITIONAL CHINESE MEDICINE FOR TREATMENT OF CANCER

目的：考察健康人体对国产Ｉ类新药爱康胶囊（人参皂甙Ｒｇ３）的耐受性、限制性毒性、毒性的可逆程度、毒性与剂量及治疗时间的关系。方法：将２１例健康受试者分为６，１２，２４，３６，６０，８４和１０８ｍｇ七个剂量组，ｐｏ，ｂｉｄ，共观察３０ｄ，停药后继续观察１５ｄ。结果：小剂量（６，１２，２４ｍｇ）组有增加食欲、体力和体重的作用；３６ｍｇ以上组（包括３６ｍｇ）口干现象十分普遍，部分志愿者出现咽干、咽痛、眼干等症状，但均能耐受，且随服药天数的延长而自行缓解。６０ｍｇ以上组个别志愿者出现头晕、耳鸣、胸闷、多梦、口腔溃疡等症状，受试者中有１例ＡＬＴ升高，１例ＡＬＰ升高，个别受试者鼻中有血丝或血痂。结论：爱康胶囊安全范围广，耐受程度高，推荐ＩＩ期临床使用剂量为２４ｍｇ，ｂｉｄ。

OBJECTIVE:To study the tolerability,limited toxicity,reversible range of toxicity and the relationship between treatment duration and toxicity and dosage of Aikang capsules(panaxoside Rg 3) in healthy volunteers.METHODS:21 healthy volunteers were divided to receive 6,12,24,36,60,84,108mg of Aikang capsule,po,bid, for 30 days and observed for further 15 days after treatment.RESULTS:The increase in appetite,physical strength,and body weight were observed in groups of 6,12,24 mg dosage.Dry mouth was a general phenomenon in groups of 36mg and above dosage and dry throat,sore throat and dry eye were occurred in some of them but they are tolerable and relieved with continuous treatment.Dizzy,tinnitus,oppressed feeling in the chest,dreamfulness,and oral ulcer were occurred in a few volunteers in groups of above 60 mg dosage with one case of increase in ALT and one case of increase in ALP.CONCLUSION:Aikang capsule has a wide range of safety with a reasonable tolerability and 24mg was the recommended dosage for phase Ⅱ clinical trial.