国产甲磺酸托烷司琼正常人体耐受性试验

国产甲磺酸托烷司琼正常人体耐受性试验
杨征;宋三泰;訾薇娜;江孝香;龚正华;罗质璞
【期刊名称】《中国新药杂志》
【年(卷),期】2001(010)005
【摘要】Objective:To observe the tolerability of domestic tropisetron mesylate in healthy volunteers.Methods:24 healthy volunteers were randomly divided to receive respectively iv injection of 3 mg,6 mg,and 12 mg tropisetron mesylate for 5 consecutive days or to receive respectively 3 mg,6 mg,12 mg,and 24 mg oral tropisetron mesylate for 5 consecutive days.Results:In the dose range used,no intoerability was observed and no effects on laboratory data of nervous and cardiovascular system as well as on liver and renal functions were observed,If an oral dose of ≤6 mg*d-1 was received,no other side effects were observed except dry
mouth,constipation and occasional headache.If an oral dose of 12 or 24 mg*d-1 was received,the side effects observed including
nausea,tiredness,anxiety,insomnia,snuffle,and dizziness.After a single dose of 12 mg iv injection,the side effects observed were
anxiety,dizziness,abdominal pain,and rash(in 1 volunteer).Conclusion:The results suggested that a regimen of 6 mg iv injection for the first day,6 mg oral administration for the 2nd～6th day is recomended.%目的：考察国产甲磺酸托烷司琼正常人体耐受性。

方法：24名健康志愿者，随机分为7组，分别参加单次静脉注射甲磺酸托烷司琼3，6，12mg组以及分别po 3，6，12，
24mg*d-1，连续5d。

结果：2种剂型在所试剂量范围内都可耐受。

对于神经系统、心血管、肝肾功能及实验室指标无明显影响；≤6mg*d-1出现口干、便秘或偶有头痛、耳鸣；口服12，24mg*d-1主要表现为乏力、恶心、焦虑、腹痛、头晕、嗜睡、失眠、鼻塞等；单次静脉注射12mg主要不良反应为焦虑、头晕、腹痛；有1例皮疹。

结论：根据耐受性试验结果，建议临床采用d1 6mg iv;d2～d6 6mg po的方案。

【总页数】4页(P367-370)
【作者】杨征;宋三泰;訾薇娜;江孝香;龚正华;罗质璞
【作者单位】军事医学科学院附属307医院,;军事医学科学院附属307医院,;军事医学科学院附属307医院,;军事医学科学院附属307医院,;军事医学科学院毒物药物研究所,;军事医学科学院毒物药物研究所,
【正文语种】中文
【中图分类】R971;R969.4
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