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目的 :考察国产甲磺酸托烷司琼正常人体耐受性。方法 :2 4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 ,2 4mg·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 ,2 4mg·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d16mgiv ;d2～d6 6mgpo的方案。
Objective: To investigate the normal human tolerance of domestic tropisetron. Methods: Twenty-four healthy volunteers were randomly divided into 7 groups. Patients were enrolled in a single intravenous injection of 3, 6 and 12 mg of tropisetron mesylate, and po 3, 6, 12 and 24 mg · d -1, respectively. Continuous 5d. Results: Both formulations were tolerated within the dosage range tested. No significant effect on the nervous system, cardiovascular, liver and kidney function and laboratory indicators; dry mouth, constipation or occasional headache, tinnitus ≤ 6mg · d-1; oral 12,24 mg · d-1 mainly manifested as fatigue, Nausea, anxiety, abdominal pain, dizziness, lethargy, insomnia, stuffy nose, etc .; a single intravenous injection of 12mg the main adverse reactions of anxiety, dizziness, abdominal pain; 1 case of rash. Conclusion: According to the results of the tolerance test, it is recommended that the clinical use of d16mgiv; d2 ~ d6 6mgpo regimen.