托拉塞米的利尿作用和安全性

目的 观察健康受试者口服托拉塞米的利尿作用和安全性。方法 19名健康男性受试者单次口服不同剂量托拉塞米5,10和20 mg(n=9)或连续7天每日口服托拉塞米10 mg(n=10)。观察血压,尿量,24 h尿钾、钠、氯和血钾、钠、氯,心率,呼吸,心电图和心电监测,血常规,尿常规,血生化等指标。 结果 5,10,20mg 3组单次服药后24 h总尿量分别为2.24,2.60和3.17 L(P<0.05),24 h尿钾、钠、氯的排泄随托拉塞米剂量增加而略增加(P>0.05)。连续服药,首次药后的24h尿量及尿钾、钠、氯的量最多。单次和连续给药后血钾、钠、氯均未见下降,甘油三脂增加0.1~0.4 mmol.L-1(P<0.05)。4例受试者出现药物不良反应。 结论 在5~20 mg,托拉塞米利尿作用随剂量增加而增加,国人对托拉塞米耐受性良好。

Safety and tolerance of torasemide after a single and multiple oral administration

Objective To evaluate the diuretic effect and safety of different andmultiple doses torasemide. Methods Nineteen normal male healthy subjects receivedsingle dose of either 5, 10 or 20 mg po with one week interval or single dose of 10 mgpo every morning for 7 days. Urine and volume of intake over 24 h period, bloodpressure, respiratory and heart rates, 24 h urine potassium/ sodium/chloride/creatinine/ calcium, complete blood count and chemistry, urinalysis andelertrocardiogram before and after the administration. Results Twenty-four h urinevolume after taking torasemide 5,10,20 mg were 2.14,2.60,3.17 L, respectively(P<0.05). There are a little increase with three doses about the urine potassium, sodium,chloride excretion over 24 h period. Urine volume and urine potassium, sodium,chloride excretion over 24 h period were highest after the first administration. Nodecrease in serum potassium, sodium, chloride after single dose and multiple doseswhile triglyceride increased 0.1~0.4 mmol.L-1. Four volunteers had adverse effects.Conclusion There was a clear dose-response relationship for diuretic activity. Goodtolerance and safety profile were observed in the given doses.