摘要
目的评价中国健康志愿者单次及连续静脉滴注血塞通氯化钠注射液的安全性和耐受性,推荐临床安全有效的用药剂量。方法将31例健康志愿者随机分为100,200,400,600 mg单次给药组及400 mg连续给药组(qd×14d)。观察各组用药后的临床症状、生命体征,检查心电图、血尿常规、肝肾功能、凝血功能等。结果单次给药后0,1,8,24 h受试者的生命体征及实验室检查等各项指标均在正常范围内,发生与药物无关的不良事件1例,表现为头晕,休息后自行恢复。连续给药耐受性实验结果显示,服药后第4天、第8天、第12天及第15天受试者的生命体征和实验室检查等各项指标均在正常值范围内,发生与药物有关的不良反应2例,表现为皮疹,停药治疗后恢复。结论中国健康男性或女性志愿者单次静脉滴注血塞通氯化钠注射液100～600 mg及连续静脉滴注400 mg是安全的,且人体可以耐受。推荐临床400 mg的剂量可以接受,但要密切注意观察过敏反应的发生。
Objective To assess the safety and tolerance of single-dose and continuous intravenous drip of Xuesaitong saline injection in Chinese volunteers, thus to establish the effective clinical dosage. Methods Thirty-one healthy volunteers were randomized into 4 single-dose groups （ 100, 200, 400 and 600 mg respectively） and a multiple-dose group （400 rag, qd × 14 d）. Subjective symptoms, objective signs, vital signs including blood pressure, heart rate, respiration were observed, and routine blood tests, routine urine tests, hepatic function, renal function, clotting function, electrocardio- gram were monitored after medication. Results In the single-dose groups, there were no abnormal findings in the vital signs and the lab examinations Oh, 1h, 8h, 24h after medication. Dizziness without association with Xuesaitong occurring in one volunteers of the 200 mg group. It could subside after taking a rest. In the multiple-dose group, no significant changes were found in the vital signs and the lab examinations 4 d, 8 d, 12 d, 15 d after the first dosing. Rash occurred in 2 volunteers, being considered potentially related to the drug and disappearing in one week. Conclusions Xuesaitong is safe at a dose of 100 - 600 mg in a single administration or at a dose of 400 mg once day for 14 days for male or female Chinese volunteers, 400 mg being suggested for the clinical use. However, Further studies are needed to evaluate the safety of xuesaitong in the target population and allergic reaction should be observed.
出处
《中药新药与临床药理》
CAS
CSCD
2005年第5期380-382,共3页
Traditional Chinese Drug Research and Clinical Pharmacology
