奥沙恩注射液Ⅰ期耐受性临床研究

A phase Ⅰ trial for the tolerability of Aoshaen injection

目的：评价健康人体对奥沙恩注射液的耐受性和安全性。方法：将40例受试者随机分为单次给药组和连续给药组;单次给药组分别单次静脉滴注奥沙恩注射液30,60,100,150,200和250 mg;连续给药组以200 mg·d^-1剂量连续用药7 d;观察药物的不良反应、实验室检查、心电图以及生命体征。结果：在单次服药30-250 mg及200 mg·d^-1连续服药7 d的观察剂量范围内,奥沙恩注射液可引起一过性的血压下降,对其他生命体征和肝肾功能没有明显影响;主要不良反应有面色潮红、头晕、恶心、出汗等,个别有体温升高、心慌、腹痛等。结论：在观察剂量范围内,奥沙恩注射液的耐受性和安全性良好。

Objective： To assess the safety and tolerance of Aoshaen injection in Chinese healthy volunteers. Methods： Healthy volunteers （n = 40） were randomly divided into either single-dose or multiple-doses group. In the single dose group, Aoshaen was intravenously dripped at dose of 30, 60, 100, 150, 200 or 250 mg. In the multiple-dose group, it was intravenously dripped at 200 mg once daily for 7 days. The safety profiles and tolerability were evaluated based on vital signs, routine blood and urine tests, hepatic and renal functions, blood electrolytes, and electrocardiogram and incidence of adverse events. Results： Aoshaen injection induced a temporary drop in blood pressure, but did not induce any significant changes in all laboratory and physical examinations in both groups. Common adverse events included flushing, dizziness, headache, nausea, and sweating; hypertemperature, palpitation, and bellyache were occasionally observed in few subjects. Conclusion： Aoshaen injection shows better safety profile and tolerability in the dosage we observed in this phase Ⅰ trial.