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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 evaluate the tolerance and safety of Osborn injection in healthy human. Methods: Forty subjects were randomly divided into a single administration group and a continuous administration group. In the single administration group, 30, 60, 100, 150, 200 and 250 mg of oseltam was injected intravenously. 200 mg.d-1 dose of continuous medication for 7 days; observed adverse drug reactions, laboratory tests, ECG and vital signs. Results: In a single dose of 30 ~ 250 mg and 200 mg.d-1 for 7 days of continuous dose of the observed dose, Oshaun injection can cause transient drop in blood pressure, and other vital signs and liver and kidney function are not Significant effects; The main adverse reactions are flushed, dizziness, nausea, sweating, etc., some individuals have body temperature, palpitation, abdominal pain and so on. Conclusion: Olson injection is well tolerated and safe in the observed dose range.