摘要
Abstract
Objective To assess the safety and tolerance of single -dose and multiple-dose intravenous drip of Shenqifuzheng saline injections in Chinese volunteers , thus to establish the safe clinical dosage.Methods Twenty-two healthy volunteers were randomly divided into 5 single-dose groups ( 125 , 250 , 410 , 625 and 700 mL ) and twelve volunteers were randomized into 2 multiple -dose groups ( six for 625 mL, six for 750 mL, qd ×7 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 , electrocardiogram were monitored after medication.Results There were no abnormal findings in the vital signs , subjective symptoms , objective signs , electrocardiograph and no significant changes were found in the lab examinations .There were 5 subjects with prothrombin time ( PT ) slightly prolonged and 7 subjects with activation of prothrombin time ( APTT ) prolonged among single -dose groups.5 subjects with PT prolonged and 2 subjects with partial APTT prolonged among multiple -dose groups.Creatine kinase rising in one volunteer of the 625 mL single-dose group had no association with the Shenqifuzheng injection.It could subside after taking a one -week rest .Conclusion Shenqifuzheng saline injections is safe at a dose of 125-750 mL in a single administration or at a dose of 750 mL once daily for 7 days in Chinese volunteers.关键词
参芪扶正注射液/Ⅰ期临床试验/安全性/耐受性Key words
Shenqifuzheng saline injection/phase I clinical trial/safety/drug tolerance分类
医药卫生
