盐酸去甲乌药碱在健康人体的耐受性

Tolerability of higenamine hydrochloride in healthy volunteers

目的研究盐酸去甲乌药碱(防治心绞痛药)注射液在健康人体的耐受性。方法健康志愿者32名,分A、B、C、D4组,按0.5,1.0,2.0,4.0μg.kg-1.min-1静脉持续给药6min。分别测定给药前、后受试者的心率、血压、心电图(ECG),记录不良事件。结果盐酸去甲乌药碱可使心率加快,增加幅度4组分别为(8.3±7.0),(19.5±14.2),(38.5±6.5),(51.3±12.2)times.min-1,C组可达有效剂量;小剂量对心电图影响不大;本品可使收缩压略升,舒张压略降;对神经系统及消化道的影响较小;停药后,作用消失较快。结论本品可使心率加快,不良反应轻,耐受性良好。

Objective To investigate the tolerability of higenamine hydrochlofide （HG） in healthy volunteers. Methods Thirty -two volunteers were divided into four groups, group A, B, C and D . HG was infused intravenously in escalating doses from 0.5 μg·kg^-1·min^-1 through 1.0, 2.0 to 4.0 μg·kg^-1·min^-1, each dose being given for 6 minute. Two volunteers in each group were given 0.9% NaCl as placebo, and the others were given HG. Heart rate （HR）, blood pressure （BP） and electrocardiograph （ECG） were monitored during the test. All undesirable effects related to the administration of the agent were recorded, tolerability and safety were observed. Results The HR were increased in dose - dependent after intravenous administration of HG . HG did not cause significant change in systolic blood pressure, but a slight decrease in diastolic blood pressure was found. No significant ECG abnormality was seen except a short time of the T wave reduced in group C and D＇s volunteers. The adverse drug reaction of HG was a few occasional dizzy. Conclusion HG can show a marked increase of HR at the dosage of 2.0 and 4.0 μg·kg^-1·min^-1. It can be used in pharmacological stress test with remarkable tolerability and safety even at the dosage of 4.0μg·kg^-1·min^-1（ group D） without serious undesirable effects .