单次口服复方尼群地平片在健康人体的耐受性  

Toleration of compound nitrendipine tablets in healthy volunteers after a single oral administration

作　　者：陈绍行[1] 张瑾[1] 胡亚蓉[1] 杜月凌[1] 魏福荣[2] 张宏业[2] 朱鼎良[1] 

机构地区：[1]上海第二医科大学附属瑞金医院高血压科,上海200025 [2]江苏吉贝尔药业有限公司,江苏南京210029

出　　处：《中国临床药理学杂志》2006年第3期176-179,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价健康志愿者单次口服复方尼群地平片(抗高血压药)的耐受性。方法 40名健康志愿者随机分为5组,每组分别单次口服复方尼群地平0．2,1,2,3,及4片。观察服药前后,各组的血压、心率、临床症状、心电图和实验室指标变化。结果单次口服复方尼群地平片后,平均坐位收缩压和舒张压均下降(P<0．05),降压作用1 h起效,且可维持6～8 h(除0．2片组);服药后,降压幅度各组比较无显著性差异(P>0．05);平均坐位心率减慢(P<0．05),以服4片组心率减慢最明显;服药后,平均坐位心率下降幅度各组比较有显著性差异(P<0．05);未发生体位性低血压、不能耐受药物不良反应及实验室指标异常。结论健康志愿者对复方尼群地平片能较好耐受。Objective To assess the toleration of compound nitrendipine tablet in healthy volunteers after a single oral taking. Methods Forty volunteers were enrolled and randomly divided into 5 groups （8 subjects in each group） , including 0.2,1,2, 3 and 4 tablets of compound nitrendipine tablet. The charges of blood pressure, heart rate, clinical symptoms, electrocardiography and laboratory test were observed before and after dosing. Results There were decreased significantly on the mean seated systolic and diastolic blood pressure as well as on the mean seated heart rate after single oral taking 0.2,1,2,3 and 4 tablets of compound nitredipine;the antihypertensive effect was occurred 1 hour and sustained over 6 - 8 hours after dosing （ expect the group of 0.2 tablet）. The changes of blood pressure and heart rate were compared with among the 5 groups, the former was no significant difference, but there was significant difference in the latter（ especially at the group of 4 tablets）. There were no observation on the postural hypotension, the serious adverse reactions and changes of the laboratory examinations. Conclusion The tolerance of compound nitrendipine is good in healthy volunteers.

关 键 词：复方尼群地平 单次服药 耐受性 

分 类 号：R972.4[医药卫生—药品] R965.3[医药卫生—药学]