探讨健康志愿者多次口服复方尼群地平片的耐受性  

Research on tolerance of compound nitrendipine tablets in healthy volunteers after successive oral administration

作　　者：张瑾[1] 陈绍行[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]上海交通大学医学院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,南京210029

出　　处：《中国临床药学杂志》2008年第1期28-31,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的探讨健康志愿者多次口服复方尼群地平片的安全性及安全、有效的临床用药方案。方法9名健康志愿者连续口服复方尼群地平片(每片含尼群地平5 mg和阿替洛尔10 mg)4片,qd×7 d。观察BP,HR,ECG,血、尿常规,肝、肾功能等实验室指标及不良事件。结果多次服药后9名健康志愿者的血压均有所下降,心率也减慢;实验室检查与给药前相比差异无统计学意义(P>0.05).未出现严重不良事件。结论健康志愿者对复方尼群地平片多次给药有很好的耐受性,服药前及服药过程中应做ECG监测。AIM To explore safe and effective dosage in clinical practice through discussing the safety of compound nitrendipine tablet for healthy volunteers. METHODS After seven-days successive administration （a compound nitrendipine tablet = nitrendipine 5 mg ＋ atenolol 10 mg;4 tablets,qd × 7 d ） 9 healthy volunteers were observed. The observation items included BP, HR and electrocardiogram, blood and urine routine examination, liver and renal function and adverse drag reaction. RESULTS Their BP and HR were decreased. There was not any difference in the laboratory results between before and after administration（ P 〉 0.05）, and there was not any severe adverse drug event. CONCLUSION Healthy volunteers show good tolerance after taking multiple dose of compound nitrendipine tablet. HR should be monitored by electrocardiogram.

关 键 词：复方尼群地平片 耐受性试验 健康志愿者 安全性 

分 类 号：R96[医药卫生—药理学]