国产与进口硝苯地平控释片治疗高血压病疗效比较  

Domestic and imported nifedipine controlled release tablets in treatment of essential hypertention

作　　者：朱福[1] 朱旭婷[1] 胡珺[1] 胡春燕[2] 黄波[2] 唐志红 蒋庆渊[2] 

机构地区：[1]上海市徐汇区中心医院老年科,上海200031 [2]上海市南汇区中心医院心内科,上海201300 [3]上海市南汇区南华医院心内科,上海201300

出　　处：《中国临床药学杂志》2008年第5期289-292,共4页Chinese Journal of Clinical Pharmacy

摘　　要：目的评价国产硝苯地平控释片治疗高血压病(EH)的临床疗效和不良反应。方法采用随机对照研究,将120例EH患者分为试验组60例给予国产硝苯地平控释片,对照组60例服用进口硝苯地平控释片,2组用药剂量均30～60 mg,qd×8 wk。治疗前后行人工血压测定、24 h动态血压测定(ABPM)、血生化、血常规、尿常规检验、测ECG并计算其谷峰比值和平滑指数。结果国产与进口硝苯地平控释片总有效率分别为95%和97%,显效率为78%和82%,2组比较差异无统计学意义(P>0.05)。2组服药前、服药8 wk后的24 h、白昼和夜间的平均SBP、DBP明显下降,有高度统计学意义(P<0.01)。国产组SBP和DBP的谷峰比值分别为71.2%和69.2%,而进口组分别为72.5%和68.2%。国产组SBP和DBP的平滑指数分别为4.06和2.31,而进口组分别为4.13和2.42。2组不良反应均轻微,不良反应发生率分别为13.3%和11.7%,撤药率分别为1.7%和3.3%(P>0.05)。结论国产与进口硝苯地平控释片治疗EH疗效、安全性相仿,而且耐受性良好。AIM To evaluate the clinical efficacy and adverse drug reactions of domestic nifedipine controlled release tablets in treatment of essential hypertention（EH）. METHODS One hundred and twenty patients with EH were included. Sixty patients were treated with domestic nifedipine controlled release tablets（ test group）, 30 - 60 mg·d^-1 for 8 weeks and another sixty patients were treated with imported nifedipine controlled release tablets（ control group） 30- 60 mg·d^-1 for 8 weeks. AJnbulatory blood pressure monitoring for 24 h, blood and urine routine examination, blot biochemical testing and ECG were examined before and after treatment. Trough/peak and smooth indexes were analyzed after treatment. RESULTS The total effective rote of test group was 95 %, remarkable effective rate of test group was 78 % ; while those of control group were 97% and 82 % respectively. There was no significant difference between two groups （P 〉 0.05）. Blood and urine routine examination, hepatic and renal function, blood lipids, blood glucose were unchanged before and after treatments. At the end of the 8th week, the mean SBP/DBP of 24 h, day-time and night-time in each group was decreased significantly（ P 〈 0.01）. The trough/peak ratio of SBP and DBP in test group was 71.2% and 69.2% respectively, meanwhile that in control group was 72.5% and 68.2% respectively. The smooth index of SBP and DBP in test group was 4.06 and 2.31 respectively, meanwhile that in control group was 4.13 and 2.42 respectively. The adverse drug reaction rates in test and control groups were 13.3 % and 11.7 % respectively（ P 〉 0.05）and the withdrawal rates were 1.7 % and 3.3 % respectively（ P 〉 0. 05）. CONCLUSION Domestic nifedipine controlled release tablets as well as imported nifedipine controlled release tablets are effective, safe and well tolerated in mild to moderate hypertensive patients.

关 键 词：硝苯地平控释片 高血压病 药物评价 

分 类 号：R544.1[医药卫生—心血管疾病] R749.3[医药卫生—内科学]