贝尼地平治疗原发性高血压的疗效与安全性研究  

Study of the Anti-Hypertensive Efficacy and Safety of Benidipine in Patients with Essential Hypertension

作　　者：李新芳[1] 柯元南[2] 姜红[2] 魏嘉平[3] 李耘[3] 吴树燕[4] 苏加林[4] 郭静萱[5] 李昭屏[5] 

机构地区：[1]中国人民解放军白求恩国际和平医院国家药品临床研究基地,河北石家庄050082 [2]中日友好医院心血管内科,北京110001 [3]首都医科大学宣武医院心血管内科,北京100053 [4]北京大学第一医院心血管内科,北京110016 [5]北京大学第三医院心血管内科,北京110016

出　　处：《解放军药学学报》2005年第6期429-432,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的评价国产贝尼地平的降压效应及安全性。方法本试验为多中心、随机、双盲、对照研究。201例原发性高血压病人随机分配到贝尼地平组(n=99)和拉西地平组(n=102),第1周口服贝尼地平2mg或拉西地平4mg,4周后舒张压>85mmHg者,贝尼地平增加到4mg、拉西地平增加到8mg,8周为一疗程。结果贝尼地平组服药8周后SBP和DBP下降(15.51±17.19)和(11.82±9.84)mmHg(P<0.01),拉西地平组SBP和DBP下降(19.26±15.85)和(13.51±7.26)mmHg(P<0.01);试验组和对照组总有效率分别为74.7%和78.4%(P>0.05)。服药8周有效的36例患者继续服药到24周,仍维持88.9%的总有效率。对12例服贝尼地平患者作动态血压资料分析,24h、白天和夜间平均收缩压/舒张压均显著下降,收缩压和舒张压的谷峰比值分别为78%和80%。2药的不良反应轻微,发生率分别为10.80%、11.5%(P>0.05)。结论贝尼地平是一种安全有效的抗高血压药。Aim To assess the efficacy and safety of benidipine on patients with essential hypertension compared with lacidipine. Methods The test was a multicenter randomized, double-blind, actively controlled clinical trial. All the 201 patients volunteers with essential hypertension were selected and randomly double-blind divided into benidipine （ n = 99） and lacidipine（ n = 102） groups, each of which, respectively, received a single oral dose of benidipine 2mg or lacidipine 4mg, Qd, for eight weeks. The dosage titrated to benidipine 4mg Qd or lacidipine 8mg Qd if the setting DBP exceeded 85mmHg at the end of the fourth week. Results In patients who were administrated with benidipine for eight weeks, the systolic blood pressure（SBP） and diastolic blood pressure（SBP） depressed （15.51 ±17.19）mmHg and 11.82 ±9. 84mmHg（ P 〈 0.01 ）, and in patients who administrated lacidipine, SBPand DBP depressed by （ 19.26± 15.85） mmHg and （ 13.51 ± 7.26）mmHg（ P 〈 0.01 ） ; The total response rate was 74.7% for benidipine and 78.4% for lacidipine （ P 〉 0.05）. After 8 weeks of treatment with benidipine, the 36 patients who reached the target blood pressrue stayed on the treatment with the same dosage for 16 weeks, and their total response rate still was 88.9%. ABPM for 12 patients administrated benidipine showed that benidipine reduced the average blood pressure （24h, day, night） and the mean troughto-peak ratio was 78% for SBP and 80% for DBP.The adverse drug reactions of both groups were mild,making up 10. 8 % and 11.5 % （ P 〉 0.05） respectively. Conclusion These results suggest that benidipine is a safe and effective antihypertension drug.

关 键 词：贝尼地平 拉西地平 原发性高血压 随机双盲对照研究 

分 类 号：R972.4[医药卫生—药品]