苯磺酸左旋氨氯地平和氯沙坦治疗140例原发性高血压病人的比较  

Comparison of efficacy and safety of levoamlodipine besylate and losartan in treating 140 patiants with essential hypertension

作　　者：郭冀珍[1] 钱岳晟[1] 陶波[1] 秦永文[2] 王一尘[3] 郑柏生[4] 龚兰生[1] 

机构地区：[1]上海第二医科大学附属瑞金医院上海市高血压研究所,上海200025 [2]上海第二军医大学附属长海医院心内科,上海200433 [3]上海第二医科大学附属新华医院,上海200092 [4]华东医院心内科,上海200040

出　　处：《中国新药与临床杂志》2003年第12期766-769,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :比较国产苯磺酸左旋氨氯地平与氯沙坦对轻、中度原发性高血压病人的降压疗效和安全性。方法 :随机、单盲、多中心、平行对照设计。轻、中度原发性高血压病人 14 0例 ,经 2wk安慰剂导入期后 ,分成治疗组 73例和对照组 6 7例 ,分别服苯磺酸左旋氨氯地平 2 .5mg或氯沙坦 5 0mg ,qd。其中 4 9例新发病人持续服药 8wk ,剂量不变 ;另 91例非新发病人 4wk后如血压≥ 18.7/12kPa则将剂量加倍 ,共 8wk。 2组各有 18和 12例病人做 2 4h动态血压监测。结果 :治疗 8wk后 ,在非新发病例中 ,治疗组和对照组总有效率为 6 9%和 6 9% (P>0 .0 5 ) ;新发病例中 ,治疗组和对照组总有效率为10 0 %和 84 % (P >0 .0 5 )。不良反应 2组分别为2 9 %和 2 1%。结论 :苯磺酸左旋氨氯地平是有效且不良反应少的长效降压药物 ,降压疗效与氯沙坦在统计学上无显著差异。AIM:To compare the antihypertensive efficacy and safety of levoamlodipine besylate and losartan in patiants with mild to moderate essential hypertension. METHODS: A randomized,multi center, paralleled, single blind, controlled trial was designed. One hundred and forty patients with mild to moderate essential hypertension were divided into two groups. Seventy three patients of the treatment group received levoamlodipine besylate 2.5 mg, qd and 67 patients of control group received losartan 50 mg, qd after taking 2 wk placebo. The dosage would be unchanged for 8 wk in 49 patients who were at the first onset, while it could increase to either levoamlodipine besylate 5 mg, qd or losartan 100 mg, qd for 8 wk in the other 91 patients if the blood pressure was above 18.7/12 kPa after 4 wk administration. Twenty four hours blood pressure monitoring was conducted in 30 patients (respectively 18 and 12 in the two groups). RESULTS: After 8 wk treatment, the total effective rate of the treatment group and the control group was 69 %, 69 % ( P >0.05) respectively in the patients who were not at the first onset, while that was 100 %, 84 % ( P >0.05) respectively in the patients who were at the first onset. The adverse reaction rate was 29 % and 21 %, respectively. CONCLUSION: Levoamlodipine besylate is a long term effective antihypertensive drug with less adverse reactions. The antihypertensive effect is similar to losartan in statistics.

关 键 词：高血压 抗高血压药 血压监测 便携式 多中心研究 随机对照试验 苯磺酸左旋氨氯地平 氯沙坦 

分 类 号：R972.4[医药卫生—药品] R544.1[医药卫生—药学]