摘要
目的 :评价国产厄贝沙坦对轻、中度原发性高血压病人的降压疗效和安全性。方法 :多中心、随机、双盲、双模拟设计。轻、中度原发性高血压病人 2 16例 ,经 2wk安慰剂导入期后 ,分成 2组 ,分别服厄贝沙坦 15 0mg加氯沙坦模拟药片 1片或氯沙坦 5 0mg加厄贝沙坦模拟药片 2片 ,qd。 4wk后如血压≥ 18.7/12kPa则将剂量加倍 ,共 8wk。另有 2 0例病人开放服厄贝沙坦。结果 :治疗 8wk后 ,厄贝沙坦组和氯沙坦组总有效率为 81.9%和77.0 %。收缩压下降 (2 .9±s 1.9)kPa和 (2 .6±2 .0 )kPa ,舒张压下降 (1.8± 1.1)kPa和 (1.8± 1.2 )kPa ,治疗前后差异均有非常显著意义 (P <0 .0 1) ,组间比较差异无显著意义 (P >0 .0 5 ) ;不良反应 2组分别为 8.7%和 8.9% ,无一例停药 ;开放组 2 4h动态血压监测T/P比值SBP 6 2 % ,DBP 5 6 %。结论
AIM:To evaluate the antihypertensive effects and safety of irbesartan in treating mild to moderate essential hypertension. METHODS: A multiple-center, randomized, double blind, double simulated study was designed. Two hundreds and sixteen patients with mild to moderate essential hypertension were randomly divided into two groups. All patients received irbesartan 150 mg, qd+ 1 losartan simulated tablet, qd (n=104) or losartan 50 mg, qd+ 2 irbesartan simulated tablet, qd (n=112) after taking 2 wk placebo. The dosage could be increased to either irbesartan 300 mg, qd or losartan 100 mg,qd for 8 wk if the blood pressure was above 18.7/12 kPa after 4 wk administration. The other twenty patients took irbesartan openly. RESULTS: After 8 wk treatment, there was no significant difference in the effective rate between the groups of irbesartan and losartan ( 81.9 % vs 77.0 %, P>0.05). The SBP was descended (2.9± 1.9)kPa and (2.6±2.0)kPa and the DBP was descended ( 1.8±1.1)kPa and ( 1.8±1.2)kPa, respectively. There was significant difference before and after treatment (P<0.01). The adverse reactions occurred respectively 8.7 % and 8.9 % with no patient discontinued. Twenty-four hours blood pressure monitoring was measured in the opening groups with irbesartan and the T/P ratio were: SBP 62 % and DBP 56 %. CONCLUSION: Irbesartan is a long-term effective antihypertensive drug with less adverse reactions.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2002年第11期645-648,共4页
Chinese Journal of New Drugs and Clinical Remedies
