国产厄贝沙坦片治疗原发性高血压的随机双盲临床试验

A Randomized, Double-blind Trials of Irbesartan in The Treatment of Essential Hypertension

目的 观察国产厄贝沙坦片治疗轻、中度原发性高血压的疗效和不良反应。方法 采用双盲、双模拟、前瞻性平行试验设计 ,对照药为赖诺普利片。入选者 4 0例经 2周的安慰剂治疗后 ,分别给予厄贝沙坦 1～ 3片 (75～ 2 2 5mg)和赖诺普利安慰剂 1～ 3片或赖诺普利 1～ 3片 (10～ 30mg)和厄贝沙坦安慰剂 1～ 3片 ,均为 1次 /日、口服 ,疗程8周。治疗前后检查 :血尿常规、肝肾功能、血电解质和血脂 ,心电图。结果 两组用药前血压和心率组间比较无差异。用药后组内比较 ,2周时血压均已明显下降 ,至第 8周仍呈继续下降趋势 ,厄贝沙坦组由 (15 4 .8± 9.5 / 10 1.3± 3.8)mmHg下降至 (135 .7± 9.8/ 86 .6± 5 .6 )mmHg ,收缩压 (SBP)和舒张压 (DBP)分别降低 18.1mmHg(11.6 % )和 14 .2mmHg(14 .0 % ) ;赖诺普利组由 (15 5 .6± 11.5 / 10 1.0± 3.5 )mmHg下降至 (139.6± 11.0 / 89.1± 6 .2 )mmHg ,SBP和DBP分别下降 15 .3mmHg(9.7% )和 13.0mmHg(12 .8% )。两药降压的总有效率分别为 83.3%和 70 6 % ,无显著差异。两组用药后心率均无明显减慢 ,实验室检查无异常改变。不良反应情况 :厄贝沙坦组心悸 1例、味觉改变 1例 ,总发生率 11.1%。赖诺普利组咳嗽 5例 (2 7.8% ) ,咽痒、头晕各 1例 ,总发生率为 38.9%。?

Aim\ To investigate the effect of irbesartan on mild\|to\|moderate essential hypertension.\ Method\ A prospective, randomized and double\|blind trial was performed in 40 patients with hypertension assigned to irbesartan group(group Ⅰ) or lisinopril group(group C).\ Group I received oral irbesartan tablets (75～225 mg/d)and group C received lisinopril tablets(10～30 mg/d)for 8 weeks.\ Results\ There were no difference in BP and HR between the 2 groups before treatment.\ BP decreased significantly 2 weeks after administration in both groups and continued to decrease till the end of experiment.\ There was little changes in HR.\ There were no significant changes in blood and urine routine examination, liver and renal functions, serum K\++?Na\++?Cl\++ and lipids and electrocardiogram records.\ The incidence of adverse effects (palpitation in 1 case, changes of taste in 1 case)in group I was 11.1%, lower than that of group C (38.9%, cough in 5 cases, discomfort of throat in 1 case and dizziness in 1 case).\ Conclusion\ Irbesartan has a stable hypotensive effect with good compliance ,though slight adverse reactions were observed.