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血管紧张素II受体拮抗剂氯沙坦对日本高血压患者的临床疗效及耐受性

The clinical efficacy and tolerability of the angiotensin II-receptor antagonist losartan in Japanese patients with hypertension.

作者信息

Ogihara T, Yoshinaga K

机构信息

Department of Geriatric Medicine, Osaka University Medical School, Japan.

出版信息

Blood Press Suppl. 1996;2:78-81.

PMID:8913545
Abstract

The clinical efficacy and tolerability of losartan were studied in clinical trials in Japanese patients with essential hypertension. In a short-term trial, losartan (25 to 100 mg once daily) provided good control of blood pressure for 24 h without affecting the patient's own diurnal blood pressure profile. In a double-blind study, the efficacy and tolerability of losartan (25 to 50 mg once daily) were compared to enalapril (5 to 10 mg) in Japanese patients with mild to moderate essential hypertension. Losartan, 25 to 50 mg given once daily, produced an antihypertensive effect comparable to enalapril, 5 to 10 mg, in these patients. The incidence of adverse reactions in the losartan group was 9.0% (13/144), which was lower than that observed in the enalapril group, 20.3% (29/143). The incidence of cough in the losartan group (0.7%) was lower than that of the enalapril group (13.3%). No discontinuation due to cough was observed in the losartan group: however, seven patients were discontinued from the enalapril group. Losartan exhibited antihypertensive efficacy comparable to enalapril and a tolerability profile superior to enalapril in this study. The efficacy and tolerability of losartan were also investigated in 29 hypertensive patients with renal impairment. When losartan (25 to 100 mg) once daily was used, blood pressure was controlled in 62.1% (18/29) of patients. The rate of cases assessed as "useful" was 58.3% when the pretreatment serum creatinine level was less than 3.0 mg/dL. No cases, however, were assessed as "useful" in patients in which the level was 3.0 mg/dL or higher. In a trial with hypertensive diabetic patients, losartan did not adversely affect glucose tolerance and lipid metabolism. Losartan was associated with a decreased total cholesterol (p < 0.01) and LDL cholesterol (p < 0.01) without significantly changing HDL cholesterol in patients with total serum cholesterol of > 220 mg/dL. In summary, losartan, the first angiotensin II antagonist, is an effective antihypertensive agent with an excellent tolerability profile.

摘要

在日本原发性高血压患者的临床试验中研究了氯沙坦的临床疗效和耐受性。在一项短期试验中,氯沙坦(每日一次,25至100毫克)可在24小时内有效控制血压,且不影响患者自身的血压昼夜变化规律。在一项双盲研究中,将氯沙坦(每日一次,25至50毫克)与依那普利(5至10毫克)在日本轻至中度原发性高血压患者中的疗效和耐受性进行了比较。在这些患者中,每日一次给予25至50毫克氯沙坦产生的降压效果与5至10毫克依那普利相当。氯沙坦组的不良反应发生率为9.0%(13/144),低于依那普利组的20.3%(29/143)。氯沙坦组咳嗽的发生率(0.7%)低于依那普利组(13.3%)。氯沙坦组未观察到因咳嗽而停药的情况;然而,依那普利组有7名患者停药。在本研究中,氯沙坦显示出与依那普利相当的降压疗效,且耐受性优于依那普利。还对29例肾功能损害的高血压患者研究了氯沙坦的疗效和耐受性。当每日一次使用氯沙坦(25至100毫克)时,62.1%(18/29)的患者血压得到控制。当治疗前血清肌酐水平低于3.0毫克/分升时,评定为“有效”的病例率为58.3%。然而,在血清肌酐水平为3.0毫克/分升或更高的患者中,没有病例被评定为“有效”。在一项高血压糖尿病患者试验中,氯沙坦对葡萄糖耐量和脂质代谢没有不利影响。在总血清胆固醇>220毫克/分升的患者中,氯沙坦与总胆固醇降低(p<0.01)和低密度脂蛋白胆固醇降低(p<0.01)相关,而高密度脂蛋白胆固醇没有显著变化。总之,首个血管紧张素II拮抗剂氯沙坦是一种有效的抗高血压药物,具有出色的耐受性。

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