【摘要】 目的评价伊贝沙坦治疗中国人轻中度原发性高血压的疗效和安全性。方法多中心开放设计。入选18～70岁已明确诊断为轻中度原发性高血压、坐位舒张压90～109 mm Hg(1 mm Hg=0．133 kPa)、坐位收缩压＜180mm Hg的中国患者。所有入选者应用伊贝沙坦单药治疗8周。初始剂量为150mg/d,在第4周末时血压未达有效标准者,将伊贝沙坦剂量增至300 mg/d。结果共69个中心参加试验,总研究病例974例,完成所有随访计划者共937例。采用完成治疗分析(per protocol,PP)和意向治疗分析(intention—to-treat,ITT),伊贝沙坦8周治疗达标率分别为74．81%和73．51%,总有效率分别为90．07%和88．91%。研究中不良事件的发生率为1 7．15%,未发现严重不良事件。结论在本研究的中国人群中,伊贝沙坦150～300 mg/d治疗轻中度原发性高血压,降压疗效确切,不良反应少。更多还原

【Abstract】 Objective To assess the efficacy and safety of Irbesartan in Chinese patients with mild to moder- ate essential hypertension.Methods A multicenter,open-label,uncontrolled,prospective study was conducted in Chinese patients with mild to moderate essential hypertension[seated diastolic BP(DBP)90-109 mm Hg(1 mm Hg=0.133 kPa)and systolic BP (SBP)＜180 mm Hg].Patients younger than 18 years of age or older than 70 years of age were excluded.All patients were treated with Irbesartan alone for 8 weeks,and the starting dose was 150 mg once a day individually.After 4 weeks treatment,the dose should be doubled(300 mg,qd)if the initial dose was ineffective.Results The trial enrolled 974 patients from 69 medical centers in China.Among them,937 patients completed 8-week treatment period.Per-protocol(PP)analysis and intention-to-treat(ITT)analysis were both performed.In PP analysis,74.81% of the patients achieved the treatment goal at the end of the follow-up pe- riod and the total effective rate was 90.07 %.In ITT analysis,73.51% arrived at the treatment goal and the total effective rate was 88.91%.The overall incidence of adverse events was 17.15% including no serious one.Conclu- sion Irbesartan 150 to 300 mg/d is effective and safe in treatment of mild to moderate essential hypertension. (Shanghai Med J,2006,29:610-613)更多还原