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

Efficacy and safety of lrbesartan in Chinese patients with mild to moderate essential hypertension

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。

Objective To assess the efficacy and safety of Irbesartan in Chinese patients with mild to moderate essential hypertension. Methods A multicenter, open-label, uncontrolled, prospective study was conducted in Chinese patients with mild to moderate essential hypertension Eseated 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 period 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. Conclusion 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）