厄贝沙坦治疗2型糖尿病伴白蛋白尿患者有效性和安全性——多中心随机双盲对照研究

Efficacy and safety of irbesartan in the treatment of type 2 diabetes mellitus with aibuminuria： a multicentre, double-blind, parallel controlled, randomized clinical trial

目的 评估厄贝沙坦治疗2型糖尿病伴白蛋白尿患者的疗效与安全性。方法采用随机、双盲、安慰剂对照、多中心临床研究方法，8个医院326例受试者随机分配到厄贝沙坦（300mg／d）组（160例）或安慰剂组（166例），治疗24周。检测尿白蛋白排泄率（UAER）、收缩压、舒张压、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇（LDL-C）和HbA1C水平。结果厄贝沙坦组UAER与基线相比显著下降（P〈0．01），安慰剂组无明显变化（P〉0．05），两组差异有统计学意义（P〈0．01）。在意向治疗（ITT）人群高血压和非高血压患者的收缩压、舒张压均有不同程度下降（P〈0．01），而在符合方案（PP）人群却无明显下降。治疗24周后，厄贝沙坦组的LDL—C水平明显低于安慰剂组（P〈0．01）。治疗期间厄贝沙坦组低血压的发生率高于安慰剂组，个别患者出现血钾升高。结论厄贝沙坦300mg／d可以有效降低2型糖尿病伴白蛋白尿患者的UAER，其疗效独立于降血压作用之外，并且具有良好的安全性和耐受性。

Objective To evaluate the efficacy and safety of irbesartan in the treatment of type 2 diabetic patients with albuminuria. Methods A multi-centre, double-blind, parallel controlled and randomized trial was conducted in 326 patients with or without hypertension in 8 hospitals, 166 patients were treated with irbesartan 300 mg/d for 24 weeks and the other 160 patients were given placebo as control. Urinary albumin excretion rate （UAER）, systolic blood pressure （SBP）, diastolic blood pressure （DBP）, triglyceride, high density lipoproteincholesterol, low density lipoprotein-cholesterol （LDL-C） and HbA1C were measured. Results After treatment for 24 weeks, UAER in irbesartan group significantly decreased from baseline （P 〈 0.01 ）. No significant reduction in UAER was observed in placebo group （P 〉 0.05）. There was significantly difference in UAER between irbesartan group and placebo group （ P 〈 0.01 ）. Both SBP and DBP decreased significantly in intention to treat （ITT） patients with or without hypertension （P 〈 0.05 ）, while no significant reduction was observed in pre protocol （PP） patients （ P 〉 0.05 ）. LDL-C in irbesartan group was significantly decreased as compared with placebo group （ P 〈 0.01 ）. The incidence of hypotension in irbesartan group was higher than that in placebo group. Very few patients in irbesartan group showed hyperkalemia. Conclusion Irbesartan （300 mg/d） is effective, safe and welltolerated in the management of patients with type 2 diabetes mellitus with albuminuria. The effect of irbesartan on reducing UAER is independent of blood pressure reduction.