Renoprotection of Optimal Antiproteinuric Doses (ROAD) study: A Randomized controlled study of benazepril and losartan in chronic renal insufficiency
Renoprotection of Optimal Antiproteinuric Doses (ROAD) study: A Randomized controlled study of benazepril and losartan in chronic renal insufficiency
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DOI：
10.1681/asn.2006121372
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发表时间：
2007-06-01
影响因子：
13.6
通讯作者：
Jiang, Jian Ping
中科院分区：
文献类型：
--
作者：
Hou, Fan Fan;Xie, Di;Jiang, Jian Ping
进行了最佳抗蛋白尿剂量的肾保护（ROAD）研究，以确定是否滴定贝那普利或氯沙坦至最佳抗蛋白尿剂量可以安全地改善慢性肾功能不全的肾脏结局。共有360例无糖尿病、有蛋白尿和慢性肾功能不全的患者被随机分为四组。患者接受开放标签治疗，包括常规剂量的贝那普利（10 mg/d）、个体剂量上调的贝那普利（中位数20 mg/d;范围10 - 40）、常规剂量的氯沙坦（50 mg/d）或个体剂量上调的氯沙坦（中位数100 mg/d;范围50 - 200）。将剂量上调至最佳抗蛋白尿和耐受剂量，然后维持这些剂量。中位随访时间为3.7年。主要终点是至血清肌酐加倍、终末期肾病或死亡的复合终点的时间。次要终点包括蛋白尿水平和肾脏疾病进展率的变化。与常规剂量相比，通过上调剂量达到的苯那普利和氯沙坦的最佳抗蛋白尿剂量与主要终点风险降低51%和53%相关（P分别为0.028和0.022）。在血压控制相当的情况下，最佳抗蛋白尿剂量的苯那普利和氯沙坦与其常规剂量相比，在蛋白尿和肾功能下降率方面都取得了更大的减少。在常规剂量组和最佳剂量组之间，主要不良事件的总体发生率无显著差异。可以得出结论，上调苯那普利或氯沙坦对蛋白尿的剂量可进一步改善未患糖尿病但有蛋白尿和肾功能不全的患者的肾脏结局。
The Renoprotection of Optimal Antiproteinuric Doses (ROAD) study was performed to determine whether titration of benazepril or losartan to optimal antiproteinuric doses would safely improve the renal outcome in chronic renal insufficiency. A total of 360 patients who did not have diabetes and had proteinuria and chronic renal insufficiency were randomly assigned to four groups. Patients received open-label treatment with a conventional dosage of benazepril (10 mg/d), individual uptitration of benazepril (median 20 mg/d; range 10 to 40), a conventional dosage of losartan (50 mg/d), or individual uptitration of losartan (median 100 mg/d; range 50 to 200). Uptitration was performed to optimal antiproteinuric and tolerated dosages, and then these dosages were maintained. Median follow-up was 3.7 yr. The primary end point was time to the composite of a doubling of the serum creatinine, ESRD, or death. Secondary end points included changes in the level of proteinuria and the rate of progression of renal disease. Compared with the conventional dosages, optimal antiproteinuric dosages of benazepril and losartan that were achieved through uptitration were associated with a 51 and 53% reduction in the risk for the primary end point (P = 0.028 and 0.022, respectively). Optimal antiproteinuric dosages of benazepril and losartan, at comparable BP control, achieved a greater reduction in both proteinuria and the rate of decline in renal function compared with their conventional dosages. There was no significant difference for the overall incidence of major adverse events between groups that were given conventional and optimal dosages in both arms. It is concluded that uptitration of benazepril or losartan against proteinuria conferred further benefit on renal outcome in patients who did not have diabetes and had proteinuria and renal insufficiency.