Strippoli Giovanni F M, Craig Maria C, Schena Francesco P, Craig Jonathan C
National Health and Medical Research Council Centre for Clinical Research Excellence in Renal Medicine, University of Sydney, Australia.
J Am Soc Nephrol. 2006 Apr;17(4 Suppl 2):S153-5. doi: 10.1681/ASN.2005121337.
This study evaluated the comparative effects of antihypertensive agents in patients with diabetes and normoalbuminuria and the evidence supporting equivalent use of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) in patients with diabetes and micro- or macroalbuminuria. A systematic review was conducted by searching for randomized controlled trials (RCT) of antihypertensive agent versus placebo or another agent in hypertensive or normotensive patients with diabetes and no nephropathy and RCT of ACEi or ARB in patients with diabetic nephropathy. Medline, Embase, the Cochrane Controlled Trials Register, conference proceedings, and contact with investigators were used to identify available evidence. Two investigators independently extracted data and assessed quality of trials. Sixteen RCT (7603 patients) of antihypertensive agents conducted in patients with diabetes and no nephropathy and 43 (7739 patients) of ACEi or ARB in patients with diabetic nephropathy were identified. A significant reduction in the risk for developing microalbuminuria in patients who had diabetes with no nephropathy was demonstrated for ACEi only (six trials, 3840 patients; relative risk [RR] 0.60; 95% confidence interval [CI] 0.43 to 0.84), and in patients with diabetic nephropathy, existing RCT have shown a survival benefit of ACEi (20 trials, 2383 patients; RR 0.79; 95% CI 0.63 to 0.99; P = 0.04) but not ARB (four trials, 3329 patients; RR 0.99; 95% CI 0.85 to 1.17). On the basis of available RCT evidence, ACEi are the only agents with proven renal benefit in patients who have diabetes with no nephropathy and the only agents with proven survival benefit in patients who have diabetes with nephropathy.
本研究评估了抗高血压药物对糖尿病伴正常白蛋白尿患者的比较效果,以及支持在糖尿病伴微量或大量白蛋白尿患者中同等使用血管紧张素转换酶抑制剂(ACEi)和血管紧张素受体阻滞剂(ARB)的证据。通过检索高血压或血压正常的糖尿病且无肾病患者中抗高血压药物与安慰剂或其他药物对比的随机对照试验(RCT),以及糖尿病肾病患者中ACEi或ARB的RCT,进行了一项系统评价。使用医学期刊数据库(Medline)、荷兰医学文摘数据库(Embase)、考克兰对照试验注册库、会议论文集,并与研究者联系以识别可用证据。两名研究者独立提取数据并评估试验质量。识别出了16项在糖尿病且无肾病患者中进行的抗高血压药物RCT(7603例患者),以及43项在糖尿病肾病患者中进行的ACEi或ARB的RCT(7739例患者)。仅在使用ACEi的糖尿病无肾病患者中(六项试验,3840例患者;相对危险度[RR] 0.60;95%置信区间[CI] 0.43至0.84),以及糖尿病肾病患者中,现有RCT显示ACEi有生存获益(20项试验,2383例患者;RR 0.79;95% CI 0.63至0.99;P = 0.04),但ARB没有(四项试验,3329例患者;RR 0.99;95% CI 0.85至1.17)。基于现有RCT证据,ACEi是唯一在糖尿病无肾病患者中已证实有肾脏获益的药物,也是唯一在糖尿病肾病患者中已证实有生存获益的药物。