Strippoli Giovanni F M, Craig Maria, Deeks Jonathan J, Schena Francesco Paolo, Craig Jonathan C
NHMRC Centre for Clinical Research Excellence in Renal Medicine, Cochrane Renal Group, Children's Hospital at Westmead, Westmead, NSW 2145, Australia.
BMJ. 2004 Oct 9;329(7470):828. doi: 10.1136/bmj.38237.585000.7C. Epub 2004 Sep 30.
To evaluate the effects of angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists (AIIRAs) on renal outcomes and all cause mortality in patients with diabetic nephropathy.
Medline, Embase, the Cochrane controlled trials register, conference proceedings, and contact with investigators.
Trials comparing ACE inhibitors or AIIRAs with placebo or with each other in patients with diabetic nephropathy.
Mortality, renal outcomes (end stage renal disease, doubling of serum creatinine concentration, prevention of progression of microalbuminuria to macroalbuminuria, remission of microalbuminuria), and quality of trials.
36 of 43 identified trials compared ACE inhibitors with placebo (4008 patients), four compared AIIRAs with placebo (3331 patients), and three compared ACE inhibitors with AIIRAs (206 patients). We obtained unpublished data for 11 trials. ACE inhibitors significantly reduced all cause mortality (relative risk 0.79, 95% confidence interval 0.63 to 0.99) compared with placebo but AIIRAs did not (0.99, 0.85 to 1.17), although baseline mortality was similar in the trials. Both agents had similar effects on renal outcomes. Reliable estimates of the unconfounded relative effects of ACE inhibitors compared with AIIRAs could not be obtained owing to small sample sizes.
Although the survival benefits of ACE inhibitors for patients with diabetic nephropathy are known, the relative effects of ACE inhibitors and AIIRAs on survival are unknown owing to the lack of adequate head to head trials.
评估血管紧张素转换酶(ACE)抑制剂和血管紧张素II受体拮抗剂(AIIRA)对糖尿病肾病患者肾脏结局和全因死亡率的影响。
医学索引数据库(Medline)、荷兰医学文摘数据库(Embase)、Cochrane对照试验注册库、会议论文集,并与研究者联系。
在糖尿病肾病患者中比较ACE抑制剂或AIIRA与安慰剂或相互比较的试验。
死亡率、肾脏结局(终末期肾病、血清肌酐浓度翻倍、预防微量白蛋白尿进展为大量白蛋白尿、微量白蛋白尿缓解)以及试验质量。
在43项已识别的试验中,36项比较了ACE抑制剂与安慰剂(4008例患者),4项比较了AIIRA与安慰剂(3331例患者),3项比较了ACE抑制剂与AIIRA(206例患者)。我们获得了11项试验的未发表数据。与安慰剂相比,ACE抑制剂显著降低了全因死亡率(相对风险0.79,95%置信区间0.63至0.99),但AIIRA没有(0.99,0.85至1.17),尽管试验中的基线死亡率相似。两种药物对肾脏结局的影响相似。由于样本量小,无法获得ACE抑制剂与AIIRA无混杂相对效应的可靠估计值。
虽然ACE抑制剂对糖尿病肾病患者的生存益处是已知的,但由于缺乏足够的直接对比试验,ACE抑制剂和AIIRA对生存的相对效应尚不清楚。