Maschio G, Alberti D, Janin G, Locatelli F, Mann J F, Motolese M, Ponticelli C, Ritz E, Zucchelli P
Divisione di Nefrologia, Ospedale Civile, Verona, Italy.
N Engl J Med. 1996 Apr 11;334(15):939-45. doi: 10.1056/NEJM199604113341502.
Drugs that inhibit angiotensin-converting enzyme slow the progression of renal insufficiency in patients with diabetic neuropathy. Whether these drugs have a similar action in patients with other renal diseases is not known. We conducted a study to determine the effect of the angiotensin-converting-enzyme inhibitor benazepril on the progression of renal insufficiency in patients with various underlying renal diseases.
In a three-year trial involving 583 patients with renal insufficiency caused by various disorders, 300 patients received benazepril and 283 received placebo. The underlying diseases included glomerulopathies (in 192 patients), interstitial nephritis (in 105), nephrosclerosis (in 97), polycystic kidney disease (in 64), diabetic nephropathy (in 21), and miscellaneous or unknown disorders (in 104). The severity of renal insufficiency was classified according to the base-line creatinine clearance: 227 patients had mild insufficiency (creatinine clearance, 46 TO 60 ml per minute), and 356 had moderate insufficiency (creatinine clearance, 30 to 45 ml per minute). The primary end point was a doubling of the base-line serum creatine concentration or the need for dialysis.
At three years. 31 patients in the benazepril group and 57 in the placebo group had reached the primary end point (P<0.001). In the benazepril group, the reduction in the risk of reaching the end point was 53 percent overall (95 percent confidence interval, 27 to 70 percent), 71 percent (95 percent confidence interval, 21 to 90 percent) among the patients with mild renal insufficiency, and 46 percent (95 percent confidence interval, 12 to 67 percent) among those with moderate renal insufficiency. The reduction in risk was greatest among the male patients; those with glomerular diseases, diabetic nephropathy, or miscellaneous or unknown causes of renal disease; and those with base-line urinary protein excretion above 1 g per 24 hours. Benazepril was not effective in patients with polycystic disease. Diastolic pressure decreased by 3.5 to 5.0 mm Hg in the benazepril group and increased by 0.2 to 1.5 mm Hg in the placebo group.
Benazepril provides protection against the progression of renal insufficiency in patients with various renal diseases.
抑制血管紧张素转换酶的药物可减缓糖尿病性神经病变患者肾功能不全的进展。这些药物在其他肾脏疾病患者中是否有类似作用尚不清楚。我们开展了一项研究，以确定血管紧张素转换酶抑制剂贝那普利对各种潜在肾脏疾病患者肾功能不全进展的影响。
在一项为期三年的试验中，583例因各种疾病导致肾功能不全的患者参与研究，300例患者接受贝那普利治疗，283例患者接受安慰剂治疗。潜在疾病包括肾小球病（192例）、间质性肾炎（105例）、肾硬化（97例）、多囊肾病（64例）、糖尿病肾病（21例）以及其他或不明疾病（104例）。根据基线肌酐清除率对肾功能不全的严重程度进行分类：227例患者为轻度肾功能不全（肌酐清除率为每分钟46至60 ml），356例患者为中度肾功能不全（肌酐清除率为每分钟30至45 ml）。主要终点为基线血清肌酐浓度翻倍或需要进行透析。
三年时，贝那普利组有31例患者、安慰剂组有57例患者达到主要终点（P<0.001）。在贝那普利组，总体达到终点的风险降低了53%（95%置信区间为27%至70%），轻度肾功能不全患者中降低了71%（95%置信区间为21%至90%），中度肾功能不全患者中降低了46%（95%置信区间为12%至67%）。风险降低在男性患者、患有肾小球疾病、糖尿病肾病或其他或不明原因肾病的患者以及基线24小时尿蛋白排泄量超过1 g的患者中最为显著。贝那普利对多囊肾病患者无效。贝那普利组舒张压下降了3.5至5.0 mmHg，安慰剂组舒张压升高了0.2至1.5 mmHg。
贝那普利可预防各种肾脏疾病患者肾功能不全的进展。
