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阿利吉仑对非糖尿病慢性肾脏病蛋白尿的影响:一项双盲、交叉、随机、对照试验。

Effect of aliskiren on proteinuria in non-diabetic chronic kidney disease: a double-blind, crossover, randomised, controlled trial.

机构信息

Department of Nephrology, Transplantology and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.

出版信息

Int Urol Nephrol. 2012 Dec;44(6):1763-70. doi: 10.1007/s11255-011-0110-z.

DOI:10.1007/s11255-011-0110-z
PMID:23326865
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3510412/
Abstract

AIM

To evaluate the proteinuria-lowering effect of a renin inhibitor (aliskiren), compared to placebo and to an angiotensin-converting enzyme inhibitor (perindopril), in patients with non-diabetic chronic kidney disease.

METHODS

A randomised, double-blind, crossover trial was performed in 14 patients with nondiabetic chronic kidney disease with 24-h mean proteinuria of 2.01 g (95% CI, 1.36–2.66) and estimated creatinine clearance of 93±6.8 ml/min. The study consisted of five treatment periods. The patients were randomly assigned to receive aliskiren (150 mg), aliskiren (300 mg), perindopril (5 mg), perindopril (10 mg) or placebo.

RESULTS

Aliskiren and perindopril reduced proteinuria. These effects were dose-dependent. Furthermore, 24-h proteinuria was reduced by 23% (mean 95% CI; 2–44) by treatment with aliskiren (150 mg), by 36% (95% CI, 17–55; P<0.001) with aliskiren (300 mg), by 7.1% (95% CI, 11–26) with perindopril (5 mg) and by 25% (95% CI, 11–39; P<0.05) with perindopril (10 mg), compared to placebo. No significant difference was found between the effects of aliskiren and perindopril.

CONCLUSIONS

Aliskiren significantly reduced proteinuria. The antiproteinuric effect is probably similar to that of perindopril, for equivalent hypotensive dosages. The renin inhibitor provides a promising alternative approach for the treatment of patients with chronic proteinuric non-diabetic kidney disease.

摘要

目的

评估肾素抑制剂(阿利克仑)在非糖尿病慢性肾病患者中降低蛋白尿的效果,与安慰剂和血管紧张素转换酶抑制剂(培哚普利)进行比较。

方法

这是一项在 14 名非糖尿病慢性肾病患者中进行的随机、双盲、交叉试验,这些患者的 24 小时平均蛋白尿为 2.01g(95%可信区间,1.36-2.66),估算的肌酐清除率为 93±6.8ml/min。该研究包括五个治疗期。患者被随机分配接受阿利克仑(150mg)、阿利克仑(300mg)、培哚普利(5mg)、培哚普利(10mg)或安慰剂。

结果

阿利克仑和培哚普利均降低蛋白尿。这些效果是剂量依赖性的。此外,阿利克仑(150mg)治疗使 24 小时蛋白尿减少 23%(平均 95%可信区间,2-44),阿利克仑(300mg)治疗使蛋白尿减少 36%(95%可信区间,17-55;P<0.001),培哚普利(5mg)治疗使蛋白尿减少 7.1%(95%可信区间,11-26),培哚普利(10mg)治疗使蛋白尿减少 25%(95%可信区间,11-39;P<0.05),与安慰剂相比。阿利克仑和培哚普利的作用之间未发现显著差异。

结论

阿利克仑显著降低蛋白尿。降蛋白尿的效果可能与培哚普利相似,在等效的降压剂量下。肾素抑制剂为治疗慢性蛋白尿性非糖尿病肾病患者提供了一种有前景的替代方法。

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本文引用的文献

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Aliskiren combined with losartan in immunoglobulin A nephropathy: an open-labeled pilot study.阿利克仑联合氯沙坦治疗免疫球蛋白 A 肾病:一项开放标签的初步研究。
Nephrol Dial Transplant. 2012 Feb;27(2):613-8. doi: 10.1093/ndt/gfr349. Epub 2011 Jun 16.
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Beneficial effect of aliskiren combined with olmesartan in reducing urinary protein excretion in patients with chronic kidney disease.阿利吉仑联合奥美沙坦对降低慢性肾脏病患者尿蛋白排泄的有益作用。
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Renoprotective Effects of Various Angiotensin II Receptor Blockers in Patients with Early-Stage Diabetic Nephropathy.
肾素抑制剂与血管紧张素转换酶(ACE)抑制剂治疗原发性高血压的比较。
Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
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Direct renin inhibition--a promising strategy for renal protection?直接肾素抑制——肾脏保护的有前途策略?
Med Sci Monit. 2013 Jun 12;19:451-7. doi: 10.12659/MSM.883949.
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Direct renin inhibition in chronic kidney disease.直接肾素抑制在慢性肾脏病中的应用。
Br J Clin Pharmacol. 2013 Oct;76(4):580-6. doi: 10.1111/bcp.12072.
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Approach to cardiovascular disease prevention in patients with chronic kidney disease.慢性肾脏病患者心血管疾病的预防方法
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不同血管紧张素II受体阻滞剂对早期糖尿病肾病患者的肾脏保护作用
Kidney Blood Press Res. 2010;33(3):213-20. doi: 10.1159/000316707. Epub 2010 Jun 24.
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Renal effects of aliskiren compared with and in combination with irbesartan in patients with type 2 diabetes, hypertension, and albuminuria.在2型糖尿病、高血压和蛋白尿患者中,阿利吉仑与厄贝沙坦相比及联合使用时对肾脏的影响。
Diabetes Care. 2009 Oct;32(10):1873-9. doi: 10.2337/dc09-0168. Epub 2009 Jul 8.
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Inhibition of the renin-angiotensin system and chronic kidney disease.肾素-血管紧张素系统抑制与慢性肾脏病
Int Urol Nephrol. 2008;40(4):1015-25. doi: 10.1007/s11255-008-9424-x. Epub 2008 Aug 14.
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Renal and hormonal responses to direct renin inhibition with aliskiren in healthy humans.阿利吉仑对健康人体直接抑制肾素的肾脏和激素反应。
Circulation. 2008 Jun 24;117(25):3199-205. doi: 10.1161/CIRCULATIONAHA.108.767202. Epub 2008 Jun 16.
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Aliskiren combined with losartan in type 2 diabetes and nephropathy.阿利吉仑与氯沙坦联合用于2型糖尿病和肾病
N Engl J Med. 2008 Jun 5;358(23):2433-46. doi: 10.1056/NEJMoa0708379.
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Effects of aliskiren on blood pressure, albuminuria, and (pro)renin receptor expression in diabetic TG(mRen-2)27 rats.阿利吉仑对糖尿病TG(mRen - 2)27大鼠血压、蛋白尿及(前)肾素受体表达的影响
Hypertension. 2008 Jul;52(1):130-6. doi: 10.1161/HYPERTENSIONAHA.107.108845. Epub 2008 May 19.
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Time course of the antiproteinuric and antihypertensive effects of direct renin inhibition in type 2 diabetes.2型糖尿病中直接肾素抑制的抗蛋白尿和降压作用的时间进程。
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