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血管紧张素II受体拮抗剂缬沙坦在肾移植术后高血压治疗中的疗效与安全性:一项随机多中心研究

Efficacy and safety of valsartan, an angiotensin II receptor antagonist, in hypertension after renal transplantation: a randomized multicenter study.

作者信息

Andrés A, Morales E, Morales J M, Bosch I, Campo C, Ruilope L M

机构信息

Hospital 12 de Octubre, Nephrology Department, Barcelona, Spain.

出版信息

Transplant Proc. 2006 Oct;38(8):2419-23. doi: 10.1016/j.transproceed.2006.08.066.

DOI:10.1016/j.transproceed.2006.08.066
PMID:17097955
Abstract

BACKGROUND

The prevalence of posttransplant hypertension is high, and it appears to be a major risk factor for graft and patient survival. The aim of this study was to assess the efficacy and safety of valsartan, an angiotensin-receptor blocker (ARB), in the treatment of posttransplant hypertension.

METHODS

A multinational, multicenter, prospective, randomized, double-blind, placebo-controlled study was performed on the treatment of hypertension (systolic blood pressure [BP] >/= 140 and/or diastolic BP >/= 90 mm Hg) in adult cyclosporin-treated renal transplant recipients randomized to receive either valsartan (80 mg once daily) or a matching placebo for 8 weeks. After the first 4 weeks, furosemide 20 mg twice daily was added on a open basis if systolic BP remained >/= 130 mm Hg and/or diastolic BP remained >/= 85 mm Hg.

RESULTS

One hundred fifteen (valsartan = 57, placebo = 58) uncontrolled hypertensive patients despite monotherapy for hypertension, other than angiotensin-converting enzyme inhibitor or ARB, were randomized. In the valsartan group, significant decreases were seen in systolic BP (from 153 +/- 11 to 140.9 +/- 18.35 mm Hg at 4 weeks, and 136.5 +/- 15 mm Hg at 8 weeks) and diastolic BP (from 93 +/- 9 to 85.2 +/- 11.28 mm Hg at 4 weeks, and 83.8 +/- 9.2 mm Hg at 8 weeks). There was no significant change in the placebo group. In the valsartan group, a statistically but not clinically significant reduction was observed in the mean hemoglobin concentration (12.9 +/- 1.6 g/dL versus 13.8 +/- 1.6 g/dL at 4 weeks, P < .01; and 12.3 +/- 1.6 versus 13.8 +/- 1.7 at 8 weeks; P < .001) as well as a significant increase in serum potassium (4.4 +/- 0.5 mmol/L versus 4.1 +/- 0.4 mmol/L at 4 weeks, P < .01) vs placebo.

CONCLUSIONS

Valsartan is effective in the treatment of posttransplant hypertension and is well tolerated.

摘要

背景

移植后高血压的患病率很高,它似乎是影响移植物和患者生存的主要危险因素。本研究的目的是评估血管紧张素受体阻滞剂(ARB)缬沙坦治疗移植后高血压的有效性和安全性。

方法

对接受环孢素治疗的成年肾移植受者的高血压(收缩压[BP]≥140和/或舒张压BP≥90mmHg)治疗进行了一项多国、多中心、前瞻性、随机、双盲、安慰剂对照研究,随机分为接受缬沙坦(80mg每日一次)或匹配安慰剂治疗8周。在最初4周后,如果收缩压仍≥130mmHg和/或舒张压仍≥85mmHg,则在开放基础上加用呋塞米20mg每日两次。

结果

115例(缬沙坦组=57例,安慰剂组=58例)尽管接受了除血管紧张素转换酶抑制剂或ARB以外的高血压单一疗法但仍未控制的高血压患者被随机分组。在缬沙坦组中,收缩压显著降低(4周时从153±11降至140.9±18.35mmHg,8周时为136.5±15mmHg),舒张压也显著降低(4周时从93±9降至85.2±11.28mmHg,8周时为83.8±9.2mmHg)。安慰剂组无显著变化。在缬沙坦组中,观察到平均血红蛋白浓度有统计学意义但无临床意义的降低(4周时为12.9±1.6g/dL对13.8±1.6g/dL,P<.01;8周时为12.3±1.6对13.8±1.7;P<.001),血清钾与安慰剂相比有显著升高(4周时为4.4±0.5mmol/L对4.1±0.4mmol/L,P<.01)。

结论

缬沙坦治疗移植后高血压有效且耐受性良好。

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