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缬沙坦的肾保护作用是否与剂量相关?80mg 与 160mg 日剂量的对比研究。

Is the reno-protective effect of valsartan dose dependent? A comparative study of 80 and 160 mg day(-1).

机构信息

Department of Clinical Examination and Diagnostics, Oita University, Oita, Japan.

出版信息

Hypertens Res. 2010 Sep;33(9):886-91. doi: 10.1038/hr.2010.108. Epub 2010 Jun 17.

DOI:10.1038/hr.2010.108
PMID:20555331
Abstract

Whether the reno-protective effect of angiotensin receptor blockers is dose dependent is unknown for the Japanese population. We sought to elucidate the dose-dependent reno-protective effects of valsartan in Japanese hypertensive patients with albuminuria. This was a multi-center, open-label, parallel-group trial. A total of 181 patients were randomized to receive either 80 (n=89) or 160 mg day(-1) (n=92) of valsartan for 24 weeks. Then, the effects on blood pressure, urinary albumin excretion (UAE), type IV collagen and beta(2)-microglobulin (beta2MG) were determined. Systolic and diastolic blood pressures decreased substantially by almost the same extent in the low-dose and high-dose groups, showing no inter-group difference during the treatment. The UAE value decreased significantly by 35% in both groups. Urinary excretion of beta2MG was significantly decreased in the high-dose group (17%), but not in the low-dose group (13%), although the decrease was not significantly different between the two groups (P=0.74). Urinary excretion of type IV collagen decreased non-significantly by 10% in the low-dose group and by 8% in the high-dose group, showing no significant inter-group difference (P=0.78). Low (80 mg day(-1)) and high (160 mg day(-1)) doses of valsartan showed a similar effect of lowering blood pressure. The high dose of valsartan resulted in a slightly greater decrease in urinary beta2MG, but it was inconclusive whether the high dose was more reno-protective as compared with the low dose.

摘要

血管紧张素受体阻滞剂的肾保护作用是否与剂量有关,目前尚不清楚。我们旨在阐明血管紧张素受体阻滞剂缬沙坦在日本伴有蛋白尿的高血压患者中的剂量依赖性肾保护作用。这是一项多中心、开放标签、平行分组试验。共有 181 名患者随机接受 80mg (n=89)或 160mg (n=92)缬沙坦治疗 24 周。然后,测定血压、尿白蛋白排泄(UAE)、IV 型胶原和β2-微球蛋白(β2MG)的影响。低剂量和高剂量组的收缩压和舒张压均显著降低,治疗期间两组间无差异。两组 UAE 值均显著降低 35%。高剂量组(17%)β2MG 尿排泄量显著降低,但低剂量组(13%)无显著降低(两组间无差异,P=0.74)。低剂量组(10%)和高剂量组(8%)IV 型胶原尿排泄量均非显著降低,两组间无显著差异(P=0.78)。低(80mg/d)和高(160mg/d)剂量的缬沙坦均具有相似的降压作用。高剂量缬沙坦可使β2MG 尿排泄量略有降低,但高剂量是否比低剂量更具肾保护作用尚无定论。

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