静脉注射重组人脑利钠肽与硝酸甘油对失代偿性急性心力衰竭患者疗效的比较：一项多中心、随机、开放标签、平行设计研究

[Comparison of the effects of intravenous recombinant human brain natriuretic peptide and nitroglycerin in patients with decompensated acute heart failure: a multicenter, randomized, open-label, parallel-design study].

出版信息

Zhonghua Xin Xue Guan Bing Za Zhi. 2006 Mar;34(3):222-6.

Abstract

OBJECTIVE

To compare the efficacy and safety of intravenous infusion recombinant human brain natriuretic peptide (rhBNP) versus nitroglycerin (NIT) in treating patients with decompensated acute heart failure.

METHODS

A total of 209 patients characterized of decompensated acute heart failure were enrolled in this multicenter, randomized, open-label, parallel-design study. The patients were randomly allocated to catheter group and non-catheter group (depending on the use of Swan-Ganz). Each group was then randomly assigned to receive rhBNP (0.15 microg/kg bolus intravenous injection followed by 0.0075 microg.kg(-1).min(-1) for 24 hours, n = 105) or NIT (starting at 10 microg/min and increasing 5 microg/min each time till clinical effective dose for 24 hours, n = 104). Blood pressure, heart rate, dyspnea grade, 24 hours fluid in- and output and improvement in patient symptoms and signs were evaluated and adverse events were documented.

RESULTS

Urine output was significantly increased after both rhBNP and NIT treatments. Dyspnea and symptom improvements were more significant in rhBNP group compared to NIT group. PCWP and PAP were both decreased after rhBNP and NIT therapies and there was more significant reduction in PCWP and PAP between 30 min and 2 hours in rhBNP group compared to NIT group. However, RAP and CI were similar between the two groups at various time points. The total adverse events were comparable between the two groups (20.0% vs. 19.2%, P > 0.05) and 7 patients withdrew the study due to adverse events (4 in rhBNP and 3 in NIT group).

CONCLUSIONS

rhBNP is superior to nitroglycerin in improving dyspnea and symptoms and decreasing PCWP and PAP in patients with decompensated acute heart failure patients. The safety of rhBNP was comparable to nitroglycerin in treating patients with decompensated acute heart failure.

摘要

目的

比较静脉输注重组人脑利钠肽（rhBNP）与硝酸甘油（NIT）治疗失代偿性急性心力衰竭患者的疗效和安全性。

方法

本多中心、随机、开放标签、平行设计研究共纳入209例失代偿性急性心力衰竭患者。患者根据是否使用 Swan - Ganz 导管随机分为导管组和非导管组。然后每组再随机分配接受 rhBNP（0.15μg/kg 静脉推注，随后以 0.0075μg·kg⁻¹·min⁻¹ 持续 24 小时，n = 105）或 NIT（起始剂量为 10μg/min，每次增加 5μg/min 直至达到临床有效剂量并持续 24 小时，n = 104）。评估血压、心率、呼吸困难分级、24 小时液体出入量以及患者症状和体征的改善情况，并记录不良事件。

结果

rhBNP 和 NIT 治疗后尿量均显著增加。与 NIT 组相比，rhBNP 组呼吸困难及症状改善更显著。rhBNP 和 NIT 治疗后肺毛细血管楔压（PCWP）和肺动脉压（PAP）均降低，且与 NIT 组相比，rhBNP 组在 30 分钟至 2 小时之间 PCWP 和 PAP 的降低更显著。然而，两组在不同时间点的右心房压（RAP）和心脏指数（CI）相似。两组总不良事件发生率相当（20.0% 对 19.2%，P > 0.05），7 例患者因不良事件退出研究（rhBNP 组 4 例，NIT 组 3 例）。