摘要
目的观察重组人脑利钠肽（rhBNP）对心力衰竭（心衰）患者心功能的保护作用和安全性。方法采用前瞻性多中心研究，选择全国58家医院重症加强治疗病房/心脏重症加强治疗病房（ICU/CCU）收治的年龄〉18岁、美国纽约心脏学会（NYHA）心功能分级Ⅲ~Ⅳ级的急性心功能不全及慢性心功能急性加重患者。所有患者在常规治疗基础上，给予rhBNP（商品名：新活素）负荷剂量1.5 μg/kg静脉推注3~5 min，继以维持剂量0.010~0.015 μg·kg-1·min-1静脉滴注3~7 d。于治疗前及治疗1、3、7 d检测患者心、肾功能指标，包括N末端B型利钠肽前体（NT-proBNP）、左室射血分数（LVEF）、心排血量（CO）、肺毛细血管楔压（PCWP）、中心静脉压（CVP）、尿素氮（BUN）、血肌酐（SCr）、尿量；给药后30 d随访评价肾功能指标及再次入ICU、再住院和心血管事件发生情况。结果408例患者中男性241例，女性167例；年龄28~95岁，平均（63.0±15.8）岁，50~70岁者占46.8%。与治疗前比较，全部患者给予rhBNP治疗6 h起NT-proBNP、PCWP、CVP即显著降低〔NT-proBNP（μg·kg-1·min-1）：4？378.58±4？082.29比6？403.41±5？759.48，PCWP（mmHg，1 mmHg=0.133 kPa）：12.41±2.21比14.26±2.85，CVP（mmHg）：10.63±2.62比11.45±3.45，均P〈0.05〕，且随给药时间延长呈逐渐下降趋势；治疗1 d CO（mL：4.89±0.81比4.40±0.92，P〈0.05）、治疗3 d LVEF（0.465±0.100比0.431±0.107）即显著升高（均P〈0.05），且随给药时间延长更为显著。治疗期间，BUN、SCr无明显变化，但治疗后30 d SCr显著低于治疗前（μmol/L：110.98±47.40比132.62±75.60，P〈0.01）。治疗3 h内每小时尿量较治疗前显著增加（mL：129.59±82.16比89.60±53.49，P=0.000）；给药1 d、3 d的24 h尿量较治疗前显著增加（mL：2？676.54±1？006.83、2？678.74±975.97比2？150.36±283.76，均P〈0.01）。治疗7 d内再入ICU率为2.7%，30 d内再住院率为2.88%，30 d内再心衰率为1.43%，30 d总病死率为9.55%。结论rhBNP能迅速改善心衰患者心功能，对肾功能有一定保护作用，可改善预后，安全性良好。
To explore the efficacy and safety of recombinant human brain natriuretic peptide （rhBNP） in the patients with severe heart failure （HF）.MethodsA prospective multicenter study was conducted. Patients whose age 〉 18 years old, and with the New York Heart Association （NYHA） cardiac function grade over Ⅲ-Ⅳ, acute cardiac insufficiency and the acute exacerbation of chronic cardiac insufficiency admitted to intensive care unit/cardiovascular care unit （ICU/CCU） of 58 Hospitals in China were enrolled. On the basis of the conventional treatment, all patients would be given rhBNP （neo adjuvant） with a loading dose of 1.5 μg/kg for 3-5 minutes, and followed by a maintenance dose of 0.010-0.015 μg·kg-1·min-1 for 3-7 days. Before the treatment and 1, 3, 7 days after treatment, researchers detected indexes of cardiac and renal function, the levels of N-terminal B-type natriuretic peptide （NT-proBNP）, left ventricular ejection fraction （LVEF）, cardiac output （CO）, pulmonary capillary wedge pressure （PCWP）, central venous pressure （CVP）, urea nitrogen （BUN）, serum creatinine （SCr）, and urine output; the renal function index was re-evaluated at 30 days after administration, and the time entering ICU again, re-admission, cardiovascular events were recorded.Results408 patients were enrolled, with 241 males and 167 females. Age range was 28-95 years, the average age was （63.0±15.8） years, and 50-70 years old accounted for 46.8%. Compared with the data before treatment, NT-proBNP, PCWP and CVP significantly decreased at 6 hours after treatment [NT-proBNP （μg·kg-1·min-1）： 4？378.58±4？082.29 vs. 6？403.41±5？759.48, PCWP （mmHg, 1 mmHg = 0.133 kPa）： 12.41±2.21 vs. 14.26±2.85 , CVP （mmHg）： 10.63±2.62 vs. 11.45±3.45, all P 〈 0.05], and with the prolongation of injection, NT-proBNP, PCWP and CVP were gradually declined; CO 1 day after treatment （mL： 4.89±0.81 vs. 4.40±0.92） and LVEF 3 days after treatment （0.465±0.100 vs. 0.431±0.107） were significantly increased （both P 〈 0.05）, and with the prolongation of injection, CO and LVEF were gradually increased. There were no obvious changes in BUN and SCr during the treatment, but 30 days after treatment, SCr was significantly lower than that pre-treatment （μmol/L： 110.98±47.40 vs. 132.62±75.60, P 〈 0.01）. Compared with the data pre-treatment, urine output per hour was significantly increased at 3 hours after treatment （mL： 129.59±82.16 vs. 89.60±53.49, P = 0.000）; urine output every 24 hours was significantly increased at day 1 and day 2 after administration （mL： 2 676.54±1 006.83, 2 678.74±975.97 vs. 2 150.36±283.76, both P 〈 0.01）. In 7 days, the re-entry ICU rate was 2.7%, and the re-hospitalization rate was 2.88% within 30 days, re-cardiac failure rate was 1.43% in 30 days, and the overall fatality rate was 9.55% in 30 days.ConclusionsThe rhBNP can significantly improve heart function in patients with HF. And, it has a certain effect on renal function. The rhBNP is effective and safe for the treatment of cardiac insufficiency.
出处
《中华危重病急救医学》
CAS
CSCD
北大核心
2017年第6期520-524,共5页
Chinese Critical Care Medicine
关键词
心脏重症
心功能不全
心力衰竭
重组人脑利钠肽
新活素
疗效
安全性
Cardiac in sufficiency
Cardiac ysfunction
Heart failure
Recombinant human brainnatriuretic peptide
Neo adjuvant
Efficacy
Safety
作者简介
通讯作者：魏以帧，Email：weiyizhen@sohu．com
