县急诊科急性失代偿性心力衰竭：奈西立肽与安慰剂治疗的双盲随机对照比较

Acutely decompensated heart failure in a county emergency department: a double-blind randomized controlled comparison of nesiritide versus placebo treatment.

作者信息

Miller Adam H, Nazeer Shameem, Pepe Paul, Estes Barbi, Gorman April, Yancy Clyde W

机构信息

Department of Surgery/Division of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX 75390-8579, USA.

出版信息

Ann Emerg Med. 2008 May;51(5):571-8. doi: 10.1016/j.annemergmed.2007.12.003. Epub 2008 Mar 4.

DOI:10.1016/j.annemergmed.2007.12.003

PMID:18304693

Abstract

STUDY OBJECTIVE

Acutely decompensated congestive heart failure is a major cause of emergency department (ED) visits in county hospitals. This often underserved population has a high rate of return visits to the ED for heart failure. Nesiritide has been demonstrated to relieve symptoms of acutely decompensated congestive heart failure. We examined the effect of an 8-hour infusion of nesiritide on the composite of return to the ED or hospitalization at 30 days.

METHODS

A prospective, randomized, double-blinded, placebo-controlled trial of nesiritide plus protocol-specified standard therapy versus standard therapy done in the ED for acutely decompensated congestive heart failure.

RESULTS

One hundred one patients were randomized during a 16-month enrollment period. Sixty-six percent of the patients were men and 34% were women. Fifty-six percent were black; all patients had New York Heart Association class II to IV heart failure and most had dyspnea at rest or with minimal exertion. Complete follow-up data were available in 97 of 101 patients. After the 8-hour treatment period, acute symptom relief was experienced in 95.7% of the nesiritide group (95% confidence interval [CI] 88.9% to 100%) versus 86.8% of the placebo group (95% CI 72% to 98.9%), with an absolute difference between the 2 groups of 8.9% (95% CI -3.3% to 24.2%). Diuresis was similar between the 2 groups, but hypotension occurred more frequently in the nesiritide-treated group. The primary outcome measure of return visit to the ED or hospitalization at 30 days was higher for nesiritide (41.5%) than placebo (39.6%; absolute difference 1.9%; 95% CI -17.2% to 21.1%). There was only 1 death. No measurable change in renal function was observed.

CONCLUSION

Administration of nesiritide for acutely decompensated congestive heart failure in a county ED was no better than standard therapy alone for return to the ED or hospitalization at 30 days.

摘要

研究目的

急性失代偿性充血性心力衰竭是县医院急诊科就诊的主要原因。这一常未得到充分治疗的人群因心力衰竭返回急诊科就诊的比例很高。奈西立肽已被证明可缓解急性失代偿性充血性心力衰竭的症状。我们研究了8小时输注奈西立肽对30天内返回急诊科或住院这一综合指标的影响。

方法

在急诊科针对急性失代偿性充血性心力衰竭进行了一项前瞻性、随机、双盲、安慰剂对照试验，比较奈西立肽加方案指定的标准治疗与标准治疗的效果。

结果

在16个月的入组期间，101例患者被随机分组。66%的患者为男性，34%为女性。56%为黑人；所有患者的心功能分级为纽约心脏病协会II至IV级，大多数患者在休息或轻微活动时出现呼吸困难。101例患者中有97例获得了完整的随访数据。在8小时治疗期后，奈西立肽组95.7%的患者急性症状得到缓解（95%置信区间[CI]88.9%至100%），而安慰剂组为86.8%（95%CI72%至98.9%），两组之间的绝对差异为8.9%（95%CI -3.3%至24.2%）。两组的利尿情况相似，但奈西立肽治疗组低血压的发生更频繁。奈西立肽组30天内返回急诊科或住院的主要结局指标（41.5%）高于安慰剂组（39.6%；绝对差异1.9%；95%CI -17.2%至21.1%）。仅1例死亡。未观察到肾功能有可测量的变化。