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随机安慰剂对照试验呋塞米对高血压危象引起的肺水肿患者呼吸困难主观感知的影响。

Randomized placebo controlled trial of furosemide on subjective perception of dyspnoea in patients with pulmonary oedema because of hypertensive crisis.

机构信息

Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.

出版信息

Eur J Clin Invest. 2011 Jun;41(6):627-34. doi: 10.1111/j.1365-2362.2010.02450.x. Epub 2010 Dec 29.

DOI:10.1111/j.1365-2362.2010.02450.x
PMID:21198560
Abstract

BACKGROUND

To compare the administration of furosemide with placebo on the subjective perception of dyspnoea in patients with acute pulmonary oedema because of hypertensive crisis. Design  Randomized, controlled and double-blinded clinical trial.

SETTING

Municipal emergency medical service system and university-based emergency department.

PARTICIPANTS

Fifty-nine patients with pulmonary oedema because of hypertensive crisis.

INTERVENTIONS

Additional to administration of oxygen, morphine-hydrochloride and urapidil until the systolic blood pressure was below 160mmHg, the patients were randomized to receive furosemide 80mg IV bolus (furosemide group) or saline placebo (placebo group).

MAIN OUTCOME MEASURES

The primary outcome was the subjective perception of dyspnoea as measured with a modified BORG scale at one hour after randomization. Secondary outcome parameters were the subjective perception of dyspnoea of patients as measured with a modified BORG scale and a visual analogue scale at 2, 3 and 6h after randomization of the patient; course of the systolic arterial pressure and peripheral oxygen saturation and lactate at admission and at 6h after admission.

RESULTS

In 25 patients in the furosemide group and in 28 patients in the placebo group, a BORG score could be obtained. There was no statistically significant difference in the severity of dyspnoea at one hour after randomization (P=0·40). The median BORG score at 1h after randomization in the furosemide group was 3 (IQR 2 to 4) compared to 3 (IQR 2 to 7) in the placebo group (P=0·40). Those patients who were randomized to the placebo group needed higher doses of urapidil at 20min after randomization. There were no significant differences in the rate of adverse events, nonfatal cardiac arrests or death between the two groups.

CONCLUSIONS

The subjective perception of dyspnoea in patients with hypertensive pulmonary oedema was not influenced by the application of a loop-diuretic. Therefore, additional furosemide therapy needs to be scrutinized in the therapy of these patients.

摘要

背景

比较呋塞米和安慰剂在高血压危象引起的急性肺水肿患者主观呼吸困难感知方面的作用。方法 随机、对照、双盲临床试验。

地点

市紧急医疗服务系统和大学急诊室。

参与者

59 例高血压危象合并肺水肿患者。

干预措施

除给予氧、盐酸吗啡和乌拉地尔后使收缩压降至 160mmHg 以下外,患者被随机分为呋塞米 80mg 静脉推注(呋塞米组)或生理盐水安慰剂(安慰剂组)。

主要观察指标

主要结局是随机分组后 1 小时时用改良 BORG 量表评估的主观呼吸困难感知。次要结局参数是随机分组后 2、3 和 6 小时时用改良 BORG 量表和视觉模拟量表评估的患者主观呼吸困难感知;入院时和入院后 6 小时时的收缩压和外周血氧饱和度及血乳酸水平的变化。

结果

在呋塞米组的 25 例患者和安慰剂组的 28 例患者中,获得了 BORG 评分。随机分组后 1 小时时呼吸困难严重程度无统计学差异(P=0·40)。呋塞米组随机分组后 1h 的 BORG 评分中位数为 3(IQR 2 至 4),安慰剂组为 3(IQR 2 至 7)(P=0·40)。随机分组至安慰剂组的患者在随机分组后 20 分钟时需要更高剂量的乌拉地尔。两组间不良反应、非致命性心脏骤停或死亡的发生率无显著差异。

结论

高血压性肺水肿患者的主观呼吸困难感知不受利尿剂的影响。因此,需要仔细考虑在这些患者的治疗中是否添加呋塞米治疗。

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