加压素不能降低感染性休克患者死亡率

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Vasopressin versus Norepinephrine Infusion in Patients with Septic Shock

ABSTRACT

Background
Vasopressin is commonly used as an adjunct to catecholamines to support blood pressure in refractory septic shock, but its effect on mortality is unknown. We hypothesized that low-dose vasopressin as compared with norepinephrine would decrease mortality among patients with septic shock who were being treated with conventional (catecholamine) vasopressors.

Methods
In this multicenter, randomized, double-blind trial, we assigned patients who had septic shock and were receiving a minimum of 5 礸 of norepinephrine per minute to receive either low-dose vasopressin (0.01 to 0.03 U per minute) or norepinephrine (5 to 15 礸 per minute) in addition to open-label vasopressors. All vasopressor infusions were titrated and tapered according to protocols to maintain a target blood pressure. The primary end point was the mortality rate 28 days after the start of infusions.

Results
A total of 778 patients underwent randomization, were infused with the study drug (396 patients received vasopressin, and 382 norepinephrine), and were included in the analysis. There was no significant difference between the vasopressin and norepinephrine groups in the 28-day mortality rate (35.4% and 39.3%, respectively; P=0.26) or in 90-day mortality (43.9% and 49.6%, respectively; P=0.11). There were no significant differences in the overall rates of serious adverse events (10.3% and 10.5%, respectively; P=1.00).

In the prospectively defined stratum of less severe septic shock, the mortality rate was lower in the vasopressin group than in the norepinephrine group at 28 days (26.5% vs. 35.7%, P=0.05); in the stratum of more severe septic shock, there was no significant difference in 28-day mortality (44.0% and 42.5%, respectively; P=0.76). A test for heterogeneity between these two study strata was not significant (P=0.10).

Conclusions
Low-dose vasopressin did not reduce mortality rates as compared with norepinephrine among patients with septic shock who were treated with catecholamine vasopressors.
血管加压素与去甲肾上腺素输注在败血症休克病人中的作用
背景：
血管加压素是儿茶酚胺类药物，通常用于维持难治性败血症休克病人的血压，但是它对病死率的影响作用却不为人知。我们假定与去甲肾上腺素相比，低剂量的常规血管加压素治疗可以降低败血症休克病人的病死率。

方法：
在这个多中心、随机、双盲的临床试验中，我们给予正在接受（每分钟至少5ug）去甲肾上腺素治疗的败血症休克病人同时随机接受低剂量的血管加压素（每分钟0.01到0.03U）治疗，或者随机接受去甲肾上腺素（每分钟5到15ug）治疗（这些病人同时已经接受开放性的升压药物治疗）。所有的血管加压素剂量的输注根据试验规程进行滴定和分级，以达到能维持目标血压。第一个观察终点是药物输注28天后的病死率。

结果：
778例病人随机分组，同时给予研究药物输注（396例病人接受血管加压素，382例接受去甲肾上腺素）和对结果进行分析。血管加压素组与去甲肾上腺素组间，输注28天后的病死率无统计学差异（病死率分别是35.4%和39.3%，P=0.26）；90天后的病死率也无统计学差异（病死率分别是43.9%和49.6%，P=0.11）。严重副反应两组间也无统计学差异（分别是10.3%和10.5%，P=1.00）。
在前瞻性分层研究中，对于轻的败血症休克病人，28天时血管加压素组与去甲肾上腺组的病死率间有统计学差异（26.5%和35.7%，P=0.05）；对于严重的败血症休克病人，28天时血管加压素组与去甲肾上腺组的病死率间无统计学差异（44.0%和42.5%，P=0.76）。两分层组之间异质性检验无统计学差异（P=0.10）。

在前瞻性分层研究中，对于轻的败血症病人，28天时血管加压素组与去甲肾上腺组的死亡率间有统计学差压（26.5%和35.7%，P=0.05）；对于严重的败血症病人，28天时血管加压素组与去甲肾上腺组的死亡率间无统计学差压（44.0%和42.5%，P=0.76）。两分层组之间异质性检验无统计学差异（P=0.10）。

结论：
对于处于败血症休克的病人，与去甲肾上腺相比较，低剂量血管加压素输注不能降低同时伍用儿茶酚胺类升压药治疗的病人的病死率。