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期刊来源：JAMA

文献发表时间：2023-10-25

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2811213

关键点内容如下：

问题

关键点问题对于心动过速和感染性休克的危重患者，使用大剂量去甲肾上腺素治疗超过24小时后，通过序贯器官衰竭评估（SOFA）评分测量，使用兰地洛尔长达14天的β-受体阻滞剂是否能减少器官衰竭？

调查结果

结果在这项随机临床试验中，纳入了126例心动过速和感染性休克（去甲肾上腺素治疗>24小时）患者，与标准治疗相比，静脉注射兰地洛尔将心率降至95次/分以下，在随机分组后14天内，平均SOFA评分（分别为8.8和8.1）并未显著降低器官衰竭。

意义

这些结果不支持使用兰地洛尔治疗使用去甲肾上腺素治疗已确诊的感染性休克的心动过速患者。

摘要内容如下：

重要性

感染性休克患者会经历肾上腺素能应激，从而影响心脏、免疫、炎症和代谢途径。β-受体阻滞剂可减轻儿茶酚胺暴露的不良反应，并可降低死亡率。

目的

评估兰地洛尔对心动过速和需要长时间（>24小时）血管加压药支持的感染性休克患者的疗效和安全性。

研究设计和参与者

一项开放标签、多中心、随机试验，纳入了40个英国国家医疗服务重症监护病房的126名心动过速（心率≥95次/min）和感染性休克患者（≥18岁），持续给予去甲肾上腺素（≥0.1μg/kg/min）治疗至少24小时。试验从2018年4月持续到2021年12月，由于可能的伤害信号，试验于2021年12月提前终止。

干预措施

63名患者随机接受标准治疗，63名患者接受兰地洛尔输注。

主要结局和措施

主要结果是从随机分组到14天的平均序贯器官衰竭评估（SOFA）评分。次要转归包括第28天和第90天的死亡率以及各组不良事件的数量。

结果

在独立数据监测委员会的建议下，该试验被提前终止，因为它不太可能显示出益处和可能的危害。在计划的340名参与者中，126名（37%的）（平均年龄55.6岁[95%CI，52.7至58.5岁]；58.7%为男性）。兰地洛尔组的平均（SD）SOFA评分为8.8（3.9），而标准护理组为8.1（3.2 UNK6 UNK7平均差异[MD]，0.75[95%CI，-0.49至2.0]；P=.24）。兰地洛尔组随机分组后第28天的死亡率为37.1%（标准护理组62名）中的23名和63名）中的16名（25.4%（绝对差异，11.7%[95%CI，-4.4%至27.8%]；P=.16）。随机分组后第90天的死亡率为43.5%（兰地洛尔组62名）中的27名，标准治疗组63名）中的18名为28.6%（（绝对差异，15%[95%CI，-1.7%至31.6%]；P=.08）。至少发生一次不良事件的患者数量没有差异。

结论和相关性

在患有感染性休克伴心动过速并接受去甲肾上腺素治疗超过24小时的患者中，输注兰地洛尔并不能减少器官衰竭（根据随机分组后14天内的SOFA评分测量）。这些结果并不支持在使用去甲肾上腺素治疗感染性休克的患者中使用兰地洛尔来控制心动过速。

英文原文如下：

Key Points

Question  Does β-blockade for up to 14 days with landiolol reduce organ failure as measured by the Sequential Organ Failure Assessment (SOFA) score for critically ill patients with tachycardia and septic shock treated with high-dose norepinephrine for more than 24 hours?

Findings  In this randomized clinical trial enrolling 126 patients with tachycardia and established septic shock (treated with norepinephrine for >24 hours), the administration of landiolol intravenously to reduce heart rate to less than 95/min compared with standard care did not significantly decrease organ failure as measured by the mean SOFA score (8.8 vs 8.1, respectively) in the 14 days after randomization.

Meaning  These results do not support the use of landiolol for managing patients with tachycardia treated with norepinephrine for established septic shock.

Abstract

Importance  Patients with septic shock undergo adrenergic stress, which affects cardiac, immune, inflammatory, and metabolic pathways. β-Blockade may attenuate the adverse effects of catecholamine exposure and has been associated with reduced mortality.

Objectives  To assess the efficacy and safety of landiolol in patients with tachycardia and established septic shock requiring prolonged (>24 hours) vasopressor support.

Design, Setting, and Participants  An open-label, multicenter, randomized trial involving 126 adults (≥18 years) with tachycardia (heart rate ≥95/min) and established septic shock treated for at least 24 hours with continuous norepinephrine (≥0.1 μg/kg/min) in 40 UK National Health Service intensive care units. The trial ran from April 2018 to December 2021, with early termination in December 2021 due to a signal of possible harm.

Intervention  Sixty-three patients were randomized to receive standard care and 63 to receive landiolol infusion.

Main Outcomes and Measures  The primary outcome was the mean Sequential Organ Failure Assessment (SOFA) score from randomization through 14 days. Secondary outcomes included mortality at days 28 and 90 and the number of adverse events in each group.

Results  The trial was stopped prematurely on the advice of the independent data monitoring committee because it was unlikely to demonstrate benefit and because of possible harm. Of a planned 340 participants, 126 (37%) were enrolled (mean age, 55.6 years [95% CI, 52.7 to 58.5 years]; 58.7% male). The mean (SD) SOFA score in the landiolol group was 8.8 (3.9) compared with 8.1 (3.2) in the standard care group (mean difference [MD], 0.75 [95% CI, −0.49 to 2.0]; P = .24). Mortality at day 28 after randomization in the landiolol group was 37.1% (23 of 62) and 25.4% (16 of 63) in the standard care group (absolute difference, 11.7% [95% CI, −4.4% to 27.8%]; P = .16). Mortality at day 90 after randomization was 43.5% (27 of 62) in the landiolol group and 28.6% (18 of 63) in the standard care group (absolute difference, 15% [95% CI, −1.7% to 31.6%]; P = .08). There were no differences in the number of patients having at least one adverse event.

Conclusion and Relevance  Among patients with septic shock with tachycardia and treated with norepinephrine for more than 24 hours, an infusion of landiolol did not reduce organ failure measured by the SOFA score over 14 days from randomization. These results do not support the use of landiolol for managing tachycardia among patients treated with norepinephrine for established septic shock.

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