丹麦奥尔胡斯大学Lars W. Andersen团队比较了加压素和甲基强的松龙与安慰剂对院内心脏骤停患者自主循环恢复的影响。该项研究成果发表在2021年9月29日出版的《美国医学会杂志》上。

先前的试验表明，在医院内心脏骤停时给予加压素和甲基强的松龙可能改善预后。

为了确定院内心脏骤停期间联合应用加压素和甲基强的松龙是否能改善自主循环的恢复，2018年10月15日至2021年1月21日，研究组在丹麦的10家医院进行了一项多中心、随机、双盲、安慰剂对照试验，共招募了512例住院期间心脏骤停的成人患者。最后90天随访截至2021年4月21日。

将患者随机分组，其中245例接受加压素和甲基强的松龙，267例接受安慰剂治疗。在第一剂肾上腺素后，分别给予第一剂的血管加压素（20 IU）和甲基强的松龙（40 mg）或相应的安慰剂。每增加一剂肾上腺素后，再给予额外剂量的血管加压素或相应的安慰剂，最多4次。主要结局是自主循环恢复。次要结局包括30天时的生存率和良好的神经功能结局（大脑功能类别得分为1或2）。

512名随机分组的患者中，501名符合所有纳入标准，无排除标准，均被纳入分析，平均年龄71岁，男性占64%。加压素和甲基强的松龙组的237名患者中有100名（42%）恢复了自主循环，安慰剂组的264名患者中有86名（33%），风险比为1.30，组间差异显著。

30天时，干预组中有23名患者（9.7%）存活，安慰剂组中有31名（12%），组间差异不显著。30天时，干预组中有18名患者（7.6%）观察到良好的神经功能结局，安慰剂组中有20名患者（7.6%），差异不显著。在自主循环恢复的患者中，干预组中有77例（77%）发生高血糖，安慰剂组中有63例（73%）。干预组和安慰剂组分别有28例（28%）和27例（31%）患者发生高钠血症。

研究结果表明，对于院内心脏骤停患者，与安慰剂相比，使用加压素和甲基强的松龙显著增加了自主循环恢复的可能性。

附：英文原文

Title: Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest: A Randomized Clinical Trial

Author: Lars W. Andersen, Dan Isbye, Jesper Kjrgaard, Camilla M. Kristensen, Sren Darling, Stine T. Zwisler, Stine Fisker, Jens Christian Schmidt, Hans Kirkegaard, Anders M. Grejs, Jrgen R. G. Rossau, Jacob M. Larsen, Bodil S. Rasmussen, Signe Riddersholm, Kasper Iversen, Martin Schultz, Jakob L. Nielsen, Bo Lfgren, Kasper G. Lauridsen, Christoffer Slling, Kim Plestik, Anders G. Kjrgaard, Dorte Due-Rasmussen, Fredrik Folke, Mette G. Charlot, Rikke Malene H. G. Jepsen, Sebastian Wiberg, Michael Donnino, Tobias Kurth, Maria Hybye, Birthe Sindberg, Mathias J. Holmberg, Asger Granfeldt

Issue&Volume: 2021-09-29

Abstract:

Importance  Previous trials have suggested that vasopressin and methylprednisolone administered during in-hospital cardiac arrest might improve outcomes.

Objective  To determine whether the combination of vasopressin and methylprednisolone administered during in-hospital cardiac arrest improves return of spontaneous circulation.

Design, Setting, and Participants  Multicenter, randomized, double-blind, placebo-controlled trial conducted at 10 hospitals in Denmark. A total of 512 adult patients with in-hospital cardiac arrest were included between October 15, 2018, and January 21, 2021. The last 90-day follow-up was on April 21, 2021.

Intervention  Patients were randomized to receive a combination of vasopressin and methylprednisolone (n=245) or placebo (n=267). The first dose of vasopressin (20 IU) and methylprednisolone (40 mg), or corresponding placebo, was administered after the first dose of epinephrine. Additional doses of vasopressin or corresponding placebo were administered after each additional dose of epinephrine for a maximum of 4 doses.

Main Outcomes and Measures  The primary outcome was return of spontaneous circulation. Secondary outcomes included survival and favorable neurologic outcome at 30 days (Cerebral Performance Category score of 1 or 2).

Results  Among 512 patients who were randomized, 501 met all inclusion and no exclusion criteria and were included in the analysis (mean [SD] age, 71 [13] years; 322 men [64%]). One hundred of 237 patients (42%) in the vasopressin and methylprednisolone group and 86 of 264 patients (33%) in the placebo group achieved return of spontaneous circulation (risk ratio, 1.30 [95% CI, 1.03-1.63]; risk difference, 9.6% [95% CI, 1.1%-18.0%]; P=.03). At 30 days, 23 patients (9.7%) in the intervention group and 31 patients (12%) in the placebo group were alive (risk ratio, 0.83 [95% CI, 0.50-1.37]; risk difference: 2.0% [95% CI, 7.5% to 3.5%]; P=.48). A favorable neurologic outcome was observed in 18 patients (7.6%) in the intervention group and 20 patients (7.6%) in the placebo group at 30 days (risk ratio, 1.00 [95% CI, 0.55-1.83]; risk difference, 0.0% [95% CI, 4.7% to 4.9%]; P>.99). In patients with return of spontaneous circulation, hyperglycemia occurred in 77 (77%) in the intervention group and 63 (73%) in the placebo group. Hypernatremia occurred in 28 (28%) and 27 (31%), in the intervention and placebo groups, respectively.

Conclusions and Relevance  Among patients with in-hospital cardiac arrest, administration of vasopressin and methylprednisolone, compared with placebo, significantly increased the likelihood of return of spontaneous circulation. However, there is uncertainty whether this treatment results in benefit or harm for long-term survival.

DOI: 10.1001/jama.2021.16628

Source: https://jamanetwork.com/journals/jama/fullarticle/2784625