前列环素在创伤性失血性休克患者中的应用：一项随机临床试验。
Prostacyclin in trauma patients with hemorrhagic shock: A randomized clinical trial.
作者信息
Johansson Pär I, Fenger Eriksen Christian, Bovbjerg Pernille E, Gaarder Christine, Pall Marlene, Henriksen Hanne Hee, Pedersen Kristine H, Vigstedt Martin, Lange Theis, Næss Pål Aksel, Strømgaard Andersen Mikkel, Kirkegaard Hans, Stensballe Jakob
机构信息
From the CAG Center for Endotheliomics (P.I.J.), Copenhagen University Hospital-Rigshospitalet; Department of Clinical Medicine (P.I.J.), University of Copenhagen, Copenhagen; Department of Anesthesiology (C.F.E., M.S.A.), Aarhus University Hospital, Aarhus; Department of Orthopedic Surgery (P.E.B.), Odense University Hospital, Odense, Denmark; Department of Traumatology (C.G., P.A.N.), Oslo University Hospital; Institute of Clinical Medicine (C.G., P.A.N.), University of Oslo, Oslo, Norway; Department of Anesthesiology (M.P.) and Intensive Care V (M.P.), Odense University Hospital, Odense; CAG Center for Endotheliomics (H.H.H., K.H.P., M.V.), Copenhagen University Hospital-Rigshospitalet; Section of Biostatistics (T.L.), University of Copenhagen, Copenhagen; Research Center for Emergency Medicine (H.K.), Aarhus University Hospital; Aarhus University (H.K.), Aarhus; and CAG Center for Endotheliomics (J.S.), and Department of Anesthesiology (J.S.), Department of Anesthesiology, Centre of Head and Orthopedics (J.S.), Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
出版信息
J Trauma Acute Care Surg. 2024 Mar 1;96(3):476-481. doi: 10.1097/TA.0000000000004150. Epub 2023 Nov 14.
BACKGROUND
A main cause of trauma morbidity and mortality is multiple-organ failure, and endotheliopathy has been implicated. Pilot studies indicate that low-dose prostacyclin improves endothelial functionality in critically ill patients, suggesting that this intervention may improve trauma patient outcome.
METHODS
We conducted a multicenter, randomized, blinded, clinical investigator-initiated trial in 229 trauma patients with hemorrhagic shock who were randomized 1:1 to 72 hours infusion of the prostacyclin analog iloprost (1 ng/kg/min) or placebo. The primary outcome was the number of intensive care unit (ICU)-free days alive within 28 days of admission. Secondary outcomes included 28-day all-cause mortality and hospital length of stay.
RESULTS
The mean number of ICU-free days alive within 28 days was 15.64 days in the iloprost group versus 13.99 days in the placebo group (adjusted mean difference, -1.63 days [95% confidence interval (CI), -4.64 to 1.38 days]; p = 0.28). The 28-day mortality was 18.8% in the iloprost group versus 19.6% in the placebo group (odds ratio, 1.01 [95% CI, 0.51-2.0]; p = 0.97). The mean hospital length of stay was 19.96 days in the iloprost group versus 27.32 days in the placebo group (adjusted mean difference, 7.84 days [95% CI, 1.66-14.02 days], p = 0.01).
CONCLUSION
Iloprost did not result in a statistically significant increase in the number of ICU-free days alive within 28 days of admission, whereas it was safe and a statistically significant reduction in hospital length of stay was observed. Further research on prostacyclin in shocked trauma patients is warranted.
LEVEL OF EVIDENCE
Therapeutic/Care Management; Level II.
背景
创伤发病和死亡的一个主要原因是多器官功能衰竭，内皮病变与之相关。初步研究表明，小剂量前列环素可改善危重症患者的内皮功能，提示该干预措施可能改善创伤患者的预后。
方法
我们在229例失血性休克创伤患者中开展了一项多中心、随机、双盲、临床研究者发起的试验，这些患者按1:1随机分为两组，分别接受72小时的前列环素类似物伊洛前列素（1 ng/kg/分钟）输注或安慰剂输注。主要结局是入院28天内无重症监护病房（ICU）天数的存活天数。次要结局包括28天全因死亡率和住院时间。
结果
伊洛前列素组入院28天内无ICU天数的平均存活天数为15.64天，而安慰剂组为13.99天（调整后平均差值为-1.63天[95%置信区间（CI），-4.64至1.38天]；p = 0.28）。伊洛前列素组28天死亡率为18.8%，安慰剂组为19.6%（比值比为1.01[95%CI，0.51 - 2.0]；p = 0.97）。伊洛前列素组的平均住院时间为19.96天，而安慰剂组为27.32天（调整后平均差值为7.84天[95%CI，1.66 - 14.02天]，p = 0.01）。
结论
伊洛前列素在入院28天内无ICU天数的存活天数方面未导致统计学上的显著增加，然而它是安全的，并且观察到住院时间有统计学上的显著缩短。有必要对休克创伤患者使用前列环素进行进一步研究。
证据水平
治疗/护理管理；二级。
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