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[JAMA Surg在线发表]:补充小剂量精氨酸血管加压素能够减少合并失血性休克创伤患者对血制品的需求
2019年11月11日 时讯速递, 进展交流 暂无评论

Original Investigation August 28, 2019

Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients With Trauma and Hemorrhagic Shock: A Randomized Clinical Trial

Carrie A. Sims, Daniel Holena, Patrick Kim, et al

JAMA Surg. Published online August 28, 2019. doi:10.1001/jamasurg.2019.2884

Importance 背景

Current therapies for traumatic blood loss focus on hemorrhage control and blood volume replacement. Severe hemorrhagic shock, however, is associated with a state of arginine vasopressin (AVP) deficiency, and supplementation of this hormone may decrease the need for blood products in resuscitation.

目前,创伤性失血的治疗关注于出血控制及血容量的补充。然而,严重失血性休克伴随精氨酸血管加压素(AVP)缺乏,补充这一激素可能减少复苏时血制品的需求。

Objective 目的

To determine whether low-dose supplementation of AVP in patients with trauma (hereinafter referred to as trauma patients) and with hemorrhagic shock decreases their need for transfused blood products during resuscitation.

确定伴失血性休克的创伤患者补充小剂量AVP能否减少复苏期间血制品输注的需求。

Design, Setting, and Participants 试验设计,场景和研究对象

This randomized, double-blind placebo-controlled clinical trial included adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017. Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment. Data were analyzed from May 1, 2013, through May 31, 2017, using intention to treat and per protocol.

这项随机双盲对照试验于2013年5月1日至2017年5月31日在一个城市一级创伤中心进行,纳入创伤后12小时内至少输注6个单位任何血液制品的成年患者(年龄18-65岁)。排除标准包括院前心肺复苏,急诊留置胸腔引流手术,使用皮质激素,慢性肾功能不全,冠心病,需要神经外科干预的颅脑创伤,妊娠,囚犯或入选前使用AVP。采用意向治疗及符合方案集方案进行数据分析。

Interventions 干预措施

After administration of an AVP bolus (4 U) or placebo, participants received AVP (≤0.04 U/min) or placebo for 48 hours to maintain a mean arterial blood pressure of at least 65 mm Hg.

推注AVP (4 U)或安慰剂后,患者接受AVP (≤0.04 U/min)或安慰剂输注48小时,以维持平均动脉压至少65 mmHg。

Main Outcomes 主要预后指标

The primary outcome was total volume of blood product transfused. Secondary end points included total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality.

主要预后指标为输注血液制品总量。次要预后终点包括输注晶体液总量,升压药物需求,次要并发症及30天病死率。

Results 结果

One hundred patients underwent randomization (49 to the AVP group and 51 to the placebo group). Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n = 93) with penetrating trauma (n = 79). Cohort characteristics before randomization were well balanced. At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22). Although the groups had similar rates of mortality (6 of 49 [12%] vs 6 of 51 [12%]; P = .94) and total complications (24 of 44 [55%] vs 30 of 47 [64%]; P = .37), the AVP group had less deep venous thrombosis (5 of 44 [11%] vs 16 of 47 [34%]; P = .02).

100名患者接受随机分组(49名患者分至AVP组,51名患者分至安慰剂组)。患者年纪较轻(中位年龄,27岁 [四分位区间 {IQR}, 22-25 岁]),男性 (n = 93) 和穿通伤 (n = 79) 为主。两组患者随机分组前特征均衡。至48小时,AVP组患者需要较少的血制品(中位数,1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01),但是晶体液(中位数,9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22)或升压药物(中位数,400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] 等量单位; P = .22)需求没有差异。尽管两组患者病死率(6/49 [12%] vs 6/51 [12%]; P = .94)及总并发症发生率(24/44 [55%] vs 30/47 [64%]; P = .37)没有差异,但AVP组DVT发生率较低(5/44 [11%] vs 16/47 [34%]; P = .02)。

Conclusions and Relevance 结论与意义

Low-dose AVP during the resuscitation of trauma patients in hemorrhagic shock decreases blood product requirements. Additional research is necessary to determine whether including AVP improves morbidity or mortality.

伴随失血性休克的创伤患者在复苏期间使用小剂量AVP能够减少血液制品需求。有必要进行进一步的研究,以确定使用AVP能否改善罹患率或病死率。

Trial Registration 试验注册

ClinicalTrials.gov identifier: NCT01611935

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