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[NEJM最新论文]:对具有出血性休克风险的创伤患者院前输注血浆
2018年08月07日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock

Jason L. Sperry, Francis X. Guyette, Joshua B. Brown, et al

N Engl J Med 2018; 379:315-326

DOI: 10.1056/NEJMoa1802345

Abstract

BACKGROUND 背景

After a person has been injured, prehospital administration of plasma in addition to the initiation of standard resuscitation procedures in the prehospital environment may reduce the risk of downstream complications from hemorrhage and shock. Data from large clinical trials are lacking to show either the efficacy or the risks associated with plasma transfusion in the prehospital setting.

对于受伤的伤员,在院前除标准复苏流程外,给予血浆可能降低出血及休克导致的并发症。尚缺乏大规模临床试验的数据证实院前输注血浆的疗效及风险。

METHODS 方法

To determine the efficacy and safety of prehospital administration of thawed plasma in injured patients who are at risk for hemorrhagic shock, we conducted a pragmatic, multicenter, cluster-randomized, phase 3 superiority trial that compared the administration of thawed plasma with standard-care resuscitation during air medical transport. The primary outcome was mortality at 30 days.

为明确院前给有出血性休克风险的伤员输注解冻血浆的疗效及安全性,我们进行了一项实效性、多中心、区组随机、3期优效性临床试验,对航空医疗转运过程中输注解冻血浆与标准复苏治疗进行比较。主要预后终点为30天病死率。

RESULTS 结果

A total of 501 patients were evaluated: 230 patients received plasma (plasma group) and 271 received standard-care resuscitation (standard-care group). Mortality at 30 days was significantly lower in the plasma group than in the standard-care group (23.2% vs. 33.0%; difference, −9.8 percentage points; 95% confidence interval, −18.6 to −1.0%; P=0.03). A similar treatment effect was observed across nine prespecified subgroups (heterogeneity chi-square test, 12.21; P=0.79). Kaplan–Meier curves showed an early separation of the two treatment groups that began 3 hours after randomization and persisted until 30 days after randomization (log-rank chi-square test, 5.70; P=0.02). The median prothrombin-time ratio was lower in the plasma group than in the standard-care group (1.2 [interquartile range, 1.1 to 1.4] vs. 1.3 [interquartile range, 1.1 to 1.6], P<0.001) after the patients’ arrival at the trauma center. No significant differences between the two groups were noted with respect to multiorgan failure, acute lung injury–acute respiratory distress syndrome, nosocomial infections, or allergic or transfusion-related reactions.

共有501名患者接受了评估:230名患者接受了血浆输注(血浆治疗组),271名患者接受标准复苏治疗(标准治疗组)。与标准治疗组相比,血浆治疗组患者30天病死率显著降低(23.2% vs. 33.0%;差异,−9.8%;95%可信区间;−18.6 to −1.0%;P=0.03)。对于9个预先设定的亚组均观察到相似的疗效(异质性chi方检验,12.21;P=0.79)。 Kaplan–Meier曲线显示,随机分组后3小时两条区间即已分开,且持续到随机分组后30天(log-rank chi方检验,5.70;P=0.02)。在患者抵达创伤中心后,血浆治疗组凝血酶原时间比值中位数低于标准治疗组(1.2 [四分位区间,1.1 to 1.4] vs. 1.3 [四分位区间,1.1 to 1.6],P<0.001)。两组患者多器官功能衰竭、急性肺损伤-急性呼吸窘迫综合征、医院获得性感染,以及过敏性或输血相关反应等无显著差异。

CONCLUSIONS 结论

In injured patients at risk for hemorrhagic shock, the prehospital administration of thawed plasma was safe and resulted in lower 30-day mortality and a lower median prothrombin-time ratio than standard-care resuscitation. (Funded by the U.S. Army Medical Research and Materiel Command; PAMPer ClinicalTrials.gov number, NCT01818427.)

对于有出血性休克风险的创伤患者,与标准复苏治疗相比,院前输注解冻血浆是安全的,且显著降低30天病死率及凝血酶原时间比值中位数。

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