冻干血浆治疗严重创伤 - 系统评价和荟萃分析。
Freeze-dried plasma for major trauma - Systematic review and meta-analysis.
机构信息
From the Department of Emergency Medicine (G.M., R.H.), The Ottawa Hospital, University of Ottawa, Ottawa, Canada; Department of Critical Care (M.W.K.), Liverpool Hospital, Sydney, Australia; Department of Surgery (D.P., H.T., A.N., L.T.d.L.), Sunnybrook Health Sciences Centre, University of Toronto; Toronto Research Centre (H.P.), Defence Research and Development Canada; Department of Laboratory Medicine and Molecular Diagnostics (J.C.), Sunnybrook Health Sciences Centre; Department of Laboratory Medicine and Pathobiology (J.C.), Department of Anesthesia and Pain Medicine (K.K.), University of Toronto, and Department of Surgery (A.B.), Saint Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
出版信息
J Trauma Acute Care Surg. 2021 Mar 1;90(3):589-602. doi: 10.1097/TA.0000000000003012.
BACKGROUND
Treatment of acute trauma coagulopathy has shifted toward rapid replacement of coagulation factors with frozen plasma (FP). There are logistic difficulties in providing FP. Freeze-dried plasma (FDP) may have logistical advantages including easier storage and rapid preparation time. This review assesses the feasibility, efficacy, and safety of FDP in trauma.
STUDY DESIGN AND METHODS
Studies were searched from Medline, Embase, Cochrane Controlled Trials Register, ClinicalTrials.gov, and Google Scholar. Observational and randomized controlled trials (RCTs) assessing FDP use in trauma were included. Trauma animal models addressing FDP use were also included. Bias was assessed using validated tools. Primary outcome was efficacy, and secondary outcomes were feasibility and safety. Meta-analyses were conducted using random-effect models. Evidence was graded using Grading of Recommendations Assessment, Development, and Evaluation profile.
RESULTS
Twelve human studies (RCT, 1; observational, 11) and 15 animal studies were included. Overall, studies demonstrated moderate risk of bias. Data from two studies (n = 119) were combined for meta-analyses for mortality and transfusion of allogeneic blood products (ABPs). For both outcomes, no difference was identified. For mortality, pooled odds ratio was 0.66 (95% confidence interval, 0.29-1.49), with I2 = 0%. Use of FDP is feasible, and no adverse events were reported. Animal data suggest similar results for coagulation and anti-inflammatory profiles for FP and FDP.
CONCLUSION
Human data assessing FDP use in trauma report no difference in mortality and transfusion of ABPs in patients receiving FDP compared with FP. Data from animal trauma studies report no difference in coagulation factor and anti-inflammatory profiles between FP and FDP. Results should be interpreted with caution because most studies were observational and have heterogeneous population (military and civilian trauma) and a moderate risk of bias. Well-designed prospective observational studies or, preferentially, RCTs are warranted to answer FDP's effect on laboratory (coagulation factor levels), transfusion (number of ABPs), and clinical outcomes (organ dysfunction, length of stay, and mortality).
LEVEL OF EVIDENCE
Systematic review and meta-analysis, level IV.
背景
急性创伤性凝血病的治疗已经转向快速输注冷冻血浆（FP）来补充凝血因子。然而，提供 FP 存在物流方面的困难。冻干血浆（FDP）可能具有物流方面的优势，包括更便于储存和更快的准备时间。本综述评估了 FDP 在创伤中的可行性、疗效和安全性。
研究设计和方法
从 Medline、Embase、Cochrane 对照试验登记处、ClinicalTrials.gov 和 Google Scholar 中检索研究。纳入评估 FDP 在创伤中应用的观察性研究和随机对照试验（RCT）。还纳入了涉及 FDP 使用的创伤动物模型的研究。使用经过验证的工具评估偏倚。主要结局为疗效，次要结局为可行性和安全性。使用随机效应模型进行荟萃分析。使用推荐评估、制定与评价（GRADE）方法对证据进行分级。
结果
纳入了 12 项人体研究（RCT 1 项，观察性研究 11 项）和 15 项动物研究。总体而言，研究存在中度偏倚风险。两项研究（n=119）的数据进行了荟萃分析，以评估死亡率和同种异体血液制品（ABPs）的输注。对于这两个结局，均未发现差异。对于死亡率，合并的优势比为 0.66（95%置信区间，0.29-1.49），I²=0%。FDP 的使用是可行的，且未报告不良事件。动物数据表明 FP 和 FDP 在凝血和抗炎谱方面的结果相似。
结论
评估 FDP 在创伤中应用的人体数据显示，与 FP 相比，接受 FDP 的患者在死亡率和 ABPs 的输注方面没有差异。动物创伤研究的数据表明，FP 和 FDP 之间的凝血因子和抗炎谱没有差异。由于大多数研究为观察性研究且存在人群异质性（军事和民用创伤）和中度偏倚风险，因此结果应谨慎解释。需要设计良好的前瞻性观察性研究或优先进行 RCT，以回答 FDP 对实验室（凝血因子水平）、输血（ABPs 的数量）和临床结局（器官功能障碍、住院时间和死亡率）的影响。
证据等级
系统评价和荟萃分析，IV 级。
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