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罗米司亭作为心脏或肺移植后 20 例患者的输血节约策略:单中心前后试点研究。

Romiplostim as a transfusion saving strategy in 20 patients after heart or lung transplantation: a single centre before-after pilot study.

机构信息

Intensive Care Unit of Cardiothoracic Surgery, Anesthesia and Critical Care Department, Hôpital Nord Laennec, Nantes University Hospital, Nantes, France.

School of Medicine, UPRES EA 3826, Thérapeutiques Cliniques et Expérimentales des Infections, IRS2 Nantes Biotech, France.

出版信息

Perfusion. 2020 Mar;35(2):121-130. doi: 10.1177/0267659119864814. Epub 2019 Jul 30.

Abstract

BACKGROUND

Thrombocytopenia is a common disorder after heart or lung transplantation. Platelet transfusion is often required to maintain haemostasis but represents a specific cause of morbidity and mortality in this setting including alloimmunisation and graft rejection.

STUDY DESIGN AND METHODS

As part of a health-care quality improvement project, in a single-centre before-after pilot study, the relevance of a platelet transfusion saving strategy based on romiplostim administration after transplantation was assessed in patients with platelet count <100 × 10/L. Transfusions on days 28 and 90 were compared using propensity matched score for adjustment of demographic characteristics at baseline. The primary outcome was platelet transfusion until day 28 after transplantation.

RESULTS

Ninety-three patients were analysed (73 before vs. 20 after). The median [interquartile range] number of platelet concentrate was 1 [0;4.0] before versus 0.5 [0;2.0] in the after period, mean difference 0.5 confidence interval 95% [-0.7 to 1.7], p  0.39. On day 28, median [interquartile range] red blood cell transfusion was significantly higher in the before versus the after period, 7 [2.0;13.5] versus 6 [1.5;8.5], mean difference 3.2 CI 95% [0.4-6.0], p = 0.02. At 6 months, the rate of patients with de novo anti-human leukocyte antigen alloimmunisation was 45% before versus 53% in the after period (p = 0.56). Deep venous thrombosis was detected in nine patients (12%) before versus seven patients (35%) in the after period (p = 0.04).

CONCLUSION

Romiplostim did not significantly reduce platelet transfusion after heart or lung transplantation. Its relevance and safety in a global transfusion strategy remains to be studied in this setting in a large randomised study.

摘要

背景

血小板减少症是心脏或肺移植后的常见并发症。为了维持止血,通常需要进行血小板输注,但这在这种情况下会导致特定的发病率和死亡率,包括同种免疫和移植物排斥。

研究设计和方法

作为医疗保健质量改进项目的一部分,在单中心前后试点研究中,评估了在血小板计数<100×10/L 的患者中,基于罗米司亭给药的血小板输注节省策略的相关性。使用倾向评分匹配来调整基线时的人口统计学特征,比较第 28 天和第 90 天的输血。主要结局是移植后第 28 天前的血小板输注。

结果

分析了 93 例患者(前组 73 例,后组 20 例)。前组血小板浓缩物中位数[四分位距]为 1[0;4.0],后组为 0.5[0;2.0],平均差异 0.5 置信区间 95%[-0.7 至 1.7],p >0.39。在第 28 天,前组与后组的中位[四分位距]红细胞输注显著较高,分别为 7[2.0;13.5]和 6[1.5;8.5],平均差异 3.2 CI 95%[0.4-6.0],p=0.02。6 个月时,新出现抗人类白细胞抗原同种免疫的患者在前组和后组中的比例分别为 45%和 53%(p=0.56)。前组有 9 例(12%)患者检测到深静脉血栓形成,后组有 7 例(35%)患者检测到深静脉血栓形成(p=0.04)。

结论

罗米司亭并未显著减少心脏或肺移植后的血小板输注。在这种情况下,在全球输血策略中,其相关性和安全性仍需要在一项大型随机研究中进行研究。

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