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红细胞浓缩液制备方法对地中海贫血患者输血指标的影响:一项随机交叉临床试验。

Impact of the preparation method of red cell concentrates on transfusion indices in thalassemia patients: A randomized crossover clinical trial.

机构信息

Day Hospital Thalassemia and Hemoglobinopathies, Azienda Ospedaliera Universitaria, Ferrara, Italy.

Blood Transfusion Service, Area Metropolitana, Bologna, Italy.

出版信息

Transfusion. 2021 Jun;61(6):1729-1739. doi: 10.1111/trf.16432. Epub 2021 May 4.

DOI:10.1111/trf.16432
PMID:33948969
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8252500/
Abstract

BACKGROUND

The average hemoglobin content of red cell concentrates (RCC) varies depending on the method of preparation. Surprisingly less data are available concerning the clinical impact of those differences.

STUDY DESIGN AND METHODS

The effects of two types of RCC (RCC-A, RCC-B) on transfusion regime were compared in a non-blinded, prospective, randomized, two-period, and crossover clinical trial. RCC-A was obtained by whole blood leukoreduction and subsequent plasma removal, RCC-B removing plasma and buffy coat first, followed by leukoreduction. Eligible patients were adult, with transfusion-dependent thalassemia (TDT).

RESULTS

RCC-A contained 63.9 (60.3-67.8) grams of hemoglobin per unit (median with 1 and 3 quartile), RCC-B 54.5 (51.0-58.2) g/unit. Fifty-one patients completed the study. With RCC-B, the average pre-transfusion hemoglobin concentration was 9.3 ± 0.5 g/dl (mean ± SD), the average transfusion interval 14.2 (13.7-16.3) days, the number of RCC units transfused per year 39.3 (35.4-47.3), and the transfusion power index (a composite index) 258 ± 49. With RCC-A, the average pre-transfusion hemoglobin concentration was 9.6 ± 0.5 g/dl (+2.7%, effect size 0.792), the average transfusion interval 14.8 (14.0-18.5) days (+4.1%, effect size 0.800), the number of RCC units transfused per year 34.8 (32.1-42.5) (-11.4%, effect size -1.609), and the transfusion power index 272 ± 61 (+14.1%, effect size 0.997). All differences were statistically highly significant (p < .00001). The frequency of transfusion reactions was 0.59% with RCC-A and 0.56% with RCC-B (p = 1.000).

CONCLUSION

To reduce the number of RCC units consumed per year and the number of transfusion episodes, TDT patients should receive RCC with the highest average hemoglobin content.

摘要

背景

红细胞浓缩物(RCC)的平均血红蛋白含量因制备方法而异。令人惊讶的是,关于这些差异的临床影响的数据较少。

研究设计和方法

在一项非盲、前瞻性、随机、两期和交叉临床试验中,比较了两种 RCC(RCC-A、RCC-B)对输血方案的影响。RCC-A 通过全血白细胞减少和随后的血浆去除获得,RCC-B 首先去除血浆和血小板层,然后进行白细胞减少。合格的患者为成人,依赖输血的地中海贫血(TDT)。

结果

RCC-A 每单位含有 63.9(60.3-67.8)克血红蛋白(中位数,1 分位和 3 分位),RCC-B 每单位含有 54.5(51.0-58.2)克血红蛋白。51 名患者完成了这项研究。使用 RCC-B,平均输血前血红蛋白浓度为 9.3±0.5g/dl(平均值±标准差),平均输血间隔为 14.2(13.7-16.3)天,每年输注的 RCC 单位数为 39.3(35.4-47.3),输血功率指数(综合指数)为 258±49。使用 RCC-A,平均输血前血红蛋白浓度为 9.6±0.5g/dl(增加 2.7%,效应大小 0.792),平均输血间隔为 14.8(14.0-18.5)天(增加 4.1%,效应大小 0.800),每年输注的 RCC 单位数为 34.8(32.1-42.5)(减少 11.4%,效应大小-1.609),输血功率指数为 272±61(增加 14.1%,效应大小 0.997)。所有差异均具有统计学显著性(p<.00001)。RCC-A 的输血反应发生率为 0.59%,RCC-B 的输血反应发生率为 0.56%(p=1.000)。

结论

为了减少每年 RCC 单位的消耗数量和输血次数,TDT 患者应接受平均血红蛋白含量最高的 RCC。

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