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去白细胞血小板制品治疗有效性和安全性的荟萃分析:随机对照试验研究结果。

Therapeutic efficacy and safety of pathogen-reduced platelet components: Results of a meta-analysis of randomized controlled trials.

机构信息

Apheresis & Cellular Therapy Unit, Department of Hemotherapy and Hemostasis, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic, University of Barcelona, Barcelona, Spain.

出版信息

Vox Sang. 2024 Mar;119(3):203-211. doi: 10.1111/vox.13573. Epub 2024 Jan 5.

Abstract

BACKGROUND AND OBJECTIVES

Clinical efficacy and safety of pathogen-reduced platelet concentrates (PR-PCs) concerning bleeding prevention are still debated despite conclusive real-world data from multiple countries where PR-PCs are transfused routinely. We performed a meta-analysis of randomized controlled trials (RCTs) comparing the clinical efficacy and safety of conventional platelet components (PCs) and PR-PCs prepared with the amotosalen/ultraviolet A light (INTERCEPT platelet concentrate [I-PC]) or riboflavin/ultraviolet light (Mirasol platelet concentrate [M-PC]) technologies, transfused in thrombocytopenic adult patients.

MATERIALS AND METHODS

A literature search was conducted, and 10 RCTs met the criteria for inclusion in this meta-analysis. Summary odds ratios (ORs) of clinically significant bleeding (World Health Organization [WHO] bleeding grade ≥2), severe bleeding (WHO bleeding score ≥3) and all-cause mortality were calculated.

RESULTS

The use of I-PC was not associated with an increase in the OR of clinically significant bleeding when compared to non-treated PCs (OR, 1.12; 95% CI: 0.89-1.41; p = 0.33), whereas transfusions with M-PC showed an increase in clinically significant bleeding (OR, 1.34; 95% CI: 1.03-1.75; p = 0.03). The OR of severe bleeding did not increase with either I-PC or M-PC (OR 0.88; 95% CI: 0.59-1.31; p = 0.52 for I-PC; OR 1.25; 95% CI: 0.66-2.37; p = 0.49 for M-PC). In the case of all-cause mortality, compared to non-treated PC, I-PC showed an OR of 0.61 (95% CI: 0.36-1.04; p = 0.07), and M-PC showed an OR of 3.04 (95% CI: 0.81-11.47; p = 0.1).

CONCLUSION

No differences were observed concerning the clinical efficacy and safety of overall PR-PCs when compared to non-treated PCs. However, differences are evident when analysing platelets prepared with the two PR technologies independently.

摘要

背景和目的

尽管多个国家的真实世界数据已经证实了病原体减少的血小板浓缩物(PR-PCs)在预防出血方面的临床疗效和安全性,但有关常规血小板成分(PCs)与采用亚甲蓝光化学法(amotosalen/ultraviolet A light,INTERCEPT 血小板浓缩物 [I-PC])或核黄素/紫外线光(riboflavin/ultraviolet light,Mirasol 血小板浓缩物 [M-PC])技术制备的 PR-PCs 的临床疗效和安全性的比较,仍存在争议,这些 PR-PCs 已在血小板减少的成年患者中常规输注。我们对比较血小板减少的成年患者输注常规血小板成分和采用亚甲蓝光化学法(amotosalen/ultraviolet A light,INTERCEPT 血小板浓缩物 [I-PC])或核黄素/紫外线光(riboflavin/ultraviolet light,Mirasol 血小板浓缩物 [M-PC])技术制备的 PR-PCs 的随机对照试验(RCT)进行了荟萃分析。

材料和方法

进行了文献检索,符合纳入本荟萃分析标准的 10 项 RCT 被纳入分析。计算了临床上显著出血(世界卫生组织 [WHO] 出血等级≥2)、严重出血(WHO 出血评分≥3)和全因死亡率的汇总优势比(OR)。

结果

与未处理的 PCs 相比,I-PC 的使用与临床上显著出血的 OR 增加无关(OR,1.12;95%CI:0.89-1.41;p=0.33),而 M-PC 的输注与临床上显著出血的 OR 增加相关(OR,1.34;95%CI:1.03-1.75;p=0.03)。I-PC 或 M-PC 的严重出血 OR 均无增加(OR 0.88;95%CI:0.59-1.31;p=0.52 用于 I-PC;OR 1.25;95%CI:0.66-2.37;p=0.49 用于 M-PC)。在全因死亡率方面,与未处理的 PC 相比,I-PC 的 OR 为 0.61(95%CI:0.36-1.04;p=0.07),而 M-PC 的 OR 为 3.04(95%CI:0.81-11.47;p=0.1)。

结论

与未处理的 PCs 相比,总体 PR-PCs 的临床疗效和安全性无差异。然而,当独立分析两种 PR 技术制备的血小板时,差异明显。

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