• 中国科学论文统计源期刊
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临床输血与检验

临床输血与检验 ›› 2025, Vol. 27 ›› Issue (2): 145-155.DOI: 10.3969/j.issn.1671-2587.2025.02.001

• 临床输血 •    下一篇

4 ℃冷藏保存血小板在外科出血患者的临床疗效观察：一项随机对照可行性研究*

孙杨1, 牛佳萌1, 邢莉莉1, 马婷1, 杜工亮2, 李学文3, 王亚琴4, 王李秦1, 陈萍1, 王文华1, 杨颖群1, 宋奥微1, 谢昕昕1, 宋耀军1, 王妙妮1, 常婧妍1, 田芬芳1, 杨江存1   

  1. 1陕西省人民医院输血科;
    2陕西省人民医院急诊科;
    3陕西省人民医院心脏外科;
    4陕西省人民医院产科,陕西西安 710068
  • 收稿日期:2024-12-07 出版日期:2025-04-20 发布日期:2025-04-17
  • 通讯作者: 杨江存,主要从事临床输血研究,（E-mail）yjc65@sina.com。
  • 作者简介:孙杨,主要从事临床输血与大数据精准输血研究,（E-mail）suny519@163.com。并列第一作者：牛佳萌,主要从事临床输血研究,（E-mail）njm2013512@163.com。并列第一作者：邢莉莉,主要从事临床输血研究,（E-mail）xinglili1996@126.com。
  • 基金资助:
    *本课题受陕西省科技厅科技成果转移与推广计划-获奖成果转化项目（No.2019CGHJ-09）,陕西省人民医院领军人才基金项目（No.2021LJ-14）资助

The Clinical Efficacy of 4 ℃ Stored Platelet: a Randomized Controlled Feasibility Trial Conducted in Surgical Patients with Hemorrhage

SUN Yang1, NIU Jiameng1, XING Lili1, MA Ting1, DU Gongliang2, LI Xuewen3, WANG Yaqin4, WANG Liqin1, CHEN Ping1, WANG Wenhua1, YANG Yingqun1, SONG Aowei1, XIE Xinxin1, SONG Yaojun1, WANG Miaoni1, CHANG Jingyan1, TIAN Fenfang1, YANG Jiangcun1   

  1. 1Department of Transfusion Medicine;
    2Department of Emergency Surgery;
    3Department of Cardiac Surgery;
    4Department of Obstetrics, Shaanxi People's Hospital, Xi'an, 710068
  • Received:2024-12-07 Online:2025-04-20 Published:2025-04-17

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摘要： 目的 观察冷藏保存血小板（cold stored platelets, CSP）在外科出血患者的治疗效果及不良反应。方法 一项前瞻性、双盲、随机临床试验对伴有外科出血患者进行研究,以评估CSP与室温保存血小板（room temperature platelets, RTP）的止血功能。主要结局是评价引流量、血小板计数和血栓弹力图-最大振幅（thromboelastography, maximum amplitude, TEG-MA)。次要结局包括住院时间、重症监护室（ICU）住院时间、医疗花费。结果 共有62例患者完成了最后的临床观察,CSP组和RTP组各31例。血小板输注以后1~12 h,13~24 h,25~48 h,49~72 h的引流量分别为：8.5 mL/h vs 20.83 mL/h,0.52 mL/h vs 5.0 mL/h,3.5 mL/h vs 5.0 mL/h,0.63 mL/h vs 4.1 mL/h。血小板计数：58×109/L vs 79×109/L,54×109/L vs 77×109/L,63×109/L vs 75×109/L,66×109/L vs 79×109/L。TEG-MA：50.1 mm vs 52.0 mm,50.1 mm vs 54.8 mm,53.0 mm vs 56.6,56.0 mm vs 53.2 mm。根据广义估计方程,两组在不同时间的Pdrainage=0.933,PPLT计数=0.473,PTEG-MA=0.246,差异无统计学意义（P>0.05）。住院时间、ICU住院时间、医疗费用、出院结局在CSP组与RTP组比较差异无统计学意义（P>0.05）。两组患者血小板输注不良事件发生率差异无统计学意义（P>0.05）。结论 CSP与RTP在外科大出血治疗中具有相同的治疗效果和安全性,本研究为临床应用CSP提供了可信的证据支持。

关键词: 血小板, 血小板储存, 冷藏血小板, 室温保存血小板, 出血

Abstract: Objective To observe the clinical efficacy and adverse reactions of CSP in patients with surgical hemorrhage. Methods A prospective, double-blind, randomized clinical trial was conducted on surgical patients with related bleeding to assess the hemostatic function of CSP compared with RTP. The primary outcomes measured were drainage volume, platelet counts, and Thrombelastography-maximum amplitude. Secondary outcomes included hospital stays, the intensive care unit stays and medical cost. Results A total of 62 patients were completed the final clinical observation. There were 31 cases in each of the CSP group and RTP group. Within 1~12 hours, 13~24 hours, 25~48 hours, and 49~72 hours after platelet transfusion, drainage volume: 8.5 mL/h vs 20.83 mL/h, 0.52 mL/h vs 5.0 mL/h, 3.5 mL/h vs 5.0 mL/h, 0.63 mL/h vs 4.1 mL/h. platelet counts: 58×109/L vs 79×109/L, 54×109/L vs 77×109/L, 63×109/L vs 75×109/L, 66×109/L vs 79×109/L. TEG-MA: 50.1 mm vs 52.0 mm, 50.1 mm vs 54.8 mm, 53.0 mm vs 56.6, 56.0 mm vs 53.2 mm. There were no overall differences between the two groups by Generalized Estimating Equations at different times (PDrainage=0.933, PPLTcounts=0.473, PTEG-MA=0.246). The secondary outcomes (hospital stays, ICU stays, medical cost, discharge outcome) were no differences between the CSP group and RTP group (P>0.05). There were no significant differences in adverse platelet transfusion events between the groups (P>0.05). Conclusion CSP and RTP have equivalent efficacy and safety in the treatment of surgical hemorrhage. This trial provides reliable evidence to support the clinical application of CSP.

Key words: Platelet, Platelet storage, Cold-stored platelets, Room temperature platelets, Hemorrhage

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