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  

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

作　　者：孙杨[1] 牛佳萌 邢莉莉 马婷[1] 杜工亮[2] 李学文[3] 王亚琴[4] 王李秦 陈萍[1] 王文华[1] 杨颖群 宋奥微 谢昕昕[1] 宋耀军[1] 王妙妮 常婧妍 田芬芳 杨江存[1] SUN Yang;NIU Jiameng;XING Lili;MA Ting;DU Gongliang;LI Xuewen;WANG Yaqin;WANG Liqin;CHEN Ping;WANG Wenhua;YANG Yingqun;SONG Aowei;XIE Xinxin;SONG Yaojun;WANG Miaoni;CHANG Jingyan;TIAN Fenfang;YANG Jiangcun(Department of Transfusion Medicine,Shaanxi People's Hospital,Xi'an,710068;Department of Emergency Surgery,Shaanxi People's Hospital,Xi'an,710068;Department of Cardiac Surgery,Shaanxi People's Hospital,Xi'an,710068;Department of Obstetrics,Shaanxi People's Hospital,Xi'an,710068)

机构地区：[1]陕西省人民医院输血科,陕西西安710068 [2]陕西省人民医院急诊科,陕西西安710068 [3]陕西省人民医院心脏外科,陕西西安710068 [4]陕西省人民医院产科,陕西西安710068

出　　处：《临床输血与检验》2025年第2期145-155,共11页Journal of Clinical Transfusion and Laboratory Medicine

基　　金：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。

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:58×10^(9)/L vs 79×10^(9)/L,54×10^(9)/L vs 77×10^(9)/L,63×10^(9)/L vs 75×10^(9)/L,66×10^(9)/L vs 79×10^(9)/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P_(drainage)=0.933,P_(PLT计数)=0.473,P_(TEG-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。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:58×10^(9)/L vs 79×10^(9)/L,54×10^(9)/L vs 77×10^(9)/L,63×10^(9)/L vs 75×10^(9)/L,66×10^(9)/L vs 79×10^(9)/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(P_(Drainage)=0.933,P_(PLTcounts)=0.473,P_(TEG-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.

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 

分 类 号：R331.143[医药卫生—人体生理学] R457.1[医药卫生—基础医学]