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造血干细胞移植受者预防性血小板输注与出血发生率的前瞻性随机试验:触发阈值为10,000/L与20,000/微升的比较

A prospective randomized trial of prophylactic platelet transfusion and bleeding incidence in hematopoietic stem cell transplant recipients: 10,000/L versus 20,000/microL trigger.

作者信息

Zumberg Marc S, del Rosario Maria Luz U, Nejame Christine F, Pollock Brad H, Garzarella Linda, Kao K J, Lottenberg Richard, Wingard John R

机构信息

University of Florida College of Medicine, Department of Medicine, Gainesville 32610, USA.

出版信息

Biol Blood Marrow Transplant. 2002;8(10):569-76. doi: 10.1053/bbmt.2002.v8.pm12434952.

Abstract

An optimal platelet-count threshold for prophylactic platelet transfusion in hematopoietic stem cell transplant (HSCT) recipients has yet to be determined. Between July 1997 and December 1999, we performed the first prospective randomized clinical trial addressing this issue in 159 HSCT recipients who received a prophylactic platelet transfusion when the morning platelet count fell below a 10,000/microL (10K) or 20,000/microL (20K) threshold. Subsequent prophylactic transfusions were administered according to a predetermined algorithm. The number of prophylactic and therapeutic transfusions and the incidence of minor and major bleeding were compared between the 2 groups. The groups were matched according to patient and transplantation characteristics. There were no significant differences in bleeding incidence or severity. Fourteen percent of patients in the 10K arm compared to 17% in the 20K arm had major bleeding events. Only 3 central nervous system bleeds occurred, 2 in the 10K group and 1 in the 20K group. No deaths were attributed to bleeding. An average of 11.4 days of bleeding occurred in both groups. An average of 10.4 platelet transfusions per patient were administered in the 10K group compared to 10.2 in the 20K group (P = .94). More transfusions were given above the assigned transfusion threshold in the 10K group than in the 20K group (4.3/patient versus 1.9/patient, respectively, P = .05). Safety measures incorporated into our study may have precluded demonstration of significant differences in platelet use between the groups. In conclusion, a platelet transfusion trigger of 10K was found to be safe; however, a decrease in platelet use was not achieved because of safety measures incorporated into our study design.

摘要

造血干细胞移植(HSCT)受者预防性血小板输注的最佳血小板计数阈值尚未确定。1997年7月至1999年12月,我们进行了第一项前瞻性随机临床试验,在159名HSCT受者中研究了这一问题,这些受者在早晨血小板计数低于10000/微升(10K)或20000/微升(20K)阈值时接受预防性血小板输注。随后的预防性输血按照预定算法进行。比较了两组的预防性和治疗性输血量以及轻微和严重出血的发生率。两组根据患者和移植特征进行匹配。出血发生率或严重程度没有显著差异。10K组14%的患者与20K组17%的患者发生了严重出血事件。仅发生了3例中枢神经系统出血,10K组2例,20K组1例。没有死亡归因于出血。两组平均出血天数均为11.4天。10K组患者平均接受10.4次血小板输注,20K组为10.2次(P = .94)。10K组高于指定输血阈值的输血量比20K组多(分别为4.3次/患者对1.9次/患者,P = .05)。我们研究中纳入的安全措施可能排除了两组之间血小板使用存在显著差异的证据。总之,发现10K的血小板输血触发值是安全的;然而,由于我们研究设计中纳入的安全措施,并未实现血小板使用量的减少。

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