A No-Prophylaxis Platelet-Transfusion Strategy for Hematologic Cancers
A No-Prophylaxis Platelet-Transfusion Strategy for Hematologic Cancers
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DOI：
10.1056/nejmoa1212772
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发表时间：
2013-05-09
影响因子：
158.5
通讯作者：
Murphy, Michael F.
中科院分区：
文献类型：
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作者：
Stanworth, Simon J.;Estcourt, Lise J.;Murphy, Michael F.
血小板输注预防血液系统癌症患者出血的有效性尚不清楚。这项试验评估是否不给予预防性血小板输注的政策是有效和安全的政策提供prophylaxis.METHODSWe进行了随机，开放标签，非劣效性试验在14个中心在英国和澳大利亚。当早晨血小板计数低于10 × 10（9）/L时，患者被随机分配接受或不接受预防性血小板输注。符合条件的患者为年龄≥ 16岁、正在接受化疗或干细胞移植、患有或预期患有血小板减少症的患者。主要终点为随机分组后30天内世界卫生组织（WHO）2级、3级或4级出血。2006年至2011年期间，共有600例患者（301例为非预防组，299例为预防组）接受了随机分组。未预防组300例患者中有151例（50%）发生WHO 2、3或4级出血，而预防组298例患者中有128例（43%）发生（比例校正差异为8.4个百分点; 90%置信区间为1.7 - 15.2;非劣效性P = 0.06）。与预防组相比，无预防组患者出血天数更多，首次出血时间更短。无预防组的血小板使用显著减少。一个预先指定的亚组分析确定了类似的出血率在两个研究组之间的患者接受自体干细胞transplantation.CONCLUSIONSThe的结果，我们的研究支持需要继续使用的预防与血小板输注，并显示这种预防减少出血的好处，相比，没有预防。大量患者尽管进行了预防性治疗仍发生出血。（由国家卫生服务血液和移植研究与发展委员会和澳大利亚红十字会血液服务资助; TOPPS对照试验。com number，ISRCTN08758735.）
BACKGROUNDThe effectiveness of platelet transfusions to prevent bleeding in patients with hematologic cancers remains unclear. This trial assessed whether a policy of not giving prophylactic platelet transfusions was as effective and safe as a policy of providing prophylaxis.METHODSWe conducted this randomized, open-label, noninferiority trial at 14 centers in the United Kingdom and Australia. Patients were randomly assigned to receive, or not to receive, prophylactic platelet transfusions when morning platelet counts were less than 10x10(9) per liter. Eligible patients were persons 16 years of age or older who were receiving chemotherapy or undergoing stem-cell transplantation and who had or were expected to have thrombocytopenia. The primary end point was bleeding of World Health Organization (WHO) grade 2, 3, or 4 up to 30 days after randomization.RESULTSA total of 600 patients (301 in the no-prophylaxis group and 299 in the prophylaxis group) underwent randomization between 2006 and 2011. Bleeding of WHO grade 2, 3, or 4 occurred in 151 of 300 patients (50%) in the no-prophylaxis group, as compared with 128 of 298 (43%) in the prophylaxis group (adjusted difference in proportions, 8.4 percentage points; 90% confidence interval, 1.7 to 15.2; P = 0.06 for noninferiority). Patients in the no-prophylaxis group had more days with bleeding and a shorter time to the first bleeding episode than did patients in the prophylaxis group. Platelet use was markedly reduced in the no-prophylaxis group. A prespecified subgroup analysis identified similar rates of bleeding in the two study groups among patients undergoing autologous stem-cell transplantation.CONCLUSIONSThe results of our study support the need for the continued use of prophylaxis with platelet transfusion and show the benefit of such prophylaxis for reducing bleeding, as compared with no prophylaxis. A significant number of patients had bleeding despite prophylaxis. (Funded by the National Health Service Blood and Transplant Research and Development Committee and the Australian Red Cross Blood Service; TOPPS Controlled-Trials. com number, ISRCTN08758735.)