背景
The 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.
血液惡性腫瘤病患是否需要預防性輸注血小板目前仍是未知的問題, 本研究目的在於瞭解預防性血小板輸注的功效以及安全性, 以瞭解是否預防性血小板輸注的可行性
方法
We 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 10×109 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.
在英國以及澳洲 . 使用前瞻性隨機分組, 兩組在血小板小於10×109 per liter時, 採用預防性輸血小板以及不預防輸的方式, 瞭解其之後30天內出血的機率
結果
A 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.
共有600人參與本試驗(301人為不預防輸注血小板組, 299人為預防輸注血小板組), 在不預防組裡30天內發生了約50%的出血事件, 而預防組只有43%, P值為0.06, 在統計學上並沒有意義 (在non-inferiorty的設計, 即表示不預防組的發生出血機率較高), 但出血的時間以及嚴重性, 不預防組則明顯有統計學上的差異, 有較高的出血風險
結論
The 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,
本研究支持對於血液惡性腫瘤患者, 在血小板小於10×109 per liter (10k/cumm)時,使用預防性地血小板輸注是有臨床益處的, 然而還是有許多病患雖然接受預防性血小板輸注, 仍會發生出血
Reference (TOPPS Trial)
A no-prophylaxis platelet-transfusion strategy for hematologic cancers.
N Engl J Med. 2013 May 9;368(19):1771-80. doi: 10.1056/NEJMoa1212772.
沒有留言:
張貼留言